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临床试验/NCT06140069
NCT06140069撤回不适用

Voluntary Termination of Pregnancy Between 14 and 16 Weeks of Amenorrhea: Comparison of Women's Experiences Depending on the Method Used, Surgical or Medicinal.

University Hospital, Toulouse0 个研究点目标入组 164 人开始时间: 2024年12月20日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
入组人数
164
主要终点
Evaluation of anxiety or depressive disorder depending on the method used, surgical or medicinal

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 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.

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

  • 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

排除标准

  • Protected adult patient (guardianship, curatorship, protection of justice)
  • Developing psychiatric pathologies
  • Fetal anomaly detected

结局指标

主要结局

Evaluation of anxiety or depressive disorder depending on the method used, surgical or medicinal

时间窗: At the inclusion visit before abortion and 3 weeks after abortion

Anxiety will be measured using Hospital Anxiety and Depression Scale (HADS)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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