NL-OMON50986招募中3 期
A pilot study assessing the feasibility of a randomized controlled trial evaluating aspirin in postpartum women at risk of developing venous thromboembolism - PARTUM
The University of Calgary0 个研究点目标入组 50 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •ONE (or more) First Order Criterion:
- •1. Known inherited thrombophilia prior to enrolment: Heterozygous factor V
- •heterozygous prothrombin gene variant or protein C deficiency or protein S
- •2. Antepartum immobilization (strict bedrest) for >=7 days at any time during the
- •OR TWO (or more) Second Order Criteria:
- •1. Pre-pregnancy BMI >=30 kg/m2
- •2. Smoking >=5 cigarettes/day pre-pregnancy
- •3. Previous clinical history of superficial vein thrombosis
- •4. Pre-eclampsia (SBP >=140 and/or DBP >=90 mmHg on at least one occasion and
- •proteinuria of >=0.3 grams/24 hours or >=30 mg/mmol on a random urine sample)
- •5. Current pregnancy ending in stillbirth (fetal loss >20 weeks gestation)
- •6. Emergency cesarean birth (emergency = not planned)
- •7. Small-for-gestational-age infant at time of delivery (<3rd percentile
- •adjusted for
- •gestational age and sex using the standardized international INTERGROWTH
- •8. Postpartum infection (symptoms/signs and documented fever and laboratory
- •evidence of infection)
- •9. Postpartum hemorrhage (>1000 mL regardless of delivery mode)
排除标准
- •1. More than 48 hours since delivery of the placenta at the time of
- •randomization
- •2. Received more than 2 doses of LMWH since delivery of the placenta*
- •3. Need for postpartum LMWH prophylaxis or systemic anticoagulation as judged by
- •their physician and/or local investigator. May include but is not limited to:
- •a. Documented history of provoked or unprovoked VTE
- •b. Mechanical heart valve(s)
- •c. Known antiphospholipid syndrome (APS) (according to the revised
- •Sapporo/Sydney criteria)
- •Pilot PARTUM Trial Version 1.5 08Jun2020
- •d. Known high-risk inherited thrombophilia
- •i. Antithrombin deficiency (two abnormal and no normal tests based on
- •local laboratory cutoffs)
- •ii. Homozygous factor V Leiden (genotyping result required)
- •iii. Homozygous prothrombin gene mutation (genotyping result required)
- •iv. Compound heterozygosity factor V Leiden and prothrombin gene
- •mutation (genotyping result required)
- •v. More than 1 thrombophilia: any combination of 2 or more: factor V
- •Leiden, prothrombin gene mutation, protein C deficiency, protein S
- •deficiency, as previously defined.
- •4. Need for postpartum ASA as judged by their physician and/or local
- •investigator. May
- •include but is not limited to:
- •a. Documented history of myocardial infarction
- •b. Documented history of ischemic stroke or transient ischemic attack (TIA)
- •5. Contraindication to ASA including**:
- •a. History of known ASA allergy
- •b. Documented history of a gastrointestinal ulcer
- •c. Known platelet count <50 x 109/L at any time during the current pregnancy or
- •d. Active bleeding at any site, excluding normal vaginal bleeding, at the time
- •randomization
- •e. Most recent known hemoglobin <=70 g/L during the current pregnancy or
- •f. Known severe hypertension (SBP >200 mmHg and/or DBP >120 mmHg) during
- •the current pregnancy or postpartum
- •6. <18 years of age
- •7. Unable or refused consent
- •*Pneumatic compression devices or graduated compression stockings are not a
- •contraindication to enrolment but will be recorded.
- •**Postpartum non-steroidal anti-inflammatories NSAID) use is not a
- •contraindication to
- •enrolment but will be recorded.
研究者
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