Quality of Life During a Twin Pregnancy

Twin Pregnancy Clinical Trial

— QUALIGEM  

Official title:

Evolution of the Quality of Life During a Twin Pregnancy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04353856
• Other study ID #: 69HCL20_0138
• Secondary ID: ID-RCB
• Status: Completed
• Start date: July 7, 2020
• Est. completion date: July 2, 2021

Study information

• Verified date: July 2022
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Twin Pregnancy

Intervention

Other:
• quality of life assessment
quality of life assessment using the EQ5D questionnaire once a month

Locations

Country	Name	City	State
France	Hôpital Femme Mère Enfant	Bron

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

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