September 2013

Expanding Access to Postabortion Care in through the Integration of

Misoprostol

FINAL REPORT

Zimbabwe Ministry of Health and Child Care Through the combined efforts of the government, organizations, communities and individuals, the Government of Zimbabwe aims to provide the highest possible level of health and quality of life for all its citizens, and to support their full participation in the socio-economic development of the country. This vision requires that every Zimbabwean have access to comprehensive and effective health services. The mission of the Zimbabwe Ministry of Health and Child Care (ZMoHCC) is to provide, administer, coordinate, promote and advocate for the provision of quality health services and care to Zimbabweans while maximizing the use of available resources.

Venture Strategies Innovations (VSI) VSI is a US-based nonprofit organization committed to improving women and girls' health in developing countries by creating access to effective and affordable technologies on a large scale. VSI connects women with life-saving medicines and services by engaging governments and partners to achieve regulatory approval of quality products and integrating them into national policies and practices.

Zimbabwe Ministry of Health and Child Care The Permanent Secretary Kaguvi Building, 4th Floor Central Avenue (Between 4th and 5th Street) , Zimbabwe Telephone: +263-4-798537-60 Website: http://www.mohcw.gov.zw

Venture Strategies Innovations 19200 Von Karman Avenue, Suite 400 Irvine, California 92612 USA Telephone: +1 949-622-5515 Website: www.vsinnovations.org

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Acknowledgements

Zimbabwe Ministry of Health and Child Care: Dr. Bernard Madzima, Director, Maternal and Child Health Ms. Margaret Nyandoro, Deputy Director, Director of Reproductive Health

Principal Investigators : Dr. Tsungai Chipato, Dr. Partson Zvandasara, University of Zimbabwe Dr. Velda Mushangwe, University of Zimbabwe

VSI program team: Ndola Prata, Medical Director Nuriye Nalan Sahin Hodoglugil, Associate Medical Director Katharine Rivett, Program Manager Engeline Mawere, Program Officer Molly Moran, Monitoring and Evaluation Specialist Alice Mpete, Nurse Administrator Allison Boiles, Communications Specialist

This project could not have been completed without the contributions of the expert staff and colleagues at the Zimbabwe Ministry of Health and Child Care (ZMoHCC) and Venture Strategies Innovations (VSI), whose dedication to this operations research and invaluable contributions to its development led to its successful implementation. The operations research program benefited from the participation of the district officials, who contributed to supportive supervision and monitoring of operations research activities. The operations research also benefitted from the participation of community leaders and other community members who led and participated in community awareness activities. Tarra McNally, former VSI Country Representative, initiated the preliminary work on this operations research, and oversaw the activities until August 2013 and Melody Liu provided data management support until August 2013. Debbie Koh provided programmatic support until January 2013. Most importantly, VSI would like to thank all of the women who consented to participate in this operations research.

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Executive Summary

The Zimbabwe Ministry of Health and Child Care (ZMoHCC) is committed to preventing maternal mortality and morbidity due to unsafe and miscarriage by ensuring access to high quality postabortion care (PAC). The estimated maternal mortality ratio (MMR) of 960 maternal deaths per 100,000 live births ranks Zimbabwe among the 40 countries globally with the highest MMR. Abortion-related complications are among the primary obstetric causes of in Zimbabwe.

Misoprostol and manual (MVA) are two treatment methods recommended by the World Health Organization (WHO) for the treatment of incomplete abortion and miscarriage (TIAM). Misoprostol is a safe, effective, heat-stable and inexpensive treatment method for incomplete abortion and miscarriage. Misoprostol has been shown to be as effective as MVA for TIAM and can be administered by primary care providers in facilities that lack capacity to provide MVA or other surgical methods.

In 2011, after successful advocacy by the ZMoHCC, misoprostol was added to the Essential Drugs List of Zimbabwe (EDLIZ). To advance the government objective of ensuring timely access to quality PAC services, the ZMoHCC and Venture Strategies Innovations (VSI), a US-based non-profit organization, conducted operations research (OR) to provide evidence on the feasibility and acceptability of introducing misoprostol in the PAC service package to be delivered at all levels of the health system, from hospitals to rural health centers.

The ZMoHCC’s and VSI’s joint OR was conducted in 68 health facilities in four . The OR sites included a) provincial hospitals b) district hospitals c) rural and mission hospitals and d) rural health centers. A training of trainers was conducted for 40 senior doctors and nurses, followed by cascade trainings for 135 primary care nurses (PCNs), nurses and midwives from all sites. Facility services from September 2011 to February 2012 were reviewed to provide a baseline facility assessment. Operations research (OR) was conducted from January 2013 to June 2013, during which misoprostol was available for women at these facilities. Also during this time, health providers and Village Health Workers (VHWs) disseminated key messages on the dangers of , the availability of misoprostol for TIAM and services at OR sites, and the importance of preventing unwanted .

According to the facility assessment, prior to the OR, there was limited availability of PAC services at the OR sites. In addition to the provincial hospital, only one of three district hospitals and six of thirteen rural and mission hospitals reported offering TIAM. Dilatation and curettage (D&C) was the TIAM treatment method available at the largest number of facilities (n=5) with only two facilities offering MVA.

Rural health centers (RHCs) and rural and mission hospitals readily introduced PAC services that included TIAM with misoprostol. At RHC’s, 89% of women who enrolled in the OR were treated with misoprostol. At rural and mission hospitals, 95% of those enrolled were treated with misoprostol. Primary care nurses, the highest level of trained staff at most RHCs, treated over 40% of the women who were administered misoprostol for TIAM. The number receiving misoprostol for PAC at RHCs increased fourfold in just four months.

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The introduction of misoprostol for PAC dramatically reduced the proportion of women at RHCs and rural and mission hospitals that had to be referred for treatment. Only 10% of enrolled women who sought PAC services at RHCs were referred to a higher level facility, compared with 98% at baseline. At rural and mission hospitals, the percentage of women referred for PAC treatment declined by nearly 95%, from 48% to 3%.

Health providers at the OR facilities and VHWs in the catchment areas increased community awareness of the availability of misoprostol for PAC, the dangers of unsafe abortion, and the importance of family planning during facility-based health education sessions and community meetings. Overall, 13,845 community members were reached with messages about misoprostol for PAC during the course of the OR.

Among the women who returned for follow-up for whom data were recorded (n=120), 96% were successfully treated. Only one woman at an RHC had to be referred for further treatment; at rural and mission hospitals only two women received additional treatment. These outcomes are consistent with the 91-98% efficacy rate of misoprostol for PAC observed in randomized controlled studies.

The provision of family planning counseling and services at the time and location that women access services for spontaneous or induced abortion is regarded as a proven high-impact practice to maximize investments in a comprehensive family planning strategy, especially when scaled up and institutionalized,. Over 80% of women in the OR accepted a modern contraceptive method as part of PAC services. Rates of contraceptive uptake were highest at the provincial hospital (92%) and RHCs (87%).

Women treated with misoprostol were advised to return after 7-14 days for follow-up. Women treated at RHCs were most likely to return for follow-up (75%), compared with those treated at rural and mission hospitals (39%) and the provincial hospitals (12%). Ten percent of the women who returned for follow-up received a contraceptive at follow-up and not at the initial visit.

Women treated with misoprostol experienced minimal side effects. Among the 124 women treated with misoprostol who returned for follow-up, 29 women reported having some side effect after taking the tablets. The most commonly reported side effect was abdominal pain reported by 16 women, followed by chills and/or fever (n=8), nausea and vomiting (n=5) and diarrhea (n=5).

The following recommendations on opportunities to strengthen PAC services in Zimbabwe are based on the results of the OR and lessons learned by the ZMoHCC and providers during project implementation. Consequently, a number of the recommendations encompass issues related to scaling up PAC services in Zimbabwe that are not specifically tied to data from the OR.

1. Introduce TIAM with misoprostol within a referral system at RHCs, where PAC services are not currently available. 2. Integrate misoprostol for TIAM at those health facilities currently providing PAC services. 3. Provide on-the-job training on the use of misoprostol for PAC following the treatment and referral protocols for PAC services, to all PAC service providers: physicians, midwives, and nurses, including PCNs. 4. Continue to strengthen postabortion family planning provisions.

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5. Develop and distribute practical, durable job aids to support providers in correctly identifying women eligible for treatment with different methods and those who should be referred. 6. Build community awareness on the availability of PAC services, the dangers of unsafe abortion, the importance of preventing unwanted pregnancies, and raise awareness of the availability of family planning services at health facilities, by training health providers at facilities and VHWs on how to incorporate these messages in their educational activities. 7. Complete the revision of the Comprehensive Abortion Care guidelines and protocols ensuring the inclusion of updated information on PAC services. Disseminate and implement the revised guidelines. 8. Incorporate training on misoprostol for TIAM in the pre-service curricula of the medical, nursing, and midwifery schools 9. Register misoprostol for TIAM, which is an important first step in ensuring the supply of a high-quality product. 10. Strengthen provider capacity and utilization of MVA for PAC to address cases that are not eligible for misoprostol; phase out D&C.

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Acronyms and Local Terms

D&C Dilatation and curettage D&E Dilatation and evacuation IEC Information, education and communication M&E Monitoring and Evaluation MCAZ Medicines Control Authority of Zimbabwe MVA Manual vacuum aspiration OR Operations research ZMOHCC Zimbabwe Ministry of Health and Child Care MRCZ Medical Research Council of Zimbabwe MVA Manual vacuum aspiration PAC Postabortion care RHC Rural Health Centre TIAM Treatment of incomplete abortion and miscarriage TOT Training of trainers VHW Village Health Worker VSI Venture Strategies Innovations WHO World Health Organization ZICOM Zimbabwe Confederation of Midwives ZSOG Zimbabwe Society of Obstetricians and Gynecologists

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Table of Contents

Acknowledgements ...... iii Executive Summary ...... iv Acronyms and Local Terms ...... vii

Table of Contents ...... viii List of Tables and Figures ...... ix 1. Introduction ...... 10

2. Goal and Objectives ...... 11 3. Background ...... 11 3.1 Maternal health and unsafe ...... 11 3.2 Misoprostol for the treatment of incomplete abortion and miscarriage ...... 14 3.3 Policies and regulations enabling the use of misoprostol in Zimbabwe ...... 14 3.4 Rationale for the introduction of misoprostol for PAC ...... 15 4. Operations Research Components ...... 15 5. Methods ...... 15 5.1 Participating districts ...... 15 5.2 Participating facilities ...... 17 5.3 Postabortion care service delivery ...... 19 5.4 Community awareness campaign ...... 22 5.5 Monitoring and evaluation of the operations research ...... 23 5.6 Data collection tools, data management and data analysis ...... 23 6. Operations Research Implementation Timeline ...... 25 7. Results ...... 26 7.1 Postabortion care service delivery ...... 26 7.2 Follow-up and referrals due to treatment failure ...... 31 7.3 Side effects ...... 32 7.4 Contraceptive method provision ...... 32 7.5 Access to postabortion care services ...... 35 7.6 Community awareness ...... 36 7.7 Provider perspectives on the introduction of misoprostol for treatement of incomplete abortion and miscarriage ...... 37 8. Discussion and Conclusions ...... 41 9. Programmatic Recommendations ...... 44 10. References ...... 48 Appendix A: Misoprostol Regimens, Pocket Reference for Clinicians ...... 51 Appendix B: Contraceptive Guide, Pocket Reference for Clinicians ...... 52 Appendix C: Community Brochure for Women ...... 53

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List of Tables and Figures

Table 1: Selected characteristics of participating districts ...... 16 Table 2: Levels of health facilities in Zimbabwe, services provided and staffing ...... 18 Table 3: Health facility participation, by district ...... 18 Table 4: Providers at cascade trainings, by cadre and district ...... 22 Table 5: Distribution of enrolled women, by treatment method and district ...... 27 Table 6: Distribution of operations research providers and treatment method employed ...... 28 Table 7: Obstetric history and socio-demographic traits of enrolled women, by facility ...... 29 Table 8: Number of enrolled women treated with misoprostol who returned for follow-up visit, by facility level ...... 32 Table 9: Contraceptive method used prior to for enrolled women ...... 33 Table 10: Family planning uptake at initial visit for enrolled women ...... 33 Table 11: Enrolled women who received family planning counseling and method at initial or follow- up visits, by facility level ...... 34 Table 12: Availability of clients' preferred contraceptive method, by facility level ...... 34 Table 13: Client travel time and means of transport, by facility level ...... 36 Table 14: Characteristics of providers who responded to survey ...... 38

Figure 1: Trends in maternal mortality in Zimbabwe, 1994 - 2011 ...... 12 Figure 2: Expanding access to postabortion care operations research implementation sites in Zimbabwe ...... 17 Figure 3: Postabortion care clinical protocol used for the operations research ...... 20 Figure 4: Service delivery and referral protocols for postabortion care based on facility level ...... 21 Figure 5: Data flow and management ...... 24 Figure 6: Distribution of TIAM methods for enrolled women, by facility level ...... 27 Figure 7: Method of initial treatment for enrolled and treated women, by month ...... 30 Figure 8: Proportion of enrolled women referred without treatment, at baseline and operations research ...... 30 Figure 9: Enrolled women who received misoprostol, by month ...... 31 Figure 10: Proportion of enrolled women who returned for follow-up, by facility level ...... 31 Figure 11: Contraceptive methods provided at initial visit, by facility level ...... 35 Figure 12: Cumulative number of community members reached with awareness messaging ...... 37 Figure 13: Perspectives on using misoprostol for postabortion care ...... 39 Figure 14: Provider perspectives on family planning services ...... 39

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1. Introduction

The Zimbabwe Ministry of Health and Child Care (ZMoHCC) is deeply committed to improving maternal health in Zimbabwe and to increasing access to essential drugs and services. With a population of 12.4 million, Zimbabwe has been facing severe economic challenges, which has adversely affected maternal health outcomes (United Nations Development Program and the Government of Zimbabwe, 2010). From 2000 to 2008, Zimbabwe’s GDP shrunk by an estimated 40% (United Nations and Government of Zimbabwe, 2010). The proportion of the population living below the Total Consumption Poverty Line (TCPL), which is the minimum expenditure needed to buy a basic basket of items for subsistence, was 72% in 2003; this percentage is estimated to have increased as a result of the economic crisis of 2008 (United Nations Development Program and the Government of Zimbabwe, 2010). As the economy has worsened, so has access to and delivery of maternal health services, resulting in a high maternal mortality ratio (MMR). Most recent estimates report the MMR at 960 maternal deaths per 100,000 live births (Zimbabwe National Statistics Agency (ZIMSTAT) and ICF International, 2012). Based on the 1994 MMR estimate of 283 per 100,000 live births, there was a 300% increase over fifteen years (Central Statistical Office [Zimbabwe] and Macro International Inc., 1995).

