First Trimester of Pregnancy: Impact of a History of Miscarriage on Women's Stress (Stress-FC)

December 1, 2021 updated by: Université de Reims Champagne-Ardenne

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

93

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Reims, France
        • Université de Reims Champagne-Ardenne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

pregnant women

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
"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
evaluation of women's stress
"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
evaluation of women's stress

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day 0

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Université de Reims Champagne-Ardenne

Investigators

  • Principal Investigator: Sandra CARRAU-TRUILLET, MD, Université de Reims Champagne-Ardenne - CHU de Reims

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 11, 2021

Primary Completion (Actual)

September 11, 2021

Study Completion (Actual)

November 5, 2021

Study Registration Dates

First Submitted

April 7, 2021

First Submitted That Met QC Criteria

April 7, 2021

First Posted (Actual)

April 12, 2021

Study Record Updates

Last Update Posted (Actual)

December 2, 2021

Last Update Submitted That Met QC Criteria

December 1, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-001-Stress-FC

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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