Comparison of Outcome of Foley Catheter Versus Misoprostol for Induction of Labor

February 10, 2026 updated by: Muhammad Aamir Latif

Comparison of Outcome of Foley Catheter Versus Misoprostol for Induction of Labor at Term Pregnancy

There are gaps in the local data regarding the comparative effectiveness of Foley catheter versus misoprostol for induction of labor (IOL). Therefore, the current study was planned with the objective of comparing the mean induction-to-delivery interval of Foley catheter versus misoprostol for IOL in singleton term pregnancy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Although systematic reviews and meta-analyses have compared the effectiveness and safety of pharmacologic, nonpharmacologic, mechanical, and combined methods of cervical ripening and labor induction, the optimal method of IOL is still debatable. The findings would be helpful in further assessing the conflicting evidence and furnishing the limited data regarding the use of Foley catheters or misoprostol in patients undergoing IOL from local setups.

Study Type

Interventional

Enrollment (Actual)

76

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
      • Dera Ghazi Khan, Punjab Province, Pakistan, 32200
        • D.G. Khan Medical College/Allama Iqbal Teaching Hospital

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:

  • Pregnant females
  • 18-40 years
  • With a singleton term pregnancy (37-41) weeks
  • Parity < 4
  • Vertex presentation (on ultrasound scan)
  • Intact membranes (on history and clinical examination)
  • Going through labor induction

Exclusion Criteria:

  • With a previous uterine surgery
  • Non-reassuring cardiotocography (CTG)
  • Oligohydramnios (on ultrasound scan)
  • Intrauterine growth restriction (IUGR) (on ultrasound scan)
  • Abruptio placenta (on ultrasound scan).

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Misoprostol Group
Women received intravaginal misoprostol 25 μg 4 hours apart, up to a maximum of four doses.
Drug: Misoprostol
Women received intravaginal misoprostol 25 μg 4 hours apart, up to a maximum of four doses.
Experimental: Foley Group
An intracervical Foley catheter (16 F) was inserted into the patients. The balloon was inflated with 30 mL of sterile normal saline solution and was kept in place until it expelled spontaneously.
Device: Foley catheter
An intracervical Foley catheter (16 F) was inserted into the patients. The balloon was inflated with 30 mL of sterile normal saline solution and was kept in place until it expelled spontaneously.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Delivery of the fetus
Time Frame: 24 hours
Induction-to-delivery interval was calculated from the insertion of the Foley catheter or misoprostol until the delivery of the fetus in hours.
24 hours

Collaborators and Investigators

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

Sponsor

Muhammad Aamir Latif

Investigators

  • Principal Investigator: Zunera Sumbal, D.G. Khan Medical College/Allama Iqbal Teaching Hospital

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)

February 1, 2025

Primary Completion (Actual)

December 31, 2025

Study Completion (Actual)

December 31, 2025

Study Registration Dates

First Submitted

February 10, 2026

First Submitted That Met QC Criteria

February 10, 2026

First Posted (Actual)

February 18, 2026

Study Record Updates

Last Update Posted (Actual)

February 18, 2026

Last Update Submitted That Met QC Criteria

February 10, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Dr-Zunaira-DGK

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data can be shared on a reasonable request.

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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