Bhandari et al. BMC Pregnancy and Childbirth 2014, 14:109 http://www.biomedcentral.com/1471-2393/14/109 STUDY PROTOCOL Open Access A cluster randomized implementation trial to measure the effectiveness of an intervention package aiming to increase the utilization of skilled birth attendants by women for childbirth: study protocol Gajananda P Bhandari1*, Narayan Subedi1, Janak Thapa1, Bishnu Choulagai2, Mahesh K Maskey1 and Sharad R Onta2 Abstract Background: Nepal is on track to achieve MDG 5 but there is a huge sub-national disparity with existing high maternal mortality in western and hilly regions. The national priority is to reduce this disparity to achieve the goal at sub-national level. Evidences from developing countries show that increasing utilization of skilled attendant at birth is an important indicator for reducing maternal death. Further, there is a very low utilization during childbirth in western and hilly regions of Nepal which clearly depicts the barriers in utilization of skilled birth attendants. So, there is a need to overcome the identified barriers to increase the utilization thereby decreasing the maternal mortality. The hypothesis of this study is that through a package of interventions the utilization of skilled birth attendants will be increased and hence improve maternal health in Nepal. Method/Design: This study involves a cluster randomized controlled trial involving approximately 5000 pregnant women in 36 clusters. The 18 intervention clusters will receive the following interventions: i) mobilization of family support for pregnant women to reach the health facility, ii) availability of emergency funds for institutional childbirth, iii) availability of transport options to reach a health facility for childbirth, iv) training to health workers on communication skills, v) security provisions for SBAs to reach services 24/24 through community mobilization; 18 control clusters will not receive the intervention package. The final evaluation of the intervention is planned to be completed by October 2014. Primary study output of this study is utilization of SBA services. Secondary study outputs measure the uptake of antenatal care, post natal checkup for mother and baby, availability of transportation for childbirth, operation of emergency fund, improved reception of women at health services, and improved physical security of SBAs. Discussion: The intervention package is designed to increase the utilization of skilled birth attendants by overcoming the barriers related to awareness, finance, transport, security etc. If proven effective, the Ministry of Health has committed to scale up the intervention package throughout the country. Trial registration number: ISRCTN78892490. * Correspondence: [email protected] 1Nepal Public Health Foundation, Post Box 4004, Kathmandu, Nepal Full list of author information is available at the end of the article © 2014 Bhandari et al.; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. Bhandari et al. BMC Pregnancy and Childbirth 2014, 14:109 Page 2 of 9 http://www.biomedcentral.com/1471-2393/14/109 Background child and maternal health in Nepal. These include the Millennium development goals for the improvement of Eighth Health Plan (1992–1997), the Ninth Health Plan maternal health has shown suboptimal achievements (1997–2002), Tenth Five Year Plan (2002–2007), Three in less than one fourth of countries where it is on track to Year Interim Plans (2008–11, 2011–13) and the Second reduce maternal mortality ratios (MMR) by 3/4th (below Long Term Health Plan (SLTHP) (1997–2017). The Three 139/100000 live births) [1]. Only 16 of 68 countries are on year interim plans aimed to provide free essential health track to achieve 2/3rd reduction in under-five mortality by care services for all citizens and the safe delivery incentive 2015 [2,3]. Increasing skilled attendant at birth is an im- programme to accelerate the country’sprogresstowards portant indicator for ensuring better maternal, child and achieving Millennium Development Goals 4 and 5 [15,16]. neonatal health [4]. In these plans, achieving health results in women, children Nepal is making considerable progress in achieving and vulnerable, marginalized, disadvantaged populations, Millennium Development Goals (MDG) 4 and 5 [1,3,5]. as well as those living in hard to reach areas have been However, progress is uneven at sub-national level, be- prioritized. The primary healthcare approach is central to tween developmental and ecological regions, and in popula- the delivery of services [8]. tions