PregnancyNCT06708208
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 :
An observational study of Pregnancy and Violence Against Women (VAW), run by Centre Hospitalier de Saint-Denis at 1 site in France.
Trial summary
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… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Pregnancy, Violence Against Women (VAW), Violence
- How many people
- 107 participants
- Where
- 1 siteFrance
- Study dates
- 14 Dec 2023to 20 Dec 2024
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients who expressed a request for an IMG for non-somatic maternal reasons
Who may be able to join
- 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.
Who cannot join
- Refusal of participation (patient or guardian)
- Opposition to the use of data
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
- Conditions
- Pregnancy, Violence Against Women (VAW), Violence, Abortion, Termination of Pregnancy, Voluntary Termination of Pregnancy
- Keywords
- pregnancy, voluntary termination of pregnancy, violence, abortion, termination of pregnancy, medical abortion
What is being measured
The primary outcome is the main question the study is designed to answer.
Demographic data
Age
Measured: 1 day
Demographic data
Birth place
Measured: 1 day
Demographic data
Migration history
Measured: 1 day
Medical history
Term of abotion
Measured: 1 day
Violence's history
Description of the violence. Current situation of violence.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2024
- Study start14 Dec 2023
- Primary completion1 Mar 2024
- Study completion20 Dec 2024 (estimated)
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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 107 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier de Saint-Denis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06708208
- Sponsor's protocol ID
- 0057_MATER_28bis
- Status last verified
- Nov 2024
- First submitted
- 25 Nov 2024
- Last updated
- 27 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Voluntary Termination and Medical Termination of Pregnancy for Maternal, Psychological or Social Reasons At Women's Center ( La Maison Des Femmes) in Saint-Denis
- ClinicalTrials.gov ID
- NCT06708208
- Acronym / sponsor ID
- 0057_MATER_28bis
- Conditions
- Pregnancy, Violence Against Women (VAW), Violence, Abortion, Termination of Pregnancy, Voluntary Termination of Pregnancy
- Keywords
- pregnancy, voluntary termination of pregnancy, violence, abortion, termination of pregnancy, medical abortion
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 107 participants (estimated)
- Lead sponsor
- Centre Hospitalier de Saint-DenisUniversity, hospital or other
- Study start
- 14 Dec 2023 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 20 Dec 2024 (estimated)
- First posted
- 27 Nov 2024 (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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who expressed a request for an IMG for non-somatic maternal reasons
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- Refusal of participation (patient or guardian)
- Opposition to the use of data
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Demographic data
Time frame: 1 day
Age
Demographic data
Time frame: 1 day
Birth place
Demographic data
Time frame: 1 day
Migration history
Medical history
Time frame: 1 day
Term of abotion
Violence's history
Time frame: 1 day
Description of the violence. Current situation of violence.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 and Violence Against Women (VAW), run by Centre Hospitalier de Saint-Denis 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 2 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 27 Nov 2024. 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?
This study is still under way. Results are not available in the source record yet.
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?
Demographic data (time frame: 1 day). The study lists 5 primary outcomes in all. 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 27 Nov 2024.