Thrombophilia in Pregnancy Prophylaxis Study: a multicentre, multinational, randomised controlled trial of prophylactic low molecular weight heparin in high-risk pregnant thrombophilic women.
- Conditions
- Venous thromboembolism (VTE) and placenta mediated pregnancy complications in thrombophilic women.Reproductive Health and Childbirth - Fetal medicine and complications of pregnancy
- Registration Number
- ACTRN12608000446369
- Lead Sponsor
- The Ottawa Health Research Institute
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 385
High-risk pregnant women with a confirmed thrombophilia, who have had any of the following pregnancy complications: recurrent miscarriages, stillbirth, pre-eclampsia, very small birth weight baby (IUGR), bleeding in the placenta before delivery (called abruptio placentae) or previous VTE or first degree relative with a history of VTE and confirmed thrombophilia. To be eligible women must give informed consent and be over 18 years of age.
Less than 4 weeks or greater than 20 weeks pregnant. No confirmed thrombophilia. Unwilling or unable to give informed consent. Contraindication to heparin therapy, including: previous heparin induced thrombocytopenia, platelet count of less than 100,000x10^6/L, history of osteoporosis or steroid use, actively bleeding, documented peptic ulcer. Sensitivity or allergy to pork products. Severe hypertension, severe liver or kidney failure. Need for anticoagulation - i.e. women with recurrent fetal loss and known Anti-Phospholipid Antibody Syndrome, women with prior history of idiopathic VTE and mechanical heart valves.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method