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

NCT ID: NCT06056141

Last Updated: 2025-02-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-01

Study Completion Date

2024-12-01

Brief Summary

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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

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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

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Induction of Labor

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

multicentre randomised controlled trial
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group A

Drug: Misoprostol 25mcg (200 mcg dissolved with 200 ml water and divided to 8 doses) every 2 hours

Group Type ACTIVE_COMPARATOR

Misoprostol 200mcg Tab

Intervention Type DRUG

Misoprostol 200 mcg dissolvedwith 200 ml water and divided to 25ml solution every 2 hours per os for maximum of 8 doses

Group B

Device: Foley Catheter Transcervical Foley catheter (silicone, size 20F with 30ml balloon)

Group Type ACTIVE_COMPARATOR

Foley Catheter

Intervention Type DEVICE

Transcervical Foley catheter (silicone, size 20F with 30ml balloon)

Interventions

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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

Intervention Type DRUG

Foley Catheter

Transcervical Foley catheter (silicone, size 20F with 30ml balloon)

Intervention Type DEVICE

Eligibility Criteria

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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 )
Minimum Eligible Age

18 Years

Maximum Eligible Age

49 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Asfendiyarov Kazakh National Medical University

OTHER

Sponsor Role collaborator

Kazakhstan's Medical University "KSPH"

OTHER

Sponsor Role lead

Responsible Party

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Dilfuza Sultanmuratova

principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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City Perinatology Centre 3

Almaty, , Kazakhstan

Site Status

Center for Perinatology and Pediatric Cardiac Surgery

Almaty, , Kazakhstan

Site Status

Countries

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Kazakhstan

Other Identifiers

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IRB-23-2023

Identifier Type: -

Identifier Source: org_study_id

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