of different socio-economic status [6,7]. The national The Safe Delivery Incentive Programme (SDIP), started average of Infant Mortality Rate (IMR) per thousand live in 2005, is central to government’s effort to improve ma- births is 48, but mid-western and far-western districts ternal health. It aims to increase coverage of skilled birth have 58 and 65 respectively. Likewise,mountain districts attendance and also to contribute towards poverty reduc- have the higher IMR (73) as compared to hill and terai tion by preventing death and disability [17,18]. The SDIP districts (50 and 53) as per Nepal Demographic and was developed to help households overcome financial Health Survey (NDHS) 2011 [8].Similar patterns are ob- barriers to accessing maternity care. According to the served for MMR [9]. revised policy guidelines, the SDIP provides: Women Despite a decrease in maternal mortality (770 in 1990 giving birth at eligible government health institutions to 170 in 2010), [10] the underlying causes of maternal (hospital, primary health care centre, or health post), deaths remain of serious concern. An analysis of maternal medical colleges, mission hospitals and NGO-run hos- deaths [1] reveals that nearly 83% of all maternal death pitals receive a fixed sum of 1,500 NRs ( 20 $) in moun- is attributable to direct causes: the three main causes be- tain areas, 1,000 NRs (12 $) in hill areas, and 500 NRs (6$) ing post-partum hemorrhage (32%), hypertensive disor- in the Tarai [19]. But, failure to pay the financial incentives ders during pregnancy (25%) and abortion (13%) [11]. to the women on time in many districts has resulted in Two third of infant deaths occur during the neonatal low acceptance of the offer of the cash incentive. Conse- period [12]. Without improved availability and utilization quently, low SBA coverage continues despite the financial of skilled birth attendant’s (SBAs) to address the direct incentives [20]. causes of maternal deaths, further reduction in maternal The GoN has endorsed a SBA policy in 2006 within and neonatal mortality is extremely unlikely. Amidst low the framework of the Safe Motherhood Policy 1998, and SBA service coverage at the time of birth (28.8%) against aims to increase service coverage to 60% by the year the target to be achieved by the year 2010 (50%) and 2015 2015 [21]. While the international target of SBA cover- (60%) [13] women are still facing barriers in utilization of age is 90%, the target set by Nepal is in line with the SBA services in Nepal. Research is needed to explore [1] WHO target for the countries with high levels of mater- the approach that will be cost effective and scalable to nal mortality [21,22]. overcome the barriers to utilization of skill birth attendant The progress in meeting this target, however, is slow, services in Nepal. as SBA coverage has reached only 28.8% by 2010 [23]. This coverage accounts for service provided by ‘any’ kind Efforts of national health system for maternal and child of trained health professionals, many of which do not health improvement meet the strict criteria set by the SBA policy of Nepal In response to the need for accelerated actions to reach [21] This SBA coverage would mainly refer to this mix the desired reductions in maternal and newborn mortal- of health professionals who may or may not be trained ity, the government of Nepal (GoN) has devised several as SBAs. This is to happen unless SBA training to the policy strategies and programs [14]. The National Health health professionals is expanded quickly and in massive Policy (NHP) formulated in 1991 with the objective of scale. enhancing the health status of rural population extends The government has deployed three major strategies; the primary health care system with the intention of in- promoting birth preparedness and complication readiness, creased access to modern medical facilities and trained institutional childbirth, and expansion of 24-hour emer- health care providers.The subsequent health plans were gency obstetric care through the Safe Motherhood and based on the NHP and focused on strengthening neonatal, Neonatal Health Long Term Health Plan (SMNHLTP Bhandari et al. BMC Pregnancy and Childbirth 2014, 14:109 Page 3 of 9 http://www.biomedcentral.com/1471-2393/14/109 2006–2017). The SMNHLTP also includes an increased Hypothesis focus on other areas like the importance of addressing It is hypothesized that through a package of interven- neonatal health as an integral part of safe motherhood tions which includes activities to increase family support