Twin Pregnancy Clinical Trial
— QUALIGEMOfficial title:
Evolution of the Quality of Life During a Twin Pregnancy
Verified date | July 2022 |
Source | Hospices Civils de Lyon |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 50 |
Est. completion date | July 2, 2021 |
Est. primary completion date | July 2, 2021 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
France | Hôpital Femme Mère Enfant | Bron |
Lead Sponsor | Collaborator |
---|---|
Hospices Civils de Lyon |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Quality of life EQ5D questionnaire | 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 | |
Primary | Quality of life EQ5D questionnaire | 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 | |
Primary | Quality of life EQ5D questionnaire | 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 | |
Primary | Quality of life EQ5D questionnaire | 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 | |
Primary | Quality of life EQ5D questionnaire | 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 | |
Primary | Quality of life EQ5D questionnaire | 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 | |
Primary | Quality of life EQ5D questionnaire | 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 |
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