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

NCT03866772 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2023-10-30

No results posted yet for this study

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.

Conditions

  • Pregnancy Related

Interventions

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

Sponsors & Collaborators

  • Bnai Zion Medical Center

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-06-01
Primary Completion
2023-09-24
Completion
2023-09-24
FDA Device
Yes

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03866772 on ClinicalTrials.gov