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

Evaluation of Efficacy of Two Therapeutic Strategies for Cervical Maturation Before Medical Termination: Mechanical Plus Medicinal Maturation vs Medicinal Maturation Alone

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.

Study Overview

• Status: Completed
• Conditions: Medical; Abortion, Fetus
• Intervention / Treatment: Procedure: Mifepristone + Misoprostol OR oxytocine + laminaria; Procedure: Mifepristone + Misoprostol OR oxytocine

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34295
    • CHU de Montpellier
  • Nîmes, France, 30029
    • CHU Nîmes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mifepristone + Misoprostol OR oxytocine + laminaria	Procedure: Mifepristone + Misoprostol OR oxytocine + laminaria; Three laminaria placed 12 hours prior to administration of misoprostol
Other: Mifepristone + Misoprostol OR oxytocine	Procedure: Mifepristone + Misoprostol OR oxytocine; standart support

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
time taken between administration of 1st dose of drugs and delivery between the two strategies	Up to 2 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compare pain experienced by patients between groups	scale 0-10	Day 0 - Day 2
Compare cervix length before administration of Misoprostol OR oxytocine between groups	in mm	Day 0
Compare degree of dilation before administration of Misoprostol OR oxytocine between groups	in cm	Day 0
Compare time taken between Misoprostol OR oxytocine and delivery between groups	hours	Day 0 - Day 2
Rate of delivery between groups		4 hours
Rate of delivery between groups		6 hours
Rate of delivery between groups		8 hours
Rate of delivery between groups		12 hours
Rate of delivery between groups		>12 hours
Incidence of endometritis between groups		Day 0 - Day 2
Incidence of hemorrhage between groups		Day 0 - Day 2
Patient satisfaction in peripartum between groups	Numeric Rating Scale (0-10)	Day 2
Patient anxiety between groups	Hospital Anxiety and Depression Scale questionnaire	Day 0 - 3 months
Evaluation of any post-traumatic stress between groups	Perinatal post-traumatic stress disorder questionnaire	3 months

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes

Study record dates

Study Major Dates

• Study Start (Actual): February 11, 2018
• Primary Completion (Actual): September 25, 2023
• Study Completion (Actual): September 25, 2023

Study Registration Dates

• First Submitted: June 16, 2017
• First Submitted That Met QC Criteria: June 20, 2017
• First Posted (Actual): June 21, 2017

Study Record Updates

• Last Update Posted (Actual): October 3, 2023
• Last Update Submitted That Met QC Criteria: October 2, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Gastrointestinal Agents; Hormones, Hormone Substitutes, and Hormone Antagonists; Hormone Antagonists; Contraceptive Agents, Hormonal; Contraceptive Agents; Reproductive Control Agents; Contraceptives, Oral; Contraceptive Agents, Female; Anti-Ulcer Agents; Contraceptives, Oral, Synthetic; Abortifacient Agents, Nonsteroidal; Abortifacient Agents; Oxytocics; Luteolytic Agents; Abortifacient Agents, Steroidal; Contraceptives, Postcoital, Synthetic; Contraceptives, Postcoital; Menstruation-Inducing Agents; Misoprostol; Mifepristone
• Other Study ID Numbers: LOCAL/2016/VL-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No