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

Overview

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.

Full Title of Study: “Evaluation of Efficacy of Two Therapeutic Strategies for Cervical Maturation Before Medical Termination: Mechanical Plus Medicinal Maturation vs Medicinal Maturation Alone”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Other
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: September 25, 2023

Interventions

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

Arms, Groups and Cohorts

  • Experimental: Mifepristone + Misoprostol OR oxytocine + laminaria
  • Other: Mifepristone + Misoprostol OR oxytocine

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

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

Participating in This Clinical Trial

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.

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Centre Hospitalier Universitaire de Nīmes
  • Provider of Information About this Clinical Study
    • Sponsor

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