Patient Satisfaction During Artificial Induction of Labor by Cervical Ripening
CERVICAL
1 other identifier
observational
800
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2021
Shorter than P25 for all trials
1 active site
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
CompletedStudy Start
First participant enrolled
August 6, 2021
CompletedFirst Posted
Study publicly available on registry
October 27, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 8, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
August 8, 2022
CompletedDecember 12, 2023
December 1, 2023
10 months
August 6, 2021
December 11, 2023
Conditions
Keywords
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
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
Study Officials
- PRINCIPAL INVESTIGATOR
Nicolas SANANES, MD, PhD
Service de gynécologie Obstétrique - Hôpitaux Universitaires de Strasbourg
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