Vaginal Birth After Cesarean SectionNCT06103071
Role of Membrane Sweeping on Initiation of Labor and Vaginal Birth in Previous Cesarean Section
A study testing Sweeping of membranes in people with Vaginal Birth After Cesarean Section, run by HITEC-Institute of Medical Sciences at 1 site in Pakistan.
Trial summary
In Pakistan rate of child birth through cesarean section increased from 3.2% in 1992 to 22% in 2018 .Due to increasing rates of cesarean sections and associated morbidity the investigators should focus to reduce rate of primary cesarean section as well as repeat cesarean with cephalic presentation and singleton… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vaginal Birth After Cesarean Section
- What is being tested?
- Sweeping of membranes
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 384 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Jan 2023to 15 Jul 2024
- Phase
- Interventional
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 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 1. Women willing for vaginal birth after lower segment cesarean section from 37 weeks of gestation to 40 weeks.
- 2. Previous one caesarean section for non-recurrent cause 3. Singleton pregnancy 4. Cephalic presentation
Who cannot join
- Previous uterine rupture
- Major degree placenta previa
- Any medical disorder like PIH, diabetes
- Bad obstetrics history
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Membrane Sweeping on Successful Initiation of Labor and Subsequent Vaginal Birth in Patients With Previous One Cesarean Section.
In Pakistan rate of child birth through cesarean section increased from 3.2% in 1992 to 22% in 2018 .Due to increasing rates of cesarean sections and associated morbidity the investigators should focus to reduce rate of primary cesarean section as well as repeat cesarean with cephalic presentation and singleton pregnancy after previous 1 cesarean section. Therefore, all ladies who underwent previous 1 cesarean section for non-recurrent cause should be considered for vaginal birth. Though studies show that membrane sweeping does promote the onset of labor and avoid need for formal induction of labor for prolonged pregnancy but the effects of membrane sweeping in women with a prior cesarean delivery are largely unknown. This is a randomized controlled trial. Objective of the study was to determine the effect of membrane sweeping on the onset of labor, success of vaginal delivery and neonatal outcome in patients with previous one cesarean section.
Read the detailed description
World Health Organization suggests that ideally cesarean section rate should not be more than 10% to 15%. The investigators should focus to reduce rate of primary cesarean section as well as repeat cesarean with cephalic presentation and singleton pregnancy after previous 1 cesarean section. Therefore, all ladies who underwent previous 1 cesarean section for non-recurrent cause should be considered for vaginal birth. Though studies show that membrane sweeping does promote the onset of labor and avoid need for formal induction of labor for prolonged pregnancy but the effects of membrane sweeping in women with a prior cesarean delivery are largely unknown. It is reported in literature that there is no significant increase risk to maternal or neonatal outcome with membrane sweeping. The rationale of the study was to compare the effect of membrane sweeping with no sweeping in the successful onset of labor in patients with one previous Cesarean Section so that the investigators can reduce the cesarean section rate. Objective of the study was to determine the effect of membrane sweeping on the onset of labor, success of vaginal delivery and neonatal outcome in patients with previous one cesarean section.
- Conditions
- Vaginal Birth After Cesarean Section
- Being tested
- Sweeping of membranes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sweeping of membranesProcedure or surgery
After informed consent all the patients in interventional group will have sweeping of membranes from 37 weeks of pregnancy . It will be repeated weekly till 40 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Sweeping group | Active comparator | Sweeping group include patients in which membrane sweeping started from 37 weeks and performed weekly till 40 weeks. Intervention is the sweeping of membranes from 37 weeks of gestational amenorrhea. Receives: Procedure: Sweeping of membranes |
| Non sweeping group | No intervention | Non sweeping group include patients in which no sweeping of membranes done. No intervention done. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Onset of Labor by 40 Weeks
Measured: Primary outcome include number of participants that had onset of labour from enrollment upto 40 weeks gestation
Secondary outcomes (1)
Number of Participants Having Successful Vaginal Delivery
It includes how many number of participants will have successful vaginal birth after previous 1 cesarean section
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2023
- Study start15 Jan 2023
- Primary completion10 Jul 2024
- Study completion15 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Vaginal Birth After Cesarean 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomization intervention RCT
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 384 participants (actual)
Sponsor and investigators
- Lead sponsor
- HITEC-Institute of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nida Khan, HITEC-Institute of Medical Sciences
- Investigators
- Nida Khan, MBBS, FCPS, Principal investigator, HITEC-Institute of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06103071
- Sponsor's protocol ID
- HITEC-IMS
- Status last verified
- Feb 2026
- First submitted
- 10 Sep 2023
- Last updated
- 13 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No