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

NCT04841486 | Completed

• 1 other identifier: 2021-001-Stress-FC
• Study Type: observational
• Target: 93
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy

Keywords

pregnancy; women's stress; history of spontaneous termination of pregnancy

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

"with history of spontaneous termination of pregnancy" group

pregnant women in the first trimester of pregnancy with history of spontaneous termination of pregnancy

Other: Data collection

"without history of spontaneous termination of pregnancy" group

pregnant women in the first trimester of pregnancy without history of spontaneous termination of pregnancy

Other: Data collection

Interventions

Data collection OTHER

evaluation of women's stress

"with history of spontaneous termination of pregnancy" group; "without history of spontaneous termination of pregnancy" group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Gender Eligibility Details: Female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

pregnant women

You may qualify if:

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

You may not qualify if:

• \- less than 18 years old

Sponsors & Collaborators

• Université de Reims Champagne-Ardenne: lead

Study Sites (1)

Université de Reims Champagne-Ardenne

Reims, France

Location

MeSH Terms

Interventions

Data Collection

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Sandra CARRAU-TRUILLET, MD

  Université de Reims Champagne-Ardenne - CHU de Reims

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2021
• First Posted: April 12, 2021
• Study Start: June 11, 2021
• Primary Completion: September 11, 2021
• Study Completion: November 5, 2021
• Last Updated: December 2, 2021

Record last verified: 2021-12

Locations

FR (1)