NCT06056141

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 300 (actual)
• Sponsor: Kazakhstan's Medical University "KSPH" · Academic / Other
• Sex: Female
• Age: 18 Years – 49 Years
• Healthy volunteers: Accepted

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)

Conditions

• Induction of Labor

Interventions

Type	Name	Description
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
DEVICE	Foley Catheter	Transcervical Foley catheter (silicone, size 20F with 30ml balloon)

Timeline

• Start date: 2023-10-01
• Primary completion: 2024-10-01
• Completion: 2024-12-01
• First posted: 2023-09-28
• Last updated: 2025-02-21

Locations

2 sites across 1 country: Kazakhstan