Comparison of Spontaneous Onset of Labor and Vaginal Delivery in Post-date Primigravida Undergoing Sweeping of Membranes Versus Expectant Management
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 132
- Locations
- 1
- Primary Endpoint
- Spontaneous onset of labor and vaginal delivery
Study Overview
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.
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
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 40 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: Membrane sweeping (Procedure)
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.
Outcomes
Primary Outcomes
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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Muhammad Aamir Latif
Research Consultant
RESnTEC, Institute of Research