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

Completed

• Conditions: Pregnancy
• Interventions: Other: Data collection

• Registration Number: NCT04841486
• Lead Sponsor: Université de Reims Champagne-Ardenne

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2021-04-07
• Study First Submitted QC: 2021-04-07
• Study First Posted: 2021-04-12
• Study Start: 2021-06-11
• Primary Completion: 2021-09-11
• Study Completion: 2021-11-05
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-01
• Last Update Posted: 2021-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 93

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
"with history of spontaneous termination of pregnancy" group	Data collection	pregnant women in the first trimester of pregnancy with history of spontaneous termination of pregnancy
"without history of spontaneous termination of pregnancy" group	Data collection	pregnant women in the first trimester of pregnancy without history of spontaneous termination of pregnancy

Primary Outcome Measures

Name	Time	Method
Women's stress	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.

Trial Locations

Locations (1)

Université de Reims Champagne-Ardenne; 🇫🇷 Reims, France