Thrombophilia in Pregnancy Prophylaxis Study: a multicentre, multinational, randomised controlled trial of prophylactic low molecular weight heparin in high-risk pregnant thrombophilic wome

Recruitment & Eligibility

Status: Completed

Sex: Female

Target Recruitment: 284

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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