NCT06708208

Brief 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 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
107

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 14, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2024

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

November 25, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 27, 2024

Completed
23 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2024

Completed
Last Updated

November 27, 2024

Status Verified

November 1, 2024

Enrollment Period

3 months

First QC Date

November 25, 2024

Last Update Submit

November 25, 2024

Conditions

Keywords

pregnancyvoluntary termination of pregnancyviolenceabortiontermination of pregnancymedical abortion

Outcome Measures

Primary Outcomes (5)

  • Demographic data

    Age

    1 day

  • Demographic data

    Birth place

    1 day

  • Demographic data

    Migration history

    1 day

  • Medical history

    Term of abotion

    1 day

  • Violence's history

    Description of the violence. Current situation of violence.

    1 day

Eligibility Criteria

Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsWomen who are pregnant.
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who expressed a request for an IMG for non-somatic maternal reasons

You may qualify if:

  • 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.

You may not qualify if:

  • Refusal of participation (patient or guardian)
  • Opposition to the use of data

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maison des femmes

Saint-Denis, Seine saint denis, 93200, France

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 25, 2024

First Posted

November 27, 2024

Study Start

December 14, 2023

Primary Completion

March 1, 2024

Study Completion

December 20, 2024

Last Updated

November 27, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations