EUCTR2020-000619-58-FR进行中（未招募）1 期
A pilot study assessing the feasibility of a randomized controlled trial evaluating aspirin in postpartum women at risk of developing venous thromboembolism Pilot PARTUM Trial: Postpartum Aspirin to Reduce Thromboembolism Undue Morbidity - PARTUM
CHU SAINT-ETIENNE0 个研究点目标入组 48 人开始时间: 2020年11月26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
- 48
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
- •Trial inclusion criteria includes one (or more) first order criterion or two (or more) second order criterion. A patient is still eligible if they have multiple criteria met, at the discretion of their physician and/or local investigator.
- •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 VTE:
- •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 period
- •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 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 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 chart)
- •8. Postpartum infection (symptoms/signs of infection and documented fever andlaboratory 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 48
- •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 below.
- •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)55
- •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 postpartum
- •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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