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

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作者
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. Anteen
Pavithra Mallappa Ramachandrappa
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
机构
[1] Maternal,Department of Obstetrics and Gynaecology
[2] Child and Adolescent Health Program,undefined
[3] Burnet Institute,undefined
[4] Women’s and Children’s Health Research Unit,undefined
[5] Jawaharlal Nehru Medical College,undefined
[6] KLE Academy of Higher Education and Research,undefined
[7] Instituto de Efectividad Clínica y Sanitaria (IECS-CONICET),undefined
[8] Gadag Institute of Medical Sciences,undefined
[9] General Hospital,undefined
[10] Gokak,undefined
[11] JJM Medical College,undefined
[12] Vijayanagar Institute of Medical Sciences (VIMS),undefined
[13] Department of International Health,undefined
[14] Liverpool School of Tropical Medicine,undefined
[15] Manipal Academy of Higher Education,undefined
[16] University of Botswana,undefined
[17] University of the Witwatersrand and Walter Sisulu University,undefined
[18] Thomas Jefferson University,undefined
来源
Nature Medicine | 2024年 / 30卷
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摘要
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.
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页码:463 / 469
页数:6
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