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
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Abortion, Spontaneous
• Pregnancy

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