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

October 27, 2023 updated by: Inna.bleicher, Bnai Zion Medical Center

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

250

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Israel
      • Haifa, Israel
        • Bnai Zion Mc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: MISOPROSTOL
  • 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
50 mcg oral consumption
Active Comparator: DOUBLE BALLOON
  • 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
insertion for 6 hours and followed by the above mentioned protocol
Active Comparator: MISOPROSTOL+DOUBLE BALLOON
Drug: Misoprostol Oral Tablet
50 mcg oral consumption
Device: double balloon device for cervical ripening
insertion for 6 hours and followed by the above mentioned protocol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the rate of cesarean delivery
Time Frame: from induction until 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
Time Frame: after 6 hours and after 24 hours
cervical change evaluation
after 6 hours and after 24 hours

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
time to delivery
Time Frame: from induction to delivery and from ruptured membranes to delivery
Mean time to delivery
from induction to delivery and from ruptured membranes to delivery
Use of other ripening methods after "failure" of the allocated method
Time Frame: 24 hours after initiation of the treatment
if the allocated measure was defined as "failed" after 24 hours, other methods will be used to ripen the cervix.
24 hours after initiation of the treatment
Rate of achieving active phase of labor (≥ 5 cm cervical dilatation)
Time Frame: within 24 hours of initiation
how many women had more than 5 cm cervical dilatation
within 24 hours of initiation
Cesarean delivery indication (non progressive labor or non reassuring fetal heart rate NRFHR)
Time Frame: from initiation until cesarean delivery
what was the indication for surgery
from initiation until cesarean delivery
Maternal morbidity
Time Frame: from initiation until delivery
advanced tears (3rd and 4th degree) post partum hemorrhage uterine rupture, amnionitis
from initiation until delivery
Patient satisfaction - by questioner
Time Frame: within 5 days from delivery
question addressing pain (bearable or unbearable, was the treatment comfortable for the women and would she do it again if necessary
within 5 days from delivery
tachysystole
Time Frame: from initiation until delivery
more than 5 contractions in 10 min with or without fetal heart rate changes
from initiation until delivery
Neonatal morbidity:
Time Frame: within 5 days from delivery
neonatal care unit admission, meconium with\without fetal heart rate changes, Apgar 5' <7 ,
within 5 days from delivery
use of oxytocin
Time Frame: within 24 hours
if it was in use at all (yes\no) and if yes- so for how long (time from initiation until delivery)
within 24 hours
use of emergent tocolysis
Time Frame: from induction until delivery
IV atosiban for tachysystole
from induction until delivery
how many doses of misoprostol
Time Frame: from induction until delivery
counting the number of administered doses
from induction until delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bnai Zion Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2019

Primary Completion (Actual)

September 24, 2023

Study Completion (Actual)

September 24, 2023

Study Registration Dates

First Submitted

March 3, 2019

First Submitted That Met QC Criteria

March 6, 2019

First Posted (Actual)

March 7, 2019

Study Record Updates

Last Update Posted (Actual)

October 30, 2023

Last Update Submitted That Met QC Criteria

October 27, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0166-18-BNZ

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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