Clinical trial NCT03194126: Evaluation of Efficacy of Two Therapeutic Strategies for Cervical Maturation Before Medical Termination
Official title: Evaluation of Efficacy of Two Therapeutic Strategies for Cervical Maturation Before Medical Termination: Mechanical Plus Medicinal Maturation vs Medicinal Maturation Alone
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Medical; Abortion, Fetus
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2017-06-21
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: time taken between administration of 1st dose of drugs and delivery between the two strategies
timeFrame: Up to 2 days
Secondary outcomes:
measure: Compare pain experienced by patients between groups
timeFrame: Day 0 - Day 2
measure: Compare cervix length before administration of Misoprostol OR oxytocine between groups
timeFrame: Day 0
measure: Compare degree of dilation before administration of Misoprostol OR oxytocine between groups
timeFrame: Day 0
measure: Compare time taken between Misoprostol OR oxytocine and delivery between groups
timeFrame: Day 0 - Day 2
measure: Rate of delivery between groups
timeFrame: 4 hours
measure: Rate of delivery between groups
timeFrame: 6 hours
measure: Rate of delivery between groups
timeFrame: 8 hours
measure: Rate of delivery between groups
timeFrame: 12 hours
measure: Rate of delivery between groups
timeFrame: >12 hours
measure: Incidence of endometritis between groups
timeFrame: Day 0 - Day 2
measure: Incidence of hemorrhage between groups
timeFrame: Day 0 - Day 2
measure: Patient satisfaction in peripartum between groups
timeFrame: Day 2
measure: Patient anxiety between groups
timeFrame: Day 0 - 3 months
measure: Evaluation of any post-traumatic stress between groups
timeFrame: 3 months
Other outcomes:
Locations:
city: Montpellier
country: France
facility: CHU de Montpellier
city: Nîmes
country: France
facility: CHU Nimes
Study officials:
References: