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

Medical; Abortion, Fetus Clinical Trial

— IMEGYN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03194126
• Other study ID #: LOCAL/2016/VL-01
• Status: Completed
• Phase: N/A
• Start date: February 11, 2018
• Est. completion date: September 25, 2023

Study information

• Verified date: October 2023
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: September 25, 2023
• Est. primary completion date: September 25, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Medical; Abortion, Fetus

Intervention

Procedure:
• Mifepristone + Misoprostol OR oxytocine + laminaria
Three laminaria placed 12 hours prior to administration of misoprostol
• Mifepristone + Misoprostol OR oxytocine
standart support

Locations

Country	Name	City	State
France	CHU de Montpellier	Montpellier
France	CHU Nimes	Nîmes

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	time taken between administration of 1st dose of drugs and delivery between the two strategies		Up to 2 days
Secondary	Compare pain experienced by patients between groups	scale 0-10	Day 0 - Day 2
Secondary	Compare cervix length before administration of Misoprostol OR oxytocine between groups	in mm	Day 0
Secondary	Compare degree of dilation before administration of Misoprostol OR oxytocine between groups	in cm	Day 0
Secondary	Compare time taken between Misoprostol OR oxytocine and delivery between groups	hours	Day 0 - Day 2
Secondary	Rate of delivery between groups		4 hours
Secondary	Rate of delivery between groups		6 hours
Secondary	Rate of delivery between groups		8 hours
Secondary	Rate of delivery between groups		12 hours
Secondary	Rate of delivery between groups		>12 hours
Secondary	Incidence of endometritis between groups		Day 0 - Day 2
Secondary	Incidence of hemorrhage between groups		Day 0 - Day 2
Secondary	Patient satisfaction in peripartum between groups	Numeric Rating Scale (0-10)	Day 2
Secondary	Patient anxiety between groups	Hospital Anxiety and Depression Scale questionnaire	Day 0 - 3 months
Secondary	Evaluation of any post-traumatic stress between groups	Perinatal post-traumatic stress disorder questionnaire	3 months