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

Voluntary Termination of Pregnancy Clinical Trial

— VECUVG  

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06140069
• Other study ID #: RC31/23/0563
• Status: Not yet recruiting
• Start date: August 2024
• Est. completion date: February 2026

Study information

• Verified date: April 2024
• Source: University Hospital, Toulouse
• Contact: Caroline Peyrot, CRA
• Phone: 561778486
• Email: peyrot.c[@]chu-toulouse.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 164
• Est. completion date: February 2026
• Est. primary completion date: February 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Voluntary Termination of Pregnancy

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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