NCT05096104

Brief Summary

20% of deliveries take place following an artificial induction of labor. The latter sometimes requires prior cervical ripening, of which the two most widely used methods in France are oral misoprostol and the balloon catheter, left to the discretion of clinicians. The objective of this study is to observe which cervical maturation method patients choose when an artificial induction of labor with an unfavorable cervical status must be carried out, and to observe the patient's criteria as to the choice made, as well as their experience and their satisfaction with artificial induction of labor, in order to improve our clinical practices, the experience of childbirth, and promote patient autonomy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
800

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 6, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

August 6, 2021

Completed
3 months until next milestone

First Posted

Study publicly available on registry

October 27, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 8, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 8, 2022

Completed
Last Updated

December 12, 2023

Status Verified

December 1, 2023

Enrollment Period

10 months

First QC Date

August 6, 2021

Last Update Submit

December 11, 2023

Conditions

Keywords

Cervical RipeningPREGNANCYLABOR INDUCEDArtificial induction

Outcome Measures

Primary Outcomes (1)

  • Retrospective study of the cervical ripening method that patients choose when artificial induction of labor with unfavorable cervical status must be performed

    Files analysed retrospectively from JFebruary 01, 2020 to February 29, 2021 will be examined]

Eligibility Criteria

Age18 Years+
Sexfemale
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult woman who underwent induction of labor between February 1, 2020 and February 29, 2021

You may qualify if:

  • Adult woman (≥18 years old)
  • Patient who underwent induction of labor between February 1, 2020 and February 29, 2021
  • Patient not having expressed her opposition, after information, to the reuse of her data for the purposes of this research.

You may not qualify if:

  • Patient who expressed her opposition to participating in the study
  • Absence of prior cervical maturation (Bishop score greater than or equal to 6 on the day of initiation)
  • Gestational age less than 37 weeks, multiple pregnancy, scarred uterus, non-cephalic presentation, death in utero and severe fetal malformation (requiring neonatal resuscitation or with a palliative care plan)
  • Patient for whom the triggering method was chosen by the practitioner
  • Patient under guardianship, curatorship or safeguard of justice

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service de gynécologie Obstétrique - Hôpitaux Universitaires de Strasbourg

Strasbourg, 67091, France

Location

Study Officials

  • Nicolas SANANES, MD, PhD

    Service de gynécologie Obstétrique - Hôpitaux Universitaires de Strasbourg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 6, 2021

First Posted

October 27, 2021

Study Start

August 6, 2021

Primary Completion

June 8, 2022

Study Completion

August 8, 2022

Last Updated

December 12, 2023

Record last verified: 2023-12

Locations