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

NCT06249815 | Completed Phase 4

• 1 other identifier: IRB-23-2024
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 2

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.

Conditions

Induction of Labor

Keywords

Induction of labor; low dose misoprostol; Foley Catheter

Outcome Measures

Primary Outcomes (1)

• Efficiency of induction

  Number of Participants with vaginal births

  24 hours.

Secondary Outcomes (4)

• Safety for baby

  5 minutes

• Safety for mother

  24 hour

• rete of hemorrage

  24 hour

• rate of chorioamnionitis chorioamnionitis

  24 hour

Study Arms (2)

Foley catheter + misoprostol

ACTIVE COMPARATOR

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

Combination Product: Misoprostol 200mcg Tab

misoprostol

ACTIVE COMPARATOR

25 μg oral misoprostol alone once every 2 hour, Max 200 μg.

Drug: Misoprostol 200mcg Tab

Interventions

Misoprostol 200mcg Tab COMBINATION_PRODUCT

ranscervical Foley catheter (silicone, size 20F with 30ml balloon)+Misoprostol 200 mcg dissolvedwith 200 ml water and divided to 25ml solution every 2 hours per os for maximum of 8 doses

Also known as: Transcervical Foley catheter (silicone, size 20F with 30ml balloon)

Foley catheter + misoprostol

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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 )

Sponsors & Collaborators

• Kazakhstan's Medical University "KSPH": lead
• Asfendiyarov Kazakh National Medical University: collaborator

Study Sites (2)

City Perinatology Centre 3

Almaty, 050062, Kazakhstan

Location

Center for Perinatology and Pediatric Cardiac Surgery

Almaty, A15H0K1, Kazakhstan

Location

MeSH Terms

Interventions

Misoprostol; Silicones

Intervention Hierarchy (Ancestors)

Prostaglandins E, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors; Siloxanes; Organosilicon Compounds; Organic Chemicals; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Saule Issenova

  Asfendiyarov Kazakh National Univercity

  STUDY CHAIR

• DILFUZA SULTANMURATOVA

  Kazakhstans Medical Uivercity

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: January 12, 2024
• First Posted: February 8, 2024
• Study Start: April 26, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: February 21, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR

Locations

KA (2)