Improving Safe Vaginal Deliveries for Delivering Mothers by Implementing an Intervention Package of 11 Evidence-based Practices and Robson Classification at a Semi-urban Hospital in Dhaka, Bangladesh (ISVD)

March 10, 2026 updated by: Anjuman Ara, Ashulia Women and Children Hospital

Improving Safe Vaginal Deliveries Using Evidence-based Practices at a Semi-urban Hospital in Dhaka, Bangladesh

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2475

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bangladesh
    • Dhaka Division
      • Dhaka, Dhaka Division, Bangladesh, 1349
        • Ashulia Women and Children Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Pre-intervention Baseline Phase
Participants recruited before implementation of the intervention to compare against participants that will receive the intervention
Active Comparator: Post-intervention Endline Phase
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

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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Caesarean section rate
Time Frame: 70 weeks
Proportion of caesarean sections among total deliveries
70 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Absolute and non-absolute indications for caesarean sections
Time Frame: 70 weeks

Proportion of absolute and non-absolute indications among all deliveries by caesarean sections.

Absolute indications are situations where vaginal delivery is not possible or poses a highly significant risk to the mother or baby. Non-absolute indications are situations where a caesarean section might be considered based on the potential risks and benefits for both the mother and the baby, and vaginal delivery may still be an option.

Absolute indications include: obstructed labour, grade 3 or 4 placenta praevia, impending uterine rupture, and malpresentation.

Non-absolute indications include: failure to progress in labour, prolonged labour, failed induction, previous caesarean delivery, antepartum haemorrhage, preeclampsia/eclampsia, psychological indication, maternal request, precious (valuable) pregnancy, foetal compromise, and breech presentation.
70 weeks
Robson classification for all deliveries
Time Frame: 70 weeks

Robson classification for all deliveries.

The Robson classification is a system for classifying pregnant women who undergo childbirth. There are a total of 12 mutually-exclusive groups and subgroups to which every delivering mother is assigned to. These are:

1 Nulliparous, single cephalic, >=37 weeks, spontaneous labour; 2a Nulliparous, single cephalic, >=37 weeks, induced labour; 2b Nulliparous, single cephalic, >=37 weeks, CS before labour; 3 Multiparous (no previous CS), single cephalic, >=37 weeks, spontaneous labour; 4a Multiparous (no previous CS), single cephalic, >=37 weeks, induced labour; 4b Multiparous (no previous CS), single cephalic, >=37 weeks, CS before labour; 5 Multiparous, previous CS, single cephalic, >=37 weeks; 6 Nulliparous with single breech; 7 Multiparous with single breech (including previous CS); 8 All multiple pregnancies (including previous CS); 9 All abnormal lies (including previous CS); 10 All single cephalic, <37 weeks (including previous CS).
70 weeks
Absolute CS rate by Robson Classification
Time Frame: 70 weeks

Absolute proportion of caesarean sections among all Robson groups.

Absolute rate is calculated by: number of caesarean section in the Robson group/total number of deliveries in the hospital * 100
70 weeks
Relative CS rate by Robson Classification
Time Frame: 70 weeks
Relative proportion of caesarean sections among all Robson groups. Relative rate is calculated by: number of caesarean sections in the Robson group/total number of caesarean sections in the hospital * 100
70 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ashulia Women and Children Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 10, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 18, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 3, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 6, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 10, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 12, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 10, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CWCH/ERC/2017/010

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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