To Compare Sweeping of Membranes Versus Expectant Management for Spontaneous Onset of Labor and Vaginal Delivery.

April 22, 2025 updated by: Muhammad Aamir Latif

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

132

Phase

  • 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 Contact

Study Contact Backup

Study Locations

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

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Primigravid women
  • Aged between 18 and 40 years
  • Gestational age ≥40 weeks, confirmed by ultrasound or early dating scan
  • Singleton pregnancies
  • Cephalic presentation

Exclusion Criteria:

  • Multiple gestations
  • Fetal distress or anomalies detected on ultrasound
  • Contraindications to vaginal delivery (e.g., placenta previa, previous uterine surgery)
  • Previous uterine scar

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Membrane sweeping group
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.
Procedure: Membrane sweeping
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.
No Intervention: Expectant management group
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 days

Collaborators and Investigators

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

Sponsor

Muhammad Aamir Latif

Investigators

  • Principal Investigator: Aisha Ashraf, Combined military hospital, Attock, Pakistan
  • Study Director: Tahir Ashraf, FCPS, Combined military hospital, Attock, Pakistan

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 (Estimated)

May 1, 2025

Primary Completion (Estimated)

October 31, 2025

Study Completion (Estimated)

October 31, 2025

Study Registration Dates

First Submitted

April 22, 2025

First Submitted That Met QC Criteria

April 22, 2025

First Posted (Actual)

April 29, 2025

Study Record Updates

Last Update Posted (Actual)

April 29, 2025

Last Update Submitted That Met QC Criteria

April 22, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DrAyeshaCMHAttock

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

If a reasonable request is made, the data can be shared.

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.

Clinical Trials on Post-Term Pregnancy

Clinical Trials on Membrane sweeping

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Guatemala

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe