Labor Induction With Double Balloon Device, Oral Misoprostol & Concomitant

Status Terminated

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Pregnancy Related

Clinical Trial Details

NCT number	NCT03866772
Study type	Interventional
Source	Bnai Zion Medical Center
Contact
Status	Terminated
Phase	N/A
Start date	June 1, 2019
Completion date	September 24, 2023

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms