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. 2023 Jan 20;20(1):18.
doi: 10.1186/s12978-022-01525-4.

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

Joshua P Vogel  1 , Veronica Pingray  2 , Fernando Althabe  2 , Luz Gibbons  2 , Mabel Berrueta  2 , Yeshita Pujar  3 , Manjunath Somannavar  3 , Sunil S Vernekar  3 , Alvaro Ciganda  2 , Rocio Rodriguez  2 , Saraswati A Welling  3 , Amit Revankar  3 , Savitri Bendigeri  3 , Jayashree Ashok Kumar  4 , Shruti Bhavi Patil  4 , Aravind Karinagannanavar  4 , Raveendra R Anteen  5 , M R Pavithra  5 , Shukla Shetty  6 , B Latha  6 , H M Megha  6 , Suman S Gaddi  7 , Shaila Chikkagowdra  7 , Bellara Raghavendra  7 , Elizabeth Armari  8 , Nick Scott  8 , Katherine Eddy  8 , Caroline S E Homer  8 , Shivaprasad S Goudar  3
Affiliations

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

Joshua P Vogel et al. Reprod Health. .

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).

Keywords: Caesarean section; Intrapartum care; Labour Care Guide; Partograph.

Plain language summary

The new WHO Labour Care Guide (LCG) is an innovative partograph that emphasises women-centred, evidence-based care during labour and childbirth. Together with clinicians working at four hospitals in India, we will develop and test a strategy to implement the LCG into routine care in labour wards of these hospitals. We will use a randomised trial design where this LCG strategy is introduced sequentially in each of the four hospitals, in a random order. We will collect data on all women giving birth and their newborns during this period and analyse whether the LCG strategy has any effects on the use of Caesarean section, women’s and newborn’s health outcomes, and women’s experiences during labour and childbirth. While the trial is being conducted, we will also collect qualitative and quantitative data from doctors, nurses and midwives working in these hospitals, to understand their perspectives and experiences of using the LCG in their day-to-day work. In addition, we will collect economic data to understand how much the LCG strategy costs, and how much money it might save if it is effective. Through this study, our international collaboration will generate critical evidence and innovative tools to support implementation of the LCG in other countries.

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Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
COM-B framework
Fig. 2
Fig. 2
Overview of study activities
Fig. 3
Fig. 3
Stepped wedge cluster randomisation process
See this image and copyright information in PMC

References

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