NCT06140069

Brief Summary

Voluntary termination of pregnancy (abortion) is a major current societal issue. This is a very common situation, around 225,000 abortions are carried out every year in France. The French law of March 2, 2022 (no. 2022-295) extended the legal deadline for voluntary termination of pregnancy from 14 to 16 weeks of amenorrhea (SA). The recommendations have not been updated following this legal extension, the centers performing abortions are therefore free regarding the protocol for carrying out these so-called late abortions (between 14 and 16 weeks). There are two pregnancy termination techniques practiced in France: medical or surgical. The drug method consists of drug-induced expulsion of the pregnancy. This method is carried out in the delivery room, and lasts several hours. The surgical method consists of an endouterine aspiration carried out in the operating room, which lasts approximately 30 minutes. At the Toulouse University Hospital, as in many centers in France, it is the patient who chooses the method, apart from a contraindication to one or other of these methods. Due to the recent nature of these late abortions, practitioners still have little experience of the consequences of these procedures and this compromises the quality of the information provided to patients. It is necessary to have quality studies to improve knowledge about late abortions, in order to be able to correctly inform patients and allow them to make an informed choice regarding the method used.

Trial Health

15
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Dec 2024

Status
withdrawn

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

First Submitted

Initial submission to the registry

November 10, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 18, 2023

Completed
1.1 years until next milestone

Study Start

First participant enrolled

December 20, 2024

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2024

Completed
Last Updated

July 21, 2026

Status Verified

July 1, 2026

Enrollment Period

Same day

First QC Date

November 10, 2023

Last Update Submit

July 17, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Evaluation of anxiety or depressive disorder depending on the method used, surgical or medicinal

    Anxiety will be measured using Hospital Anxiety and Depression Scale (HADS)

    At the inclusion visit before abortion and 3 weeks after abortion

Study Arms (1)

Experimental: Patient treated at the Toulouse University Hospital for an abortion

Patient treated at the Toulouse University Hospital for an abortion between 14 and 16 weeks (dating by ultrasound) presenting with a single and evolving pregnancy.

Other: Questionnaire

Interventions

A questionnaire is offered to patients who meet the eligibility criteria and who have given their non-objection during the abortion request consultation. This questionnaire includes questions for screening for anxiety and depressive disorders.

Experimental: Patient treated at the Toulouse University Hospital for an abortion

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patient coming for Voluntary termination of pregnancy (abortion)

You may qualify if:

  • Any adult patient
  • Having given her non-opposition after clear and fair information (patient who understands and reads French)
  • Patient treated at the Toulouse University Hospital for an abortion between 14 and 16 weeks (dating by ultrasound)
  • Singleton pregnancy
  • Progressive pregnancy

You may not qualify if:

  • Protected adult patient (guardianship, curatorship, protection of justice)
  • Developing psychiatric pathologies
  • Fetal anomaly detected

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Lola LOUSSERT CHAMBRE, MD

    University Hospital, Toulouse

    PRINCIPAL INVESTIGATOR
0

Study Design

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

Study Record Dates

First Submitted

November 10, 2023

First Posted

November 18, 2023

Study Start

December 20, 2024

Primary Completion

December 20, 2024

Study Completion

December 20, 2024

Last Updated

July 21, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share