NCT07461571

Brief Summary

The objective of this study was to assess whether a package of 11 evidence-based maternity practices, combined with routine monitoring and Robson Classification, could reduce C-section rates in a semi-urban hospital in Dhaka, Bangladesh. Our intervention targeted the key drivers of unnecessary caesarean section at CWCH: weak labour monitoring, low use of evidence-based induction/vaginal birth after caesarean (VBAC) criteria, limited consultant oversight of C-section indications, and insufficient antenatal counselling.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,475

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2017

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 10, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 18, 2019

Completed
6.5 years until next milestone

First Submitted

Initial submission to the registry

March 3, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 10, 2026

Completed
Last Updated

March 12, 2026

Status Verified

March 1, 2026

Enrollment Period

1.7 years

First QC Date

March 3, 2026

Last Update Submit

March 10, 2026

Conditions

Keywords

caesarean sectionRobson classificationnormal vaginal deliveryVBACreproductionmaternal healthBangladesh

Outcome Measures

Primary Outcomes (1)

  • Caesarean section rate

    Proportion of caesarean sections among total deliveries

    70 weeks

Secondary Outcomes (4)

  • Absolute and non-absolute indications for caesarean sections

    70 weeks

  • Robson classification for all deliveries

    70 weeks

  • Absolute CS rate by Robson Classification

    70 weeks

  • Relative CS rate by Robson Classification

    70 weeks

Study Arms (2)

Pre-intervention Baseline Phase

NO INTERVENTION

Participants recruited before implementation of the intervention to compare against participants that will receive the intervention

Post-intervention Endline Phase

ACTIVE COMPARATOR

Participants recruited after implementation of the intervention to compare against participants that did not receive the intervention

Other: Package of 11 evidence-based maternity practices combined with Robson TGCS Classification

Interventions

The intervention package comprised 11 evidence-based maternity practices designed to reduce unnecessary C-sections and promote safe vaginal deliveries: 1. ANC counselling for expecting mothers. 2. Waiting up to 41 weeks of gestation for spontaneous onset of labour. 3. Risk screening for NVD and induction of labour at term. 4. Assessment of Bishop Score on admission. 5. Supportive care during labour and delivery. 6. Continuous monitoring with CTG. 7. Use of partograph 8. Induction or augmentation of labour as indicated, using prostaglandin or oxytocin for induction, based on Bishop Score. 9. Consultant review of CS indications during ward rounds. 10. Vaginal birth after caesarean (VBAC) for selected cases with appropriate monitoring. 11. Immediate care of the newborn. Additionally, all deliveries were classified using the Robson Ten Group Classification System.

Post-intervention Endline Phase

Eligibility Criteria

Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsCisgender women
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • \- Admitted into the maternity and labour ward of AWCH for delivery.

You may not qualify if:

  • Unable to provide consent
  • Age is less than 18 years
  • Refused to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ashulia Women and Children Hospital

Dhaka, Dhaka Division, 1349, Bangladesh

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Department of OBGYN

Study Record Dates

First Submitted

March 3, 2026

First Posted

March 10, 2026

Study Start

June 1, 2017

Primary Completion

February 10, 2019

Study Completion

August 18, 2019

Last Updated

March 12, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations