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

Phase 4

Completed

• Conditions: Induction of Labor
• Interventions: Drug: Misoprostol 200mcg Tab; Device: Foley Catheter

• Registration Number: NCT06056141
• Lead Sponsor: Kazakhstan's Medical University "KSPH"

Brief Summary

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

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 Timeline

• Study First Submitted: 2023-09-18
• Study First Submitted QC: 2023-09-24
• Study First Posted: 2023-09-28
• Study Start: 2023-10-01
• Primary Completion: 2024-10-01
• Study Completion: 2024-12-01
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-20
• Last Update Posted: 2025-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 300

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	Misoprostol 200mcg Tab	Drug: Misoprostol 25mcg (200 mcg dissolved with 200 ml water and divided to 8 doses) every 2 hours
Group B	Foley Catheter	Device: Foley Catheter Transcervical Foley catheter (silicone, size 20F with 30ml balloon)

Primary Outcome Measures

Name	Time	Method
Efficiency of induction	24 hours.	Number of Participants with vaginal births within 24 hours.

Secondary Outcome Measures

Name	Time	Method
Safety for mother	during the labour induction	incidence of hyperstimulation
Safety for baby	5 min	Rate of cases Apgar score \<7 points

Trial Locations

Locations (2)

Center for Perinatology and Pediatric Cardiac Surgery; 🇰🇿 Almaty, Kazakhstan

City Perinatology Centre 3; 🇰🇿 Almaty, Kazakhstan