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

Study Overview
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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)

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

Conditions
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Induction of Labor

Intervention / Treatment
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* Drug: Misoprostol 200mcg Tab
* Device: Foley Catheter


Participation Criteria
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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 )

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 49 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: multicentre randomised controlled trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group A<br>Drug: Misoprostol 25mcg (200 mcg dissolved with 200 ml water and divided to 8 doses) every 2 hours | Drug: Misoprostol 200mcg Tab<br>* Misoprostol 200 mcg dissolvedwith 200 ml water and divided to 25ml solution every 2 hours per os for maximum of 8 doses<br>|
| Active Comparator: Group B<br>Device: Foley Catheter Transcervical Foley catheter (silicone, size 20F with 30ml balloon) | Device: Foley Catheter<br>* Transcervical Foley catheter (silicone, size 20F with 30ml balloon)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficiency of induction | Number of Participants with vaginal births within 24 hours. | 24 hours. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety for baby | Rate of cases Apgar score <7 points | 5 min | 
| Safety for mother | incidence of hyperstimulation | during the labour induction | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Induction of labor, low dose misoprostol, Foley Catheter