Patient Satisfaction During Artificial Induction of Labor by Cervical Ripening

Cervical Ripening Clinical Trial

— CERVICAL  

Official title:

Patient Satisfaction During Artificial Induction of Labor by Cervical Ripening

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05096104
• Other study ID #: 8294
• Status: Completed
• Start date: August 6, 2021
• Est. completion date: August 8, 2022

Study information

• Verified date: December 2023
• Source: University Hospital, Strasbourg, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 800
• Est. completion date: August 8, 2022
• Est. primary completion date: June 8, 2022
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cervical Ripening

Locations

Country	Name	City	State
France	Service de gynécologie Obstétrique - Hôpitaux Universitaires de Strasbourg	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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]