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

Medicine and Health

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

J. P. Vogel, Y. Pujar, et al.

Explore the findings of a pilot trial conducted across four Indian hospitals, examining the impact of the WHO Labour Care Guide strategy on cesarean section rates. The trial observed a 5.5% absolute reduction in cesarean rates with the strategy, highlighting key insights and a need for further research. Authors, including Joshua P. Vogel and Yeshita Pujar, contributed to this important study in maternal health.

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Playback language: English
Introduction
Globally, cesarean section rates are increasing, largely driven by medically unnecessary procedures. This rise poses significant risks to maternal and newborn health, contributing to substantial morbidity and mortality, particularly in low- and middle-income countries (LMICs). The World Health Organization (WHO) recognizes this challenge and has developed the Labour Care Guide (LCG), a next-generation partograph designed to improve the quality of intrapartum care and reduce unnecessary interventions. The LCG incorporates evidence-based recommendations, including redefined active labor phases and enhanced supportive care practices (labor companionship, mobility, pain management). While the WHO recommends global LCG implementation, its effectiveness in reducing cesarean rates hasn't been rigorously evaluated in randomized trials, particularly within LMIC contexts like India. This study aimed to fill this gap by conducting a pragmatic pilot trial to assess the feasibility and preliminary effectiveness of an LCG strategy intervention in reducing cesarean section rates in four high-volume Indian hospitals.
Literature Review
The existing literature highlights the alarming rise in global cesarean rates and the associated risks. Studies consistently demonstrate a correlation between high cesarean rates and increased maternal and neonatal morbidity and mortality. The WHO has long advocated for the use of partographs to guide intrapartum decision-making and prevent unnecessary interventions. However, challenges in consistent and accurate partograph use remain due to factors like inadequate training, heavy workloads, resource limitations, and restrictive hospital policies. The LCG represents a significant advancement, aiming to address these challenges through its evidence-based approach and emphasis on respectful, woman-centered care. While the WHO recommends its adoption, a lack of robust evidence from randomized trials on its effectiveness in real-world settings prompted this study. A recent study by Pandey et al. showed a promising reduction in cesarean rates with the LCG in a single Indian hospital, but this needed confirmation in a larger, multi-center trial.
Methodology
This study employed a pragmatic, stepped-wedge, cluster-randomized pilot trial design. Four public hospitals in Karnataka, India, were selected based on their high cesarean rates and annual birth volume. A stepped-wedge design was chosen to ensure all hospitals eventually benefited from the LCG strategy, given the ethical considerations of withholding the WHO's recommended standard of care. Hospitals were randomly allocated to different sequences of control and intervention periods. The intervention consisted of a comprehensive LCG training program for healthcare providers (including initial and refresher workshops, and eight weeks of case-based teaching) coupled with monthly audits and feedback sessions on cesarean rates using the Robson classification system. The control group received training on using the simplified partograph and dissemination of WHO intrapartum care recommendations. Data were collected on a large number of women, including various maternal, fetal, and neonatal outcomes, along with a postpartum survey assessing women's experiences. The primary outcome was the cesarean rate in Robson Group 1 (nulliparous, singleton, term, cephalic presentation, spontaneous labor). Generalized estimating equations (GEEs) were used to analyze the data, accounting for the cluster-randomized design and correcting for potential bias due to the small number of clusters.
Key Findings
A total of 26,331 women participated in the study. The primary analysis revealed a 5.5% crude absolute reduction in the cesarean rate in Robson Group 1 in the intervention group (39.7%) compared to the control group (45.2%). However, this difference was not statistically significant (RR 0.85, 95% CI 0.54–1.33, P=0.1088). A notable finding was a substantial reduction in labor augmentation with oxytocin (-18.0% absolute difference) in the intervention group, though this too lacked statistical significance due to wide confidence intervals (RR 0.34, 95% CI 0.01-15.04). Analyses of secondary maternal, fetal, neonatal health outcomes, and women's birth experiences revealed no statistically significant differences between the intervention and control groups. The intra-class correlation coefficient (ICC) for the primary outcome during the control period was 0.015 (95% CI 0; 0.043).
Discussion
This pilot trial provides valuable preliminary evidence on the potential impact of the LCG strategy in reducing cesarean rates and oxytocin augmentation in a real-world setting. While the primary outcome did not reach statistical significance, the observed trend towards reduction, combined with the significant reduction in oxytocin use, suggests the LCG strategy merits further investigation. The lack of significant differences in other outcomes is reassuring, indicating no apparent harms associated with the intervention. The wide confidence intervals observed for several outcomes reflect the inherent limitations of a pilot trial with a small number of clusters. The results are promising and encourage the conduct of a larger definitive trial to confirm these findings and determine the true effect size. The study highlights potential gaps in providing supportive care measures, such as pain relief and choice of birth position, which should be addressed in future strategies.
Conclusion
This pilot trial suggests that the LCG strategy may be a promising intervention for improving the quality of labor and childbirth care and reducing unnecessary interventions. The observed trends, while not statistically significant, warrant further investigation in a larger-scale definitive trial with a greater number of hospitals to enhance statistical power and address the limitations of this pilot study. Future research should also focus on strengthening the implementation of supportive care practices to fully leverage the LCG's potential.
Limitations
The study's limitations include the relatively small number of clusters, resulting in wide confidence intervals and limiting the power to detect smaller effects. The stepped-wedge design, while ethically appropriate, may have introduced some confounding factors. The absence of an antenatal component in the intervention could be a limitation and should be considered in future research. Potential social desirability bias in the postpartum survey data should also be acknowledged. Finally, the generalizability of findings may be limited to similar settings in India with established initiatives promoting respectful maternity care.
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