Multidisciplinary Team-Based Study to Optimize the Evaluation and Treatment of Women With Thrombophilia and Recurrent Pregnancy Loss
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Frequency of laboratory diagnosed thrombophilia
研究概览
简要总结
A PubMed search of "thrombophilia" and "infertility" yields only 98 articles, the majority found in foreign medical journals and subspecialty journals with narrow readerships. Outside of Assisted Reproduction Clinics at academic medical centers, health care providers have limited awareness of the literature supporting thrombophilia evaluation and treatment in patients with recurrent pregnancy loss. As a result, women may suffer through years of repeated miscarriages before a thrombophilia evaluation is performed. By the time thrombophilia has been diagnosed as the cause of recurrent pregnancy loss, couples have often exhausted their personal savings on costly assisted reproductive therapies and present frustrated and psychologically exhausted.
In this study, we will evaluate the frequency of thrombophilia as a cause of recurrent pregnancy loss and provide insights into our patient care experience at BWH.
详细描述
Study Design:
Over a 2-year period, we will perform a retrospective observational cohort analysis of 1000 patients referred to the BWH Center for Infertility and Reproductive Surgery for evaluation of recurrent pregnancy loss. This cohort will include a retrospective analysis of 200 infertility patients referred to Dr. Piazza's Cardiovascular Medicine clinic for evaluation of thrombophilia.
We will also enroll prospectively for 18 months patients referred to the BWH Center for Infertility and Reproductive Surgery for evaluation of recurrent pregnancy loss.
Study Population:
We will include a study population that is representative of the ethnic and racial diversity of women who receive care at BWH. We will not enroll post-menopausal women, men or children because recurrent pregnancy loss specifically affects women of child-bearing potential. We do not plan to enroll pregnant women because we are specifically focused on women with recurrent pregnancy loss presenting for assisted reproductive therapy.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age 18-40 years
- •2 or more pregnancy losses (including chemical pregnancies but not ectopic pregnancy)
- •Evaluated at the BWH Center for Infertility and Reproductive Surgery or the Watkins Cardiovascular Clinic
排除标准
- •Infertility due to uterine factors (such as Asherman's Syndrome)
- •Known translocation carrier
- •Prior venous thromboembolism on anticoagulation
- •Abnormal uterine cavity on hysterosalpingogram/hysteroscopy
结局指标
主要结局
Frequency of laboratory diagnosed thrombophilia
时间窗: 1 year
Laboratory diagnosed acquired or inherited thrombophilia
次要结局
未报告次要终点
研究者
Gregory Piazza, MD, MS
Associate Director, Thrombosis Research Group
Brigham and Women's Hospital