Induction of Labour at Term With Low Dose Oral Misoprostol Versus a Foley Catheter

February 20, 2025 updated by: Dilfuza Sultanmuratova, Kazakhstan's Medical University "KSPH"

Induction of Labour at Term With Low Dose Oral Misoprostol Versus a Foley Catheter: a Multicentre Randomised Controlled Trial

Comparison of efficacy and safety of low-dose oral Misoprostol versus folley catheter for preinduction in women with an immature cervix at term.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Open-label randomised trial in 2 hospitals in the Almaty,Kazakhstan. Women with a term singleton pregnancy in cephalic presentation, an unfavourable cervix, intact membranes, and without a previous caesarean section will be randomly allocated to 2 groups: 1 group -cervical ripening with 25 μg oral misoprostol once every 2 hour, 2 nd group- a 30 mL transcervical Foley catheter. The primary outcome will be vaginal delivery within 24 hours(to evaluate effectiveness) and secondary outcoms 1-5-min Apgar score and hospitalization in ICU, hyperstimulation frequency and hemorrage (for evaluating safety)

Study Type

Interventional

Enrollment (Actual)

300

Phase

  • Phase 4

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

  • Kazakhstan
      • Almaty, Kazakhstan, A15H0K1
        • Center for Perinatology and Pediatric Cardiac Surgery
      • Almaty, Kazakhstan, 050062
        • City Perinatology Centre 3

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:

  • women with an unfavourable cervix who will scheduled for induction of labour

Exclusion Criteria:

  • Women with previous caesarean sections unable to give informed consent Multiple pregnancy History of allergy to misoprostol Ruptured membranes Chorioamnionitis All cases when physiological childbirth is impossible (placenta previa,transverse position of the fetus )

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
Active Comparator: Group A
Drug: Misoprostol 25mcg (200 mcg dissolved with 200 ml water and divided to 8 doses) every 2 hours
Drug: Misoprostol 200mcg Tab
Misoprostol 200 mcg dissolvedwith 200 ml water and divided to 25ml solution every 2 hours per os for maximum of 8 doses
Active Comparator: Group B
Device: Foley Catheter Transcervical Foley catheter (silicone, size 20F with 30ml balloon)
Device: Foley Catheter
Transcervical Foley catheter (silicone, size 20F with 30ml balloon)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficiency of induction
Time Frame: 24 hours.
Number of Participants with vaginal births within 24 hours.
24 hours.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety for baby
Time Frame: 5 min
Rate of cases Apgar score <7 points
5 min
Safety for mother
Time Frame: during the labour induction
incidence of hyperstimulation
during the labour induction

Collaborators and Investigators

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

Sponsor

Kazakhstan's Medical University "KSPH"

Collaborators

Asfendiyarov Kazakh National Medical University

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)

October 1, 2023

Primary Completion (Actual)

October 1, 2024

Study Completion (Actual)

December 1, 2024

Study Registration Dates

First Submitted

September 18, 2023

First Submitted That Met QC Criteria

September 24, 2023

First Posted (Actual)

September 28, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 20, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-23-2023

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.

Clinical Trials on Induction of Labor

Clinical Trials on Misoprostol 200mcg Tab

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Taiwan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe