CompletedNot Applicable

Evaluation of Efficacy of Two Therapeutic Strategies for Cervical Maturation Before Medical Termination

France120 participantsStarted 2018-02-11

Plain-language summary

Reducing the time patients spend in the labor and delivery room saves money and reduces patient discomfort as well and reducing complications. We will compare two methods for inducing cervical maturation in order to shorten the time taken between administration of drugs and delivery.

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: * The patient must have given their free and informed consent and signed the consent form * The patient must be a member or beneficiary of a health insurance plan * The patients is at least 18 years old * Patient with a singleton pregnancy between 14 and 34 weeks gestation with an indication for medical termination due to maternal or fetal problem as validated by pluridisciplinary prenatal diagnosis center. Exclusion Criteria: * The subject is participating in an interventional study or is in a period of exclusion determined by a previous study * The patient is under safeguard of justice * The subject refuses to sign the consent * It is impossible to give the subject informed information * Patient has vaginismus * Patient has a cervix permitting artificial rupture of membrane * Patients taking one of the following treatments, contraindicated for mifepristone: ketoconazole, itraconazole, erythromycin, grapefruit juice, rifampicin, dexamethasone, St John's wort and certain anti-convulsants (phenytoin, phenobarbital, carbamazepine). Patients contraindicated for oxytocine.

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

time taken between administration of 1st dose of drugs and delivery between the two strategies

Timeframe: Up to 2 days

Trial details

NCT IDNCT03194126

SponsorCentre Hospitalier Universitaire de Nīmes

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-09-25

View on ClinicalTrials.gov More Medical; Abortion, Fetus trials