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: Completed
• Conditions: Twin Pregnancy
• Intervention / Treatment: Other: quality of life assessment

• Study Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• France
  • Bron, France, 69500
    • Hôpital Femme Mère Enfant

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

women over 18 years old, followed for a twin pregnancy

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?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 7, 2020
• Primary Completion (ACTUAL): July 2, 2021
• Study Completion (ACTUAL): July 2, 2021

Study Registration Dates

• First Submitted: April 16, 2020
• First Submitted That Met QC Criteria: April 16, 2020
• First Posted (ACTUAL): April 21, 2020

Study Record Updates

• Last Update Posted (ACTUAL): July 25, 2022
• Last Update Submitted That Met QC Criteria: July 22, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 69HCL20_0138; ID-RCB (Other Identifier: 2025-A02239-40)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No