Globally, 47,000 women each year are estimated to die from complications due to unsafe abortion (WHO, 2011b) and one in four women having an unsafe abortion is likely to face severe complications (WHO, 2007). Hundreds of thousands of disabilities are caused by unsafe abortion annually (WHO, 2007) and almost all of these occur in developing countries (Grimes et al., 2006). Deaths due to complications of abortion are one of the major causes of maternal mortality. According to one community-based study in Zimbabwe, complications from unsafe abortion was a primary cause of maternal deaths in urban and rural settings (Mbizvo et al., 1994).

Postabortion care (PAC) is defined as a package of services to address complications related to incomplete abortion and miscarriage. The components of PAC are community and service provider partnerships, counseling, treatment, contraceptive services and reproductive and other health services (Corbett and Turner, 2003). As such, PAC links curative services, such as treatment of incomplete abortion and miscarriage (TIAM), with preventive services, like family planning (Ipas and VSI, 2011) (Figure X). As part of a comprehensive reproductive health strategy, PAC services can also be vital in preventing unintended pregnancies, thereby contributing to the reduction of maternal morbidity and mortality. The 1994 International Conference on Population and Development (ICPD) Program of Action urged all governments and organizations to “strengthen their commitment to women’s health” and “deal with the health impact of unsafe abortion as a major public health concern (United Nations, 1995).” Since then, PAC has been widely embraced as an important intervention to reduce maternal mortality.

The Zimbabwe Ministry of Health and Child Care collaborated with Venture Strategies Innovations (VSI), a US-based nonprofit organization, to expand access to high quality PAC services through the integration of misoprostol for the treatment of incomplete abortion and miscarriage (TIAM) at all levels of public sector health facilities in four districts in Zimbabwe. Operations research (OR) was conducted to demonstrate the feasibility and acceptability to patients and providers of integrating misoprostol into existing reproductive health services. With the integration of misoprostol, this joint OR made PAC newly available at rural health centers (RHCs), the lowest level health facilities in Zimbabwe. The expansion of PAC services to the periphery was intended to afford women,

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especially those living in rural areas, greater access to TIAM and postabortion family planning services.

The expansion of high quality PAC services is critical to reaching Zimbabwe’s long-term goal of reducing maternal mortality and morbidities due to complications of unsafe abortion.

2. Goal and Objectives

The main goal of this operations research (OR) was to assess the feasibility of integrating misoprostol for treatment of incomplete abortion and miscarriage (TIAM) into postabortion care (PAC) services in Zimbabwe.

The specific objectives of this OR were: • To demonstrate that the provision of misoprostol for the treatment of incomplete abortion is feasible to implement in all health facilities in Zimbabwe’s health system; • To understand the logistics and other management implications when introducing the use of misoprostol for treatment of incomplete abortion in all public and private sector settings; • To provide evidence for integrating misoprostol into the existing PAC strategy for Zimbabwe; • To understand postabortion contraceptive uptake, method choice, and client characteristics after treatment of incomplete abortion with medication; • To provide empirical evidence for the establishment of a revised protocol for the treatment of incomplete abortion in Zimbabwe, according to provider and level of access; • To document provider perspectives on the inclusion of misoprostol in PAC services.

3. Background

3.1 MATERNAL HEALTH AND UNSAFE ABORTION IN ZIMBABWE The impact of political and economic factors on maternal health in Zimbabwe has been particularly significant. As noted earlier, Zimbabwe’s maternal and mortality rate (MMR) has increased significantly since 1994 (Figure 1).

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Figure 1: Trends in maternal mortality in Zimbabwe, 1994 - 2011 (maternal deaths per 100,000 live births)

1200 1994¹ 1000 960 1999² 880 2005³ 800 695 725 2005-06⁴ 600 555 2007⁵

400 2010-11⁶ 283 200

0 1994¹ 1999² 2005³ 2005-06⁴ 2007⁵ 2010-11⁶

¹Central Statistical Office [Zimbabwe] and Macro International Inc. 1995. Zimbabwe Demographic and Health Survey, 1994. Calverton, Maryland: Central Statistical Office and Macro International Inc. ²Central Statistical Office [Zimbabwe] and Macro International Inc. 2000. Zimbabwe Demographic and Health Survey 1999. Calverton, Maryland: Central Statistical Office and Macro International Inc. ³WHO/UNICEF/UNFPA and The World Bank. Maternal mortality in 2005. Estimates developed by WHO, UNICEF, UNFPA and the World Bank. Geneva: World Health Organisation; 2007. ⁴Central Statistical Office (CSO) [Zimbabwe] and Macro International Inc. 2007. Zimbabwe Demographic and Health Survey 2005-06. Calverton, Maryland: CSO and Macro International Inc. ⁵Zimbabwe Ministry of Health and Child Welfare. Maternal and Perinatal Mortality Study. Ministry of Health and Child Welfare [Zimbabwe], 2007. ⁶Zimbabwe National Statistics Agency (ZIMSTAT) and ICF International. 2012. Zimbabwe Demographic and Health Survey 2010-11. Calverton, Maryland: ZIMSTAT and ICF International Inc.

Based on MDG 5, which aims to reduce the maternal mortality ratio by 75% by 2015, Zimbabwe’s target is to reach a MMR of 174 (United Nations Development Program and Government of Zimbabwe, 2010). This is considered to be unattainable based on recent trends and the current MMR of 960. A number of health system constraints make achieving this goal extremely difficult. For example, as of 2010, 80% of public sector midwifery posts were vacant (United Nations Development Program and Government of Zimbabwe, 2010). Additionally, the National Pharmaceutical Company (NatPharm) of Zimbabwe, which is the national drug procurement and distribution body for all government hospitals and clinics, has experienced a sharp decrease in funding over the past two decades, leading to a lack of procurement of essential pharmaceuticals (United Nations Industrial Development Organization, 2011).

The main obstetric causes of maternal death in Zimbabwe, as reported in the 2007 Maternal and Perinatal Mortality Study, were postpartum hemorrhage (PPH) (18.6%), pregnancy-induced hypertension/eclampsia (15.7%), sepsis (12.3%), and abortion-related causes (2.6%) (ZMoHCW, 2007). An earlier study of maternal mortality from 1996 found 23% and 15% of maternal deaths in Harare city and Masvingo district, respectively, to be attributable to unsafe abortion (Fawcus et al., 1996). It is important to note that abortion-related mortality and morbidity are typically under- reported (Grimes et al., 2006).Given the weakening of the health system since then, a decline in unsafe abortion deaths from 1996 to 2007 would have been unlikely.

Unsafe abortion is defined by the World Health Organization (WHO) as a procedure for terminating an unintended pregnancy that is carried out by individuals without the necessary skills and/or in an

12 environment that does not conform to minimum medical standards (WHO, 2011b). Globally, an estimated 21.6 million unsafe occur each year (Shah and Ahman, 2010). An estimated 6.2 million unsafe abortions occur each year in Africa alone. The number of unsafe abortions worldwide has increased in recent years, and will likely continue to increase with population growth unless women’s access to contraception and safe abortion is expanded and strengthened (WHO, 2011b).

When women do not receive timely and appropriate treatment for complications from unsafe abortion, the consequences can be severe. Common complications related to unsafe abortion are hemorrhage, sepsis, peritonitis, and trauma to the cervix, uterus, vagina and abdominal organs (WHO, 2012). About one in four women undergoing an unsafe abortion is likely to develop temporary or lifelong disabilities requiring medical care (WHO, 2012). Complications from unsafe abortions also lead to a loss of productivity, an economic burden on public health systems, and stigma (Benson et al., 2012; Grimes et al., 2006).

According to Zimbabwe’s Termination of Pregnancy Act No. 29 of 1977, abortions may be performed where the life of the mother is endangered, where there is a serious risk that the child will be born with a physical or mental defect, and where there is a reasonable possibility that the was conceived as a result of unlawful intercourse. A magistrate is required to confirm unlawful intercourse, and two physicians must certify the medical indications required for an abortion (ZMoHCW, 2001). Additionally, a directive from the ZMoHCC states that an abortion may be performed where the woman is HIV positive and chooses to terminate the pregnancy. If a woman has an illegal induced abortion she can be jailed as a criminal offender. As a result of this abortion policy, health providers are sometimes hesitant to perform abortions, even in situations where the woman meets the legal requirements (Johnson et al., 2002). Consequently, many women seeking abortions turn to unskilled providers, whose methods may include traditional medicine, overdoses of malaria tablets or contraceptive pills, or the insertion of needles or roots into the vagina (Pierce and Settergreen, 2000).

The ZMoHCC is committed to scaling up high-quality postabortion care (PAC) services, and the Department of Reproductive Health launched a drive in 2008 to train doctors, midwives and clinical officers to use MVA. A total of 100 providers (selected from across all eight provinces in Zimbabwe) were trained to use MVA. It is important to note that no primary care nurses from rural health centers (RHCs) were trained. Despite this initiative, MVA is still only available in a small number of district, provincial and central level hospitals, leaving limited treatment options for women at the lower-level RHCs. While some nurse midwives and physicians at the district, provincial and central hospitals have been trained on MVA by UNFPA and the ZMoHCC, MVA is not used widely in practice. The moving of trained providers outside of the country and high staff turnover at all levels of the health system may also limit the consistent provision of MVA at facilities. Dilatation and curettage (D&C) continues to be the primary treatment method for incomplete abortion at district and provincial hospitals, despite the fact that the World Health Organization no longer recommends its use (WHO, 2012). The use of D&C as a primary treatment method is problematic because it has higher complication rates (WHO, 2012) and it restricts PAC access to facilities with physicians, the only providers allowed to undertake this procedure in Zimbabwe. Consequently, increasing women’s access to PAC, particularly in rural areas, is challenging when D&C is the primary treatment method.

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3.2 MISOPROSTOL FOR THE TREATMENT OF INCOMPLETE ABORTION AND MISCARRIAGE The WHO defines incomplete abortion as the retention of products of conception after an induced abortion or a spontaneous abortion and considers its treatment an essential element of obstetric care (WHO, 1991). Misoprostol, a prostaglandin E1 analogue in tablet form, and vacuum aspiration, are two of the treatment methods recommended by the WHO for the treatment of incomplete abortion and miscarriage (TIAM) (WHO, 2012). In 2009, the WHO included misoprostol for the treatment of incomplete abortion in its Model List of Essential Medicines (WHO, 2009) and in 2011, in its list of Priority Life-saving Medicines for Women and Children (WHO, 2011a). Further, misoprostol has been recommended for use in postabortion care (PAC) by the International Federation of Gynecology and Obstetrics (Shaw, 2007), along with many other international professional organizations and associations (ACOG, 2009). In recent years, misoprostol has increasingly been used for TIAM and other obstetric conditions (Karanja et al., 2013; Fawole et al., 2012; Osur et al., 2013; Shochet et al., 2012). For evacuation of the uterus, it has efficacy rates of 91% to 99%, a range that is comparable to the efficacy rates of surgical evacuation procedures (Raghavan and Bynum, 2009). Reported satisfaction with misoprostol for PAC is high among both women and health providers. Over 90% of women report being satisfied or very satisfied with treatment of incomplete abortion using misoprostol (Bique et al., 2007; Dao et al., 2007; Diop et al., 2009), and providers also report high levels of satisfaction with the treatment (Ipas and SOGON, 2011).

Misoprostol presents a number of advantages as a treatment in resource-constrained settings. Firstly, it can be administered orally or sublingually for the treatment of incomplete abortion. Further, it is inexpensive (Blum et al., 2007), easy to store, stable in field conditions, and has an excellent safety profile (el-Refaey et al., 2006). The effectiveness of misoprostol means that it can be used as a safe alternative to surgical methods.

