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

Not Applicable

Completed

• Conditions: Medical; Abortion, Fetus
• Interventions: Procedure: Mifepristone + Misoprostol OR oxytocine + laminaria; Procedure: Mifepristone + Misoprostol OR oxytocine

• Registration Number: NCT03194126
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-06-16
• Study First Submitted QC: 2017-06-20
• Study First Posted: 2017-06-21
• Study Start: 2018-02-11
• Primary Completion: 2023-09-25
• Study Completion: 2023-09-25
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-02
• Last Update Posted: 2023-10-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mifepristone + Misoprostol OR oxytocine + laminaria	Mifepristone + Misoprostol OR oxytocine + laminaria	-
Mifepristone + Misoprostol OR oxytocine	Mifepristone + Misoprostol OR oxytocine	-

Primary Outcome Measures

Name	Time	Method
time taken between administration of 1st dose of drugs and delivery between the two strategies	Up to 2 days

Secondary Outcome Measures

Name	Time	Method
Patient anxiety between groups	Day 0 - 3 months	Hospital Anxiety and Depression Scale questionnaire
Evaluation of any post-traumatic stress between groups	3 months	Perinatal post-traumatic stress disorder questionnaire
Compare cervix length before administration of Misoprostol OR oxytocine between groups	Day 0	in mm
Compare time taken between Misoprostol OR oxytocine and delivery between groups	Day 0 - Day 2	hours
Incidence of hemorrhage between groups	Day 0 - Day 2
Compare degree of dilation before administration of Misoprostol OR oxytocine between groups	Day 0	in cm
Patient satisfaction in peripartum between groups	Day 2	Numeric Rating Scale (0-10)
Compare pain experienced by patients between groups	Day 0 - Day 2	scale 0-10
Rate of delivery between groups	>12 hours
Incidence of endometritis between groups	Day 0 - Day 2

Trial Locations

Locations (2)

CHU Nimes; 🇫🇷 Nîmes, France

CHU de Montpellier; 🇫🇷 Montpellier, France