TerminatedNot Applicable

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

Stopped: RECRUTIMENT DIFICULTIES

Israel250 participantsStarted 2019-06-01

Plain-language 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.

Who can participate

Age range

18 Years – 50 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

the rate of cesarean delivery

Timeframe: from induction until delivery

Trial details

NCT IDNCT03866772

SponsorBnai Zion Medical Center

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2023-09-24

View on ClinicalTrials.gov More Pregnancy Related trials