Pregnancy RelatedNCT05499325
Requests for Medical Termination of Pregnancy for Psychological or Social Maternal Reasons
An observational study of Pregnancy Related, run by Centre Hospitalier de Saint-Denis at 1 site in France.
Trial summary
When the request for termination of pregnancy is made at a term of less than sixteen weeks of amenorrhea, the patients have complete decision-making autonomy. This is called voluntary termination of pregnancy. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Pregnancy Related
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- 17 Aug 2022to 30 Nov 2022
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients followed at the Maison des Femmes, having consulted between 01/01/2016 and 02/28/2022, having undergone a medical termination of pregnancy for psychological or social maternal reasons
Who may be able to join
- Minor or adult patients who have been seen at the Maison des Femmes in the context of a request for termination of pregnancy for psychological and/or social maternal reasons, including patients subject to a legal protection measure (guardianship , curators) during the consultation
- Consultation between 01/01/2016 and 02/28/2022
Who cannot join
- Refusal of inclusion in a study explained in the medical file (patient or guardian)
- Objection to the use of data or refusal to participate (patient or guardian)
Trial locations and contacts
1 site in 1 country.
France1 site
Hôpital DELAFONTAINE
Saint-Denis, Île-de-France Region, 93200
Stéphanie COSSEC, 01 42 35 61 40 ext. 6962, coordination.rechercheclinique@ghtpdfr.fr
Anne BEDU, JD
About this study
Official title: Requests for Medical Termination of Pregnancy for Psychological or Social Maternal Reasons at the "Maison Des Femmes" in Saint-Denis : Retrospective Study Between 2016 and 2022
When the request for termination of pregnancy is made at a term of less than sixteen weeks of amenorrhea, the patients have complete decision-making autonomy. This is called voluntary termination of pregnancy. On the other hand, when they are made after this term, their requests must be subject to a multidisciplinary assessment. This is called medical termination of pregnancy for maternal indication. Schematically, there are two categories of indications: "organic" (progressive cancer, severe heart disease, etc.) and "psycho-social". In the latter case, and although the recommendations of the CNGOF recommend a formalization of these requests in the centers where the patients are received, strong disparities are observed in practice. In addition, there are few epidemiological and clinical data concerning these medical terminations of pregnancy with a psychological or social maternal indication in the literature.
The objective of this work is to describe the demographic characteristics of patients who have made a request for termination of pregnancy after the legal deadline for psychological or social maternal reasons, and to specify the care pathways of these patients.
Read the detailed description
Retrospective cohort (from 01/01/2016 to 02/28/2022) single-centre involving data from patients followed at the Maison des Femmes, and eligible for the study.
The demographic and care pathway variables will be the subject of a descriptive statistical analysis.
Expected results: improvement of knowledge relating to patients who consulted for termination of pregnancy after sixteen weeks of amenorrhea and their care pathway.
Outlook:
- Improving the knowledge of health professionals and therefore of care pathways, with a view to a more homogeneous use of legal systems.
- Improvement and simplification of care pathways.
- Conditions
- Pregnancy Related
- Keywords
- Medical termination of pregnancy, Psychic or social reason
What is being measured
The primary outcome is the main question the study is designed to answer.
age
epidemiology of patients who have undergone medical termination of pregnancy for psychological or social maternal reasons
Measured: Day 1
place of life
epidemiology of patients who have undergone medical termination of pregnancy for psychological or social maternal reasons
Measured: Day 1
social security
epidemiology of patients who have undergone medical termination of pregnancy for psychological or social maternal reasons
Measured: Day 1
level of studies
epidemiology of patients who have undergone medical termination of pregnancy for psychological or social maternal reasons
Measured: Day 1
occupation / resources
epidemiology of patients who have undergone medical termination of pregnancy for psychological or social maternal reasons
Measured: Day 1
marital status
epidemiology of patients who have undergone medical termination of pregnancy for psychological or social maternal reasons
Measured: Day 1
number of children
epidemiology of patients who have undergone medical termination of pregnancy for psychological or social maternal reasons
Measured: Day 1
native country
epidemiology of patients who have undergone medical termination of pregnancy for psychological or social maternal reasons
Measured: Day 1
recent life events
epidemiology of patients who have undergone medical termination of pregnancy for psychological or social maternal reasons
Measured: Day 1
Secondary outcomes (3)
migratory route
care pathway for patients who have undergone medical termination of pregnancy for psychological or social maternal reasons
Measured: Day 1
medical and surgical history
care pathway for patients who have undergone medical termination of pregnancy for psychological or social maternal reasons
Measured: Day 1
gynecological follow-up, and follow-up of the current pregnancy
care pathway for patients who have undergone medical termination of pregnancy for psychological or social maternal reasons
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2022
- Study start17 Aug 2022 (estimated)
- Primary completion17 Aug 2022 (estimated)
- Study completion30 Nov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy RelatedStudies 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
- 120 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
- NCT05499325
- Sponsor's protocol ID
- CHSD_0028_MATER
- Status last verified
- Aug 2022
- First submitted
- 11 Aug 2022
- Last updated
- 12 Aug 2022
- 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 12 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Requests for Medical Termination of Pregnancy for Psychological or Social Maternal Reasons at the "Maison Des Femmes" in Saint-Denis : Retrospective Study Between 2016 and 2022
- ClinicalTrials.gov ID
- NCT05499325
- Acronym / sponsor ID
- CHSD_0028_MATER
- Conditions
- Pregnancy Related
- Keywords
- Medical termination of pregnancy, Psychic or social reason
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Centre Hospitalier de Saint-DenisUniversity, hospital or other
- Study start
- 17 Aug 2022 (estimated)
- Primary completion
- 17 Aug 2022 (estimated)
- Study completion
- 30 Nov 2022 (estimated)
- First posted
- 12 Aug 2022 (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.
When the request for termination of pregnancy is made at a term of less than sixteen weeks of amenorrhea, the patients have complete decision-making autonomy. This is called voluntary termination of pregnancy. On the other hand, when they are made after this term, their requests must be subject to a multidisciplinary assessment. This is called medical termination of pregnancy for maternal indication. Schematically, there are two categories of indications: "organic" (progressive cancer, severe heart disease, etc.) and "psycho-social". In the latter case, and although the recommendations of the CNGOF recommend a formalization of these requests in the centers where the patients are received, strong disparities are observed in practice. In addition, there are few epidemiological and clinical data concerning these medical terminations of pregnancy with a psychological or social maternal indication in the literature.
The objective of this work is to describe the demographic characteristics of patients who have made a request for termination of pregnancy after the legal deadline for psychological or social maternal reasons, and to specify the care pathways of these patients.
Detailed description
Retrospective cohort (from 01/01/2016 to 02/28/2022) single-centre involving data from patients followed at the Maison des Femmes, and eligible for the study.
The demographic and care pathway variables will be the subject of a descriptive statistical analysis.
Expected results: improvement of knowledge relating to patients who consulted for termination of pregnancy after sixteen weeks of amenorrhea and their care pathway.
Outlook:
- Improving the knowledge of health professionals and therefore of care pathways, with a view to a more homogeneous use of legal systems.
- Improvement and simplification of care pathways.
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 followed at the Maison des Femmes, having consulted between 01/01/2016 and 02/28/2022, having undergone a medical termination of pregnancy for psychological or social maternal reasons
Key inclusion criteria (2 listed)
- Minor or adult patients who have been seen at the Maison des Femmes in the context of a request for termination of pregnancy for psychological and/or social maternal reasons, including patients subject to a legal protection measure (guardianship , curators) during the consultation
- Consultation between 01/01/2016 and 02/28/2022
Key exclusion criteria (2 listed)
- Refusal of inclusion in a study explained in the medical file (patient or guardian)
- Objection to the use of data or refusal to participate (patient or guardian)
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
age
Time frame: Day 1
epidemiology of patients who have undergone medical termination of pregnancy for psychological or social maternal reasons
place of life
Time frame: Day 1
epidemiology of patients who have undergone medical termination of pregnancy for psychological or social maternal reasons
social security
Time frame: Day 1
epidemiology of patients who have undergone medical termination of pregnancy for psychological or social maternal reasons
level of studies
Time frame: Day 1
epidemiology of patients who have undergone medical termination of pregnancy for psychological or social maternal reasons
occupation / resources
Time frame: Day 1
epidemiology of patients who have undergone medical termination of pregnancy for psychological or social maternal reasons
marital status
Time frame: Day 1
epidemiology of patients who have undergone medical termination of pregnancy for psychological or social maternal reasons
number of children
Time frame: Day 1
epidemiology of patients who have undergone medical termination of pregnancy for psychological or social maternal reasons
native country
Time frame: Day 1
epidemiology of patients who have undergone medical termination of pregnancy for psychological or social maternal reasons
recent life events
Time frame: Day 1
epidemiology of patients who have undergone medical termination of pregnancy for psychological or social maternal reasons
3 secondary outcomes
migratory route
Time frame: Day 1
medical and surgical history
Time frame: Day 1
gynecological follow-up, and follow-up of the current pregnancy
Time frame: Day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2022.
- Women victims of violenceLink provided by the sponsor.
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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.
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 Related, 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: status not confirmed, as of the sponsor's last update on 12 Aug 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anne BEDU, JD (01.42.35.61.28, annebedu.ab@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
age (time frame: Day 1). The study lists 9 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 12 Aug 2022.