Is There an Interest in Repeating the Vaginal Administration of Dinoprostone (Propess®), to Promo… (NCT02888041) | Clinical Trial Compass
TerminatedPhase 3
Is There an Interest in Repeating the Vaginal Administration of Dinoprostone (Propess®), to Promote Induction of Labor of Pregnant Women at Term?
Stopped: Not enough patients
France160 participantsStarted 2016-12
Plain-language summary
According perinatal surveys, induction of labor is performed at more than 20% of pregnant women.
According to a survey on the trigger practices in France, prostaglandins are widely used to initiate cervical ripening, usually by laying intravaginal dinoprostone (Propess®).
The overall work-up rate due to the use of a single Propess® is 74.6% with 80% of vaginal deliveries.
Currently, 25.4% of patients who was not put in work after 24 hours are triggered by oxytocin (Syntocinon®) or directly caesarean. The initial installation of intravaginal dinoprostone limits the use of oxytocin (Syntocinon®) or in lower doses.
Using a second Propess® is carried out in several maternity hospitals, as reported by the survey on the cervical ripening practices in France. This second administration could be the solution to reduce the rate of caesarean in France which amounted to 20.8%.
Who can participate
Age range
18 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:
* Patient who is \>=18 years.
* Term pregnancy \> 37 weeks
* Induction of labor in progress, medically indicated
* Patients who have had the establishment of a first Propess®, within 24 to 36 hours (before signing the consent)
* Cephalic presentation
* Unfavorable cervical conditions (Bishop score \<6) 1 hour prior to inclusion
* Intact Membranes
* Affiliated with a social security system
* Having signed the consent form.
Exclusion Criteria:
* Multiple pregnancy
* Uterus scar
* Contraindications to epidural anesthesia
* Contraindications to Propess®: recent history of pelvic inflammatory disease; hypersensitivity to prostaglandins Adverse effects appeared in the first Propess®: anaphylactic shock, disseminated intravascular coagulation (DIC).
* Contraindications to Syntocinon: Hypersensitivity to oxytocin, cardiovascular disorders and severe toxemia of pregnancy.
* Contraindications to vaginal delivery (placenta previa, previa obstacle ...)
* Premature Rupture of Membranes (PROM)
* Intra Uterine Growth Retardation (IUGR) \<3rd percentile
* Macrosomia\> 97th percentile
* Severe Impaired fetal heart rate
* In Utero Fetal Death (IUFD)
* Medical Termination of pregnancy or lethal fetal pathology
* Patient under guardianship or trusteeship safeguard justice
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.