The use of misoprostol as part of PAC presents minimal service delivery requirements in terms of staff and facilities. Neither physicians nor operating theatres are required for safe and effective use; thus, it creates an opportunity to extend PAC services to health facilities where surgical capacity may not be available (Ipas and VSI, 2011). In areas where vacuum aspiration or other surgical methods are available, it provides clients and providers with an additional, non-surgical treatment option. This adds value for a number of reasons, including reduced staff time, allowing women to choose between undergoing surgical or medical treatment, and task-shifting treatment to primary care providers. Misoprostol as part of PAC also provides potential cost savings to both the health care system (Hodoglugil et al., 2011) and to women, as medical methods are typically available at a lower-cost than surgical methods (Ipas and VSI, 2011). Most significantly, by enabling PAC at primary levels of the health system, misoprostol can bring these services closer to women and significantly expand access to timely, safe and effective care.

3.3 POLICIES AND REGULATIONS ENABLING THE USE OF MISOPROSTOL IN ZIMBABWE As a result of the strong evidence on the safety and efficacy of misoprostol for TIAM in numerous countries and the effectiveness of misoprostol in resource-constrained settings, the ZMoHCC strongly supports expanding access to misoprostol. A Misoprostol Technical Working Group (TWG) was formed by VSI in January 2011 and was composed of stakeholders from the ZMoHCC, NGOs, and professional groups including the Zimbabwe Confederation of Midwives (ZICOM) and the Zimbabwe

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Society of Obstetricians and Gynaecologists (ZSOG). The primary purpose of the TWG was to provide input on the operations research (OR) protocols. As leaders of the Misoprostol TWG, the ZMoHCC successfully advocated for the inclusion of misoprostol on the Essential Drugs List of Zimbabwe (EDLIZ) for obstetric and gynaecological indications in 2011. Additionally, the ZMoHCC will include misoprostol for TIAM in the Comprehensive Abortion Care (CAC) Guidelines that are currently being updated.

3.4 RATIONALE FOR THE INTRODUCTION OF MISOPROSTOL FOR PAC Training all providers who are authorized to provide PAC services in the use of misoprostol for TIAM will help increase access to essential PAC services for women in Zimbabwe. Dilatation and curettage (D&C), a method no longer recommended by the WHO, is the current primary treatment method used in Zimbabwe’s hospitals. While MVA is approved for use, it is not widely utilized. Given this reality, integrating misoprostol for PAC at all levels of the health care system, including RHCs, will serve to: 1) leverage the current staffing levels available in Zimbabwe to expand women’s access to PAC services, particularly in the rural areas and 2) provide an additional method of uterine evacuation that offers an effective and safe non-surgical option to women seeking TIAM.

4. Operations Research Components

In January 2013, the ZMoHCC, with the support of VSI, launched operations research (OR) to assess the feasibility of introducing misoprostol for the treatment of incomplete abortion and miscarriage (TIAM) into postabortion care (PAC) services in four districts in Zimbabwe. As part of standard PAC protocol, the OR was designed to ensure that women presenting for PAC were offered misoprostol (or a choice of methods where available), provided with postabortion contraceptive counseling and offered a modern method choice, and that women experiencing complications were referred to higher-level facilities per the existing referral system.

The OR included three components: 1) PAC Service delivery: Service delivery included 1) integrating misoprostol into existing facility-based clinical PAC services by training providers at higher-level facilities to use misoprostol as an additional treatment option and 2) expanding PAC services to rural health centers (RHCs) and rural hospitals through introducing non-surgical treatment with misoprostol. 2) Community awareness: A community awareness campaign was conducted to provide information on the availability of PAC at RHCs and hospitals and to establish links between the community and medical system to improve PAC care, including postabortion contraception and prevention of unwanted pregnancies. 3) Monitoring and evaluation: Data was collected on service delivery provision, community awareness activities, and provider perspectives on the introduction of misoprostol. In addition, supportive supervision was undertaken to monitor OR activities.

5. Methods

5.1 PARTICIPATING DISTRICTS The Technical Working Group (TWG) selected four of Zimbabwe’s 59 districts, located in three of the country’s eight provinces, for participation in the operations research (OR). These districts were: Mutare, Chimanimani, Matobo and Umguza. Mutare and Chimanimani are located in Manicaland Province in eastern Zimbabwe. Umguza and Matobo districts, both of which are in southern

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Zimbabwe, are located in Matebeleland North and Matebeleland South Provinces, respectively (Figure 2). The districts were selected by the Misoprostol TWG with the aim of representing the country’s diversity in terms of geography, resources, and political affiliation. The districts were chosen specifically because they have high mortality and morbidity rates (MMRs) and relatively poor obstetric services. Capturing this diversity was intended to help ensure that the challenges of introducing misoprostol across a variety of settings would be documented in the OR, and that the lessons learned would provide more complete insight into how the ZMoHCC could scale up the introduction of misoprostol and postabortion care (PAC) nationally.

Table 1: Selected characteristics of participating districts Mutare Chimanimani Umguza Matobo Population 434,379 136,055 81,781 110,266 Total fertility rate(a) 4.8 4.8 4.1 4.2 Percentage Delivered in Health 60.9% 60.9% 63.5% 69.3% Facility (a) Median Years of Education 8.7 8.7 7.2 8.3 Completed (Women) (a) Median Years of Education 9.8 9.8 7.1 7.9 Completed (Men) (a) Literacy (Women) (a) 94.4% 94.4% 87.9% 92.9% Literacy (Men) (a) 96.0% 96.0% 83.5% 91.5% Health Insurance Coverage 4.7% 4.7% 3.0% 4.7% (Women) (a) Health Insurance Coverage 9.6% 9.6% 4.2% 7.4% (Men) (a) Wealth quintile(a) Lowest 17.5% 17.5% 61.0% 26.8% Second 21.5% 21.5% 13.5% 23.2% Middle 29.2% 29.2% 8.6% 26.7% Fourth 20.4% 20.4% 8.5% 17.3% Highest 11.3% 11.3% 8.3% 6.1% (a)Zimbabwe National Statistics Agency (ZIMSTAT) and ICF International, 2012

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Figure 2: Expanding access to postabortion care operations research implementation sites in Zimbabwe

UMGUZA DISTRICT ! MUTARE DISTRICT! Pop. = 81,781! Pop. = 434,379! HARARE! Rural Health Center = 8! Rural Health Center = 20! Rural/Mission Hospital = 1! Rural/Mission Hospital = 3! District Hospital = 1 Provincial District Hospital = 1! Hospital = 0! Provincial Hospital = 1!

MATOBO DISTRICT! ! Pop. = 110,266! Pop. = 136,055! Rural Health Center = 8! Rural Health Center = 15! Rural/Mission Hospital = 4! Rural/Mission Hospital = 5! District Hospital = 1! District Hospital = 0! Provincial Hospital = 0! Provincial Hospital = 0!

5.2 PARTICIPATING FACILITIES The healthcare system in Zimbabwe operates on four levels from the primary to the specialist/referral level: rural health center (RHC), rural hospital, district-level hospital, provincial hospital, and central hospital with some variations (clinics, maternity hospitals, mission hospitals, and rural hospitals) depending on the district. The referral system is hierarchical with increasingly complex cases referred to higher-level facilities. In urban catchment areas such as Harare and , RHCs can refer patients directly to the central hospitals.

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Table 2: Levels of health facilities in Zimbabwe, services provided and staffing* Level of facility Services Provided Staffing • Specialty services • Obstetricians, gynecologists, • Management of complicated cases neonatologists, pediatricians, pediatric surgeons Central Hospital • Midwives, Registered General Nurses (RGNs) and State Certified Maternity Nurses (SCMNs) • Management of complicated cases • Obstetricians, gynecologists, Provincial hospitals neonatologists, pediatricians, anesthetists • Midwives, RGNs and SCMNs • Basic Emergency Obstetric and • District medical officer, MDs Neonatal Care (BEmONC) and • Clinical officers Comprehensive Emergency Obstetric • Midwives, RGNs, nurse anesthetists District /mission/rural and Neonatal Care (CEmONC) • Pharmacists hospitals • Long-acting and permanent contraceptive methods • Supervision of lower levels: RHCs and Village Health Workers • Antenatal Care (ANC) • Sometimes a midwife or RGN • Basic delivery care including ENC; • SCMN Clinics/Rural Health Basic Emergency Obstetric and • Primary care nurses Centers (RHCs) Neonatal Care (BEmONC) • Nurse aides • Family planning Village Health • Immunization; health promotion • 1 VHW per 100 families Workers (VHW) • Family planning: counseling, resupplies and referrals *Adapted from: Taylor, P., P. Gomez, et al. (2010). Maternal and Child Health Integrated Program: Zimbabwe Situation.

A total of 68 health facilities participated in the OR (Table 3). All facilities in three of the four districts that conducted deliveries were selected to participate in the OR. The exception was Mutare District where 25 of the 50 eligible facilities were selected to participate because the project scope could not allow for monitoring and supervision of more than 25 facilities per district. In Mutare, the VSI Program Officer worked with the Mutare District Nursing Officer to select 25 facilities that included a diversity of facility levels in rural and urban settings. Three urban health centers from Mutare were selected to participate; for the purposes of this OR, they are grouped with the RHCs as they are all health centers.

Table 3: Health facility participation, by district District Facility Level Mutare Chimanimani Umguza Matobo Total Rural Health Center* 20 15 8 8 51 Rural and Mission 3 5 1 4 13 Hospital District Hospital 1 0 1 1 3 Provincial Hospital 1 0 0 0 1 TOTAL 25 20 10 13 68 *Three facilities in Mutare District that are included in the category of “rural health center” are actually classified as “urban health centers;” for the purpose of this analysis they are included in this category as they are both health centers.

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5.3 POSTABORTION CARE SERVICE DELIVERY Postabortion care services included: • Treatment of incomplete abortion and miscarriage (TIAM): Providers treated with misoprostol, manual vacuum aspiration (MVA), dilatation & curettage (D&C) and dilatation and evacuation (D&E). Treatment method was dependent upon the level of facility, and what facility staff were authorized and equipped to do. • Family planning counseling and distribution of contraceptives: All women were to be provided with postabortion family planning counseling and their choice of a modern contraceptive method. • Referral: To ensure comprehensive services appropriate to the needs of the individual patient, all heath facilities followed established ZMoHCC referral protocols linking lower level facilities to district or provincial hospitals.

The introduction of TIAM with misoprostol at RHCs was seen as having the greatest potential to expand PAC access to rural women. In the OR, these facilities provided PAC services to women presenting with incomplete abortion and miscarriage with a uterine size equivalent to 13 weeks and without signs of complications. Women in need of PAC outside of the OR districts generally had to travel to mission or district hospitals for PAC services.

5.3.1 Clinical Protocols When a woman presented at any of the 68 participating health facilities with signs of incomplete abortion, the provider conducted a clinical assessment, described the OR, and enrolled her after obtaining informed consent. All women who agreed to participate were included, regardless of the method of PAC treatment they received, whether they were eligible for misoprostol, or whether they had to be referred to a higher-level facility without receiving treatment. The clinical assessment established whether any emergency treatment was needed; the woman’s eligibility to receive misoprostol; whether a referral was needed; and the consequent treatment plan. The course of treatment for the woman depended on the woman’s condition, treatment methods available, and the woman’s preference (if more than one option was available and deemed appropriate by the provider), per the established clinical protocols presented below (Figure 3). The World Health Organization (WHO)-recommended regimen of 600mcg oral misoprostol for the treatment of incomplete abortion was used in the OR (WHO, 2012).

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Figure 3: Postabortion care clinical protocol used for the operations research* !"#$%&'()*)%+%,&-./0&*.,%*&$%1&*2#'/"#*&"3&& .%4"#'5)/)&$6"(+"%7#.*4$((.$,)&

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*Dilatation & curettage (D&C) was included in the operations research clinical protocol because it is widely used in Zimbabwe despite the fact that it is not a method recommended by the WHO.

5.3.2 Patient Eligibility A woman was eligible to receive misoprostol if she had an open cervical os, vaginal bleeding, and was at or under 13 weeks since her last menstrual period (LMP). A woman was ineligible to receive misoprostol if she had a known allergy to misoprostol or other prostaglandins; confirmed or suspected ectopic pregnancy, signs of sepsis or active pelvic inflammatory disease; and/or hemodynamic instability or shock. For women presenting with signs of incomplete abortion and miscarriage with thirteen weeks or fewer after the last menstrual period (LMP), providers offered women the choice of treatment method (MVA or misoprostol) if she was medically eligible for both methods. Women’s gestational age was identified through medical history (the first day of her last menstrual period) and pelvic exam.

All women were asked to return for a follow-up visit between seven and fourteen days after the initial visit to confirm that the treatment was complete. Women were advised to return to the health facility prior to their appointment if they experienced any excessive pain, bleeding, or showed signs of infection. They were given a Misoprostol for PAC brochure (in English, Shona or Ndebele), which used pictorials to illustrate when the woman needed to return to the facility prior to her follow-up appointment (Appendix C). All women received contraceptive counseling during their first and follow-up visit, and were either offered the method of their choice or referred to another facility if their preferred method was not available.

