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Clinical Trials/NCT04897451
NCT04897451CompletedNot Applicable

Quality of Life 3 Months After Cervical Ripening

Centre Hospitalier Departemental Vendee1 site in 1 country160 target enrollmentStarted: July 8, 2021Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
160
Locations
1
Primary Endpoint
EuroQol 5 Dimension Score

Study Overview

Brief Summary

Women's experience of childbirth differs with type of labor, mode of delivery and parity. Induction of labor (IOL) is associated with lower satisfaction of women than spontaneous labor.

A Nigerian study of 252 women with induced labor, irrespective of parity and device used for IOL and a French cohort study of 3042 women with IOL have been published. Theses latter identified several determinants of maternal dissatisfaction.

However, no published study has reported the assessment of quality of life of women at long term after cervical ripening according to the device required for cervical ripening.

The aim of this study is to characterize the quality of life of women after cervical ripening according to parity and device required, and to assess possible factors associated with this quality of life at long-term after delivery.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Woman who experienced at least one method of cervical ripening in our hospital

Exclusion Criteria

  • Patient's refusal

Outcomes

Primary Outcomes

EuroQol 5 Dimension Score

Time Frame: 3 months after delivery

Quality of life from the EuroQol 5 Dimension questionnaire For each of the dimensions, there are 5 levels coded from 1 to 5. A one-digit number is obtained for each dimension. By combining the 5 dimensions, a 5-digit number is obtained, ranging from 11111 to 55555, representing the health status of the respondent. The code 11111 indicates a person with no problems on the 5 dimensions.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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