Modification of oxytocin use through a coaching-based intervention based on the WHO Safe Childbirth Checklist in Uttar Pradesh, India: a secondary analysis of a cluster randomised controlled trial.

OBJECTIVE: To understand the prevalence of intrapartum oxytocin use, assess associated perinatal and maternal outcomes, and evaluate the impact of a WHO Safe Childbirth Checklist intervention on oxytocin use at primary-level facilities in Uttar Pradesh, India. DESIGN: Secondary analysis of a cluster-randomised controlled trial. SETTING: Thirty Primary and Community public health facilities in Uttar Pradesh, India from 2014 to 2017. POPULATION: Women admitted to a study facility for childbirth at baseline, 2, 6 or 12 months after intervention initiation. METHODS: The BetterBirth intervention aimed to increase adherence to the WHO Safe Childbirth Checklist. We used Rao-Scott Chi-square tests to compare (1) timing of oxytocin use between study arms and (2) perinatal mortality and resuscitation of infants whose mothers received intrapartum oxytocin versus who did not. MAIN OUTCOME MEASURES: Intrapartum and postpartum oxytocin administration, perinatal mortality, use of neonatal bag and mask. RESULTS: We observed 5484 deliveries. At baseline, intrapartum oxytocin was administered to 78.2% of women. Two months after intervention initiation, intrapartum oxytocin (I) was administered to 32.1% of women compared with 70.6% in the control (C) (P < 0.01); this difference diminished after the end of the intervention (I = 48.2%, C = 74.7%, P = 0.03). Partograph use remained at <1% at all facilities. Resuscitation was performed on 7.5% of infants whose mother received intrapartum oxytocin versus 2.0% who did not (P < 0.0001). CONCLUSIONS: In this setting, intrapartum oxytocin use was high despite limited maternal/fetal monitoring or caesarean capability, and was associated with increased neonatal resuscitation. The BetterBirth intervention was successful at decreasing intrapartum oxytocin use. Ongoing support is needed to sustain these practices. TWEETABLE ABSTRACT: Coaching + WHO Safe Childbirth Checklist reduces intrapartum oxytocin use and need for newborn resuscitation.

Implementing a modified World Health Organization safe childbirth checklist in health centers of Ethiopia: a pre and post intervention study.

BACKGROUND: Childbirth is a complex process, and checklists are useful tools to remember steps of such complex processes. The World Health Organization safe childbirth checklist is a tool used to improve the quality of care provided to women giving birth. The checklist was modified by Ministry of Health and was introduced to health centers in Ethiopia by the USAID Transform: Primary Health Care Activity. METHODS: A pre and post intervention study design with prospective data collection was employed. The availability of essential childbirth supplies and adherence of health care providers to essential birth practices were compared for the pre and post intervention periods. RESULTS: The pre and post intervention assessments were conducted in 247 and 187 health centers respectively. A statistically significant improvement from 63.6% pre intervention to 83.5% post intervention was observed in the availability of essential childbirth supplies, t (389.7) = - 7.1, p = 0.000. Improvements in adherence of health care providers to essential birth practices were observed with the highest being at pause point three (26.2%, t (306.3) = - 10.6, p = 0.000) followed by pause point four (21.1%, t (282.5) = - 8.0, p = 0.000), and pause point two (18.2%, t (310.8) = - 9.7, p = 0.000). The least and statistically non-significant improvement was observed at pause point one (3.3%, t (432.0) = - 1.5, p = 0.131). CONCLUSION: Improvement in availability of essential childbirth supplies and adherence of health care providers towards essential birth practices was observed after introduction of a modified World Health Organization safe childbirth checklist. Scale up of the use of the checklist is recommended.

Effectiveness of the World Health Organization Safe Childbirth Checklist (WHO-SCC) in preventing poor childbirth outcomes: a study protocol for a matched-pair cluster randomized control trial.

BACKGROUND: Women delivering in health facilities in sub-Saharan Africa and their newborns do not always receive proven interventions needed to prevent and/or adequately manage severe complications. The gaps in quality of care are increasingly pointed out as major contributing factor to the high and slow declining perinatal mortality rates. The World Health Organization Safe Childbirth Checklist (WHO-SCC), as a quality improvement strategy, targets low cost and easy to perform interventions and suits well with the context of limited resource settings. In this matched-pair cluster randomized controlled trial, we assess the effectiveness of the WHO-SCC in improving healthcare providers' adherence to best practices and ultimately improving childbirth outcomes. METHODS: This is a multi-country study. In each country we will carry out a matched-pair cluster randomized controlled trial whereby four pairs of regional hospitals will be randomized on a 1:1 basis to either the intervention or control group. A context specific WHO-SCC will be implemented in the intervention facilities along with trainings of healthcare providers on best childbirth practices and ongoing supportive supervisions. The standard of care will prevail in the control group. The primary outcome is a summary composite metric that combine the following poor childbirth outcomes: stillbirths, maternal deaths, early neonatal deaths, severe postpartum hemorrhage, maternal infections, early neonatal infections, prolonged obstructed labor, severe pre-eclampsia, uterine rupture in the health facility, eclampsia and maternal near miss. The occurrence of these outcomes will be ascertained in a sample of 2530 childbirth events in each country using data extraction. A secondary outcome of interest is the adherence of healthcare providers to evidence best practices. This will be measured through direct observations of a sample of 620 childbirth events in each country. DISCUSSION: Our study has the potential to provide strong evidence on the effectiveness of the WHO-SCC, a low cost and easy to implement intervention that can be easily scaled up if found effective. TRIAL REGISTRATION: The trial was registered in the Pan-African Clinical Trials Registry on 21st January 2020 under the following number: PACTR202001484669907. https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=9662.

Impact of the Safe Childbirth Checklist on health worker childbirth practices in Luapula province of Zambia: a pre-post study.

BACKGROUND: A strong evidence base exists regarding routine and emergency services that can effectively prevent or reduce maternal and new-born mortality. However, even when skilled providers care for women in labour, many of the recommended services are not provided, despite being available. Barriers to the provision of appropriate childbirth services may include lack of availability of supplies, limited health worker knowledge and confidence, or inadequate time. The WHO Safe Childbirth Checklist (SCC) includes reminders for evidenced-based practices at specific points in the childbirth process. Zambia is currently considering nation-wide adoption of the SCC, but there is a need for context-specific evidence. Beginning in September 2017, a program is being implemented in Nchelenge District to pilot use of the SCC, along with coaching that focuses on strengthening the systems that allow the essential practices in childbirth to be performed. METHODS: This study will use a pre-post study design to measure health worker adherence to the essential practices for delivery care outlined in the SCC. Data will be collected through observations of health workers as they care for mothers during childbirth at four facilities. Data collection will take place before the start of the intervention, at 3 months, and at 6 months post-intervention. The primary outcome interest is the change in the average proportion of essential childbirth practices completed. A health worker questionnaire will be administered at the time that the SCC is introduced and 6 months later to gather their perspectives on incorporating the SCC into clinical practice in Zambia. DISCUSSION: Findings are expected to inform plans for introducing the SCC in Zambia. This evaluation will aim to understand uptake and impact of the SCC and associated coaching in the context of a basic level of mentorship that the government could feasibly provide at a national scale. TRIAL REGISTRATION: Clinical Trials.gov ( NCT03263182 ) Registered August 28, 2017.

Evaluation of Dakshata, a scale-up WHO SCC and mentoring-based program, for improving quality of intrapartum care in public sector in Rajasthan, India: repeated mixed-methods surveys.

