Implementing the WHO Labour Care Guide to reduce the use of Caesarean section in four hospitals in India: protocol and statistical analysis plan for a pragmatic, stepped-wedge, cluster-randomized pilot trial

Abstract

Background The World Health Organization (WHO) Labour Care Guide (LCG) is a paper-based labour monitoring tool designed to facilitate the implementation of WHO’s latest guidelines for effective, respectful care during labour and childbirth. Implementing the LCG into routine intrapartum care requires a strategy that improves healthcare provider practices during labour and childbirth. Such a strategy might optimize the use of Caesarean section (CS), along with potential benefits on the use of other obstetric interventions, maternal and perinatal health outcomes, and women’s experience of care. However, the effects of a strategy to implement the LCG have not been evaluated in a randomised trial. This study aims to: (1) develop and optimise a strategy for implementing the LCG (formative phase); and (2) To evaluate the implementation of the LCG strategy compared with usual care (trial phase). Methods In the formative phase, we will co-design the LCG strategy with key stakeholders informed by facility assessments and provider surveys, which will be field tested in one hospital. The LCG strategy includes a LCG training program, ongoing supportive supervision from senior clinical staff, and audit and feedback using the Robson Classification. We will then conduct a stepped-wedge, cluster-randomized pilot trial in four public hospitals in India, to evaluate the effect of the LCG strategy intervention compared to usual care (simplified WHO partograph). The primary outcome is the CS rate in nulliparous women with singleton, term, cephalic pregnancies in spontaneous labour (Robson Group 1). Secondary outcomes include clinical and process of care outcomes, as well as women’s experience of care outcomes. We will also conduct a process evaluation during the trial, using standardized facility assessments, in-depth interviews and surveys with providers, audits of completed LCGs, labour ward observations and document reviews. An economic evaluation will consider implementation costs and cost-effectiveness. Discussion Findings of this trial will guide clinicians, administrators and policymakers on how to effectively implement the LCG, and what (if any) effects the LCG strategy has on process of care, health and experience outcomes. The trial findings will inform the rollout of LCG internationally. Trial registration: CTRI/2021/01/030695 (Protocol version 1.4, 25 April 2022).

Global research priorities related to the World Health Organization Labour Care Guide: results of a global consultation

“…Nine ongoing or planned research efforts were identified (Additional file 1: Table S8), mainly responding to the second priority to improve understanding of the effect of WHO LCG on maternal and perinatal outcomes, and the process and experience of labour and childbirth care [24][25][26][27][28]. One completed, but noy yet published study in India was identified under the theme "optimize implementation".…”

Effects of introducing the WHO Labour Care Guide on Caesarean section: a pragmatic, stepped-wedge, cluster randomized trial in India

“…(28,29) The trial protocol was pre-registered (CTRI/2021/01/030695), with the protocol and statistical analysis plan published prior to trial closure; there were no major deviations or changes. (30) We sought permission from the head of study hospitals (gatekeepers) and individual providers before commencing the trial. The study protocol specified a waiver of individual consent for data collected on women giving birththese data were non-identifiable, routinely-collected clinical variables in medical records and labour ward registries.…”

Labour Care Guide implementation as a decision-making tool for monitoring labour among healthcare providers in Uganda: protocol for a mixed-methods study

“…This recommendation was made with anticipation that the new tool was easy to use, promptly identifies deviations from normal through regular assessments, encourages self-efficacy, stimulates HCP interaction and shared decision-making, recognises participation of labour companions to promote women-centred care, but importantly the LCG has been developed for HCPs to identify deviations from normal through regular monitoring and assessment of women and their unborn babies. Based on pilot studies, this LCG has been suggested to facilitate HCPs to quickly identify any deviation from normality and thus improve labour monitoring as well as the well-being of women and their babies in comparison with the partograph 15 16. The LCG also has been suggested to encourage interaction between the healthcare team, women and labour companion or family members, while emphasising safety and providing the needed supportive care for the expectant women in our setting 17.…”

“…The LCG also has been suggested to encourage interaction between the healthcare team, women and labour companion or family members, while emphasising safety and providing the needed supportive care for the expectant women in our setting 17. In fact, according to Vogel and colleagues, this new WHO LCG monitoring tool is regarded as the ‘next-generation’ partograph incorporating recent effective intrapartum care guidelines 18 19. When used properly, the LCG is thought to accurately detect prolonged labour in time for HCPs to avoid unnecessary practices and interventions, and perform required interventions in time before progressing to obstructed labour and its sequelae, such as ruptured uterus, postpartum haemorrhage, sepsis, maternal and neonatal deaths.…”