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OpenTrials
Completed

NCT Number: NCT04841486

First Trimester of Pregnancy: Impact of a History of Miscarriage on Women's Stress

Miscarriage is the spontaneous termination of pregnancy before 22 weeks of amenorrhea. The most frequent complication of pregnancy, it represents 10 to 25% of pregnancies and affects one in four women.

Miscarriage is considered by medical personnel to be common and trivial. however, for women, it is very often a traumatic event, a source of worry for futures pregnancies.

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Key information

Conditions

Age range

18 year–60 year

Sex eligibility

Female

Study type

Observational

Primary location

Université de Reims Champagne-Ardenne

Reims, France

About this study

The aim of the study is to evaluate association between history of spontaneous termination of pregnancy and women's stress during the first trimester of pregnancy.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • female
  • pregnant (positive plasma HCG)
  • in the first trimester of pregnancy
  • aged 18 years old and more
  • agreeing to participate in the study

Exclusion criteria

  • less than 18 years old

Treatment and study plan

Data Collection

Other

evaluation of women's stress

Primary outcomes

  1. Women's stress

    Time frame: Day 0

    Women's stress evaluated using Antenatal Perceived Stress Inventory (APSI). APSI includes 12 items on medico-obstetric risks and baby's health (4 items), psychosocial changes related to pregnancy (3 items) and childbirth projections (5 items). Each item is coded from 1 to 5 points: not at all stressed, a little stressed, moderately stressed, very stressed and enormously stressed. The overall score ranges from 12 to 60 points.

Sponsors and collaborators

Lead sponsor

Université de Reims Champagne-Ardenne

Other

Registry information

Acronym: Stress-FC

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Apr 12, 2021
Registry last updated
Dec 2, 2021

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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