Comparison of Two Rhythm of Administration of Prostaglandin Gel for Induction of Labor (NCT04413890) | Clinical Trial Compass
CompletedPhase 2
Comparison of Two Rhythm of Administration of Prostaglandin Gel for Induction of Labor
Martinique268 participantsStarted 2019-12-17
Plain-language summary
The study compares two rhythms of administration of prostaglandin vaginal gels for cervical priming before induction of labor in term patients. In our institution, prostaglandin gels are given for a maximum of three times, with induction by oxytocin and amniotomy the day after the last gel whatever Bishop score has been obtained. This management results in some patient spending four days in hospital before delivery. The aim of the study is to compare our classical management scheme with a reduced interval between to gels, of 12h instead of 24 h. The primary outcome will be the time elapsed between the first prostaglandin gel and delivery. Tolerance of both management patterns will also be evaluated through a satisfaction survey.
Who can participate
Age range
18 Years – 49 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:
* Patients above 18 years
* Gestational age ≥ 37 weeks
* With indicated induction of labor and initial Bishop score under 6
* Without any contraindication to vaginal delivery
* Who consent to participate to the clinical research
* With French Medical Public Insurance
Exclusion Criteria:
* Multiple pregnancy
* Previous uterine scar (for myomas or cesarean section)
* Fetus not in cephalic presentation
* Allergy to prostaglandins
* Who not consent to participate to the study
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
1
Time between gel administration and delivery
Timeframe: At inclusion (Day 0)
2
Time between gel administration and delivery
Timeframe: At 12 hours or 24 hours (after each gel administration)
3
Time between gel administration and delivery
Timeframe: Time 0 after the childbirth
4
Time between gel administration and delivery
Timeframe: Until 5 days postpartum (during in-hospital postpartum period)