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Completed

NCT Number: NCT06249815

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

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.

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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

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)

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 All cases when physiological childbirth is impossible (placenta previa,transverse position of the fetus )

Treatment and study plan

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

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

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

Primary outcomes

  1. Efficiency of induction

    Time frame: 24 hours.

    Number of Participants with vaginal births

Secondary outcomes

  1. Safety for baby

    Time frame: 5 minutes

    Rate of cases Apgar score <7 points

  2. Safety for mother

    Time frame: 24 hour

    incidence of hyperstimulation

  3. rete of hemorrage

    Time frame: 24 hour

    bleeding more than 500 ml during the vaginal delivery, more than 1000 ml after c-section

  4. rate of chorioamnionitis chorioamnionitis

    Time frame: 24 hour

    meconial amniotic fluid, tachycardia, leukocytosis

Sponsors and collaborators

Lead sponsor

Kazakhstan's Medical University "KSPH"

Other

Collaborators

  • Asfendiyarov Kazakh National Medical University

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Feb 8, 2024
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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