Post-Term PregnancyNCT06949787
To Compare Sweeping of Membranes Versus Expectant Management for Spontaneous Onset of Labor and Vaginal Delivery.
A study testing Membrane sweeping in people with Post-Term Pregnancy, run by Muhammad Aamir Latif at 1 site in Pakistan.
Trial summary
The study is planned to fill the gaps regarding the effectiveness of sweeping of membranes versus expectant management in terms of spontaneous onset of labor and vaginal delivery in post-date primigravida. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Post-Term Pregnancy
- What is being tested?
- Membrane sweeping
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 sitePakistan
- Study dates
- 1 May 2025to 31 Oct 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Primigravid women
- Aged between 18 and 40 years
- Gestational age ≥40 weeks, confirmed by ultrasound or early dating scan
- Singleton pregnancies
- Cephalic presentation
Who cannot join
- Multiple gestations
- Fetal distress or anomalies detected on ultrasound
- Contraindications to vaginal delivery (e.g., placenta previa, previous uterine surgery)
- Previous uterine scar
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site
Combined Military Hospital
Attock, Punjab Province, 04363
Aisha Ashraf, +923059501195, draisha2020@outlook.com
Riaz Tahir, +923237426210, riaztahira3@gmail.com
About this study
Official title: Comparison of Spontaneous Onset of Labor and Vaginal Delivery in Post-date Primigravida Undergoing Sweeping of Membranes Versus Expectant Management
The study is planned to fill the gaps regarding the effectiveness of sweeping of membranes versus expectant management in terms of spontaneous onset of labor and vaginal delivery in post-date primigravida.
Read the detailed description
This study is important as it provides localized data on the effectiveness and practicality of membrane sweeping in a low-resource setting, which is underrepresented in current literature. Potential benefits of this research may include reduced need for formal labor induction, lower healthcare costs, and improved maternal and neonatal outcomes. The findings may enhance clinical practices by offering an evidence-based, patient-friendly approach to managing postdate pregnancies, particularly in resource-limited settings where induction facilities are constrained.
- Conditions
- Post-Term Pregnancy
- Being tested
- Membrane sweeping
- Medical subject headings
- Pregnancy, Prolonged
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Membrane sweepingProcedure or surgery
Participants in the membranes sweeping group will receive membrane sweeping. If labor will not initiate within 48 hours, the procedure will be repeated up to a maximum of three times at 48-hour intervals.
| Study group | Role | What they receive |
|---|---|---|
| Membrane sweeping group | Experimental | Participants in the membranes sweeping group will receive membrane sweeping. If labor will not initiate within 48 hours, the procedure will be repeated up to a maximum of three times at 48-hour intervals. Receives: Procedure: Membrane sweeping |
| Expectant management group | No intervention | Women in the expectant management group will receive no mechanical intervention, and these women will be monitored according to the standard protocol until spontaneous labor onset or labor induction will be deemed necessary. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spontaneous onset of labor and vaginal delivery
The occurrence of regular uterine contractions (contractions occurring every 3-5 minutes, each lasting 30-60 seconds, and progressively increasing in intensity) leading to cervical changes without any form of labor induction will mark the achievement of spontaneous onset of labor.
Measured: 6 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2025
- Study start1 May 2025 (estimated)
- Primary completion31 Oct 2025 (estimated)
- Study completion31 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Term PregnancyStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Muhammad Aamir Latif
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Muhammad Aamir Latif, RESnTEC, Institute of Research
- Investigators
- Aisha Ashraf, Principal investigator, Combined military hospital, Attock, PakistanTahir Ashraf, FCPS, Study director, Combined military hospital, Attock, Pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06949787
- Sponsor's protocol ID
- DrAyeshaCMHAttock
- Status last verified
- Apr 2025
- First submitted
- 22 Apr 2025
- Last updated
- 29 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: If a reasonable request is made, the data can be shared.
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Spontaneous Onset of Labor and Vaginal Delivery in Post-date Primigravida Undergoing Sweeping of Membranes Versus Expectant Management
- ClinicalTrials.gov ID
- NCT06949787
- Acronym / sponsor ID
- DrAyeshaCMHAttock
- Conditions
- Post-Term Pregnancy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- Muhammad Aamir LatifUniversity, hospital or other
- Study start
- 1 May 2025 (estimated)
- Primary completion
- 31 Oct 2025 (estimated)
- Study completion
- 31 Oct 2025 (estimated)
- First posted
- 29 Apr 2025 (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 study is planned to fill the gaps regarding the effectiveness of sweeping of membranes versus expectant management in terms of spontaneous onset of labor and vaginal delivery in post-date primigravida.
Detailed description
This study is important as it provides localized data on the effectiveness and practicality of membrane sweeping in a low-resource setting, which is underrepresented in current literature. Potential benefits of this research may include reduced need for formal labor induction, lower healthcare costs, and improved maternal and neonatal outcomes. The findings may enhance clinical practices by offering an evidence-based, patient-friendly approach to managing postdate pregnancies, particularly in resource-limited settings where induction facilities are constrained.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Membrane sweeping group | Experimental | Procedure: Membrane sweepingParticipants in the membranes sweeping group will receive membrane sweeping. If labor will not initiate within 48 hours, the procedure will be repeated up to a maximum of three times at 48-hour intervals. |
| Expectant management group | No intervention | –Women in the expectant management group will receive no mechanical intervention, and these women will be monitored according to the standard protocol until spontaneous labor onset or labor induction will be deemed necessary. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Primigravid women
- Aged between 18 and 40 years
- Gestational age ≥40 weeks, confirmed by ultrasound or early dating scan
- Singleton pregnancies
- Cephalic presentation
Key exclusion criteria (4 listed)
- Multiple gestations
- Fetal distress or anomalies detected on ultrasound
- Contraindications to vaginal delivery (e.g., placenta previa, previous uterine surgery)
- Previous uterine scar
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 |
|---|---|---|
| Membrane sweepingParticipants in the membranes sweeping group will receive membrane sweeping. If labor will not initiate within 48 hours, the procedure will be repeated up to a maximum of three times at 48-hour intervals. | Procedure or surgery | Membrane sweeping group |
Primary outcome
Spontaneous onset of labor and vaginal delivery
Time frame: 6 days
The occurrence of regular uterine contractions (contractions occurring every 3-5 minutes, each lasting 30-60 seconds, and progressively increasing in intensity) leading to cervical changes without any form of labor induction will mark the achievement of spontaneous onset of labor.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2025.
- Individual participant dataSharing planned: No. If a reasonable request is made, the data can be shared.
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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.
Aisha Ashraf principal investigator
Combined military hospital, Attock, Pakistan
Tahir Ashraf, FCPS study director
Combined military hospital, Attock, Pakistan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Membrane sweeping in people with Post-Term Pregnancy, run by Muhammad Aamir Latif at 1 site in Pakistan.
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 5 inclusion and 4 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: opening soon, as of the sponsor's last update on 29 Apr 2025. 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 Pakistan. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aisha Ashraf (+923059501195, draisha2020@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spontaneous onset of labor and vaginal delivery (time frame: 6 days). 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 29 Apr 2025.