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

  • STATUS
    Recruiting
  • End date
    Dec 31, 2024
  • participants needed
    750
  • sponsor
    Bnai Zion Medical Center
Updated on 4 October 2022
cesarean section
misoprostol
induction of labor
Accepts healthy volunteers

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.

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.

Details
Condition Pregnancy Related
Treatment Misoprostol Oral Tablet, double balloon device for cervical ripening
Clinical Study IdentifierNCT03866772
SponsorBnai Zion Medical Center
Last Modified on4 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

unfavourable cervix (Bishop score ≤ 4)
indication for induction of labor (medical or obstetrical)
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
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