The Safe Childbirth Checklist is a WHO-branded tool developed by frontline health workers and technical experts in maternal health, newborn health, checklist-based programs, quality improvement, and implementation science [
10]. After several years in development, including field-testing for usability and a pilot study of its impact on health worker practices, the multicenter trial, testing the BetterBirth approach to Checklist implementation in UP will now assess the effectiveness of the program in reducing avoidable maternal, fetal, and newborn harm. The trial, as designed, will provide crucial rigorous evidence to the global maternal, neonatal and child health community; this information is anticipated to inform policies and practice towards accelerating the improvement quality and safety of facility-based delivery care and reducing mortality and morbidity of women and newborns. As is the case with many randomized controlled trials in resource-poor settings, the overall intensity of the intervention provided within the trial may be more extensive than what can be brought to scale, but it is structured to allow for the identification of the key elements required for wider-spread success.
Challenges and opportunities
There are a number of risks to the successful completion of this large, complex trial in UP at each level—state, district, facility, and individual—reflecting local context, knowledge and what is required to successfully implement a Checklist program at scale along with more universal clinical trial challenges. India is a large and diverse country with health agencies at both the national and state levels. Rolling out a health program in the public sector at scale in this context requires collaboration and support from national, state, and district political leaders. To ensure alignment of the trial with policies and priorities at these levels, we will establish regular channels of formal and informal communication and engagement. This includes providing updates on progress and feedback of implementation data, partnering with key figures at each level to hold joint public meetings with national, state, and district leaders to reflect on progress of the program and trial, and providing training to government officials in areas of local interest. These partnerships have ensured that our program and trial design have been carefully reviewed and tailored to ensure alignment with ongoing and planned government programs. This process has also provided key insight regarding the feasibility of study implementation within the infrastructure of UP. Challenges in this area will continue as government officials change positions, highlighting the need to ensure sustained, effective relationships even as personnel change over the relatively long period of data collection.
At all levels, one of the most critical challenges is the need for local champions, as well as strategies for sustainability of the program, particularly given the frequent reassignment of facility staff across UP. To address this potential barrier, we have incorporated the training of a facility-level Childbirth Quality Coordinator (CQC) to continue supporting the use of the SCC during the study and once study coaches have completed the 8-month-long intervention. Further, the engagement process includes a complete discussion of Checklist implementation and data collection. The participation of facility leaders in the engagement and launch processes build local buy-in for Checklist use. Similar processes are held at the district and state levels to ensure that priorities align and health leaders have ownership in the project and dedication to quality of care. All of these processes are designed to sustain the use of the SCC.
Partnerships among the investigators and the use of expert local staff for implementation and management ensure that we remain cognizant of cultural and infrastructure determinants impacting the health care and research environments. These allow us to deal with challenges in ensuring informed consent, with ensuring consistent meaning of questions despite variation in dialects across the state, and with operational issues related to how women use health care facilities and recover postpartum, as well as the role of traditional birth attendants in facility based births.
As has been shown previously, simply adding a checklist to workflow will not create uptake or sustainability [
28]. The greatest challenge is in ensuring that individual health workers successfully adopt the SCC program into clinical practice. Sustained behavior change in any health care setting is challenging, especially in resource-limited settings [
29]. Early pilot studies resulted in the better understanding of how to educate birth attendants on how to use the SCC and be motivated to improve their own clinical practice [
30]. In our lessons learned from the pilot studies, one key finding is the importance of using education and peer-to-peer coaching to empower health workers to believe in their own capacity for progress, and to realize that through their own practices they can ensure that maternal and neonatal outcomes may be improved. Further, with the development of the CQCs and facility staff to take on responsibility and utilization of the SCC, we hope to empower the CQCs such that they will be able to collect, collate, coach, interpret, and feedback data to the frontline workers and provide information to the facility leaders.
The main risk with the data collection stems from the lack of a comprehensive, robust existing health management information system in the study setting. Based on learning from the pilot, the original plan to use standardized birth registers to collect routinely available demographics and in-facility outcome data has required compilation of multiple primary data sources. In baseline data collection, we have successfully collated the data and been able to follow up women and their newborns after discharge by telephone. After the pilot studies, the standard maternal severe morbidity definitions were modified to reflect the available resources. We reviewed a range of methodologies for self-report on these and other time-delineated outcomes [
24,
31,
32]. In addition, the use of maternal near-missed deaths as a component of a composite indicator that combines maternal and newborn outcomes is novel. Another potential risk is contamination of the control sites in this matched-pair, randomized controlled trial. However, this is a limited risk as the WHO Safe Childbirth Checklist has been part of the Government of India Maternal Health Toolkit since 2013, yet the Checklist has not been widely adopted.
To mitigate the above risks, we adopted methodological strategies to maximize the implementation of successful trial conduct in this real-world setting. We completed several pilot studies in facilities in UP, using a quality improvement methodology, and then measured success in both effectiveness of education as well as rates of adoption of the care practices comprising the SCC. Through these pilot tests in nine facilities, we progressively modified our approach until we were certain that we had removed all identifiable impediments to successful implementation, data collection, and monitoring [
30]. These changes included but were not limited to a complete re-evaluation of the methods for launch and coaching support. Data from this extensive pilot phase will not be used in the final analyses.
In summary, simple, scalable solutions are essential, and desperately needed, to improve maternal and neonatal outcomes around the time of childbirth. In partnership with the co-principal investigators (Ariadne Labs, a joint center of Brigham and Women’s Hospital and Harvard T.H. Chan School of Public Health; Community Empowerment Lab; Jawaharlal Nehru Medical College), Population Services International, the World Health Organization and the Governments of Uttar Pradesh and India, along with guidance by a Scientific Advisory Committee comprised of technical experts in maternal and newborn health, the BetterBirth Trial in UP has been successfully designed and initiated implementation. Utilization of pilot studies and iterative learning has improved the design of the trial and intervention, as well as the data collection systems, for implementation of a high-quality, large-scale study. Studies such as this with large land coverage and sample size require immense coordination at all levels of the health system. If the SCC and coaching intervention are found to reduce maternal, fetal and neonatal harm, patients and other stakeholders stand to benefit from a proven quality improvement strategy that could potentially help influence outcomes in millions of births each year.