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
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
-
-
-
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
|
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
|
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.
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
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.