BACKGROUND: The Dakshata program in India aims to improve resources, providers' competence, and accountability in labour wards of public sector secondary care hospitals. Dakshata is based on the WHO Safe Childbirth Checklist coupled with continuous mentoring. In Rajasthan state, an external technical partner trained, mentored and periodically assessed performance; identified local problems, supported solutions and assisted the state in monitoring implementation. We evaluated effectiveness and factors contributing to success and sustainability. METHODS: Using three repeated mixed-methods surveys over an 18-month period, we assessed 24 hospitals that were at different stages of program implementation at evaluation initiation: Group 1, training had started and Group 2, one round of mentoring was complete. Data on recommended evidence-based practices in labour and postnatal wards and in-facility outcomes were collected by directly observing obstetric assessments and childbirth, extracting information from case sheets and registers, and interviewing postnatal women. A theory-driven qualitative assessment covered key domains of efficiency, effectiveness, institutionalization, accountability, sustainability, and scalability. It included in-depth interviews with administrators, mentors, obstetric staff, and officers/mentors from the external partner. RESULTS: Overall, average adherence to evidence-based practices improved: Group 1, 55 to 72%; and Group 2, 69 to 79%, (for both p < 0.001) from baseline to endline. Significant improvement was noted in several practices in the two groups during admission, childbirth, and within 1 hour of birth but less in postpartum pre-discharge care. We noted a dip in several evidence-based practices in 2nd assessment, but they improved later. The stillbirth rate was reduced: Group 1: 1.5/1000 to 0.2; and Group 2: 2.5 to 1.1 (p < 0.001). In-depth interviews revealed that mentoring with periodic assessments was highly acceptable, efficient means of capacity building, and ensured continuity in skills upgradation. Nurses felt empowered, however, the involvement of doctors was low. The state health administration was highly committed and involved in program management; hospital administration supported the program. The competence, consistency, and support from the technical partner were highly appreciated by the service providers. CONCLUSION: The Dakshata program was successful in improving resources and competencies around childbirth. The states with low capacities will require intensive external support for a head start.

Safe birth matters: facilitators and barriers to uptake of the WHO safe childbirth checklist tool in a Tanzania Regional Hospital.

BACKGROUND: The World Health Organization (WHO) developed the Safe Birth Checklist (SCC) to facilitate best practices in safe birthing practices. The SCC is utilizing existing evidence-based WHO guidelines and recommendations which has combined those into a single and practical bedside tool. The SCC is the first checklist-based intervention to target the prevention of maternal and neonatal deaths. OBJECTIVE: The objective of this project was to pilot-test the World Health Organization Safe Childbirth Checklist with Maternity Regional Hospital in, Tanzania. STUDY DESIGN AND METHODS: Retrospective analysis on 35 charts were completed to identify presence or absence of documentation aligned with evidenced based checklist items. Staff training, end user observations and focus group discussions were utilized to elicit feedback about the tool and the process. Descriptive statistics and manual content analysis were used to analyze the rate of uptake and ownership over the checklist. The Checklist is broken down into four sections or time points (that are considered natural pause points in the care of laboring women). The four different pause points are admission, delivery, post-partum, and discharge. RESULTS: We trained 26 participants out of 32 staff how to use the SCC. Delivery time point had the lowest at SCC completion rate at 39% compared to discharge having the highest completion rate at 93%. There was variation in completion rate of the checklist items at each time point. Checklist items at the beginning of each time point were completed between 94% and 100% of the time with the latter checklist list items completed between 29% and 57% of the time. CONCLUSION: This project was able to identify facilitators and potential barriers to the successful uptake of the Safe Childbirth Checklist in Shinyanga Regional Hospital. Based on these findings, the MOH have opportunities to utilize those findings in the scale-up of the implementation of the checklist and future evaluation activities.

Optimizing the development and evaluation of complex interventions: lessons learned from the BetterBirth Program and associated trial.

BACKGROUND: Despite extensive efforts to develop and refine intervention packages, complex interventions often fail to produce the desired health impacts in full-scale evaluations. A recent example of this phenomenon is BetterBirth, a complex intervention designed to implement the World Health Organization's Safe Childbirth Checklist and improve maternal and neonatal health. Using data from the BetterBirth Program and its associated trial as a case study, we identified lessons to assist in the development and evaluation of future complex interventions. METHODS: BetterBirth was refined across three sequential development phases prior to being tested in a matched-pair, cluster randomized trial in Uttar Pradesh, India. We reviewed published and internal materials from all three development phases to identify barriers hindering the identification of an optimal intervention package and identified corresponding lessons learned. For each lesson, we describe its importance and provide an example motivated by the BetterBirth Program's development to illustrate how it could be applied to future studies. RESULTS: We identified three lessons: (1) develop a robust theory of change (TOC); (2) define optimization outcomes, which are used to assess the effectiveness of the intervention across development phases, and corresponding criteria for success, which determine whether the intervention has been sufficiently optimized to warrant full-scale evaluation; and (3) create and capture variation in the implementation intensity of components. When applying these lessons to the BetterBirth intervention, we demonstrate how a TOC could have promoted more complete data collection. We propose an optimization outcome and related criteria for success and illustrate how they could have resulted in additional development phases prior to the full-scale trial. Finally, we show how variation in components' implementation intensities could have been used to identify effective intervention components. CONCLUSION: These lessons learned can be applied during both early and advanced stages of complex intervention development and evaluation. By using examples from a real-world study to demonstrate the relevance of these lessons and illustrating how they can be applied in practice, we hope to encourage future researchers to collect and analyze data in a way that promotes more effective complex intervention development and evaluation. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02148952; registered on May 29, 2014.

Feasibility study on the adoption of the WHO safe childbirth checklist by front-line healthcare providers and managers in Burkina Faso and Côte d'Ivoire.

BACKGROUND: The World Health Organization Safe Childbirth Checklist tool was specifically designed for developing countries such as sub-Saharan African countries, to ensure safety and security of the couple mother and newborn around the time of childbirth. However, the implementation of the Safe Childbirth Checklist tool requires a good knowledge of the context setting to face challenges. Our study objectives were (1) to assess the acceptability of the WHO SCC tool and (2) to identify conditions and strategies for a better introduction and use of the WHO SSC tool. METHODS: This was a pilot multi-country study conducted from January to March 2019 in Burkina Faso and Côte d'Ivoire, respectively, in the health regions of central-North and Agnéby-Tiassa-Mé. In each health region, 5 health facilities of different levels within the health system pyramid were selected through a purposive sampling. The study was conducted in 2 phases: 38 healthcare providers and 15 managers were first trained to use the Safe Childbirth Checklist tool; secondly, the trained providers were allowed to use the tool in real-life conditions for 2 weeks. Then, semi-structured interviews were conducted among healthcare providers and managers. The topics covered by the interview guides were acceptability of the tool, barriers and facilitators to its use, as well as strategies for better introduction and use within the healthcare system. Analysis was carried out using the Nvivo 12 software. RESULTS: Respondents reported an overall good acceptance of using the tool. However, they suggested minor content adaptation. The design of the tool and increased workload were the main barriers to its use. Potential facilitators to its introduction were managers' commitment, healthcare providers' motivation, and the availability of supplies. The best strategies for optimal use were its attachment to existing tool such as partograph or/and its display in the maternity ward. CONCLUSIONS: The findings showed that the implementation of the Safe Childbirth Checklist tool is acceptable in Burkina Faso and Côte d'Ivoire. These findings are important and will help to design a trial aiming at assessing the effectiveness of the tool WHO SCC tool in these two countries.

Implementing the World Health Organization safe childbirth checklist in a district Hospital in Rwanda: a pre- and post-intervention study.

BACKGROUND: Worldwide maternal mortality remains high, with approximately 830 maternal deaths occurring each day. About 90% of these deaths occur in low-income countries. Evidenced-based essential birth practices administered during routine obstetrical care and childbirth are key to reducing maternal and neonatal deaths. The WHO Safe Childbirth Checklist (SCC) is a low-cost tool designed to ensure birth attendants perform 29 essential birth practices (EBP) at four critical periods in the birth continuum. This study aimed to evaluate compliance with EBP in Masaka District Hospital both before and after the implementation of the WHO-SCC. METHODS: This quality improvement project took place in the Masaka District Hospital in Rwanda. Observations of the 29 EBPs were done before and after WHO SCC implementation. The implementation process consisted of providing training in the use of the checklist to all clinical staff and posting SCC posters at different locations in the maternity unit. RESULTS: A total 391 birth events were observed pre-intervention and 389 post-intervention. The overall EBP compliance rate increased from 46% pre-intervention to 56% post-intervention (P = 0.005). Significant improvements were seen in 11 out of 29 EBPs. CONCLUSION: The implementation of the WHO SCC improved the overall EBP compliance rate in Masaka District Hospital. Determining the root cause of low compliance rate of some EBP may allow for more successful implementation of EBP interventions in the future. After further study, the SCC should be considered for scale up.

