Caesarean SectionISVDNCT07461571
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
A study testing Package of 11 evidence-based maternity practices combined with Robson TGCS Classification in people with Caesarean Section, run by Ashulia Women and Children Hospital at 1 site in Bangladesh.
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Caesarean Section
- What is being tested?
- Package of 11 evidence-based maternity practices combined with Robson TGCS Classification
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,475 participants
- Where
- 1 siteBangladesh
- Study dates
- 1 Jun 2017to 18 Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Admitted into the maternity and labour ward of AWCH for delivery.
Who cannot join
- Unable to provide consent
- Age is less than 18 years
- Refused to participate in the study
Trial locations and contacts
1 site in 1 country.
Bangladesh1 site
Ashulia Women and Children Hospital
Dhaka, Dhaka Division, 1349
About this study
Official title: 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.
- Conditions
- Caesarean Section
- Being tested
- Package of 11 evidence-based maternity practices combined with Robson TGCS Classification
- Keywords
- caesarean section, Robson classification, normal vaginal delivery, VBAC, reproduction, maternal health, Bangladesh
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Package of 11 evidence-based maternity practices combined with Robson TGCS ClassificationOther
The intervention package comprised 11 evidence-based maternity practices designed to reduce unnecessary C-sections and promote safe vaginal deliveries:
- ANC counselling for expecting mothers.
- Waiting up to 41 weeks of gestation for spontaneous onset of labour.
- Risk screening for NVD and induction of labour at term.
- Assessment of Bishop Score on admission.
- Supportive care during labour and delivery.
- Continuous monitoring with CTG.
- Use of partograph
- Induction or augmentation of labour as indicated, using prostaglandin or oxytocin for induction, based on Bishop Score.
- Consultant review of CS indications during ward rounds.
- Vaginal birth after caesarean (VBAC) for selected cases with appropriate monitoring.
- Immediate care of the newborn.
Additionally, all deliveries were classified using the Robson Ten Group Classification System.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Package of 11 evidence-based maternity practices combined with Robson TGCS Classification |
What is being measured
The primary outcome is the main question the study is designed to answer.
Caesarean section rate
Proportion of caesarean sections among total deliveries
Measured: 70 weeks
Secondary outcomes (4)
Absolute and non-absolute indications for caesarean sections
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.
Measured: 70 weeks
Robson classification for all deliveries
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).
Measured: 70 weeks
Absolute CS rate by Robson Classification
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
Measured: 70 weeks
Relative CS rate by Robson Classification
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
Measured: 70 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2026
- Study start1 Jun 2017
- Primary completion10 Feb 2019
- Study completion18 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Caesarean SectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 2,475 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ashulia Women and Children Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anjuman Ara, Ashulia Women and Children Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07461571
- Sponsor's protocol ID
- CWCH/ERC/2017/010
- Acronym
- ISVD
- Status last verified
- Mar 2026
- First submitted
- 3 Mar 2026
- Last updated
- 12 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Safe Vaginal Deliveries Using Evidence-based Practices at a Semi-urban Hospital in Dhaka, Bangladesh
- ClinicalTrials.gov ID
- NCT07461571
- Acronym / sponsor ID
- ISVD / CWCH/ERC/2017/010
- Conditions
- Caesarean Section
- Keywords
- caesarean section, Robson classification, normal vaginal delivery, VBAC, reproduction, maternal health, Bangladesh
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,475 participants (actual)
- Lead sponsor
- Ashulia Women and Children HospitalUniversity, hospital or other
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 10 Feb 2019 (actual)
- Study completion
- 18 Aug 2019 (actual)
- First posted
- 10 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: Package of 11 evidence-based maternity practices combined with Robson TGCS ClassificationParticipants recruited after implementation of the intervention to compare against participants that did not receive the intervention |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Admitted into the maternity and labour ward of AWCH for delivery.
Key exclusion criteria (3 listed)
- Unable to provide consent
- Age is less than 18 years
- Refused to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Package of 11 evidence-based maternity practices combined with Robson TGCS ClassificationThe 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. | Other | Post-intervention Endline Phase |
Primary outcome
Caesarean section rate
Time frame: 70 weeks
Proportion of caesarean sections among total deliveries
4 secondary outcomes
Absolute and non-absolute indications for caesarean sections
Time frame: 70 weeks
Robson classification for all deliveries
Time frame: 70 weeks
Absolute CS rate by Robson Classification
Time frame: 70 weeks
Relative CS rate by Robson Classification
Time frame: 70 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Package of 11 evidence-based maternity practices combined with Robson TGCS Classification in people with Caesarean Section, run by Ashulia Women and Children Hospital at 1 site in Bangladesh.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bangladesh. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Caesarean section rate (time frame: 70 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2026.