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RPPH C-Section FINAL Report Page 1 SECTION A. GENERAL SECTION A. GENERAL INFORMATION 1. Title of Research Project Factors behind the growing rate of unnecessary caesarian sections in Three Tertiary care hospital of Rawalpindi, Pakistan. 2. Code of the project: RPPH 18-15 3. Name of Principal Investigator: Prof. Dr Rizwana Chaudhri 4. Country: Pakistan 5. TSA Number: Contract # 202400707 6. Reporting period: 21st March till 1st November 2019 7. Objectives of the research proposal: The project was designed with the following objectives: General objective: the overall aim expected to be achieved from this research The overall purpose of this research is to study the overall burden of Cesarean sections in public health hospitals in Pakistan. The study also aims to identify the un-necessary cesarean sections along with associated factors to provide recommendations to avoid unnecessary cesarean sections. Specific objectives: Following are the specific objectives of this research: . To calculate the proportion of Cesarean sections conducted in public health hospitals in Rawalpindi, Pakistan to assess the burden of CS . To determine the appropriateness of Cesarean sections in public health hospitals in Pakistan by using Robson criteria . To explore the various factors including personal, social, cultural, medical provider and system related factors that influence the non-judicious use of Cesarean sections in Pakistan . To provide recommendations which could be implemented to avoid non-judicious and unnecessary use of cesarean sections SECTION B. TECHNICAL REPORT METHODOLOGY It was a cross-sectional study conducted in district Rawalpindi; one of the largest districts of Punjab Pakistan, with a population of over 5.5 million. It is geographically connected to Islamabad, the capital city of Pakistan and not only serves the population of the district itself but gets huge influx of patients from Islamabad and Khyber Pakhtunkhwa (the 3rd most populous province in Pakistan). Study site includes 03 largest tertiary care public hospitals which serve more than 50% of the population in the district. These institutions are Holy Family Hospital WCCPRD9946948 | 2019/935864 (HFH), Benazir Bhutto Hospital (BBH) and District Headquarter Hospital (DHQ). These 03 public sector hospitals are affiliated with Rawalpindi Medical University (RMU). These RPPH C-Section FINAL Report Page 1 hospitals are the main referral hospitals providing medical facilities to Rawalpindi as well as neighboring areas including Chakwal, Attock, Mianwali, Taxila and Azad Jammu & Kashmir. There are four separate departments of gynecology and obstetrics working in these 3 facilities and altogether an average number of 2000 deliveries are conducted per month. Since many stakeholders were involved in the project, the initial time was spent in careful planning and ensuring all stakeholders were involved. Preparatory Phase: During this phase pre-data collection were undertaken to facilitate the data collection. Broadly these activities included: Stakeholders meeting Ethical approval Hiring and training of research medical officers incl. refresher Pilot testing Stakeholder meetings: Number of meetings was held to create an enabling environment. The details of these meeting were as following: Meeting with HODs: Meeting were held with all the four head of the departments of three tertiary care hospitals of Rawalpindi Medical University (RMU) which included Holy Family Hospital Gynae unit I (HFH GU1) and Gynae Unit II (HFH GU 2), Benazir Bhutto Hospital (BBH) and District Headquarter Hospital (DHQ). The main purpose of the meeting was to inform them of the project details, assist in identification of doctors working in the hospital who will facilitate the research activities, identification of the data collection team and helped core research team including to understand the registration process of a woman who comes for delivery, record keeping of all deliveries, C-section patient hospitalization etc. One focal person apart from HOD of the Gynae unit was also identified to work with core research team in each unit. Meeting with focal person and doctors: An initial meeting was held with focal person of each unit followed by meeting all doctors working within the units. Through the morning meeting which is part of hospital routine, study objectives, methodology and requirement of information were briefed. All procedure of women registration till delivery was reviewed; different registers where data of woman were recorded were checked to assess the quality of data for the core 6 variables of Robson classification. Process of recruitment and obtaining the data of all deliveries especially the women who had under gone C-section was discussed and how the hospital staff would facilitate the research medical offices was emphasized. To update and maintain registers were also stressed in the meeting. Modification of the registers; In all units it was observed that two main registers one for SVDs and one for C-section including both elective and emergency were maintained. All 6 core variables of Robson were part of the registers