Voluntary Surgical Terminations of Pregnancy: Comparison of the Hemorrhagic Risk Depending on the Term

NCT06396338 | Completed

• 1 other identifier: RC31/24/0167
• Study Type: observational
• Target: 312
• Locations: 1 country
• Sites: 1

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 legislation has recently been amended, with the law of March 2, 2022 aimed at strengthening the right to abortion (no. 2022-295) which extended the legal period for voluntary termination of pregnancy from 14 to 16 weeks amenorrhea (AS). The National College of French Obstetrician Gynecologists (CNGOF), in a press release published on October 12, 2020 in response to the proposed law adopted by the National Assembly, wishes to draw attention to the fact that the procedure of surgical abortion between 14 and 16 AS changes nature. He states that additional procedures are necessary beyond 14 weeks, which could be a source of complications. In addition, the practice recommendations have not been updated following this extension of time, 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. 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-term abortions, in order to be able to correctly inform patients and allow them to make an informed choice regarding the method used. This study follows the modification of the legislation extending the legal period for abortion, with the aim of providing arguments regarding the safety of carrying out surgical abortions at these more advanced stages of pregnancy. In addition, abortion often generates anxiety, the term at which it is carried out could influence the experience of patients. This study would therefore also improve knowledge about the experience of abortion, in order to better support patients throughout their journey.

Conditions

Voluntary Termination of Pregnancy

Outcome Measures

Primary Outcomes (1)

• Evaluation of anxiety or depressive disorder

  Anxiety will be measured using State-Trait Anxiety Inventory (STAI) Scale

  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 10 and 16 weeks (dating by ultrasound) presenting with a single and evolving pregnancy

Other: Questionnaire

Interventions

Questionnaire OTHER

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

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient coming at hospital for voluntary termination of pregnancy (abortion)

You may qualify if:

• Woman treated for the performance of a surgical abortion between 10 and 16 weeks (dating by ultrasound)
• Singleton pregnancy

You may not qualify if:

• Protected adult patient (guardianship, curatorship, safeguard of justice)
• Refusal to participate expressed by the patient

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

CHU Toulouse

Toulouse, France

Location

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Lola LOUSSERT-CHAMBRE, MD

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: April 29, 2024
• First Posted: May 2, 2024
• Study Start: July 26, 2024
• Primary Completion: February 6, 2025
• Study Completion: February 6, 2025
• Last Updated: January 27, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)