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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06396338
Other study ID # RC31/24/0167
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date September 2024
Est. completion date September 2025

Study information

Verified date April 2024
Source University Hospital, Toulouse
Contact Caroline Peyrot, CRA
Phone 0561778486
Email peyrot.c@chu-toulouse.fr
Is FDA regulated No
Health authority
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 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 SA 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 168
Est. completion date September 2025
Est. primary completion date September 2025
Accepts healthy volunteers
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: - Woman treated for the performance of a surgical abortion between 10 and 16 weeks (dating by ultrasound) - Singleton pregnancy Exclusion Criteria: - Protected adult patient (guardianship, curatorship, safeguard of justice) - Refusal to participate expressed by the patient

Study Design


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
France CHU Toulouse Toulouse

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Evaluation of anxiety or depressive disorder Anxiety will be measured using State-Trait Anxiety Inventory (STAI) Scale 3 weeks after abortion
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Not yet recruiting NCT06140069 - Voluntary Termination of Pregnancy: Comparison of Women's Experiences Depending on the Method Used.