Figure 4 presents the service delivery and referral protocols, based on the facility level where the woman presents for treatment. The figure includes the procedures to follow if initial treatment fails.

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Figure 4: Service delivery and referral protocols for postabortion care based on facility level ! ! ! Health !Center! District !Hospital! Provincial! Hospital! ! ! ! ! ! ! Uterine size 䍸13 wks LMP! Uterine size 䍸13 wks LMP! Uterine size 䍸13 wks LMP! Administer !misoprostol! Administer misoprostol! or Administer misoprostol! or !! MVA*! ! MVA*! ! ! ! ! Refer! if:! Uterine size !>13 wks LMP! Uterine size !>13 wks LMP! Uterine size >13! wks LMP, or! D&E*! ! D&E*! ! Complicated case, or! ! ! Woman prefers! other method! Refer for severe! complications! Other uterine! evacuation ! ! methods, surgery! or other ! ! procedures! to treat complications as needed! ! ! ! ! ! If medical! If medical! ! management! fails management! fails If medical! and woman! is and woman! is management! fails! clinically stable! clinically stable! ! ! ! ! ! ! ! ! ! Repeat misoprostol treatment or Repeat treatment or ! ! ! Re-assess and treat! as necessary! Refer for further treatment! Refer for further treatment! ! ! ! ! *Where MVA or D&E is not available, D&C can be used as a Refer if necessary! Refer if necessary! second line treatment.!

Contraceptive counseling and method provision!

5.3.3 Health Provider Training The OR training included the following topics: diagnosing and assessing women who present with symptoms of incomplete abortion; the different treatment methods used for incomplete abortion; identifying the eligibility of women for misoprostol treatment (600 mcg orally); the adherence to the clinical protocols for the treatment of incomplete abortion including misoprostol; informing women about treatment methods (i.e., what to expect, warning signs and follow-up schedule); and comprehensive counseling on family planning and contraceptives. The training was conducted through interactive methods, including case discussions, role plays and demonstrations. Providers also participated in values clarification activities related to providing PAC services. Additionally, providers were trained in OR monitoring and evaluation, including how to complete data collection tools. Providers were given pocket guides (one set for each facility), with information on misoprostol dosages and postabortion contraception (Appendix A, B).

A training of trainers (TOT) was conducted in Harare in February 2012 for 40 doctors, senior nurses, midwives, district pharmacists and Reproductive Health Officers (RHOs) from the four OR districts. Cascade trainings organized by the ZMoHCC and VSI were held in December 2012 in Bulawayo and Mutare. Two providers from each of the OR facilities participated in the cascade trainings. The District Nursing Officers and community sisters from each OR district selected the providers who would participate in the cascade trainings. Most RHCs are manned by 2 nurses (typically primary

21 care nurses) so because two providers were trained per facility, all the nurses at RHCs were trained. At district and provincial hospitals nurses were chosen from the relevant departments and wards (for example, FCH and the female ward).

In total, 135 providers were trained, 50 from Mutare District, 40 from Chimanimani District, 25 from Matobo District, and 20 from Umguza District (Table 4). In addition, refresher trainings were held in December 2012 for the 40 providers who had attended the initial TOT. The refresher trainings were held to review the materials that had initially been presented in February and the final OR protocols and data collection tools.

Table 4: Providers at cascade trainings, by cadre and district Provincial and Mutare Chimanimani Matobo Umguza central hospital Total health officers Training of trainers (TOT) 5 5 5 5 20 40 Cascade trainings 50 40 25 20 --- 135 Primary Care Nurse 20 22 12 12 -- 66 Nurse 25 12 3 4 -- 44 Midwife 4 6 8 4 -- 22 Sister in Charge 1 2 -- 3 TOTAL 50 40 25 20 20 175

Providers who attended the cascade trainings gave feedback to all providers involved in conducting deliveries at their respective facilities, so that all of these providers had correct information on how to use misoprostol for PAC. “Feedback training” is used as a term in Zimbabwe to describe sharing of information received at a training with other providers at their facility. Additionally, on-the-job refresher trainings and supportive supervision were conducted throughout the OR by project monitoring staff, to ensure that all providers involved in PAC services at each participating facility had received training on misoprostol and were following the OR protocol.

5.4 COMMUNITY AWARENESS CAMPAIGN The expansion of PAC services can only have impact if women who need them know that they are available and have confidence in the facilities that offer them. Accordingly, the program included a community awareness campaign to ensure that communities were aware of where misoprostol was available to treat incomplete abortion and miscarriage.

Key messages of the community awareness campaign were based on the following themes: • The dangers of unsafe abortion • The availability of PAC services with misoprostol at participating OR health facilities • The importance of preventing unwanted pregnancies • The availability of family planning methods at health facilities

Providers and Village Health Workers (VHWs) were trained on the key messages and asked to educate women and other community members during village-level meetings about these messages. Providers were asked to incorporate education sessions on misoprostol into existing weekly group education sessions held at their facilities. Village Health Workers were tasked to include messages on misoprostol for PAC in the community sensitization sessions and home visits that they held in their locales.

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5.5 MONITORING AND EVALUATION OF THE OPERATIONS RESEARCH The ZMoHCC, in collaboration with VSI, developed data collection tools for the OR. Tools were developed to collect: baseline data on PAC service provision prior to the OR, PAC service delivery data during the OR, community awareness activities conducted during the OR, and provider perspectives and acceptability with using misoprostol for TIAM. The data collection tools used for the OR are described below in Section 5.6 of the Methods: Data Collection Tools. VSI and ZMoHCC monitoring staff were responsible for collecting completed data collection tools on a monthly basis.

Monitoring and evaluation (M&E) activities were undertaken by monitoring staff hired for the OR as well as district nursing officers and community sisters who were trained in monitoring and supportive supervision. Additionally, VSI’s Zimbabwe Program Officer provided oversight to all M&E activities. In coordination with high-level officials from the ZMoHCC, the Program Officer conducted targeted supportive supervision to facilities that were encountering challenges during the OR.

Supportive Supervision Regular monthly visits by OR monitoring staff took place in order to assess the status of the project and to provide supportive supervision to health providers and other facility staff. OR monitoring staff ensured that providers were following the correct clinical protocols that had been laid out for the OR; if there were protocol violations, they worked with providers to ensure that they understood how to correct them. They also reviewed all data collection tools, confirming that forms were being filled out correctly, that there were no additional issues to be addressed or need to retrain providers. In addition to quantitative data collected with the M&E tools, OR monitoring staff also collected qualitative information from providers and district supervisors about the OR to monitor the integrity of implementation and to ensure timely identification of challenges.

5.6 DATA COLLECTION TOOLS, DATA MANAGEMENT AND DATA ANALYSIS The ZMoHCC, VSI and the Misoprostol TWG collaboratively developed data collection tools for the OR. The tools included the Facility Assessment Tool; Monthly Facility Form; PAC Service Delivery Form; PAC Logbook; Community Education Logbook; and Provider Survey. The data flow for each tool is represented in Figure 5.

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Figure 5: Data flow and management

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Facility Assessment Tool Baseline data from the 68 facilities participating in the OR was collected by VSI monitoring staff in August 2012 prior to the initiation of any OR program components. The baseline gathered information on current PAC service provision, costs and available equipment. The data were gathered using the Facility Assessment Tool developed for the OR. VSI’s monitoring staff completed a Facility Assessment Tool at each of the 68 OR facilities. These tools were then mailed to VSI’s M&E team in Irvine, CA, where they were entered into Microsoft Excel and then exported into Stata/SE 12 (StataCorp 2011) for analysis.

Monthly Facility Form Operations research monitoring staff used a Monthly Facility Form to record key service delivery indicators, misoprostol stock, and record challenges or questions that providers brought up during monitoring visits. Monthly Facility Forms were completed during the OR by monitors during their monthly supervisory visits. The OR monitoring staff then entered the forms into an Excel spreadsheet and emailed them to the VSI Zimbabwe Program Officer in Harare, as well as to VSI’s M&E team in Irvine, CA.

Postabortion Care Service Delivery Form and Postabortion Care Logbook A PAC Service Delivery Form was completed by health providers for each woman enrolled in the OR after she granted consent. The form documented PAC services provided at the facility, including assessment of clinical condition, method of treatment, and contraceptive method provided. The form also included a referral section. One part of the section stayed at the health facility where the referral was made, and the other was given to the woman to bring to the facility to which she was referred. The PAC Service Delivery Forms were collected on a monthly basis by OR monitoring staff and sent to the VSI Program Officer in Harare. VSI’s Data Manager in Harare then entered the data from the PAC Service Delivery Forms into a central database in Epi Info 3.5.4, which was emailed to

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VSI’s M&E team in Irvine, CA on a monthly basis. VSI’s M&E team then exported the data into Stata/SE 12 (StataCorp 2011). Data analysis was conducted by VSI’s M&E team in Stata in August 2013.

Data on all women enrolled in the OR presenting with incomplete abortion were also entered into a PAC Logbook, which summarized key information (age, gestational age, diagnosis, method of treatment, etc.) for each woman.

Community Education Logbook Providers, VHWs, and OR monitoring staff completed entries in a Community Education Logbook to capture the number of community educations sessions they led, the date of the education sessions, and how many community members were involved. Health providers at OR sites and VHWs completed entries in the Community Education Logbook when they held education sessions about misoprostol. Village Health Worker logbooks were deposited at the OR sites. OR monitoring staff collected the logbooks and mailed them to the VSI Zimbabwe Program Officer in Harare, who mailed them to VSI’s M&E team in Irvine, CA. Data from the Community Education Logbooks were entered into Microsoft Excel and then exported into Stata/SE 12 (StataCorp 2011).The data were analyzed by VSI’s M&E team using Stata/SE 12 (StataCorp 2011).

Provider Survey All providers who participated in the OR and were trained on the appropriate use of misoprostol for TIAM were asked to complete a short self-administered survey to share their perspectives on the program, their level of acceptability with misoprostol for TIAM, their level of satisfaction and challenges they experienced, and any other relevant experiences with using misoprostol for TIAM. In May and June 2013, OR monitoring staff distributed and collected the surveys as part of their routine supervisory visits. Providers completed the surveys in private and returned them to the monitor in a sealed envelope; they took an average of less than 15 minutes to complete. The OR monitoring staff left a copy of the survey and an envelope if one of the providers was not present during the visit; the provider then completed the survey and returned it to the monitoring staff member at the next visit. The completed Provider Surveys were collected by monitoring staff and mailed to the VSI Data Manager in Harare. The VSI Data Manager in Harare then entered the data using Epi Info 3.5.4 and emailed the data to VSI’s M&E team, who exported the data into Stata/SE 12 (StataCorp 2011). This database was analyzed by the VSI M&E team in Irvine, CA using Stata/SE 12 (StataCorp 2011).

The final data analysis for this report was conducted by VSI’s M&E team in August 2013. The final technical report was written by VSI’s M&E team in September 2013 in Irvine, CA.

6. Operations Research Implementation Timeline

All of the operations research (OR) activities, including the preparatory phase, implementation, data collection and analysis, took place between 2010 and 2013 (Figure X). The ZMoHCC and VSI were responsible for the ongoing management and oversight of the OR activities. A formal, full assessment of the capacity of stakeholders to introduce misoprostol was conducted in November 2010. During this assessment, VSI staff met with the Ministry of Health, the National Pharmaceutical Company of Zimbabwe (Natpharm), and various maternal health stakeholders.

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In February 2012, VSI conducted a training of trainers (TOT), which was followed by the cascade training of providers in December 2012. In July and August 2012, the ZMoHCC and VSI staff conducted facility assessments at all facilities in the four OR districts to gather baseline information about resources, staffing and current postabortion care (PAC) services. The protocol for the operations research was approved by the Medical Research Council of Zimbabwe (MRCZ), the Medicines Control Authority of Zimbabwe (MCAZ) and the Joint Research Ethics Committee (JRECH) in November 2012. Cascade trainings were held in December 2012.

Provision of services with misoprostol was initiated only after ensuring that facilities had the required supplies. For this reason, implementation started at different times in the different districts. Implementation began between January and February 2013.

At the end of March 2013, the Medicines Control Authority of Zimbabwe (MCAZ) and Medical Research Council of Zimbabwe (MRCZ) conducted facility site visits to check for protocol compliance and regulation of misoprostol by pharmacists and providers. US-based VSI staff conducted a monitoring and evaluation visit in April 2013, during which time they visited 33 facilities across all four districts (eight in Mutare, eight in Chimanimani, eight in Matobo and nine in Umguza).

At the beginning of June 2013 VSI replaced all current misoprostol stock in the OR facilities with new stock to enable the facilities to continue to offer PAC services until the ZMoHCC restocks them through Natpharm.

At the end of June 2013, OR implementation ended. During the two months that followed, VSI staff cleaned and analyzed OR data. The final report was completed in September 2013.

7. Results

Data collection began at the 68 operations research facilities in January 2013. While some facilities did not receive their misoprostol until February, providers could still enroll women in the operations research (OR) and provide treatment, or refer, as specified in the clinical protocol. The time period for data collection was intended to be six months (January – June 2013); however, data continued to be collected through mid-July, in order to ensure that follow-up data could be gathered for women who enrolled in June.

