Quality of Life After Cervical Ripening (MATUCOL-QOL)

Quality of Life 3 Months After Cervical Ripening

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 Overview

• Status: Completed
• Conditions: Delivery
• Intervention / Treatment: Other: Questionnaire

• Study Type: Observational
• Enrollment (Actual): 160

Contacts and Locations

Study Locations

• France
  • La Roche Sur Yon, France, 85000
    • CHD Vendee

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

- Patient's refusal

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Women with cervical ripening in the context of artificial labor induction	Other: Questionnaire; EQ5D-5L questionnaire self-reported 3 months after delivery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Departemental Vendee
• Investigators: Principal Investigator: Guillaume DUCARME, CHD Vendee

Study record dates

Study Major Dates

• Study Start (Actual): July 8, 2021
• Primary Completion (Actual): December 12, 2021
• Study Completion (Actual): December 12, 2021

Study Registration Dates

• First Submitted: May 18, 2021
• First Submitted That Met QC Criteria: May 18, 2021
• First Posted (Actual): May 21, 2021

Study Record Updates

• Last Update Posted (Actual): September 28, 2022
• Last Update Submitted That Met QC Criteria: September 27, 2022
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: CHD21-0028

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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