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临床试验/NCT07342127
NCT07342127已完成不适用

Evaluation of a Preventive Therapeutic Strategy for Postpartum Venous Thromboembolism in Asymptomatic Women With Heterozygous Factor V Leiden ou Factor II Mutation.

Hospices Civils de Lyon2 个研究点 分布在 1 个国家目标入组 86 人开始时间: 2026年2月4日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
86
试验地点
2
主要终点
Thromboprophylaxis treatment duration

研究概览

简要总结

Background : pregnancy and postpartum period are times of increased risk for deep vein thrombosis (DVT).

The incidence of venous thromboembolic disease (VTE) during pregnancy is estimated at 1-2 per 1,000, and this risk increases in the postpartum period, rising up to 80-fold. VTE is a multifactorial condition, and several studies have identified risk factors for DVT during this period. These factors may be related to the patient herself-such as age, overweight, smoking, a personal or family history of DVT, and/or thrombophilia. Factors related to the pregnancy itself and peripartum events-such as preeclampsia, multiple pregnancy, the mode of delivery (emergency or elective cesarean section), and postpartum hemorrhage-have also been identified as DVT risk factors.

Resistance to activated protein C caused by the Factor V Leiden mutation affects about 5% of the population and, in its heterozygous form, increases the risk of VTE by 3- to 10-fold depending on the study, raising the absolute risk to approximately 1 in 400. The heterozygous mutation of the prothrombin (Factor II) gene affects about 2% of the population and increases the risk of VTE threefold. However, although the risk is increased, the absolute risk of VTE remains low (0.5 to 1%).

Regarding prevention, recommendations are heterogeneous and often based on a low level of evidence. In certain situations (e.g., history of provoked thrombosis, moderate thrombophilia), prophylaxis is not always recommended, or its duration is not clearly defined, and the benefit-risk balance remains uncertain.

The main objective of this study is to describe the duration of anticoagulation prescribed after delivery according to the characteristics of patients carrying these mutations and their mode of delivery. The secondary composite objective is to compare two treatment durations (less than 2 weeks vs. 6 weeks) to determine whether a shorter treatment is less effective in preventing deep vein thrombosis, and whether a longer treatment is associated with more adverse effects.

The target population therefore consisted of adult women carrying an asymptomatic heterozygous mutation of Factor V or Factor II, who had been followed up or had consulted at the Hospices Civils de Lyon for obstetric or hematologic evaluation related to this mutation.

Investigators extracted health data of the included patients from the Hospices Civils de Lyon medical software. They also contacted patients by phone to complete data collection, particularly to determine whether they had experienced a deep vein thrombosis within 12 weeks after delivery, or any adverse effects related to anticoagulant therapy.

研究设计

研究类型
Observational
观察模型
Other
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

  • Age > 18
  • Heterozygous asymptomatic Factor V Leiden mutation or Factor II mutation, diagnosed before or during pregnancy
  • Delivering between 01/01/2020 and 31/12/2025
  • Patient with French social security rights

排除标准

  • 未提供

研究组 & 干预措施

2 weeks or less postpartum thromboprophylaxis

Patients receiving 2 weeks (or less) preventive anticoagulation with low molecular weight heparin after giving birth

干预措施: Retrospective collection of health data (Other)

2 weeks or less postpartum thromboprophylaxis

Patients receiving 2 weeks (or less) preventive anticoagulation with low molecular weight heparin after giving birth

干预措施: Phone call to every participant (Other)

6 weeks postpartum thromboprophylaxis

Patients receiving 6 weeks preventive anticoagulation with low molecular weight heparin after giving birth

干预措施: Retrospective collection of health data (Other)

6 weeks postpartum thromboprophylaxis

Patients receiving 6 weeks preventive anticoagulation with low molecular weight heparin after giving birth

干预措施: Phone call to every participant (Other)

结局指标

主要结局

Thromboprophylaxis treatment duration

时间窗: At baseline

Evaluation of the given thromboprophylaxis treatment duration according to patients' characteristics

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 (2)

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