- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04897451
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
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
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La Roche Sur Yon, France, 85000
- CHD Vendée
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Women with cervical ripening in the context of artificial labor induction
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EQ5D-5L questionnaire self-reported 3 months after delivery
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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EuroQol 5 Dimension Score
Time Frame: 3 months after delivery
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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.
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3 months after delivery
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Collaborators and Investigators
Investigators
- Principal Investigator: Guillaume DUCARME, CHD Vendée
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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