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Completed

NCT Number: NCT03194126

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

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.

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Key information

Conditions

Medical; Abortion, Fetus

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Montpellier, Montpellier, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mifepristone + Misoprostol OR oxytocine + laminaria

Procedure

Three laminaria placed 12 hours prior to administration of misoprostol

Mifepristone + Misoprostol OR oxytocine

Procedure

standart support

Primary outcomes

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

    Time frame: Up to 2 days

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Official study title

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

Acronym: IMEGYN

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Jun 21, 2017
Registry last updated
Oct 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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