Sequential Use of Foley's Catheter and Misoprostol Versus Misoprostol Alone for Induction of Labour: a Multicentre Randomised Controlled Trial

Phase 4

Completed

• Conditions: Induction of Labor
• Interventions: Drug: Misoprostol 200mcg Tab

• Registration Number: NCT06249815
• Lead Sponsor: Kazakhstan's Medical University "KSPH"

Brief Summary

Evaluation of efficacy of inducing labour using a Foley's catheter and low dose oral misoprostol sequentially, in comparison with low dose oral misoprostol alone.

Detailed Description

a multicentre, open-label randomised controlled 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 Foley's catheter for 16 hour and sequentially 25 μg oral misoprostol once every 2 hour, 2 nd group- 25 μg oral misoprostol once every 2 hour. 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, rate of hyperstimulation ,hemorrage,chorioamnionitis (for evaluating safety)

Study Timeline

• Study First Submitted: 2024-01-12
• Study First Submitted QC: 2024-02-06
• Study First Posted: 2024-02-08
• Study Start: 2024-04-26
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-20
• Last Update Posted: 2025-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 400

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 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
Foley catheter + misoprostol	Misoprostol 200mcg Tab	-cervical ripening with transcervical Foley catheter 22 F for 16 hours, then sequentially 25 μg oral misoprostol once every 2 hour.Max 200 μg
misoprostol	Misoprostol 200mcg Tab	25 μg oral misoprostol alone once every 2 hour, Max 200 μg.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Safety for mother	24 hour	incidence of hyperstimulation
Safety for baby	5 minutes	Rate of cases Apgar score \<7 points
rete of hemorrage	24 hour	bleeding more than 500 ml during the vaginal delivery, more than 1000 ml after c-section
rate of chorioamnionitis chorioamnionitis	24 hour	meconial amniotic fluid, tachycardia, leukocytosis

Trial Locations

Locations (2)

City Perinatology Centre 3; 🇰🇿 Almaty, Kazakhstan

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