Integration of the Opportunity-Ability-Motivation behavior change framework into a coaching-based WHO Safe Childbirth Checklist program in India.

OBJECTIVE: To evaluate whether integration of the Opportunity-Ability-Motivation plus Supplies (OAMS) framework into coaching improved the delivery of essential birth practices in a low-resource setting. METHODS: This prospective mixed-methods study used routine coaching visit data obtained from the first eight intervention facilities of the BetterBirth trial in Uttar Pradesh, India, between December 19, 2014, and October 21, 2015. The 8-month intervention was peer coaching that integrated the OAMS framework to support uptake of the WHO Safe Childbirth Checklist. Descriptive statistics were used to measure nonadherence to essential birth practices. The frequency and accuracy of coaches' coding of barriers and the appropriateness of chosen resolution strategies to measure feasibility, acceptability, and fidelity of using OAMS, were assessed. RESULTS: Coaches observed 666 deliveries, including 12 602 practices. Overall, essential practice nonadherence decreased from 15.6% (262/1675 practices observed) to 4.5% (4/88 practices) (P<0.001). Of the 1048 barriers identified, opportunity (556 [53.1%]) and motivation (287 [27.4%]) were the most frequently reported categories; the frequency of both decreased over time (P=0.003 and P<0.001, respectively). The coaches appropriately categorized 930 (99.8%) of 932 barriers and provided an appropriate strategy for 800 (85.8%). The commonest reason for unaddressed barriers was lack of coaching opportunities. CONCLUSION: Successful integration of OAMS framework into delivery attendant coaching enabled coaches to rapidly diagnose barriers to practice adherence and develop responsive strategies. CLINICALTRIALS.GOV: NCT2148952 (WHO Universal Trial Number: U11111-1315-647).

Effectiveness of the WHO Safe Childbirth Checklist program in reducing severe maternal, fetal, and newborn harm in Uttar Pradesh, India: study protocol for a matched-pair, cluster-randomized controlled trial.

BACKGROUND: Effective, scalable strategies to improve maternal, fetal, and newborn health and reduce preventable morbidity and mortality are urgently needed in low- and middle-income countries. Building on the successes of previous checklist-based programs, the World Health Organization (WHO) and partners led the development of the Safe Childbirth Checklist (SCC), a 28-item list of evidence-based practices linked with improved maternal and newborn outcomes. Pilot-testing of the Checklist in Southern India demonstrated dramatic improvements in adherence by health workers to essential childbirth-related practices (EBPs). The BetterBirth Trial seeks to measure the effectiveness of SCC impact on EBPs, deaths, and complications at a larger scale. METHODS/DESIGN: This matched-pair, cluster-randomized controlled, adaptive trial will be conducted in 120 facilities across 24 districts in Uttar Pradesh, India. Study sites, identified according to predefined eligibility criteria, were matched by measured covariates before randomization. The intervention, the SCC embedded in a quality improvement program, consists of leadership engagement, a 2-day educational launch of the SCC, and support through placement of a trained peer "coach" to provide supportive supervision and real-time data feedback over an 8-month period with decreasing intensity. A facility-based childbirth quality coordinator is trained and supported to drive sustained behavior change after the BetterBirth team leaves the facility. Study participants are birth attendants and women and their newborns who present to the study facilities for childbirth at 60 intervention and 60 control sites. The primary outcome is a composite measure including maternal death, maternal severe morbidity, stillbirth, and newborn death, occurring within 7 days after birth. The sample size (n = 171,964) was calculated to detect a 15% reduction in the primary outcome. Adherence by health workers to EBPs will be measured in a subset of births (n = 6000). The trial will be conducted in close collaboration with key partners including the Governments of India and Uttar Pradesh, the World Health Organization, an expert Scientific Advisory Committee, an experienced local implementing organization (Population Services International, PSI), and frontline facility leaders and workers. DISCUSSION: If effective, the WHO Safe Childbirth Checklist program could be a powerful health facility-strengthening intervention to improve quality of care and reduce preventable harm to women and newborns, with millions of potential beneficiaries. TRIAL REGISTRATION: BetterBirth Study Protocol dated: 13 February 2014; ClinicalTrials.gov: NCT02148952 ; Universal Trial Number: U1111-1131-5647.