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Completed

NCT Number: NCT04353856

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.

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Key information

Conditions

Twin Pregnancy

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Hôpital Femme Mère Enfant

Bron, 69500, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Quality of Life Assessment

Other

quality of life assessment using the EQ5D questionnaire once a month

Primary outcomes

  1. Quality of life EQ5D questionnaire

    Time frame: 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.

  2. Quality of life EQ5D questionnaire

    Time frame: 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.

  3. Quality of life EQ5D questionnaire

    Time frame: 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.

  4. Quality of life EQ5D questionnaire

    Time frame: 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.

  5. Quality of life EQ5D questionnaire

    Time frame: 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.

  6. Quality of life EQ5D questionnaire

    Time frame: 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.

  7. Quality of life EQ5D questionnaire

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

Evolution of the Quality of Life During a Twin Pregnancy

Acronym: QUALIGEM

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Apr 21, 2020
Registry last updated
Jul 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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