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Completed

NCT Number: NCT06056141

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

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

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Key information

Conditions

Induction of Labor

Age range

18 year–49 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Center for Perinatology and Pediatric Cardiac Surgery, Almaty, Kazakhstan

Loading trial locations.

About this study

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)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 )

Treatment and study plan

Misoprostol 200Mcg Tab

Drug

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

foley catheter

Device

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

Primary outcomes

  1. Efficiency of induction

    Time frame: 24 hours.

    Number of Participants with vaginal births within 24 hours.

Secondary outcomes

  1. Safety for baby

    Time frame: 5 min

    Rate of cases Apgar score <7 points

  2. Safety for mother

    Time frame: during the labour induction

    incidence of hyperstimulation

Sponsors and collaborators

Lead sponsor

Kazakhstan's Medical University "KSPH"

Other

Collaborators

  • Asfendiyarov Kazakh National Medical University

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Sep 28, 2023
Registry last updated
Feb 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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