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

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

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-26

Study Completion Date

2024-12-31

Brief Summary

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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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Detailed Description

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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)

Conditions

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Induction of Labor

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Foley catheter + misoprostol

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

Group Type ACTIVE_COMPARATOR

Misoprostol 200mcg Tab

Intervention Type 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

misoprostol

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

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

Interventions

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Misoprostol 200mcg Tab

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

Intervention Type COMBINATION_PRODUCT

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

Other Intervention Names

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

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 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