PregnancyStress-FCNCT04841486
First Trimester of Pregnancy: Impact of a History of Miscarriage on Women's Stress
An observational study of Pregnancy, run by Université de Reims Champagne-Ardenne at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Pregnancy
- What is being tested?
- Data collection
- How many people
- 93 participants
- Where
- 1 siteFrance
- Study dates
- 11 Jun 2021to 5 Nov 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- No healthy volunteers
- Adult
Study population: pregnant women
Who may be able to join
- female
- pregnant (positive plasma HCG)
- in the first trimester of pregnancy
- aged 18 years old and more
- agreeing to participate in the study
Who cannot join
- less than 18 years old
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Pregnancy
- Being tested
- Data collection
- Keywords
- pregnancy, women's stress, history of spontaneous termination of pregnancy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data collectionOther
evaluation of women's stress
| Study group | Role | What they receive |
|---|---|---|
| "with history of spontaneous termination of pregnancy" group | pregnant women in the first trimester of pregnancy with history of spontaneous termination of pregnancy Receives: 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 Receives: Other: Data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2021
- Study start11 Jun 2021
- Primary completion11 Sep 2021
- Study completion5 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université de Reims Champagne-Ardenne
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sandra CARRAU-TRUILLET, MD, Principal investigator, Université de Reims Champagne-Ardenne - CHU de Reims
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04841486
- Sponsor's protocol ID
- 2021-001-Stress-FC
- Acronym
- Stress-FC
- Status last verified
- Dec 2021
- First submitted
- 7 Apr 2021
- Last updated
- 2 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- First Trimester of Pregnancy: Impact of a History of Miscarriage on Women's Stress
- ClinicalTrials.gov ID
- NCT04841486
- Acronym / sponsor ID
- Stress-FC / 2021-001-Stress-FC
- Conditions
- Pregnancy
- Keywords
- pregnancy, women's stress, history of spontaneous termination of pregnancy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Université de Reims Champagne-ArdenneUniversity, hospital or other
- Study start
- 11 Jun 2021 (actual)
- Primary completion
- 11 Sep 2021 (actual)
- Study completion
- 5 Nov 2021 (actual)
- First posted
- 12 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| "with history of spontaneous termination of pregnancy" group | – | Other: Data collectionpregnant women in the first trimester of pregnancy with history of spontaneous termination of pregnancy |
| "without history of spontaneous termination of pregnancy" group | – | Other: Data collectionpregnant women in the first trimester of pregnancy without history of spontaneous termination of pregnancy |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- pregnant women
Key inclusion criteria (5 listed)
- female
- pregnant (positive plasma HCG)
- in the first trimester of pregnancy
- aged 18 years old and more
- agreeing to participate in the study
Key exclusion criteria (1 listed)
- less than 18 years old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Data collectionevaluation of women's stress | Other | "with history of spontaneous termination of pregnancy" group, "without history of spontaneous termination of pregnancy" group |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sandra CARRAU-TRUILLET, MD principal investigator
Université de Reims Champagne-Ardenne - CHU de Reims
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy, run by Université de Reims Champagne-Ardenne at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Women's stress (time frame: Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2021.