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

Vogel, JP; Pujar, Y; Vernekar, SS; Armari, E; Pingray, V; Althabe, F; Gibbons, L; Berrueta, M; Somannavar, M; Ciganda, A; Rodriguez, R; Bendigeri, S; Kumar, JA; Patil, SB; Karinagannanavar, A; Anteen, RR; Mallappa Ramachandrappa, P; Shetty, S; Bommanal, L; Haralahalli Mallesh, M; Gaddi, SS; Chikkagowdra, S; Raghavendra, B; Homer, CSE; Lavender, T; Kushtagi, P; Hofmeyr, GJ; Derman, R; Goudar, S

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

Vogel, JP Pujar, Y Vernekar, SS Armari, E Pingray, V Althabe, F Gibbons, L Berrueta, M Somannavar, M Ciganda, A Rodriguez, R Bendigeri, S Kumar, JA Patil, SB Karinagannanavar, A Anteen, RR Mallappa Ramachandrappa, P Shetty, S Bommanal, L Haralahalli Mallesh, M Gaddi, SS Chikkagowdra, S Raghavendra, B Homer, CSE Lavender, T Kushtagi, P Hofmeyr, GJ Derman, R Goudar, S

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Publisher:: NATURE PORTFOLIO
Publication Type:: Journal Article
Citation:: Nat Med, 2024, 30, (2), pp. 463-469
Issue Date:: 2024-02

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Field	Value	Language
dc.contributor.author	Vogel, JP
dc.contributor.author	Pujar, Y
dc.contributor.author	Vernekar, SS
dc.contributor.author	Armari, E
dc.contributor.author	Pingray, V
dc.contributor.author	Althabe, F
dc.contributor.author	Gibbons, L
dc.contributor.author	Berrueta, M
dc.contributor.author	Somannavar, M
dc.contributor.author	Ciganda, A
dc.contributor.author	Rodriguez, R
dc.contributor.author	Bendigeri, S
dc.contributor.author	Kumar, JA
dc.contributor.author	Patil, SB
dc.contributor.author	Karinagannanavar, A
dc.contributor.author	Anteen, RR
dc.contributor.author	Mallappa Ramachandrappa, P
dc.contributor.author	Shetty, S
dc.contributor.author	Bommanal, L
dc.contributor.author	Haralahalli Mallesh, M
dc.contributor.author	Gaddi, SS
dc.contributor.author	Chikkagowdra, S
dc.contributor.author	Raghavendra, B
dc.contributor.author	Homer, CSE
dc.contributor.author	Lavender, T
dc.contributor.author	Kushtagi, P
dc.contributor.author	Hofmeyr, GJ
dc.contributor.author	Derman, R
dc.contributor.author	Goudar, S
dc.date.accessioned	2024-08-01T03:32:23Z
dc.date.available	2023-12-02
dc.date.available	2024-08-01T03:32:23Z
dc.date.issued	2024-02
dc.identifier.citation	Nat Med, 2024, 30, (2), pp. 463-469
dc.identifier.issn	1078-8956
dc.identifier.issn	1546-170X
dc.identifier.uri	http://hdl.handle.net/10453/179903
dc.description.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 .
dc.format	Print-Electronic
dc.language	eng
dc.publisher	NATURE PORTFOLIO
dc.relation	http://purl.org/au-research/grants/nhmrc/2016379
dc.relation.ispartof	Nat Med
dc.relation.isbasedon	10.1038/s41591-023-02751-4
dc.rights	info:eu-repo/semantics/openAccess
dc.subject	11 Medical and Health Sciences
dc.subject.classification	Immunology
dc.subject.classification	32 Biomedical and clinical sciences
dc.subject.classification	42 Health sciences
dc.subject.mesh	Female
dc.subject.mesh	Humans
dc.subject.mesh	Pregnancy
dc.subject.mesh	Cesarean Section
dc.subject.mesh	Delivery, Obstetric
dc.subject.mesh	Gestational Age
dc.subject.mesh	Oxytocin
dc.subject.mesh	Pilot Projects
dc.subject.mesh	Humans
dc.subject.mesh	Oxytocin
dc.subject.mesh	Delivery, Obstetric
dc.subject.mesh	Cesarean Section
dc.subject.mesh	Pilot Projects
dc.subject.mesh	Gestational Age
dc.subject.mesh	Pregnancy
dc.subject.mesh	Female
dc.subject.mesh	Female
dc.subject.mesh	Humans
dc.subject.mesh	Pregnancy
dc.subject.mesh	Cesarean Section
dc.subject.mesh	Delivery, Obstetric
dc.subject.mesh	Gestational Age
dc.subject.mesh	Oxytocin
dc.subject.mesh	Pilot Projects
dc.title	Effects of the WHO Labour Care Guide on cesarean section in India: a pragmatic, stepped-wedge, cluster-randomized pilot trial.
dc.type	Journal Article
utslib.citation.volume	30
utslib.location.activity	United States
utslib.for	11 Medical and Health Sciences
pubs.organisational-group	University of Technology Sydney
pubs.organisational-group	University of Technology Sydney/Faculty of Health
pubs.organisational-group	University of Technology Sydney/Strength - CHSP - Health Services and Practice
pubs.organisational-group	University of Technology Sydney/Strength - WHO CC
utslib.copyright.status	open_access	*
dc.rights.license	This work is licensed under a Creative Commons Attribution 4.0 International License (CC BY 4.0). To view a copy of this license, visit https://creativecommons.org/licenses/by/4.0/
dc.date.updated	2024-08-01T03:32:16Z
pubs.issue	2
pubs.publication-status	Published
pubs.volume	30
utslib.citation.issue	2

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 .

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http://hdl.handle.net/10453/179903