Patient Satisfaction During Artificial Induction of Labor by Cervical Ripening (CERVICAL)

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.

Study Overview

• Status: Completed
• Conditions: Cervical Ripening

• Study Type: Observational
• Enrollment (Actual): 800

Contacts and Locations

Study Locations

• France
  • Strasbourg, France, 67091
    • Service de gynécologie Obstétrique - Hôpitaux Universitaires de Strasbourg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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]

Collaborators and Investigators

• Sponsor: University Hospital, Strasbourg, France
• Investigators: Principal Investigator: Nicolas SANANES, MD, PhD, Service de gynécologie Obstétrique - Hôpitaux Universitaires de Strasbourg

Study record dates

Study Major Dates

• Study Start (Actual): August 6, 2021
• Primary Completion (Actual): June 8, 2022
• Study Completion (Actual): August 8, 2022

Study Registration Dates

• First Submitted: August 6, 2021
• First Submitted That Met QC Criteria: October 14, 2021
• First Posted (Actual): October 27, 2021

Study Record Updates

• Last Update Posted (Estimated): December 12, 2023
• Last Update Submitted That Met QC Criteria: December 11, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Cervical Ripening; PREGNANCY; LABOR INDUCED; Artificial induction
• Other Study ID Numbers: 8294

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No