- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06708208
Requests for Voluntary Termination and Medical Termination of Pregnancy for Maternal, Psychological or Social Reasons At the Women's Center ( La Maison Des Femmes) in Saint-Denis :
Voluntary Termination and Medical Termination of Pregnancy for Maternal, Psychological or Social Reasons At Women's Center ( La Maison Des Femmes) in Saint-Denis
In France, Article L2213-1 of the Public Health Code (law of July 4, 2001) clearly establishes that "voluntary termination of pregnancy may be performed at any time if two doctors, who are part of a multidisciplinary team, certify-after this team has provided its advisory opinion-that continuing the pregnancy seriously endangers the woman's health." Consequently, when a request for termination of pregnancy is made within the first sixteen weeks of amenorrhea, patients exercise complete autonomy in their decision-making. This process is unequivocally recognized as voluntary termination of pregnancy (VTP).
If an abortion is performed after the pregnancy has ended, the patient's request must undergo a multidisciplinary assessment. This procedure is known as medical termination of pregnancy for maternal indications.
There are generally two categories of indications for this procedure:
Organic reasons such as progressive cancer or severe heart disease. Psychosocial reasons: which include psychological and social factors.
In the case of medical terminations of pregnancy for psychological or social reasons, the National College of French Gynaecologists and Obstetricians (CNGOF) recommends that these requests be formally documented within the centers where patients receive care. However, there is considerable variability in how these practices are implemented across different locations. Furthermore, the existing literature reveals a significant lack of epidemiological and clinical data on the subject, highlighting the need for more comprehensive research in this area.
Opened in 2016, the Maison des Femmes (Women's Center) in Saint-Denis houses a family planning center and a multi-professional support service for patients who have experienced violence. It provides care for many women who have sought a termination of pregnancy but have exceeded the legal time limit for abortion.
A study conducted in 2021-2022, as part of a medical thesis, revealed a significantly high prevalence of violence experienced by women seeking a pregnancy termination for non-medical reasons at Delafontaine Hospital. The findings indicated that 65% of these patients had suffered from violence.
To strengthen our epidemiological findings, we propose a study comparing this group of women with another group who had an abortion during the same timeframe.
Study Overview
Status
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
-
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Seine saint denis
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Saint Denis, Seine saint denis, France, 93200
- Maison des femmes
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients (minors or adults) who have been seen at the Women's center (Maison des Femmes) for assistance with a request of termination of pregnancy for maternal, psychological and/or social reasons, including patients under legal protection (guardianship, curatorship) at the time of the consultation.
- medical consultation between 01/01/2016 and 28/02/2022.
Exclusion Criteria:
- Refusal of participation (patient or guardian)
- Opposition to the use of data
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Demographic data
Time Frame: 1 day
|
Age
|
1 day
|
|
Demographic data
Time Frame: 1 day
|
Birth place
|
1 day
|
|
Demographic data
Time Frame: 1 day
|
Migration history
|
1 day
|
|
Medical history
Time Frame: 1 day
|
Term of abotion
|
1 day
|
|
Violence's history
Time Frame: 1 day
|
Description of the violence.
Current situation of violence.
|
1 day
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 0057_MATER_28bis
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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