7.1 POSTABORTION CARE SERVICE DELIVERY Health providers enrolled a total of 315 women presenting for treatment of incomplete abortion and miscarriage (TIAM) in the OR between 1 January 2013 and 15 July 2013. Misoprostol was used to treat the majority of enrolled women (76%), and dilatation and curettage (D&C) was the second most commonly used treatment (16%). In Mutare district, D&C was used to treat almost one-third of enrolled women. Manual vacuum aspiration (MVA) was only used to treat two enrolled women, both in Mutare district. It is noteworthy that data collected during the baseline assessment revealed that only two facilities reported having functioning MVA equipment (data not shown). Four women were treated with other methods (two with oxytocin, one with dilatation and evacuation (D&E), and one with expectant management). A total of 15 women (5%) were referred at their initial visit without receiving treatment.

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Table 5: Distribution of enrolled women, by treatment method and district District Treatment Chimanimani Matobo Mutare Umguza TOTAL method (n=86) (n=28) (n=177) (n=24) (n=315) 81 26 117 20 244 Misoprostol* (94.2%) (92.9%) (66.1%) (83.3%) (77.5%) Dilatation and 2 48 50 Curettage 0 0 (7.1%) (27.1%) (15.9%) (D&C) Manual vacuum 2 2 aspiration 0 0 0 (1.1%) (0.6%) (MVA) 2 1 1 4 Other methods** 0 (2.3%) (0.6%) (4.2%) (1.2%) Referred without 3 9 3 15 0 treatment (3.5%) (5.1%) (12.5%) (4.8%) *Four women (two from Chimanimani and two from Umguza) were referred after initial treatment with misoprostol. **Other methods include oxytocin (n=2), dilatation and evacuation (n=1) and expectant management (n=1).

According to the facility assessment, prior to the OR, there was limited availability of postabortion care (PAC) services at the OR facilities. In addition to the provincial hospital, only one of three district hospitals and six of thirteen rural and mission hospitals reported offering TIAM. Dilatation and curettage (D&C) was the TIAM treatment method available at the largest number of facilities (n=5), with only two facilities offering MVA. Only one rural health center reported offering TIAM at the time of the assessment; they administered oxytocin (data not shown).

During the OR, all levels of health facilities in participating districts were able to provide TIAM. Treatment methods used for women enrolled in the OR varied by facility level (Figure 6). Rural and mission hospitals used misoprostol to treat the highest proportion of enrolled women (95%). The proportion of enrolled women treated with misoprostol was similar at RHCs and district hospitals (89% and 83%, respectively). The proportion of cases treated with misoprostol was lowest at the provincial hospital, where only half of enrolled women received misoprostol. Almost half of the enrolled women at the provincial hospital were treated with D&C.

Figure 6: Distribution of TIAM methods for enrolled women, by facility level

100% 3% 1% 10% 3% 2% 1% 17% 80% 47%

60% Referred Without Treatment

89% 95% Other Methods 40% 83% MVA 50% 20% D&C Misoprostol 0% Rural Rural/ District Provincial Health Mission Hospital Hospital Center Hopsital (n= (12) (n=102) (n=128) (n=73)

*Four women (two from Chimanimani and two from Umguza) were referred after initial treatment with misoprostol. **Other methods include oxytocin (n=2), dilatation and evacuation (n=1) and expectant management (n=1).

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Treatment methods for enrolled women varied by the level of provider. Close to three-fourths of enrolled women given misoprostol were treated by a primary care nurse (PCN) or nurse: about half received treatment from a PCN (43%), and almost one-third received treatment from a nurse (30%). Midwives provided misoprostol to 15% of the enrolled women who received the drug for treatment, and doctors provided the medicine to 9%. Of the 50 enrolled women treated with D&C, the vast majority (92%) received treatment from a nurse, while 6% received treatment from a doctor. It is important to note here that all D&C cases were treated by a doctor, in collaboration with a team of nurses; so while nurses documented 46 cases of D&C, and listed their provider level on the documentation, a doctor conducted the surgical procedure.

Table 6: Distribution of operations research providers and treatment method employed Referred Other Misoprostol* D&C MVA without Total methods** (n=244) (n=50) (n=2) treatment (n=315) (n=4) (n=15) Primary Care 105 2 5 112 Nurse 0 0 (43.0%) (50.0%) (33.3%) (35.6%) (PCN) 74 46 1 1 7 129 Nurse (30.3%) (92.0%) (50.0%) (25.0%) (46.7%) (41.0%) 37 2 39 Midwife 0 0 0 (15.2%) (13.3%) (12.4%) Clinical 3 3 0 0 0 0 Officer (1.2%) (1.0%) 21 3 1 25 Doctor 0 0 (8.6%) (6.0%) (50.0%) (7.9%) 4 1 1 1 7 Other 0 (1.6%) (2.0%) (25.0%) (6.7%) (2.2%) *Of the women treated with misoprostol, four were also referred, two by midwives (for “proc fever” and excess bleeding/severe anemia), one by a nurse (for D&C) and one by a PCN (patient was pale). ** Other methods include oxytocin, dilatation and evacuation (D&E) and expectant management.

For the remainder of the report, the majority of analyses are presented by facility level, as this is where there was the most variation in the data.

Obstetric history and socio-demographics for women enrolled in the OR are presented in Table 7. Women enrolled at RHCs had the highest number of pregnancies and children (mean gravida 3.1 and mean parity 1.9). One-fifth of enrolled women were less than or equal to 19 years of age. A higher proportion of women aged 36 and above (18%) presented at RHCs, compared to other facility levels. Women enrolled at the provincial hospital reported the highest levels of education, with 81% reporting completing secondary education and 14% reporting completing post-secondary education. Approximately one-quarter of the enrolled women at RHCs, rural and mission hospitals and district hospitals reported completing primary education. The majority of enrolled women (87%) reported being married. A total of 53 enrolled women (17%) reported having a previous abortion, and 5% reported having more than one previous abortion (data not shown).

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Table 7: Obstetric history and socio-demographic traits of enrolled women, by facility level Facility level Rural Rural and District Provincial Health Mission Total Hospital Hospital Center Hospital Obstetric history (n=315) 3.1 2.5 3.0 2.3 2.7 Mean gravida (min; max) (1; 12) (1; 8) (1; 5) (0; 6) (0; 12) 1.9 1.3 1.8 1.2 1.5 Mean parity (min; max) (0; 11) (0; 11) (0; 4) (0; 5) (0; 11) Socio-demographic characteristics Mean age 27.2 25.2 28.3 25.1 26.1 (min; max) (n=312)* (15; 43) (14; 40) (16; 47) (15; 39) (14; 47) 26 17 3 16 62 <19 (20.3%) (23.3%) (25.0%) (16.2%) (19.9%) 21 18 1 22 62 20-24 (16.4%) (24.7%) (8.3%) (22.2%) (19.9%) 58 33 6 58 155 25-35 (45.3%) (45.2%) (50.0%) (58.6%) (49.7%) 23 5 2 3 33 36 and above (18.0%) (6.9%) (16.7%) (3.0%) (10.6%) Education (n=291)** 1 1 1 3 None 0 (0.8%) (1.4%) (1.1%) (1.0%) 30 18 3 4 55 Primary (24.6%) (26.1%) (27.3%) (4.5%) (18.9%) 85 43 8 72 208 Secondary (69.7%) (62.3%) (72.7%) (80.9%) (71.5%) 6 7 12 25 Post-secondary 0 (4.9%) (10.1%) (13.5%) (8.6%) Marital status (n=293)*** 10 13 5 9 37 Single (8.1%) (18.3%) (45.5%) (10.3%) (12.6%) Married/in 114 57 6 78 255 union/cohabitating (91.9%) (80.3%) (54.5%) (89.7%) (87.0%) 1 1 Widowed/divorced 0 0 0 (1.4%) (0.3%) *Where the total is less than 315, * indicates missing values for that variable. Three providers at the Provincial Hospital are missing data on age. **A total of 24 women were missing data on education, six from RHCs, four from rural and mission hospitals, one from a district hospital and 13 from the provincial hospital. ***A total of 22 women were missing data on marital status, four from RHCs, two from rural and mission hospitals, one from a district hospital and 15 from the provincial hospital.

The total number of women enrolled in the OR who were treated with misoprostol increased from January to May (Figure 7). The number of women treated with misoprostol in May (n=57) and June (n=55) remained steady, and the number of reported cases in July, where data was only collected through the 15th of the month, was 38. The number of enrolled women treated with D&C increased during the first four months of the OR (from zero cases in January to 15 cases in April), and decreased during the remaining months. MVA was used to treat only two enrolled women, one in April and one in June.

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Figure 7: Method of initial treatment for enrolled women, by month

60

50

40

30

20

10

0 January February March April (n=60) May June July (n=13) (n=17) (n=38) (n=72) (n=66) (n=49)

Misoprostol D&C MVA

*Data was only collected for the first two weeks of the month in July.

The baseline data revealed that of all PAC cases presenting at RHCs between September 2011 and February 2012, 98% had to be referred to a higher-level facility for treatment (Figure 8). At rural and mission hospitals, almost half of presenting PAC cases had to be referred for treatment at baseline. During the OR, referrals at these lower-level health facilities decreased, with only 10% of enrolled women at RHCs and 3% at rural and mission hospitals being referred without receiving treatment.

Figure 8: Proportion of PAC cases referred without treatment, at baseline and during the operations research 98% 100%

80%

60% 48%

40%

20% 10% 3% 0% Rural Health Center Rural/Mission Hospital Baseline (September 2011-February 2012)

Operaons Research (1 January-15 July 2013)

A total of 115 enrolled TIAM cases were treated at RHCs during the OR, compared to only three cases that were treated at baseline (data not shown). The number of women receiving misoprostol for PAC at RHCs increased fourfold in just four months, while the number of women presenting at RHCs who had to be referred remained low throughout the OR (Figure 9).

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Figure 9: Enrolled women at Rural Health Centers who received misoprostol or were referred, by month

30

25

20

15

10

5

0 January February March April May June July

Treated with misoprostol Referred

7.2 FOLLOW-UP AND REFERRALS DUE TO TREATMENT FAILURE All women who were treated for incomplete abortion or miscarriage were asked to return for follow-up any time between seven and fourteen days after their initial treatment with misoprostol. However, data on follow-up visits were only reported by providers for women who received misoprostol as their initial treatment method; follow-up data is not available for enrolled women who received other treatment methods.

Of the 244 women initially treated with misoprostol, almost half returned for follow-up. Follow-up was highest at the RHCs (75%), and lowest at the provincial hospital (12%) and district hospital (10%) (Figure X).

Figure 10: Proportion of enrolled women who were initially treated with misoprostol who returned for follow-up, by facility level

100%

80% 75%

60% 49% 39% 40%

20% 10% 12%

0% Rural Health Rural/Mission District Hospital Provincial Total Center Hospital (n=12) Hospital (n=315) (n=128) (n=73) (n=102)

Of the women who returned for follow-up and for whom data was available on treatment diagnosis, 96% were diagnosed as successfully treated (Table 8). Only five enrolled women were diagnosed as not having been successfully treated and only one of these women had to be referred for completion of uterine evacuation. Of the remaining four women, one was sent home to wait

31 another week (she had come back one week after initial treatment), one was treated with MVA, and two were given an additional dose of misoprostol.

Table 8: Number of enrolled women treated with misoprostol who returned for follow-up visit, by facility level Rural and Rural Health District Provincial Mission Total Center Hospital Hospital Hospital (n=315) (n=128) (n=12) (n=102) (n=73) Initially treated with 114 69 10 51 244 misoprostol (89.1%) (94.5%) (83.3%) (50.0%) (77.5%) Returned for follow-up and 86 27 1 6 120 available data on the (75.4%) (39.1%) (10.0%) (11.8%) (49.2%) treatment diagnosis* 84 25 1 5 115 Patient successfully treated (97.7%) (92.6%) (100.0%) (83.3%) (95.8%) Patient not successfully 2 2 1 5 0 treated (2.3%) (7.4%) (16.7%) (4.1%) Received additional intervention or referral at follow-up 1 1 2 Misoprostol 0 0 (50.0%) (100.0%) (40.0%) 1 1 MVA 0 0 0 (50.0%) (20.0%) 1 1 Referred 0 0 0 (50.0%) (20.0%) Sent home to wait another 1 1 0 0 0 week (50.0%) (20.0%) *A total of 124 women returned for follow-up, but data on treatment diagnosis was missing for four women (two from RHCs, one from a rural and mission hospital, and one from a district hospital).Only data on the 120 women who returned for follow-up and had data on their treatment diagnosis are presented here.

There were no abortion-related deaths reported in the four districts during the OR.

7.3 SIDE EFFECTS Providers asked women who were initially treated with misoprostol and who returned for follow-up whether they had experienced any side effects from the drug. The majority of women (77%) did not report experiencing any side effects. Twenty-nine (23%) women out of the 124 who returned for follow-up reported experiencing at least one side effect. The most prominent side effects reported was pain/cramping (13%), followed by chills/fever (7%).

