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Labour Care Guide Trial for reducing Caesarean Section in India

Implementing the WHO Labour Care Guide to reduce the use of Caesarean section in four hospitals in India: a pragmatic, stepped wedge, cluster randomized pilot trial - LCG

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/01/030695
Enrollment
25000
Registered
2021-01-22
Start date
Unknown
Completion date
Unknown
Last updated
2023-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: Z139- Encounter for screening, unspecified

Interventions

Intervention1: Co-designed implementation strategy targeting healthcare providers to improve intrapartum care: The strategy will target the use of the LCG by maternity care providers, as well as promo

Sponsors

Bill Melinda Gates Foundation
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Cluster: Health facility is the randomization unit. Participating clusters (formative phase and trial phase) are four public hospitals in India. Across these hospitals, the mean CS rate is =30% Healthcare providers attending childbirth will be the target of the intervention.

Exclusion criteria

Exclusion criteria: Facilities with C Section rate less than 30%

Design outcomes

Primary

MeasureTime frame
Use of CS amongst women in Robson Group 1 (i.e. women who are nulliparous, singleton, cephalic, =37 weeks’ gestation, in spontaneous labour).Timepoint: At discharge from the facility

Secondary

MeasureTime frame
Fetal / Neonatal outcomes 1. Antepartum stillbirth (Fetal death prior to admission) 2. Intrapartum stillbirth 3. Neonatal death (Neonatal death in a liveborn infant by day 7 or discharge, whichever came first) Timepoint: At discharge from the facility;Maternal outcomes 1. CS rate in women in Robson Groups 1 and 2 2. CS rate in women in Robson Groups 1 to 5 3. Overall CS rate 4. Augmentation with oxytocin during labour rate 5. Early artificial rupture of the membranes rate 6. Episiotomy rate 7. Operative vaginal birth rate 8. Duration of hospital admissionTimepoint: At discharge from the facility;Women’s experience outcomes 1. Woman’s experience with labour companion 2. Woman’s experience of coping with pain 3. Woman’s experience of offering oral fluids 4. Woman’s experience of mobilising during labour 5. Woman’s experience of birth position of choice 6. Woman’s experience of time health worker spent with them 7. Woman’s experience of privacy 8. Woman’s overall experience of care Timepoint: At discharge from the facility

Countries

India

Contacts

Public ContactDr Yeshita V Pujar

KLE Academy of Higher Education and Researchs J N Medical College

yvpujar@hotmail.com9448142989

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 10, 2026