- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04353856
Quality of Life During a Twin Pregnancy (QUALIGEM)
Evolution of the Quality of Life During a Twin Pregnancy
Quality of life has recently appeared as a component of health. Pregnancy has an impact on the quality of life of the parturient, whether through physical or psychological changes.
It is common to think that quality of life is altered in the context of a twin pregnancy, but this has never been scientifically demonstrated.
The hypothesis is to observe a decrease in the quality of life of pregnant women with twins at the end of pregnancy, in particular in case of a pregnancy-related pathology.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Bron, France, 69500
- Hopital Femme Mere Enfant
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- woman over 18
- ongoing twin pregnancy (2 live fetuses)
- pregnancy <15 weeks (weeks of gestation) completed
- patient with follow-up at the Hôpital Femme Mère Enfant
- person having expressed her non-opposition
Exclusion Criteria:
- inability to understand the information given and the questionnaire
- person deprived of liberty, under guardianship
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
twin pregnancy
Women followed for a twin pregnancy
|
quality of life assessment using the EQ5D questionnaire once a month
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Quality of life EQ5D questionnaire
Time Frame: Month 3
|
Quality of life score established by the EQ5D questionnaire (EUROQOL EQ-5D-3L). The EQ-5D-3L descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. |
Month 3
|
|
Quality of life EQ5D questionnaire
Time Frame: Month 4
|
Quality of life score established by the EQ5D questionnaire (EUROQOL EQ-5D-3L) The EQ-5D-3L descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. |
Month 4
|
|
Quality of life EQ5D questionnaire
Time Frame: Month 5
|
Quality of life score established by the EQ5D questionnaire (EUROQOL EQ-5D-3L) The EQ-5D-3L descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. |
Month 5
|
|
Quality of life EQ5D questionnaire
Time Frame: Month 6
|
Quality of life score established by the EQ5D questionnaire (EUROQOL EQ-5D-3L) The EQ-5D-3L descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. |
Month 6
|
|
Quality of life EQ5D questionnaire
Time Frame: Month 7
|
Quality of life score established by the EQ5D questionnaire (EUROQOL EQ-5D-3L) The EQ-5D-3L descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. |
Month 7
|
|
Quality of life EQ5D questionnaire
Time Frame: Month 8
|
Quality of life score established by the EQ5D questionnaire (EUROQOL EQ-5D-3L) The EQ-5D-3L descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. |
Month 8
|
|
Quality of life EQ5D questionnaire
Time Frame: Month 9
|
Quality of life score established by the EQ5D questionnaire (EUROQOL EQ-5D-3L) The EQ-5D-3L descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. |
Month 9
|
Collaborators and Investigators
Sponsor
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
- 69HCL20_0138
- ID-RCB (Other Identifier: 2025-A02583-46)
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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