7.4 CONTRACEPTIVE METHOD PROVISION Women enrolled in the OR were asked which contraceptive method they were using prior to this current pregnancy. As the question did not specify a time period prior to the pregnancy, it is important to note that some of these women may have reported a method that they were using prior to the time period when they got pregnant. Almost half of the enrolled women for whom data was available on contraceptive use prior to this pregnancy reported not using a contraceptive method prior to this pregnancy. Of the 55% of enrolled women who did report using a method, the majority (39%) was taking the pill, while 8% was using injectables and 1% was using implants.

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Table 9: Contraceptive method used prior to pregnancy for enrolled women

50% 45% 39% 40%

30%

20%

8% 10% 6% 1% 2% 0% Pills Injectables Condoms Implant Natural Family None Planning

*Data on contraceptive method using prior to pregnancy is missing for 23 enrolled women.

Of the 131 women who reported using no contraceptive method prior to this pregnancy, 82% took a contraceptive method home with them at their initial visit (Table 10). Of the women who reported using a contraceptive method prior to this pregnancy, it is noteworthy that 15% did not take home a method at their initial visit. Only 26% of enrolled women aged 19 or less took home a contraceptive method at initial visit (data not shown).

Table 10: Family planning uptake at initial visit for enrolled women Reported not using a family Reported using a family planning planning method prior to this method prior to this pregnancy pregnancy (n=161) (n=131) Received contraceptive method 137 107 at initial visit (85.1%) (81.7%) Did not receive contraceptive 24 27 method at initial visit (14.9%) (20.6%)

Overall, providers reported that 96% of women enrolled in the OR received family planning counseling at their initial visit (Table 11). The majority (91%) of enrolled women who returned for follow-up also received family planning counseling. Higher proportions of women at the provincial hospital and RHCs (91% and 81%, respectively) received a contraceptive method at their initial visit, compared to rural and mission hospitals (58%) and district hospitals (50%). In total, 82% of enrolled women received family planning at either the initial or follow-up visit. Ten percent of women received a contraceptive method at follow-up and not at the initial visit.

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Table 11: Enrolled women who received family planning counseling and method at initial or follow-up visits, by facility level Rural Rural and District Provincial Health Mission Total Hospital Hospital Center Hospital (n=315) (n=12) (n=102) (n=128) (n=73) Initial visit Family planning counseling 71 11 101 302 119 (93.0%) provided at initial visit (97.3%) (91.7%) (99.0%) (95.9%) Received contraceptive 103 42 6 93 244 method at initial visit (80.5%) (57.5%) (50.0%) (91.2%) (77.5%) Women returned for follow- 97 31 2 7 137 up visit (75.8%) (42.5%) (16.7%) (6.9%) (43.5%) Family planning counseling 88 28 1 7 provided at follow-up 124 (90.5%) (90.7%) (90.3%) (50.0%) (100.0%) visit Received contraceptive 72 19 7 98 0 method at follow-up visit (74.2%) (61.3%) (100.0%) (71.5%) Received contraceptive 8 4 1 13 method at follow-up and 0 (8.2%) (12.9%) (14.3%) (9.5%) NOT at initial visit Received contraceptive 111 46 6 94 257 method at either initial or (86.7%) (63.0%) (50.0%) (92.2%) (81.6%) follow-up visit

The majority of enrolled women (94%) reported that their preferred method of contraception was available at initial visit (Table 12). For the fifteen women whose preferred method was not available, ten took home a method and five did not (data not shown).

Table 12: Availability of clients' preferred contraceptive method, by facility level Rural and Rural Health District Provincial Preferred contraceptive Mission Total Center Hospital Hospital available? Hospital (n=261)* (n=101) (n=9) (n=92) (n=59) 91 58 7 90 246 Yes (90.1%) (98.3%) (77.8%) (97.8%) (94.3%) 10 1 2 2 15 No (9.9%) (1.7%) (22.2%) (2.2%) (5.7%) *Data on availability of client’s preferred contraceptive method was missing from a total of 54 women: 27 from RHCs, 14 from rural and mission hospitals, 3 from district hospitals and 10 from the provincial hospital.

Of the women who took home a contraceptive method at initial visit, 70% took pills, 15% took condoms and 15% took injectables. Ten women (4%) received implants.

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Figure 11: Contraceptive methods provided at initial visit, by facility level

120%

4% 17% 4% 100% 2% 4% 22% 10% 9% 15% 80% 33% Implant 60% Injectables 64% 74% 33% 76% 70% 40% Pills Condoms 20% 33% 18% 14% 11% 15% 0% Rural Health Rural/Mission District Provincial Total Center Hospital Hospital Hospital (n=244) (n=103) (n=42) (n=6) (n=93)

*Columns will not always sum to 100% because some women took more than one family planning method.

7.5 ACCESS TO POSTABORTION CARE SERVICES Women enrolled in the OR were asked by a provider how long it took them to get to the health facility. On average, it took women 65 minutes to travel to the facility. These times ranged from 43 minutes (provincial hospital) to 66 minutes (RHCs) to 93 minutes (rural and mission hospitals) (Table 13).

Over one-third of enrolled women walked to the facility where they received treatment. The highest proportion of women who walked was reported at the RHCs (54%). One-fourth of women took a bus (24%) and almost one-third (29%) took a car. Women were asked about the cost of their transport to the health facility (data not shown). Amongst the 112 women who reported paying for transport, 98 had data on the amount of money they paid for transport. The highest average transport amounts were to the rural and mission hospitals (6.0 USD) and district hospitals (8.6 USD). Women at RHCs and provincial hospitals reported the lowest amounts (2.9 USD and 2.1 USD, respectively).

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Table 13: Client travel time and means of transport, by facility level Rural and Time and mode of Rural Health District Provincial Mission Total transport Center Hospital Hospital Hospital Time to facility (n=315) Mean time to facility in 65.8 92.7 64.7 43.4 64.7 minutes (min; max) (0; 480) (0; 780) (15; 180) (0; 900) (0; 900) Median time to facility 40 60 52.5 30.0 30.0 in minutes (min; max) (0; 480) (0; 780) (15; 180) (0; 900) (0; 900) Means of transport (n=281)* 65 23 3 9 100 Walk (53.7%) (33.3%) (25.0%) (11.4%) (35.6%) 14 2 16 Wheelbarrow 0 0 (11.6%) (2.9%) (5.7%) 2 1 1 4 Bike 0 (1.7%) (1.4%) (8.3%) (1.4%) 11 23 3 31 68 Bus (9.1%) (33.3%) (25.0%) (39.2%) (24.2%) 27 18 4 32 81 Car (22.3%) (26.1%) (33.3%) (40.5%) (28.8%) 1 1 4 6 Ambulance 0 (1.4%) (8.3%) (5.1%) (2.1%) More than one 2 1 3 6 0 method** (1.7%) (1.4%) (3.8%) (2.1%) *Data on means of transport is missing for 34 women (seven from RHCs, four from rural and mission hospitals, and 23 from the provincial hospital. **At RHCs, two women walked and took a car. At a rural hospital, one woman walked and took the bus. At the provincial hospital, two women walked and took the bus and one woman walked and took a car.

7.6 COMMUNITY AWARENESS Health providers, VHWs, OR monitoring staff, and Health Promotion Officers were trained on the key messages of the OR (dangers of unsafe abortion, the availability of PAC services with misoprostol at participating OR health facilities, the importance of preventing unwanted pregnancies, and the availability of family planning methods at health facilities). They were asked to disseminate these messages to community members. Health providers primarily did this via education sessions at their health facilities, while VHWs focused on spreading messages at community meetings. A total of 565 education sessions were held over the course of the OR; health providers led the majority of the sessions (54%) and VHWs led 14% of the sessions (data not shown). The number of community members reached by health providers, VHWs and OR monitoring staff steadily increased throughout the OR (Figure 12). Overall, 13,845 community members were reached with messages about misoprostol for PAC during the course of the OR.

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Figure 12: Cumulative number of community members reached with awareness messaging

9000 8000 n=7,790 7000 6000 5000 4000 n=3,062 3000 n=2,527 2000 1000 n=529 n=529 0 December January February March April May June Health Promoon Officer Monitoring Staff Village Health Worker Other Provider

7.7 PROVIDER PERSPECTIVES ON THE INTRODUCTION OF MISOPROSTOL FOR TREATEMENT OF INCOMPLETE ABORTION AND MISCARRIAGE Providers who had either been trained at the cascade trainings or received feedback from their colleagues about their trainings were invited to complete a Provider Survey. During the last two months of the OR, monitoring staff visited each facility and explained to providers the purpose of the Provider Survey, which was to gather provider perspectives on using misoprostol for TIAM. Monitoring staff left Provider Surveys at the facility and asked that staff member(s) who had received training on using misoprostol for TIAM complete the survey, which they would then collect at their supportive supervision visit the following month. In total, 94 surveys were completed (Table 14) and at least one provider from each OR facility completed a survey.

The majority of providers who completed a survey worked at RHCs (69%), and over half were primary care nurses (53%). Almost all of respondents (92%) reported working in a rural area and two-thirds had between one and ten years of work experience. Only 12 respondents (13%) reported having ever been trained on MVA.

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Table 14: Characteristics of providers who responded to survey Level of facility where provider works 65 Rural Health Center (69.2%) Mission/Rural 23 Hospital (24.5%) 1 District Hospital (1.1%) 5 Provincial Hospital (5.3%) Provider level 50 Primary Care Nurse (53.2%) 18 Nurse (19.2%) 23 Midwife (24.5%) 3 Physician (3.2%) Location of primary work site 86 Rural (91.5%) 8 Urban (8.5%) Years providing PAC services 35 1 – 5 years (37.2%) 33 6 – 10 years (35.1%) 11 11-20 years (11.7%) 10 21 – 30 years (10.6%) 5 31 – 40 years (5.3%) Ever trained in MVA* 12 Yes (13.0%) 80 No (87.0%) *Missing data on two providers (one at a rural health center and one at a rural and mission hospital) on whether they have ever received training on MVA. Percents are calculated out of the 92 providers for whom we have data for this question.

Providers were asked their level of agreement with a number of statements relating to misoprostol for PAC and family planning provision (Figure 13). The vast majority of providers agreed or strongly agreed that it was easy to learn how to use misoprostol to treat incomplete abortion (95%) and that they were able to manage their clients’ pain/symptoms after they took misoprostol (89%). However, over half of providers felt that they needed more training on using misoprostol for TIAM.

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Figure 13: Perspectives on using misoprostol for postabortion care*

"I am able to manage the pain and symptoms of 89% my clients aer they take misoprostol." (n=91)

"I feel that I need more training to be confident in using misoprostol to treat incomplete 55% aboron." (n=91)

"It was easy to learn how to use misoprostol to 95% treat incomplete aboron." (n=92)

0% 20% 40% 60% 80% 100%

*N’s in this figure reflect the number of providers who responded to each specific question.

The majority of providers stated that they were able to provide postabortion family planning (93%) and 89% stated that they had an adequate supply of family planning methods (Figure 14).

Figure 14: Provider perspectives on family planning services*

"I have an adequate supply of family planning 89% methods." (n=90)

"I am able to regularly counsel my clients on 93% postaboron contracepon." (n=90)

0% 20% 40% 60% 80% 100%

*N’s in this figure reflect the number of providers who responded to each specific question.

Providers were asked a number of open-ended questions relating to the provision of misoprostol for PAC, as well as questions around PAC service delivery and community perceptions of PAC services. Four key themes emerged: 1) positive perceptions of misoprostol for PAC, 2) stigma associated with seeking PAC and the importance of raising community awareness of PAC services, 3) effective counseling and privacy are essential to providing high-quality PAC services, and 4) the need for additional training and scaling up misoprostol for PAC.

Perceptions of Misoprostol for Postabortion Care Providers noted that people in their communities felt very positive about the availability of misoprostol for PAC. One midwife noted that initially women needed a lot of health education to inform them about misoprostol, but now that women have been successfully treated with misoprostol, “they are beginning to believe.” Numerous providers noted that women appreciated misoprostol because it is “easy to swallow and efficient,” as well as being safe, highly effective, and convenient.

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The majority of respondents noted that misoprostol was cheap, both in terms of the price of the drug (which was free during the OR) and in terms of transport. The fact that women did not have to take transport to a hospital to access PAC services was cited as one of the key benefits of misoprostol. One midwife, 54 years old, working at a RHC noted: “They [people in the community] really felt good because in the past we used to refer to the hospital for PAC, but with the use of misoprostol we are treating without complications, no costs, and it is very effective.” A PCN working at a RHC stated, “The community is appreciating postabortion care services because it prevents death or other complications that may arise.” Some providers said men and women appreciated that PAC services could now be accessed “while they are near their families,” as they no longer had to travel to a hospital to get the services.

Stigma and Community Awareness of Postabortion Care Services Providers felt that the stigma attached to seeking PAC can prevent women from accessing services, particularly if the woman is unmarried. Lack of knowledge about the availability of PAC services was cited as a key constraint, particularly in communities served by RHCs where misoprostol was being introduced as the sole PAC treatment available. Distance and the need for referral to hospitals was cited as a key barrier preventing women from accessing PAC.

