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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

132 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-01

Study Completion Date

2025-10-31

Brief Summary

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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.

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Detailed Description

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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

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Post-Term Pregnancy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Membrane sweeping

Intervention Type 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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No