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

Vogel, Joshua P, Pujar, Yeshita, Vernekar, Sunil S, Armari, Elizabeth, Pingray, Veronica, Althabe, Fernando, Gibbons, Luz, Berrueta, Mabel, Somannavar, Manjunath, Ciganda, Alvaro, Rodriguez, Rocio, Bendigeri, Savitri, Kumar, Jayashree Ashok, Patil, Shruti Bhavi, Karinagannanavar, Aravind, Anteen, Raveendra R, Mallappa Ramachandrappa, Pavithra, Shetty, Shukla, Bommanal, Latha, Haralahalli Mallesh, Megha, Gaddi, Suman S, Chikkagowdra, Shaila, Raghavendra, Bellara, Homer, Caroline S E, Lavender, Tina, Kushtagi, Pralhad, Hofmeyr, G Justus, Derman, Richard and Goudar, Shivaprasad (2024) 'Effects of the WHO Labour Care Guide on cesarean section in India: a pragmatic, stepped-wedge, cluster-randomized pilot trial'. Nature Medicine, Vol 30, pp. 463-469.

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Abstract

Cesarean section rates worldwide are rising, driven by medically unnecessary cesarean use. The new World Health Organization Labour Care Guide (LCG) aims to improve the quality of care for women during labor and childbirth. Using the LCG might reduce overuse of cesarean; however, its effects have not been evaluated in randomized trials. We conducted a stepped-wedge, cluster-randomized pilot trial in four hospitals in India to evaluate the implementation of an LCG strategy intervention, compared with routine care. We performed this trial to pilot the intervention and obtain preliminary effectiveness data, informing future research. Eligible clusters were four hospitals with >4,000 births annually and cesarean rates ≥30%. Eligible women were those giving birth at ≥20 weeks' gestation. One hospital transitioned to intervention every 2 months, according to a random sequence. The primary outcome was the cesarean rate among women in Robson Group 1 (that is, those who were nulliparous and gave birth to a singleton, term pregnancy in cephalic presentation and in spontaneous labor). A total of 26,331 participants gave birth. A 5.5% crude absolute reduction in the primary outcome was observed (45.2% versus 39.7%; relative risk 0.85, 95% confidence interval 0.54-1.33). Maternal process-of-care outcomes were not significantly different, though labor augmentation with oxytocin was 18.0% lower with the LCG strategy. No differences were observed for other health outcomes or women's birth experiences. These findings can guide future definitive effectiveness trials, particularly in settings where urgent reversal of rising cesarean section rates is needed. Clinical Trials Registry India number: CTRI/2021/01/030695

Item Type: Article
Subjects: WA Public Health > Health Problems of Special Population Groups > WA 309 Women's health
WQ Obstetrics > Obstetric Surgical Procedures > WQ 430 Cesarean section. Symphysiotomy and similar techniques
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Item titleItem URI
Database and Syntax for Analysis of the Paper: "Effects of introducing the WHO Labour Care Guide on Caesarean section: a pragmatic, stepped-wedge, cluster randomized trial in India"https://archive.lstmed.ac.uk/24022/
Faculty: Department: Clinical Sciences & International Health > International Public Health Department
Digital Object Identifer (DOI): https://doi.org/10.1038/s41591-023-02751-4
SWORD Depositor: JISC Pubrouter
Depositing User: JISC Pubrouter
Date Deposited: 13 Feb 2024 10:23
Last Modified: 04 Mar 2024 14:46
URI: https://archive.lstmed.ac.uk/id/eprint/24019

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