Clinical trial NCT06396338: Voluntary Surgical Terminations of Pregnancy: Comparison of the Hemorrhagic Risk Depending on the Term
Official title: Voluntary Surgical Terminations of Pregnancy: Comparison of the Hemorrhagic Risk Depending on the Term, Between 10 and 14 Weeks of Amenorrhea or Between 14 and 16 Weeks of Amenorrhea
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Voluntary Termination of Pregnancy
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2024-05-02
Enrollment: 168
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient coming at hospital for voluntary termination of pregnancy (abortion)

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.


Eligibility criteria: 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

Primary outcomes:
measure: Evaluation of anxiety or depressive disorder
timeFrame: 3 weeks after abortion
Secondary outcomes:
Other outcomes:
Locations:
city: Toulouse
country: France
facility: CHU Toulouse
Study officials:
affiliation: University Hospital, Toulouse
name: Lola LOUSSERT-CHAMBRE, MD
role: PRINCIPAL_INVESTIGATOR
References: