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

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ClinicalTrials.gov Identifier: NCT03194126
Recruitment Status : Recruiting
First Posted : June 21, 2017
Last Update Posted : September 17, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Medical; Abortion, Fetus Procedure: Mifepristone + Misoprostol OR oxytocine + laminaria Procedure: Mifepristone + Misoprostol OR oxytocine Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Other
Official Title: Evaluation of Efficacy of Two Therapeutic Strategies for Cervical Maturation Before Medical Termination: Mechanical Plus Medicinal Maturation vs Medicinal Maturation Alone
Actual Study Start Date : February 11, 2018
Estimated Primary Completion Date : May 2022
Estimated Study Completion Date : May 2022

Resource links provided by the National Library of Medicine


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

Mifepristone + Misoprostol OR oxytocine Procedure: Mifepristone + Misoprostol OR oxytocine
standart support




Primary Outcome Measures :
  1. time taken between administration of 1st dose of drugs and delivery between the two strategies [ Time Frame: Up to 2 days ]

Secondary Outcome Measures :
  1. Compare pain experienced by patients between groups [ Time Frame: Day 0 - Day 2 ]
    scale 0-10

  2. Compare cervix length before administration of Misoprostol OR oxytocine between groups [ Time Frame: Day 0 ]
    in mm

  3. Compare degree of dilation before administration of Misoprostol OR oxytocine between groups [ Time Frame: Day 0 ]
    in cm

  4. Compare time taken between Misoprostol OR oxytocine and delivery between groups [ Time Frame: Day 0 - Day 2 ]
    hours

  5. Rate of delivery between groups [ Time Frame: 4 hours ]
  6. Rate of delivery between groups [ Time Frame: 6 hours ]
  7. Rate of delivery between groups [ Time Frame: 8 hours ]
  8. Rate of delivery between groups [ Time Frame: 12 hours ]
  9. Rate of delivery between groups [ Time Frame: >12 hours ]
  10. Incidence of endometritis between groups [ Time Frame: Day 0 - Day 2 ]
  11. Incidence of hemorrhage between groups [ Time Frame: Day 0 - Day 2 ]
  12. Patient satisfaction in peripartum between groups [ Time Frame: Day 2 ]
    Numeric Rating Scale (0-10)

  13. Patient anxiety between groups [ Time Frame: Day 0 - 3 months ]
    Hospital Anxiety and Depression Scale questionnaire

  14. Evaluation of any post-traumatic stress between groups [ Time Frame: 3 months ]
    Perinatal post-traumatic stress disorder questionnaire



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03194126


Locations
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France
CHU de Montpellier Not yet recruiting
Montpellier, France, 34295
Contact: Florent Fuchs, MD    07 82 66 75 09    f-fuchs@chu-montpellier.fr   
Principal Investigator: Florent Fuchs, MD         
Sub-Investigator: Emmanuelle Vintejoux, MD         
Sub-Investigator: Romy Rayssiguier, MD         
Sub-Investigator: Caroline Therond         
Sub-Investigator: Marc Simon         
CHU Nimes Recruiting
Nîmes, France, 30029
Contact: Anissa Megzari    04.66.68.42.36    drc@chu-nimes.fr   
Principal Investigator: Vincent Letouzey, MD         
Sub-Investigator: Eve Moustey, MD         
Sub-Investigator: Frédéric Grosjean, MD         
Sub-Investigator: Sandrine Sarda         
Sub-Investigator: Manuel Ferrer         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes

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Responsible Party: Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier: NCT03194126     History of Changes
Other Study ID Numbers: LOCAL/2016/VL-01
First Posted: June 21, 2017    Key Record Dates
Last Update Posted: September 17, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Misoprostol
Mifepristone
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Anti-Ulcer Agents
Gastrointestinal Agents
Oxytocics
Abortifacient Agents, Steroidal
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Contraceptives, Postcoital, Synthetic
Contraceptives, Postcoital
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Luteolytic Agents
Menstruation-Inducing Agents