Health education and improved awareness of the availability of PAC services were cited as extremely important in influencing women to access PAC, and as priority areas for improving services. A number of respondents noted the importance of involving VHWs in awareness activities, as well as traditional leaders, kraal heads, and village headmen. Respondents felt it was important to train VHWs to disseminate messages about the availability of misoprostol for PAC. They also identified “broadcasting though the media” as a means for disseminating messages, and one respondent said that the government should try to reach men with messages about PAC via radio announcements. The continued provision of pamphlets to women was cited as essential, in order to continually raise awareness about misoprostol for PAC services. Posters were also mentioned as an important means of communicating messages about PAC services.

Effective Counseling and Privacy for High-Quality PAC Services Respondents stated that some women feel fear “They come expecting to be transferred and go and anxiety when coming to a facility for PAC for invasive procedures, i.e. D&C, but after services; they may be scared of needing to be discussing with them they end up accepting the transferred and getting an invasive procedure, misoprostol. In our community a few success fear losing fertility, or be scared of being stories have made them believe in PAC.” accused of having a “criminal abortion.” They Midwife may also be scared of stigmatization from their community and their husband. However, providers noted that after talking to women, they were able to alleviate many of these fears, and after receiving counseling, most women “become relaxed.”

Providers universally agreed that privacy is extremely important to women when they come to a health facility for PAC: “That is where their dignity lies.” It is important as “no one wants to be seen while examination or treatment is being done” and additionally, they may be “grieving over the lost pregnancy.” One provider noted that privacy was particularly important to women belonging to the Apostolic Church, as these women may face serious repercussions from elders within their church if it is discovered that they visited a health facility. The need for women to talk openly with their

40 provider was expressed by many; women receiving PAC may need to “open up [about] all her problems,” “express views and feelings” and tell “all of her burning issues” without having fear of being overheard. Ensuring privacy has “encouraged [women] to visit the clinic whenever they have an abortion.” It was noted that hanging curtains in the wards would allow for more privacy.

Additional Training and Scaling up of Misoprostol for Postabortion Care Providers made the recommendation that “I honestly met it with skepticism but have since misoprostol should always be available at then taken it in and it’s a worthy alternative to health facilities and one provider suggested it other more invasive procedures.” be made available over the counter. The vast Doctor majority of respondents stated that more staff should be trained on using misoprostol for PAC. Most said that all nurses should be trained, while some stated that nurse aides should be trained as well, in case a PAC case presented while a nurse was away from the facility. One provider felt that “all health workers” should be trained in using misoprostol for PAC. Refresher trainings were identified as important, as well as conducting regular “review meetings” so that nurses can share their experiences using misoprostol and “discuss challenges and the way forward.” It was also noted that receiving “feedback” after training was not sufficient, and that all providers offering PAC services should be trained to use misoprostol. Providers highlighted the importance of providing pamphlets to women so that they can continue to read and learn about PAC. One provider also noted the need for a big chart to put on the wall, outlining how to use misoprostol for PAC. In addition to needing further training on misoprostol for PAC, providers also highlighted the need to be trained on MVA, Jadelle insertions, and conducting pap smears.

8. Discussion and Conclusions

POSTABORTION CARE SUCCESSFULLY PROVIDED AT RURAL HEALTH CENTERS Introducing misoprostol into postabortion care (PAC) services enabled providers at rural health centers (RHCs) in operations research (OR) districts to offer PAC services. Prior to the OR, RHCs referred almost all PAC cases for treatment to a hospital. The number of RHCs providing PAC services increased from one to 51 during the OR, and the program brought services closer to women in their communities. The proportion of women presenting for PAC who were referred without being treated dropped from 98% at baseline to 10% during the OR. During the OR, 114 women were treated at RHCs, an increase from the three cases that RHCs reported treating during the baseline assessment. Only one woman treated at an RHC with misoprostol during the OR had to be referred for additional treatment. Bringing services closer to women and providing treatment in a timelier manner is expected to decrease the likelihood of further complications and morbidity due to incomplete abortion and miscarriage.

POSTABORTION CARE SERVICES TASK-SHIFTED TO PRIMARY CARE NURSES Globally, there has been a general move to decentralize PAC services (Brookman-Amissa et al., 1999) and to provide services at lower-level facilities (Wanjiru et al., 2007). Further, research has shown that shifting the treatment of PAC cases to mid-level health providers can be cost effective (Johnston et al., 2007; King et al., 1997). Thirty-six percent of PAC cases in the OR were treated by primary care nurses (PCNs), demonstrating that training this cadre of providers in misoprostol for PAC can provide increased treatment options for women at RHCs where the PCNs are often the highest-level clinician available. By introducing PAC at RHCs, the OR provided increased opportunities for task-sharing

41 among different levels of providers. Additionally, the introduction of misoprostol increased the treatment options available at hospitals and provided a method that could be carried out by nurses at hospitals instead of only by physicians.

FAMILY PLANNING ESSENTIAL FOR HIGH-QUALITY POSTABORTION CARE Provision of family planning services including contraception is an essential element of PAC. The prevention of unwanted or mistimed pregnancies by the adoption of effective family planning methods will reduce the risks of maternal mortality by reducing repeat abortions and the health consequences of poor spacing or unwanted pregnancies. Ensuring that every woman who receives PAC services also receives family planning counseling and the provision of a modern contraceptive method, if she desires, has been cited as the most significant challenge to the provision of high- quality PAC (RamaRao et al., 2011). A cross-sectional study undertaken in Zimbabwe at two central hospitals showed that significantly more women who receive PAC services that include a family planning component were found at follow-up to have higher use of contraception, significantly fewer unplanned pregnancies, and fewer repeat abortions than women who had not received postabortion family planning counseling (Johnson et al., 2002).

The majority of women in the OR (82%) accepted a modern contraceptive method as part of PAC services. Rates of contraceptive uptake were highest at the RHCs (87%) and the provincial hospitals (92%). Long-lasting contraceptives, injectables and implants, which offer more reliable protection, were more likely to be the methods of choice at the RHCs (26% of accepters) than at the provincial hospital (13%). Contraceptive uptake was also high (82%) among women who reported not using a family planning method prior to the last pregnancy. While the most recent Demographic and Health Survey (DHS) data reports that 58% of reproductive age women are not currently using a modern contraceptive method (Zimbabwe National Statistics Agency (ZIMSTAT) and ICF International, 2012), the OR data showed that only 45% of enrolled women reported not using a family planning method prior to this pregnancy. As the question asked in the OR was not clear about the time period for when the contraceptive was used, this might point to the fact that there were more women in the OR who were not using a contraceptive method when they got pregnant, and that they were reporting family planning use for a time in the past, prior to this pregnancy. For the women who had not been using contraception prior to this current pregnancy, PAC presents what may be their only opportunity to access family planning.

Encouraging contraceptive uptake by youth has been shown in the literature to be challenging (Evans et al., 2013). The fact that only 26% of enrolled women aged 19 or less took home a contraceptive method at initial visit highlights the need for providers to be trained on specific counseling strategies for adolescents.

FOLLOW-UP HIGHEST AT RURAL HEALTH CENTERS Increasing follow-up rates improves overall service quality by ensuring that PAC services are comprehensive. In this OR, follow-up data was only available on women initially treated with misoprostol. Overall, 49% of enrolled women who were initially treated with misoprostol returned for follow-up. The highest follow-up rates were seen at the RHCs, where 75% of women returned for follow-up. Over half (54%) of women enrolled at RHCs reported that they walked to the facility, illustrating that these lower level facilities may be more accessible than higher-level facilities. When PAC services are closer to women’s homes, it is easier for them to return for follow-up. Women often have to travel further to reach a hospital than a health center, making it more challenging for them to return for follow-up.

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TREATMENT METHOD MIX HIGHLIGHTS CONTINUED RELIANCE ON DILATATION AND CURETTAGE AT HOSPITALS Misoprostol, a World Health Organization (WHO)-recommended method for the PAC, was used in 78% of cases throughout the OR. The highest rates of misoprostol use were seen at the lower-level facilities (89% at RHCs and 95% at rural and mission hospitals). Dilatation and Curettage (D&C) is not a method recommended by the WHO (WHO, 2012). However, during the OR, D&C was used to treat 16% of enrolled women; almost half (47%) of all enrolled women at the provincial hospital were treated with D&C. All cases treated with D&C were at the district or provincial hospitals, illustrating a continued reliance on surgical methods at these higher-level facilities. As the ZMoHCC works to decrease the reliance on D&C as a primary treatment method for PAC, misoprostol provides an alternative that is cheaper than surgical procedures, easy to learn to use, with significantly lower complication rates than D&C.

NEED FOR MORE EXTENSIVE PROVIDER TRAINING ON MISOPROSTOL FOR POSTABORTION CARE Respondents to the Provider Survey highlighted the need to train additional providers in PAC. It is important to note that while the administration of misoprostol itself is not difficult to learn, the more challenging areas are in diagnosing women presenting with symptoms of incomplete abortion and miscarriage, managing side effects, and caring for clients after the procedure. As many providers deliver PAC at the government referral hospitals, it is important to ensure that all of the providers offering PAC services are formally trained with standardized knowledge and skill assessment tools on the appropriate use of misoprostol for treatment of incomplete abortion and miscarriage (TIAM), overall assessment protocols, and management and follow-up of PAC cases. Increasing the number of providers who are comfortable with using misoprostol for TIAM and providing all other components of PAC services will help maintain quality of services during expansion. Additionally, because it is often doctors who determine the treatment choices in hospitals, their inclusion in the training and orientation to the program is essential - even if midwives and nurses are the ones to administer misoprostol. It can be also expected that involvement of doctors in misoprostol trainings will further familiarize them with different treatment options, which could decrease reliance on D&C as a primary treatment method at higher-level hospitals.

COMMUNITY AWARENESS OF UNSAFE ABORTION AND PAC SERVICES Community sensitization activities were an important component of the OR, where 18,962 community members were reached with messages about misoprostol, PAC and the dangers of unsafe abortion. However, it is important to note that the population of the four OR districts was 762,481, meaning that only 2.5% of the population was reached with these messages. Health providers led the majority of education sessions (54%), indicating that providers are able to incorporate messages about misoprostol and PAC into already-existing education sessions. Village Health Workers provided only 13% of the education sessions, and Provider Survey respondents highlighted that more VHWs should be sensitized to be able to incorporate key messages into their work.

IMPLEMENTATION CHALLENGES Providers at some district and provincial hospitals did not follow the protocol of offering all women presenting for TIAM the opportunity to enroll in the OR. Enrollment numbers at these facility levels (n=12 at district hospitals and n=102 at the provincial hospital) were much lower than expected. Despite repeated efforts to improve adherence to the protocol (including visits by high-level ZMoHCC officials to these sites), providers continued to exclude some of the PAC patients. The exact

43 reasons for exclusion were not completely understood. One explanation is that it is clear that not enough providers at the provincial and district hospitals were trained. Other factors identified during the site visits included low provider motivation, as enrolling women necessitated completing additional paperwork. This protocol violation was not observed at the RHCs or rural and mission hospitals. Despite efforts by monitoring staff to increase enrollment at the district and provincial hospitals, overall numbers remained relatively low.

Accurately estimating the gestational age, both through the date of the last menstrual period (LMP), and by bimanual exam during the OR was also identified as a challenge (data not presented). One reason was that women could not remember the first day of their LMP, and specific training for gestational age assessment through bimanual exam was not included in the provider training. Ensuring provider competency in estimating gestational age is essential for the delivery of the appropriate treatment to women seeking PAC. Estimation can be particularly challenging in rural areas where women often do not recall the date of LMP. Both misoprostol and manual vacuum aspiration (MVA) are recommended for treatment of first trimester uncomplicated cases of incomplete abortion and miscarriage. Strengthening the ability of providers, including primary care nurses, to accurately estimate gestational age is needed to better ensure that misoprostol for TIAM is administered for women in the first trimester. Midwives, who often demonstrate skill in this area, may be a valuable resource for this training.

Another implementation challenge involved the collection of follow-up data. In the OR, 49% of all women who were treated with misoprostol returned for follow-up. It is plausible that if a woman was feeling well after the procedure, she may not have felt it necessary to return to the health facility for a follow-up visit, and that the distance to the health facility could also have been a contributing factor. However, data on why or why not women returned for follow up was not collected. This gap may introduce bias into the results, as it is unknown if there were other factors involved in the decision to return (or not return) for follow-up.

Additionally, while providers and VHWs were able to effectively gather data on the number of community education sessions they led and on how many people attended, data were not collected on any socio-demographic variables on the attendees. Consequently, the age/sex/religious affiliation of the attendees are not known, all of which would have been useful in informing who the audience was for the messages. Data were also not collected on how well attendees understood or retained messages.

9. Programmatic Recommendations

The following recommendations are based both on the results of the operations research (OR) as well as lessons learned from the ZMoHCC and providers regarding ways to strengthen postabortion care (PAC) services in Zimbabwe. As such, the following recommendations go beyond the results presented in this report, and encompass larger programmatic issues in the country.

