EUCTR2020-000619-58-NL进行中（未招募）1 期
Postpartum Aspirin to Reduce Thromboembolism Undue Morbidity - PARTUM
The University of Calgary0 个研究点目标入组 336 人开始时间: 2021年4月30日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 336
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •ONE (or more) First Order Criterion:
- •1. Known inherited thrombophilia diagnosed prior to enrolment. The necessary
- •laboratory results must be available to confirm the diagnosis. Women with one of the
- •following thrombophilias will be eligible for the trial, regardless of family history of
- •i) Heterozygous factor V Leiden (genotyping result required), or
- •ii) Heterozygous prothrombin gene variant (genotyping result required), or
- •iii) Protein C deficiency (two abnormal and no normal tests based on local laboratory
- •cutoffs), or
- •iv) Protein S deficiency (two abnormal and no normal tests, one of which is done
- •outside of pregnancy/postpartum OR two abnormal tests in
- •pregnancy/postpartum and one abnormal test and no normal tests in a first
- •degree relative, based on local laboratory cutoffs), or
- •2. Antepartum immobilization (strict bedrest) for =7 days. Immobilization is defined as
- •bed rest with 90% of waking hours spent in bed at any time during the antepartum
- •TWO (or more) Second Order Criteria:
- •1. Pre-pregnancy BMI =30 kg/m2 (when possible, a documented pre-pregnancy height
- •and weight will be used when available)
- •2. Smoking =5 cigarettes/day pre-pregnancy (smoking history is based on prepregnancy
- •history, irrespective of whether they continue or stop smoking during their
- •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
- •diagnosed during pregnancy)
- •5. Current pregnancy ending in stillbirth (pregnancy loss >20 weeks gestation)
- •6. Emergency cesarean birth (emergency = not previously 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 of infection and documented fever and
- •laboratory evidence of infection with positive blood cultures or an elevated white
- •blood cell count based on local laboratory cutoffs)
- •9. Postpartum hemorrhage (>1000 mL of blood loss, regardless of delivery mode)
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 50
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Women will be excluded from the trial if they have a known increased risk of VTE where
- •there is sufficiently high risk and/or adequate evidence to determine that LMWH or ASA
- •is indicated, based on their physician and/or local investigator, with examples listed
- •The trial exclusion criteria are as listed:
- •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)
- •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 of
- •randomization
- •e. Most recent known hemoglobin =70 g/L documented during the current
- •pregnancy or postpartum
- •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.
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