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NCT04841486 Clinical Trial

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

Pregnancy Clinical Trial

— Stress-FC  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04841486
Other study ID # 2021-001-Stress-FC
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 11, 2021
Est. completion date November 5, 2021

Study information
Verified date December 2021
Source Université de Reims Champagne-Ardenne
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility
Status Completed
Enrollment 93
Est. completion date November 5, 2021
Est. primary completion date September 11, 2021
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 60 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Data collection
evaluation of women's stress

Locations
Country Name City State
France Université de Reims Champagne-Ardenne Reims

Sponsors (1)
Lead Sponsor Collaborator
Université de Reims Champagne-Ardenne

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Women's stress 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. Day 0
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