Evaluation of Efficacy of Two Therapeutic Strategies for Cervical Maturation Before Medical Termi⦠(NCT03194126) | Clinical Trial Compass
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 range18 Years
SexFEMALE
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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.
What they're measuring
1
time taken between administration of 1st dose of drugs and delivery between the two strategies