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

Voluntary Termination of Pregnancy Between 14 and 16 Weeks of Amenorrhea: Comparison of Women's Experiences Depending on the Method Used, Surgical or Medicinal.

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.

Study Overview

• Status: Withdrawn
• Conditions: Voluntary Termination of Pregnancy
• Intervention / Treatment: Other: Questionnaire

• Study Type: Observational

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patient coming for Voluntary termination of pregnancy (abortion)

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University Hospital, Toulouse
• Investigators: Principal Investigator: Lola LOUSSERT CHAMBRE, MD, CHU Toulouse

Study record dates

Study Major Dates

• Study Start (Actual): December 20, 2024
• Primary Completion (Actual): December 20, 2024
• Study Completion (Actual): December 20, 2024

Study Registration Dates

• First Submitted: November 10, 2023
• First Submitted That Met QC Criteria: November 16, 2023
• First Posted (Actual): November 18, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 6, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: RC31/23/0563

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No