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

NCT03194126 | Completed

• 1 other identifier: LOCAL/2016/VL-01
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

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.

Conditions

Medical; Abortion, Fetus

Outcome Measures

Primary Outcomes (1)

• time taken between administration of 1st dose of drugs and delivery between the two strategies

  Up to 2 days

Secondary Outcomes (14)

• Compare pain experienced by patients between groups

  Day 0 - Day 2

• Compare cervix length before administration of Misoprostol OR oxytocine between groups

  Day 0

• Compare degree of dilation before administration of Misoprostol OR oxytocine between groups

  Day 0

• Compare time taken between Misoprostol OR oxytocine and delivery between groups

  Day 0 - Day 2

• Rate of delivery between groups

  4 hours

Study Arms (2)

Mifepristone + Misoprostol OR oxytocine + laminaria

EXPERIMENTAL

Procedure: Mifepristone + Misoprostol OR oxytocine + laminaria

Mifepristone + Misoprostol OR oxytocine

OTHER

Procedure: Mifepristone + Misoprostol OR oxytocine

Interventions

Mifepristone + Misoprostol OR oxytocine + laminaria PROCEDURE

Three laminaria placed 12 hours prior to administration of misoprostol

Mifepristone + Misoprostol OR oxytocine + laminaria

Mifepristone + Misoprostol OR oxytocine PROCEDURE

standart support

Mifepristone + Misoprostol OR oxytocine

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (2)

CHU de Montpellier

Montpellier, 34295, France

Location

CHU Nimes

Nîmes, 30029, France

Location

MeSH Terms

Interventions

Mifepristone; Misoprostol

Intervention Hierarchy (Ancestors)

Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Prostaglandins E, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The primary outcome will be evaluated by a blinded evaluator: the laminaria placement is performed by the on-call team at Day-1, whilst the delivery is performed by a different team at Day 0, with the laminaria removed in the morning.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2017
• First Posted: June 21, 2017
• Study Start: February 11, 2018
• Primary Completion: September 25, 2023
• Study Completion: September 25, 2023
• Last Updated: October 3, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)