Role of Membrane Sweeping on Initiation of Labor and Vaginal Birth in Previous Cesarean Section

October 24, 2023 updated by: Nida Khan, HITEC-Institute of Medical Sciences

Effectiveness of Membrane Sweeping on Successful Initiation of Labor and Subsequent Vaginal Birth in Patients With Previous One Cesarean Section.

In Pakistan rate of child birth through cesarean section increased from 3.2% in 1992 to 22% in 2018 .Due to increasing rates of cesarean sections and associated morbidity the investigators should focus to reduce rate of primary cesarean section as well as repeat cesarean with cephalic presentation and singleton pregnancy after previous 1 cesarean section. Therefore, all ladies who underwent previous 1 cesarean section for non-recurrent cause should be considered for vaginal birth. Though studies show that membrane sweeping does promote the onset of labor and avoid need for formal induction of labor for prolonged pregnancy but the effects of membrane sweeping in women with a prior cesarean delivery are largely unknown. This is a randomized controlled trial. Objective of the study was to determine the effect of membrane sweeping on the onset of labor, success of vaginal delivery and neonatal outcome in patients with previous one cesarean section.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

World Health Organization suggests that ideally cesarean section rate should not be more than 10% to 15%. The investigators should focus to reduce rate of primary cesarean section as well as repeat cesarean with cephalic presentation and singleton pregnancy after previous 1 cesarean section. Therefore, all ladies who underwent previous 1 cesarean section for non-recurrent cause should be considered for vaginal birth. Though studies show that membrane sweeping does promote the onset of labor and avoid need for formal induction of labor for prolonged pregnancy but the effects of membrane sweeping in women with a prior cesarean delivery are largely unknown. It is reported in literature that there is no significant increase risk to maternal or neonatal outcome with membrane sweeping. The rationale of the study was to compare the effect of membrane sweeping with no sweeping in the successful onset of labor in patients with one previous Cesarean Section so that the investigators can reduce the cesarean section rate. Objective of the study was to determine the effect of membrane sweeping on the onset of labor, success of vaginal delivery and neonatal outcome in patients with previous one cesarean section.

Study Type

Interventional

Enrollment (Estimated)

384

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

  • Pakistan
    • Punjab
      • Rawalpindi, Punjab, Pakistan, 47080
        • Recruiting
        • HIT hospital
        • Contact:
        • Contact:

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

Yes

Description

Inclusion Criteria:

  • 1. Women willing for vaginal birth after lower segment cesarean section from 37 weeks of gestation to 40 weeks.

    2. Previous one caesarean section for non-recurrent cause 3. Singleton pregnancy 4. Cephalic presentation

Exclusion Criteria:

  1. Previous uterine rupture
  2. Major degree placenta previa
  3. Any medical disorder like PIH, diabetes
  4. Bad obstetrics history

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Sweeping group
Sweeping group include patients in which membrane sweeping started from 37 weeks and performed weekly till 40 weeks. Intervention is the sweeping of membranes from 37 weeks of gestational amenorrhea.
Procedure: Sweeping of membranes
After informed consent all the patients in interventional group will have sweeping of membranes from 37 weeks of pregnancy . It will be repeated weekly till 40 weeks.
No Intervention: Non sweeping group
Non sweeping group include patients in which no sweeping of membranes done. No intervention done.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants who will have onset of labour till 40 weeks
Time Frame: 4 weeks
Primary outcome include number of participants who will have onset of labour till 40 weeks between two groups ( sweeping and non sweeping groups )
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants having successful vaginal delivery and number of participants having babies admitted in NICU
Time Frame: 5 days
It includes how many number of participants will have successful vaginal birth after previous 1 cesarean section and fetal outcome, that is admission in NICU.
5 days

Collaborators and Investigators

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

Sponsor

HITEC-Institute of Medical Sciences

Investigators

  • Principal Investigator: Nida Khan, MBBS, FCPS, HITEC-Institute of Medical Sciences

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 (Actual)

January 15, 2023

Primary Completion (Estimated)

July 15, 2024

Study Completion (Estimated)

August 1, 2024

Study Registration Dates

First Submitted

September 10, 2023

First Submitted That Met QC Criteria

October 24, 2023

First Posted (Actual)

October 26, 2023

Study Record Updates

Last Update Posted (Actual)

October 26, 2023

Last Update Submitted That Met QC Criteria

October 24, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • HITEC-IMS

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.

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