Quality of Life After Cervical Ripening

NCT04897451 | Completed

• 1 other identifier: CHD21-0028
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Delivery

Outcome Measures

Primary Outcomes (1)

• EuroQol 5 Dimension Score

  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.

  3 months after delivery

Study Arms (1)

Women with cervical ripening in the context of artificial labor induction

Other: Questionnaire

Interventions

Questionnaire OTHER

EQ5D-5L questionnaire self-reported 3 months after delivery

Women with cervical ripening in the context of artificial labor induction

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All Women who experienced at least one method of cervical ripening in our hospital.

You may qualify if:

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

You may not qualify if:

• \- Patient's refusal

Sponsors & Collaborators

• Centre Hospitalier Departemental Vendee: lead

Study Sites (1)

CHD Vendée

La Roche-sur-Yon, 85000, France

Location

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Guillaume DUCARME

  CHD Vendee

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2021
• First Posted: May 21, 2021
• Study Start: July 8, 2021
• Primary Completion: December 12, 2021
• Study Completion: December 12, 2021
• Last Updated: September 28, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)