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INTRODUCE TREATMENT OF INCOMPLETE ABORTION AND MISCARRIAGE WITH MISOPROSTOL WITHIN A REFERRAL SYSTEM AT RURAL HEALTH CENTERS, WHERE POSTABORTION CARE SERVICES ARE NOT AVAILABLE It is a critical priority to expand PAC services with misoprostol to facilities that are not currently offering PAC. When PAC services are introduced at the lowest level of the health care system (at RHCs or rural hospitals), it brings essential reproductive health services closer to women. Women presenting with uncomplicated cases of incomplete abortion or miscarriage can be safely and effectively treated at RHCs. They also have access to a referral system in the event that they have complications or need to be referred to a higher-level health facility for surgical treatment. As PAC services are expanded, it will also be important to ensure that data is continuously collected on the treatment of PAC patients. Integrating the PAC Logbook, which was created for this OR, into the ZMoHCC routine health information system, will provide a means for accurately tracking treatment methods for incomplete abortion and miscarriage (TIAM), as well as key indicators such as contraceptive uptake and return for follow-up.

INTEGRATE MISOPROSTOL FOR TREATMENT OF INCOMPLETE ABORTION AND MISCARRIAGE AT THOSE HEALTH FACILITIES CURRENTLY PROVIDING PAC SERVICES Integrating misoprostol into existing PAC services at higher-level facilities that are currently providing TIAM with other methods will allow women to have a non-surgical, less expensive treatment option which will save time for both women and providers. Misoprostol can be administered by nurses, thus freeing up the time of physicians for more complicated cases.

PROVIDE ON-THE-JOB TRAINING ON THE USE OF MISOPROSTOL TO ALL POSTABORTION CARE SERVICE PROVIDERS: PHYSICIANS, MIDWIVES, AND NURSES, INCLUDING PRIMARY CARE NURSES Training providers at all levels of the health system in Zimbabwe will expand access to PAC services, particularly for women living in rural areas. It is particularly important to train primary care nurses (PCNs), who are often the highest-level clinicians at RHCs. All providers of PAC services at higher- level facilities should be trained as well, and it is not sufficient to rely on trained providers to give “feedback” to untrained providers at facilities with large staff. On-the-job trainings using standardized knowledge and skills assessment tools should be held to ensure that the maximum number of providers is trained to administer misoprostol for PAC.

CONTINUE TO STRENGTHEN POSTABORTION FAMILY PLANNING PROVISIONS While family planning uptake was high for women enrolled in the OR (82% took home a contraceptive method at either the initial or follow-up visit), there were still 58 enrolled women who did not receive a method. Women may experience pressure from family members to get pregnant again quickly, so it is important that clinicians provide culturally appropriate counseling to ensure that women have a clear understanding of when they can get pregnant again and what contraceptive methods are available to them. In addition, providers should ensure that women know how to properly use their chosen methods; with 55% of women enrolled in the OR reporting that they were using contraception prior to this pregnancy, it is possible that women experienced method failure, which proper counseling can work to address. Providers should continue to receive supportive supervision so that they understand how to properly counsel women on family planning methods in ways that are acceptable and easily understood.

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DEVELOP AND DISTRIBUTE PRACTICAL, DURABLE JOB AIDS TO SUPPORT PROVIDERS IN CORRECTLY IDENTIFYING WOMEN ELIGIBLE FOR TREATMENT WITH DIFFERENT METHODS AND THOSE WHO SHOULD BE REFERRED It is important to keep service providers’ skills and knowledge up-to-date and certain components of providers’ training need to be reinforced to assure that the protocol and reporting system are followed correctly. The misoprostol pocket guides and PAC brochures developed by VSI and the ZMoHCC should continue to be distributed to providers. In addition, larger job aids should be made, outlining PAC protocols for women, distinguishing between recommended protocols for women at less than or equal to 13 weeks gestation and over 13 weeks gestation.

BUILD COMMUNITY AWARENESS ON THE AVAILABILITY OF POSTABORTION CARE SERVICES, THE DANGERS OF UNSAFE ABORTION, THE IMPORTANCE OF PREVENTING UNWANTED PREGNANCIES, AND RAISE AWARENESS OF THE AVAILABILITY OF FAMILY PLANNING SERVICES, BY TRAINING HEALTH PROVIDERS AT FACILITIES AND VILLAGE HEALTH WORKERS ON HOW TO INCORPORATE THESE MESSAGES INTO THEIR EDUCATIONAL ACTIVITIES Engage providers, Village Health Workers (VHWs), district health staff, and local administrators in additional community awareness activities to raise awareness of unwanted pregnancy, the consequences of unsafe abortion, and availability of PAC services. In addition to the general activities for the wider community, activities and materials should be created specifically to target adolescents. Young women aged less than or equal to 19 years comprised 20% of the women enrolled in the OR, indicating that there is a need for this group to be educated both on the dangers of unsafe abortion and on how to prevent unwanted pregnancies, as well as about the availability of high-quality PAC services at all levels of the health system.

COMPLETE THE REVISION OF THE COMPREHENSIVE ABORTION CARE GUIDELINES AND PROTOCOLS ENSURING THE INCLUSION OF UPDATED INFORMATION ON POSTABORTION CARE SERVICES; DISSEMINATE AND IMPLEMENT THE REVISED GUIDELINES After the Comprehensive Abortion Care (CAC) Guidelines are finalized, it will be critical to ensure that the guidelines and protocols are disseminated to all health facilities providing PAC services. Supportive supervision should also be provided to ensure that providers are correctly implementing the protocols.

INCORPORATE TRAINING ON MISOPROSTOL FOR TREATMENT OF INCOMPLETE ABORTION AND MISCARRIAGE IN THE PRE-SERVICE CURRICULA OF THE MEDICAL, NURSING, AND MIDWIFERY SCHOOLS In order to ensure the sustainable dissemination of correct and updated clinical protocols and guidelines, training on misoprostol for TIAM should be incorporated into the pre-service curricula of all medical, nursing and midwifery schools in Zimbabwe.

REGISTER MISOPROSTOL FOR TREATMENT OF INCOMPLETE ABORTION AND MISCARRIAGE, WHICH IS AN IMPORTANT FIRST STEP IN ENSURING THE SUPPLY OF A HIGH QUALITY PRODUCT Registration, the process by which a drug is approved by a regulatory agency for importation,

46 distribution and marketing for a specific medical indication, is also a key strategy for improving access to misoprostol. Registration is important because it allows for the drug to be marketed for approved indications and to ensure that an insert with proper dosages and instructions for providers and pharmacists is included with the product. It safeguards product quality through oversight provided by a drug regulatory board. In order to ensure the availability of misoprostol for PAC at all levels of the health care system, it will be important both to ensure that a misoprostol product is registered for TIAM and that policies are in place for procurement.

STRENGTHEN PROVIDER CAPACITY AND UTILIZATION OF MANUAL VACUUM ASPIRATION FOR POSTABORTION CARE TO ADDRESS CASES THAT ARE NOT ELIGIBLE FOR MISOPROSTOL; PHASE OUT DILATATION AND CURETTAGE Providers should be trained to provide MVA and equipped with MVA supplies. Only two facilities reported having functioning MVA equipment at baseline, and only two of the women enrolled in the OR were treated with MVA. To be truly comprehensive, a PAC program should include all methods of uterine evacuation recommended by the WHO. D&C, a method of uterine evacuation not recommended by the WHO, should be phased out.

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10. References

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APPENDIX A: MISOPROSTOL REGIMENS, POCKET REFERENCE FOR CLINICIANS

CERVICAL RIPENING Dose Route Instructions Vaginal or 400 mcg Give 3 hours before the procedure. sublingual INTRAUTERINE FETAL DEATH Reduce doses in women with not use with previous cesarean section. Dose Route Instructions 13-17 weeks 200 mcg Vaginal Every 6 hours, maximum 4 doses. 18-26 weeks 100 mcg Vaginal Every 6 hours, maximum 4 doses. >26 weeks 25 mcg Vaginal Every 6 hours. OR 25 mcg Oral Every 2 hours.

MEDICATION ABORTION Use as permitted within the country’s legal framework. Regimen MEDICATION ABORTION WITH AND MISOPROSTOL Up to 9 weeks gestation Mifepristone 200 mg oral followed 24 to 48 hours later by misoprostol 800 mcg vaginal, sublingual or buccal. For oral route, 400 mcg misoprostol can be used up to 7 weeks of gestation. 9-12 weeks gestation Mifepristone 200 mg oral followed 36 to 48 hours later by misoprostol 800 mcg vagi- nal. Subsequent misoprostol 400 mcg vaginal or sublingual can be used every 3 hours until expulsion of the products of conception, up to 4 further doses. 12-24 weeks gestation Mifepristone 200 mg oral followed 36 to 48 hours later by misoprostol 800 mcg vaginal or 400 mcg oral. Subsequent misoprostol 400 mcg vaginal or sublingual can be used every 3 hours until expulsion of the products of conception, up to 4 further doses. Dose Route Instructions MEDICATION ABORTION WITH MISOPROSTOL ONLY Up to 12 weeks gestation Vaginal or 800 mcg Every 3 hours, maximum 3 doses. sublingual 12-24 weeks gestation 400 mcg Vaginal or sublingual Every 3 hours, maximum 5 doses.

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APPENDIX B: CONTRACEPTIVE GUIDE, POCKET REFERENCE FOR CLINICIANS

Contraceptive Guide for POSTPARTUM SERVICES Pocket Reference for Clinicians 48 3 4 6 6 9 DELIVERY HOURS WEEKS WEEKS WEEKS MONTHS MONTHS Condoms/Spermicides Intrauterine Device (IUD)a ALL Diaphragm/Cervical Cap WOMEN Tubal Ligation Emergency Contraception Male Sterilization Lactational Amenorrhea Methodb BREAST- Progestin-only Pills or Injectables FEEDING WOMEN Combined Oral or Injectable Contraceptivesc NON- BREAST- Progestin-only Pills or Injectables FEEDING Combined Oral or Injectable Contraceptives (COCs/CICs)c WOMEN

aIf delivery is in a health care facility, IUD can be inserted immediately postpartum (within 48 hrs). bNatural family planning (NFP) may be harder for breastfeeding women as reduced ovarian function makes fertility signs more difficult to interpret. As a result, NFP can require prolonged periods of abstinence during breastfeeding. cDuring the first 6 months postpartum, COCs/CICs may affect the quantity of breastmilk and the healthy growth of the infant. However, if no other methods are available or acceptable, a woman may use COCs/CICs starting 6 weeks postpartum. Adapted from: MAQ Exchange: Contraceptive Technology Update

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APPENDIX C: COMMUNITY BROCHURE FOR WOMEN Using misoprostol tablets to treat incomplete abortion

TREATMENT OF INCOMPLETE ABORTION AND WHAT WILL HAPPEN WHEN YOU HOW CAN YOU MANAGE THE SIDE EFFECTS? MISCARRIAGE WITH MISOPROSTOL TABLETS TAKE THE TABLETS If you are having an incomplete abortion, you Misoprostol causes the uterus to contract. You You can take pain medicines for cramps. Fever can be treated safely and effectively with will have some vaginal bleeding and cramping medicines are rarely needed. Drinking lots of misoprostol pills and you may see blood clots. water and getting rest will also help. Most side effects will disappear on their own in a short time.

CRAMPING WHEN SHOULD YOU SEEK HELP FROM A HEALTH CARE PROVIDER? BLEEDING You should seek immediate help if you have: MANY WOMEN DO NOT HAVE SIDE EFFECTS • Heavy bleeding But some women may experience fever, chills, • Fever which lasts more than a day or starts nausea or diarrhoea. These should go away on any day after the day you take misoprostol their own in a few hours. • Constant cramping and pain that does not get better with medication, rest, or heating HOW TO TAKE MISOPROSTOL TABLETS pad Swallow 3 tablets (600 mcg ) with water • The feeling of being very sick

DIARRHOEA VOMITING / NAUSEA

HEAVY BLEEDING FEVER

FEVER / CHILLS CONSTANT CRAMPING

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WHAT IS THE BEST CONTRACEPTIVE WHAT IS THE BEST CONTRACEPTIVE METHOD FOR ME? METHOD FOR ME? You are able to get pregnant again within a You are able to get pregnant again within a couple of weeks. If you would like contraception, couple of weeks. If you would like contraception, Using misoprostol tablets it should be started immediately. You can start Using misoprostol tablets it should be started immediately. You can start most methods at the same time you take your to treat incomplete abortion most methods at the same time you take your to treat incomplete abortion misoprostol tablets misoprostol tablets

WHEN SHOULD I COME BACK WHEN SHOULD I COME BACK FOR FOLLOW - UP? FOR FOLLOW - UP? Please come back for a follow-up visit in 1 - 2 Please come back for a follow-up visit in 1 - 2 weeks to ensure that your treatment was weeks to ensure that your treatment was successful. successful.

HEALTH CLINIC HEALTH CLINIC

If you are having an incomplete If you are having an incomplete abortion, you can be treated safely abortion, you can be treated safely DATE OF YOUR FOLLOW-UP VISIT: and effectively with DATE OF YOUR FOLLOW-UP VISIT: and effectively with ...... /...... /...... misoprostol tablets ...... /...... /...... misoprostol tablets

LOCATION: LOCATION:

......

PHONE PHONE

......

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