ISRCTN87441504已完成未知
Thrombophilia in Pregnancy Prophylaxis Study: a multicentre, multinational, randomised controlled trial of prophylactic low molecular weight heparin in high-risk pregnant thrombophilic women
Ottawa Hospital Research Institute (OHRI) (Canada) - formerly Ottawa Health Research Institute0 个研究点目标入组 284 人开始时间: 2003年8月7日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 284
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
- 性别
- Female
入选标准
- •1. High-risk pregnant women with a confirmed thrombophilia
- •2. Who have had any of the following pregnancy complications:
- •2.1. Recurrent miscarriages
- •2.2. Stillbirth
- •2.3. Pre-eclampsia (high blood pressure in pregnancy where protein leaks into the urine)
- •2.4. Very small birth weigh baby (called intrauterine growth restriction)
- •2.5. Bleeding in the placenta before delivery (called abruptio placenta)
- •2.6. Family history of blood clots in the legs or lungs
- •2.7. Personal history of phlebitis or blood clots in the legs or lungs
- •3. Confirmed thrombophilia
- •4. 18 years of age or older
排除标准
- •1. Greater than 19 weeks + 7 days gestational age at the time of randomisation
- •2. Contraindication to heparin therapy including:
- •2.1. History of heparin induced thrombocytopenia
- •2.2. Platelet count of less than 100,000 x 106/L
- •2.3. History of osteoporosis or steroid use (increased risk of osteoporosis and osteoporotic fracture with heparin therapy)
- •2.4. Actively bleeding
- •2.5. Documented peptic ulcer within 6 weeks (contraindication to anticoagulation)
- •2.6. Heparin, bisulfite or fish allergy
- •2.7. Severe hypertension (systolic blood pressure [SBP] greater than 200 and/or diastolic blood pressure [DBP] greater than 120 - contraindication to anticoagulation)
- •2.8. Severe hepatic failure (international normalised ratio [INR] greater than 1.8) (increased likelihood of bleeding)
- •3. Women with serum creatinines greater than 80 and an abnormal 24 hour creatinine clearance. Women with serum creatinines less than 80 do not require a normal 24 hour creatinine clearance to be eligible.
- •4. Geographic inaccessibility (less likely to comply with required follow-up visits and care)
- •5. Need for anticoagulants as judged by the local investigator such as but not limited to:
- •5.1. Women with recurrent foetal loss with antiphospholipid antibody syndrome
- •5.2. Women with prior idiopathic proximal VTE:
- •5.2.1. History of pulmonary embolism (PE) or DVT treated with anticoagulants (over one month of heparin or warfarin) or inferior vena cava (IVC) interruption
- •5.2.2. Idiopathic refers to a VTE that occurs outside all of the following periods: antepartum, postpartum, oral contraceptive use, surgery, immobilisation, cast, and/or malignancy
- •5.2.3. Proximal refers to a VTE that occurs above the bifurcation of the popliteal vein
- •5.3 Women with mechanical heart valves
- •6. Women less than 18 years of age
- •7. Women unable/unwilling to providing informed consent
- •8. Prior participation in TIPPS
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