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临床试验/NCT06396338
NCT06396338已完成不适用

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

University Hospital, Toulouse1 个研究点 分布在 1 个国家目标入组 312 人开始时间: 2024年7月26日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
312
试验地点
1
主要终点
Evaluation of anxiety or depressive disorder

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

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

排除标准

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

研究组 & 干预措施

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

干预措施: Questionnaire (Other)

结局指标

主要结局

Evaluation of anxiety or depressive disorder

时间窗: 3 weeks after abortion

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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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