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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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29 April 2013 |
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Main ID: |
NCT00967382 |
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Date of registration:
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29/05/2009 |
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Primary sponsor: |
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Public title:
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TIPPS: Thrombophilia in Pregnancy Prophylaxis Study
TIPPS |
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Scientific title:
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TIPPS - Thrombophilia in Pregnancy Prophylaxis Study: A Multicentre, Multinational, Randomized Control Trial of Prophylaxis Low Molecular Weight Heparin (LMWH) in High-risk Thrombophilic Women. |
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Date of first enrolment:
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July 2000 |
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Target sample size:
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284 |
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Recruitment status: |
Active, not recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00967382 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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Canada
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United States
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Contacts
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Name:
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Marc A Rodger, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Ottawa Hospital Research Institute, Ottawa, Canada |
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Name:
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William Hague, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Women's and Children's Hospital, Adelaide, Australia |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
One or more of the following:
- Previous preeclampsia
- Previous unexplained intra-uterine growth restriction
- Previous recurrent miscarriage:
- three(3) or more unexplained miscarriage at less than 10 weeks gestation;
- two (2) or more unexplained fetal loss between 10 and 16 weeks gestation;
- one (1) or more unexplained fetal loss at or greater than 16 weeks gestation
- Previous abruptio placenta
- Previous personal history of VTE:
- Previous documented secondary proximal VTE,
- Previous documented calf-vein thrombosis (idiopathic or secondary),
- Previous superficial phlebitis
- First degree relative with symptomatic thrombophilia
- Pregnancy - > 4weeks gestation and < 20 weeks gestation
- Thrombophilia:
- Two abnormal tests, and no normal tests
- 3.1 Protein S
- 3.2 Protein C
- 3.3 Antithrombin
- Two positive tests
- 3.4 Anticardiolipin IgM (>30 U/ml)
- 3.5 Anticardiolipin IgG (>30 U/ml)
- 3.6 Anti-b2 glycoprotein IgG (>20 U/ml)
- 3.7 Anti-b2 glycoprotein IgM (>20 U/ml)
- 3.8 Lupus anticoagulant
- One positive test
- 3.9 Factor V Leiden (heterozygous or homozygous)
- 3.10Prothrombin gene defect (heterozygous or homozygous)
Exclusion Criteria:
- Less than 4 weeks gestation or greater than 20 weeks gestation
- No confirmed thrombophilia
- Contraindication to heparin therapy
- History of heparin induced thrombocytopenia
- Platelet count less than 100,000 109/L
- History of osteoporosis or steroid use
- Actively bleeding
- Documented peptic ulcer within 6 weeks
- Heparin, bisulfite or fish allergy
- Severe hypertension (SBP >200mmhg and/or DBP >120mmHg)
- Serum creatinine greater than 80 umol/L (1.3mg/dl) and an abnormal 24 hour urine
creatine clearance (<30ml/min)
- Severe hepatic failure (INR >1.8)
- Geographic inaccessibility
- Need for anticoagulants, discretion of the investigator such as but not limited to:
- Recurrent fetal loss and phospholipid antibody syndrome
- Prior idiopathic proximal VTE:
- History of idiopathic DVT or PE treated with anticoagulants (> 1 month of
heparin or warfarin) or IVC interruption;
- Idiopathic is a VTE occurring outside all of the following periods: antepartum,
postpartum, oral contraceptive use, surgery, immobilization, cast, and
malignancy
- Mechanical heart valve
- Legal lower age limitations (country specific)
- Prior participation in TIPPS
- Unable/unwilling to provide informed consent
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Pregnancy
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Pregnancy Complications
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Thrombophilia
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Intervention(s)
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Drug: dalteparin sodium
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Primary Outcome(s)
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The primary objective of the study is to identify if LMWH prophylaxis in thrombophilic pregnant women results in a greater than 33% relative risk reduction in the composite outcome measure (VTE, pre-eclampsia, IUGR and fetal loss)
[Time Frame: 6 weeks post-partum]
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Secondary Outcome(s)
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Determine the safety of LMWH use in pregnancy (Specifically rates of bleeding, thrombocytopenia and fractures)
[Time Frame: 6 weeks post-partum]
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Identify if prophylactic LMWH will reduce rates of PIH, preterm labor and abruptio placenta in pregnant thrombophilic women compared to control
[Time Frame: 6 weeks post-partum]
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Identify whether prolonged use of LMWH in pregnancy results in decreased BMD compared to control
[Time Frame: 6 weeks post-partum]
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Secondary ID(s)
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1999210-01H
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2007-000284-21
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CIHR 200602MCT-157533-RFA
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IND 72,350
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ISRCTN 87441504
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Trial number 2004/244
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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