except information on onset of labour. Section on this information was added in hospital routine data collection register. WCCPRD9946948 | 2019/935864 Monitoring process of routine data recording mechanism: After all debriefing meeting with hospital medical doctors and staff; research medical officers and PI/Co-PIs monitor RPPH C-Section FINAL Report Page 2 the recording mechanism for next two weeks. During this phase quality of completeness of the registers were also checked. Ethical approval: Ethical approval of the study was obtained from Rawalpindi Medical University ethical board. Study population Inclusion Criteria: All female patients above 18 years of age who were admitted to the gynae/obstetric unit of the selected hospitals and had undergone a cesarean section for the delivery of the baby Exclusion Criteria: Following patients were excluded from the study i) Patients with critical post-operative complications ii) Those who left against medical advice of doctors (as they won‟t be able to provide required information) iii) Patients who refused to provide informed consent Following the above mentioned criteria, our case definition for study subjects would be “all females, aged 18 years or more who have been delivered by cesarean section at one of the selected hospitals for this study and are willing to participate in the study and provide informed consent”. Sample Size The sample size for this study was calculated to determine the two specific objectives i) To determine the proportion of non-judicious Cesarean sections among the total number of CSs conducted. With an assumed prevalence of 50% of the outcome variable to give a maximum sample size, with 95% confidence interval and a 3% bound on the error of estimation, the total sample size calculated to determine the proportion of unnecessary CS came up to be 1093, which was inflated by 10% to account for sampling errors. Thus the final sample size was calculated to be approximately 1200 patients who underwent CSs. ii) To determine the associated factors with non-judicious CS, through a case-control analysis where non judicious CS are the cases while judicious CS are the controls. With an assumption that approximately 1/3rd of the CS were non-judicious, we used the following formula to calculate the sample size r 1 ( p)(1 p)(Z Z )2 n ( ) /2 r (p p )2 1 2 With a case-control ration of 1:3 and a CI of 95% and a power of 90% with the prevalence of exposures kept at a minimum of 5% among controls we calculated a sample of 394 cases and 1182 controls. Keeping 10% inflation for data errors, we are hopeful that by studying 1800 CSs, WCCPRD9946948 | 2019/935864 we would be able to achieve our objectives. RPPH C-Section FINAL Report Page 3 Thus the total sample size to account for both component 1 and 2, we need to interview 1800 women who underwent CS. This sample size was equally divided among the 04 units of the selected hospitals with 450 women with CS per unit. Data Collection technique Data on 6 core Robson criteria of all women who were admitted in the Obstetric wards and delivered in the selected hospitals were recorded in a log sheet designed for the study. Data from the hospital registered were extracted and recoded in the log sheet. Among these women all those mothers who have undergone a cesarean section regardless of their parity were approached, consented and recruited in the study. Data collection tools: Two data collection tools were developed in light of the objectives and these were: Log sheet: Due to lack of an electronic recording system of women delivering in the hospital log sheet format was developed. This format collected information on all the 6 core Robson variables along with woman hospital registration number of all the deliveries either vaginal or C-section which were done during the study period (see Annex 1). All information required for this format was extracted from the hospital delivery registers by research medical officers on daily basis. These log sheets were maintained in hard copies and sent to central research office twice a week. Structured Questionnaire: This questionnaire collected information from all women who underwent C-section after obtaining consent via face to face interview. It collects information on variables to understand the factors for unnecessary C-section, containing questions on socio-demographic and personal characteristics, maternity information, health seeking and cultural factors etc. Data collection process Data collection was done in two steps:- First of all, a log of all deliveries conducted in the selected health facilities was made in the structured log sheet based on the 06 Robson criteria. Information was extracted from hospital registered on this log sheet on daily basis. This sheet was used to calculate the proportion of CS conducted in each health facility. All patients who under-went cesarean sections were approached and the eligibility to participate in the study were confirmed. Once the patient was found to be eligible for the study, the research team took informed consent and interviewed the patient via a face to face interview.
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