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

Kazakhstan's Medical University "KSPH"300 enrolled

Overview

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

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)

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

300

Conditions

Induction of Labor

Interventions

Misoprostol 200mcg TabDRUG

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

Foley CatheterDEVICE

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

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 49 YearsHealthy volunteers:

Medical Language ↔ Plain English

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 )

Locations (2)

City Perinatology Centre 3

Almaty, Kazakhstan

Center for Perinatology and Pediatric Cardiac Surgery

Almaty, Kazakhstan

Outcomes

Primary Outcomes

Efficiency of induction

Number of Participants with vaginal births within 24 hours.

Time frame: 24 hours.

Secondary Outcomes

Safety for baby

Rate of cases Apgar score \<7 points

Time frame: 5 min

Safety for mother

incidence of hyperstimulation

Time frame: during the labour induction

Data from ClinicalTrials.gov

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