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

Cesarean section rates are increasing globally, often driven by medically unnecessary use. The World Health Organization Labour Care Guide (LCG) was developed to improve quality of intrapartum care and could reduce overuse of cesarean. We conducted a pragmatic, stepped-wedge, cluster-randomized pilot trial in four high-volume hospitals in India to evaluate an LCG strategy (training plus audit and feedback) versus routine care. Eligible women were those giving birth at ≥20 weeks’ gestation. One hospital crossed over to the intervention every 2 months. The primary outcome was cesarean section among women in Robson Group 1 (nulliparous, singleton, term, cephalic, spontaneous labor). Among 26,331 women (26,595 babies), a crude absolute reduction of 5.5% in the primary outcome was observed (45.2% control vs 39.7% intervention; RR 0.85, 95% CI 0.54–1.33). Maternal process-of-care outcomes were not significantly different, though augmentation with oxytocin during spontaneous labor was 18.0% lower with the LCG strategy. No differences were observed in other maternal, perinatal or neonatal outcomes, nor in women’s birth experience. Findings inform the design of future definitive trials to address rising cesarean section rates. Clinical Trials Registry India: CTRI/2021/01/030695.

Joshua P. Vogel, Yeshita Pujar, Sunil S. Vernekar, Elizabeth Armari, Veronica Pingray, Fernando Althabe, Luz Gibbons, Mabel Berrueta, Manjunath Somannavar, Alvaro Ciganda, Rocio Rodriguez, Savitri Bendigeri, Jayashree Ashok Kumar, Shruti Bhavi Patil, Aravind Karinagannanavar, Raveendra R. Anteens, Pavithra Mallappa Ramachandrappas, Shukla Shetty, Latha Bommanal, Megha Haralahalli Mallesh, Suman S. Gaddi, Shaila Chikkagowdra, Bellara Raghavendra, Caroline S. E. Homer, Tina Lavender, Pralhad Kushtagi, G. Justus Hofmeyr, Richard Derman, Shivaprasad Goudar