Labor Induction With Double Balloon Device, Oral Misoprostol and Concomitant Use of Both

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to compare the rate of cesarean delivery between 3 methods of labor induction: double balloon device, oral misoprostol and combination of the two.

Detailed Description
-----------------
Induction of labor is a common obstetrical procedure. It accounts for 20% of laboring women worldwide. In the past, studies showed that cesarean delivery rates (CDR) are higher in women who are induced. These studies were comparing induction to spontaneous labor, which is not the management in practice, and when the comparison was made between induction and expectant management, the conclusion was that the induction does not increase CDR and can even reduce its' rate. Failure of induction depends on the definition, and even among randomized controlled trials, this definition may vary greatly. The decision whether to use a mechanical or pharmacological agent depends on Bishop score, parity, contraindications to one of the methods and patient-doctor preference. Recently, more data are available regarding induction with oral misoprostol (OM) and this method is becoming more popular because OM is effective, safe, convenient, cheap and easy to administer. If mechanical induction is preferable, either single or double balloon device (DBD) can be used. These methods have been previously studied and neither found to be superior. A recent study showed that, insertion of the DBD for 6 hours in nulliparous women, results in shorter time to delivery (26 hours vs. 31.4 hours, p=0.015), similar Bishop score after removal ( 5.74 vs. 5.26, p=0.2) without increasing the rate of cesarean deliveries (19% vs 32%, p=0.135) when compared to insertion of the DBD for 12 hours as instructed by the manufacturer. Several studies have shown that a combination of pharmacological and single balloon device results in higher rates to achieve vaginal delivery when compared to each method separately The investigators hypothesize that with the combination of DBD for 6 hours and OM we will be able to reduce the rate of cesarean deliveries when compared to each method separately. To date, there are no studies that compared double balloon device with oral misoprostol used concomitantly.

Official Title
-----------------
Labor Induction With Double Balloon Device, Oral Misoprostol and Concomitant Use of Both. Multicenter Randomized Controlled Trial- IDOM Trial

Conditions
-----------------
Pregnancy Related

Intervention / Treatment
-----------------
* Drug: Misoprostol Oral Tablet
* Device: double balloon device for cervical ripening


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: unfavourable cervix (Bishop score ≤ 4), indication for induction of labor (medical or obstetrical), 37 completed gestational weeks, vertex presentation, singleton pregnancy intact membranes. Exclusion Criteria: previous cesarean delivery previous uterine surgery (eg: myomectomy) noncephalic presentation multiple pregnancy pre-eclampsia with severe features oligohydramnios (Maximal vertical pocket ≤2) estimated fetal weight <10% percentile any contraindication to Vaginal delivery

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: MISOPROSTOL<br>oral misoprostol, 50 microgram, every 4 hours Repeat treatment every 4 hours until active labour begins: regular painful contractions (≥ 3 in 10 min), cervical dilatation ≥ 3 cm maximal number of doses: 6 Oxytocin infusion can be initiated 4 hours after the last dose of Misoprostol. Failure of induction will be considered if no cervical change nor uterine contractions have begun during 24 hours of treatment. Electronic fetal monitoring should be performed for 30 min after administration of misoprostol and 60 min after any tachysystole. | Drug: Misoprostol Oral Tablet<br>* 50 mcg oral consumption<br>|
| Active Comparator: DOUBLE BALLOON<br>Insertion of the DBD as instructed by the manufacturer, removal after 6 hours. Artificial rupture of membranes (AROM) if suitable + IV oxytocin administration If AROM cannot be performed- oxytocin infusion will be initiated at first. If Bishop <3 after DBD removal, clinical evaluation and lag time before considering other methods for ripening is suitable and is up to the physician on call. | Device: double balloon device for cervical ripening<br>* insertion for 6 hours and followed by the above mentioned protocol<br>|
| Active Comparator: MISOPROSTOL+DOUBLE BALLOON<br> | Drug: Misoprostol Oral Tablet<br>* 50 mcg oral consumption<br>Device: double balloon device for cervical ripening<br>* insertion for 6 hours and followed by the above mentioned protocol<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the rate of cesarean delivery | percentage of cesarean delivery from all deliveries | from induction until delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bishop score difference between groups | cervical change evaluation | after 6 hours and after 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
induction of labor, unfavorable cervix, misoprostol, cytotec, double balloon device, cervical ripening