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

NCT06949787 | Not Yet Recruiting

• 1 other identifier: DrAyeshaCMHAttock
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Post-Term Pregnancy

Outcome Measures

Primary Outcomes (1)

• 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.

  6 days

Study Arms (2)

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.

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.

Interventions

Membrane sweeping PROCEDURE

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.

Membrane sweeping group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Muhammad Aamir Latif: lead

Study Sites (1)

Combined Military Hospital

Attock, Punjab Province, 04363, Pakistan

Location

MeSH Terms

Conditions

Pregnancy, Prolonged

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Aisha Ashraf

  Combined military hospital, Attock, Pakistan

  PRINCIPAL INVESTIGATOR

• Tahir Ashraf, FCPS

  Combined military hospital, Attock, Pakistan

  STUDY DIRECTOR

Central Study Contacts

Aisha Ashraf

CONTACT

+923059501195; draisha2020@outlook.com

Tahir Riaz, FCPS

CONTACT

+923237426210; riaztahira3@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Consultant

Study Record Dates

• First Submitted: April 22, 2025
• First Posted: April 29, 2025
• Study Start: May 1, 2025
• Primary Completion: October 31, 2025
• Study Completion: October 31, 2025
• Last Updated: April 29, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)