Cervical Ripening Balloon Compared With Vaginal Misoprostol for Cervical Ripening in Obese Woman at Term

June 29, 2026 updated by: HUDDA Ahmad
Cervical ripening balloon compared with vaginal misoprostol for cervical ripening in obese woman at term

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

108

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 Locations

  • Pakistan
    • Punjab Province
      • Islamabad, Punjab Province, Pakistan, 46604
        • Pakistan institute of medical sciences Islamabad

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:

  • obese women bmi >30, Bishop score <6 at time of ripening Singleton pregnancy Gestational age more than 37 weeks

Exclusion Criteria:

  • pregnancy with fetal demise congenital anomalies, History of uterine surgery In active labour >4 cm dialated Obs complication History of uterine hyper stimulation and uterine rupture Feel malpresentation

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental group having cervical ripening with cervical folleys
We will study effectiveness of ripening with cervical folleys compared to misoprostol
Device: Cervical folleys
We will compare effectiveness of cervical ripening with cervical folleys compared to misoprostol in obese women at term
Active Comparator: Experimental group having cervical ripening with misoprostol
We will compare effectiveness of ripening with misoprostol with cervical folleys
Drug: Misoprostol
We will compare effectiveness of ripening with misoprostol comoared with cervical folleys in obese women at term

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Less rate of instrumental delivery and c section
Time Frame: 12 months
Less rate of instrumental delivery and c section in ripening of obese women with cervical folleys as compared to misoprostol at term
12 months

Collaborators and Investigators

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

Sponsor

HUDDA Ahmad

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)

May 1, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

June 29, 2026

First Submitted That Met QC Criteria

June 29, 2026

First Posted (Actual)

July 6, 2026

Study Record Updates

Last Update Posted (Actual)

July 6, 2026

Last Update Submitted That Met QC Criteria

June 29, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PIMS hospital islamabad

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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