QUALIGEM: Quality of Life During a Twin Pregnancy

Sponsor

Hospices Civils de Lyon (Other)

Overall Status

Completed

CT.gov ID

NCT04353856

Collaborator

(none)

Enrollment

Location

11.8

Actual Duration (Months)

4.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Twin Pregnancy	Other: quality of life assessment

Study Design

Study Type:

Observational

Actual Enrollment :

50 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

Evolution of the Quality of Life During a Twin Pregnancy

Actual Study Start Date :

Jul 7, 2020

Actual Primary Completion Date :

Jul 2, 2021

Actual Study Completion Date :

Jul 2, 2021

Arms and Interventions

Arm	Intervention/Treatment
twin pregnancy Women followed for a twin pregnancy	Other: quality of life assessment quality of life assessment using the EQ5D questionnaire once a month

Arm

Intervention/Treatment

twin pregnancy

Women followed for a twin pregnancy

Other: quality of life assessment

quality of life assessment using the EQ5D questionnaire once a month

Outcome Measures

Primary Outcome Measures

Quality of life EQ5D questionnaire [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.
Quality of life EQ5D questionnaire [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.
Quality of life EQ5D questionnaire [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.
Quality of life EQ5D questionnaire [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.
Quality of life EQ5D questionnaire [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.
Quality of life EQ5D questionnaire [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.
Quality of life EQ5D questionnaire [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hôpital Femme Mère Enfant	Bron		France	69500

Sponsors and Collaborators

Hospices Civils de Lyon

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hospices Civils de Lyon

ClinicalTrials.gov Identifier:

NCT04353856

Other Study ID Numbers:

69HCL20_0138
ID-RCB

First Posted:

Apr 21, 2020

Last Update Posted:

Jul 25, 2022

Last Verified:

Jul 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Jul 25, 2022