NCT03866772

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

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 250 (actual)
• Sponsor: Bnai Zion Medical Center · Other Government
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Conditions

• Pregnancy Related

Interventions

Type	Name	Description
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

Timeline

• Start date: 2019-06-01
• Primary completion: 2023-09-24
• Completion: 2023-09-24
• First posted: 2019-03-07
• Last updated: 2023-10-30

Locations

1 site across 1 country: Israel

Regulatory

• FDA-regulated device study