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

Centre Hospitalier Universitaire de Nīmes

Status

Completed

Conditions

Medical; Abortion, Fetus

Treatments

Procedure: Mifepristone + Misoprostol OR oxytocine

Procedure: Mifepristone + Misoprostol OR oxytocine + laminaria

Study type

Interventional

Funder types

Other

Identifiers

NCT03194126

LOCAL/2016/VL-01

Details and patient eligibility

About

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.

Enrollment

120 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.