NCT04353856

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 16, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 21, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

July 7, 2020

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 2, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 2, 2021

Completed
Last Updated

July 25, 2022

Status Verified

July 1, 2022

Enrollment Period

12 months

First QC Date

April 16, 2020

Last Update Submit

July 22, 2022

Conditions

Twin Pregnancy

Outcome Measures

Primary Outcomes (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 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

Study Arms (1)

twin pregnancy

Women followed for a twin pregnancy

Other: quality of life assessment

Interventions

quality of life assessmentOTHER

quality of life assessment using the EQ5D questionnaire once a month

twin pregnancy

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

women over 18 years old, followed for a twin pregnancy

You may qualify if:

  • 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

You may not qualify if:

  • inability to understand the information given and the questionnaire
  • person deprived of liberty, under guardianship

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Femme Mère Enfant

Bron, 69500, France

Location

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 16, 2020

First Posted

April 21, 2020

Study Start

July 7, 2020

Primary Completion

July 2, 2021

Study Completion

July 2, 2021

Last Updated

July 25, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)