- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07461571
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)
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
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Dhaka Division
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Dhaka, Dhaka Division, Bangladesh, 1349
- Ashulia Women and Children Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
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
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 |
Intervention / Treatment |
|---|---|
|
No Intervention: Pre-intervention Baseline Phase
Participants recruited before implementation of the intervention to compare against participants that will receive the intervention
|
|
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Active Comparator: Post-intervention Endline Phase
Participants recruited after implementation of the intervention to compare against participants that did not receive the intervention
|
The intervention package comprised 11 evidence-based maternity practices designed to reduce unnecessary C-sections and promote safe vaginal deliveries:
Additionally, all deliveries were classified using the Robson Ten Group Classification System. |
What is the study measuring?
Primary Outcome Measures
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
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
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- CWCH/ERC/2017/010
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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