VECUVG: Voluntary Termination of Pregnancy: Comparison of Women's Experiences Depending on the Method Used.

Sponsor
University Hospital, Toulouse (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06140069
Collaborator
(none)
164
24

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Questionnaire

Study Design

Study Type:
Observational
Anticipated Enrollment :
164 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Voluntary Termination of Pregnancy Between 14 and 16 Weeks of Amenorrhea: Comparison of Women's Experiences Depending on the Method Used, Surgical or Medicinal.
Anticipated Study Start Date :
Feb 1, 2024
Anticipated Primary Completion Date :
Feb 1, 2026
Anticipated Study Completion Date :
Feb 1, 2026

Arms and Interventions

Arm Intervention/Treatment
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
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.

Outcome Measures

Primary Outcome Measures

  1. Evaluation of anxiety or depressive disorder depending on the method used, surgical or medicinal [At the inclusion visit before abortion and 3 weeks after abortion]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • 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

Exclusion Criteria:
  • Protected adult patient (guardianship, curatorship, protection of justice)

  • Developing psychiatric pathologies

  • Fetal anomaly detected

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University Hospital, Toulouse

Investigators

  • Principal Investigator: Lola LOUSSERT CHAMBRE, MD, CHU Toulouse

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital, Toulouse
ClinicalTrials.gov Identifier:
NCT06140069
Other Study ID Numbers:
  • RC31/23/0563
First Posted:
Nov 18, 2023
Last Update Posted:
Nov 18, 2023
Last Verified:
Nov 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Nov 18, 2023