TIPPS: Thrombophilia in Pregnancy Prophylaxis Study (TIPPS)
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ClinicalTrials.gov Identifier: NCT00967382 |
Recruitment Status :
Completed
First Posted : August 27, 2009
Last Update Posted : May 19, 2014
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Condition or disease | Intervention/treatment | Phase |
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Pregnancy Thrombophilia Pregnancy Complications | Drug: dalteparin sodium | Phase 3 |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 292 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | TIPPS - Thrombophilia in Pregnancy Prophylaxis Study: A Multicentre, Multinational, Randomized Control Trial of Prophylaxis Low Molecular Weight Heparin (LMWH) in High-risk Thrombophilic Women. |
Study Start Date : | July 2000 |
Actual Primary Completion Date : | March 2014 |
Actual Study Completion Date : | March 2014 |

Arm | Intervention/treatment |
---|---|
No Intervention: Control
Subjects randomized to control will receive identical obstetrical care and follow-up, but not antenatal dalteparin. Within 24 hours of delivery, all subject's, regardless of randomization allocation will receive dalteparin sodium 5,000 IU s.c. daily for 6 weeks post-partum |
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Active Comparator: dalteparin sodium
Subjects randomized to the treatment group will receive daily injections of dalteparin during the antenatal period. They will be taught how to self-administer sub-cutaneous injections of dalteparin 5000 IU once daily (o.d.) until gestational age 20, then twice daily (bid) until 37 weeks gestation or onset of labour. Within 24 hours of delivery, all subject's, regardless of randomization allocation will receive dalteparin sodium 5,000 IU s.c. daily for 6 weeks post-partum |
Drug: dalteparin sodium
Subject's randomize to treatment arm will receive dalteparin sodium 5,000 IU s.c. daily starting on randomization day until 20 weeks gestational age then; dalteparin sodium 5,000 IU s.c. bid from 20 weeks to onset of labour or 37 weeks gestation (discontinued at the discretion of the investigator/obstetrician) Within 24 hours of delivery, all subject's, regardless of randomization allocation will receive dalteparin sodium 5,000 IU s.c. daily for 6 weeks post-partum Other Name: Fragmin |
- 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 ]
- Identify if prophylactic LMWH will reduce rates of pregnancy induced hypertension (PIH), preterm labor and abruptio placenta in pregnant thrombophilic women compared to control [ Time Frame: 6 weeks post-partum ]
- Determine the safety of LMWH use in pregnancy (Specifically rates of bleeding, thrombocytopenia and fractures) [ Time Frame: 6 weeks post-partum ]
- Identify whether prolonged use of LMWH in pregnancy results in decreased bone mineral density (BMD) compared to control [ Time Frame: 6 weeks post-partum ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
One or more of the following:
- Previous preeclampsia
- Previous unexplained intra-uterine growth restriction
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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
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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
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Two positive tests
- 3.4 Anticardiolipin immunoglobulin M (IgM) (>30 U/ml)
- 3.5 Anticardiolipin immunoglobulin G (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
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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
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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 (Systolic Blood Pressure >200mmhg and/or Diastolic Blood Pressure >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
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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 deep venous thrombosis (DVT) or pulmonary embolism (PE) treated with anticoagulants (> 1 month of heparin or warfarin) or inferior vena cava (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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00967382
United States, Missouri | |
Saint Louis University | |
Saint Louis, Missouri, United States, 63117 | |
United States, Utah | |
University of Utah Health Sciences Centre | |
Salt Lake City, Utah, United States, 84132 | |
Canada, Alberta | |
Royal Alexandra Hospital | |
Edmonton, Alberta, Canada | |
Canada, Nova Scotia | |
QEII Health Sciences Centre | |
Halifax, Nova Scotia, Canada | |
Canada, Ontario | |
Hamilton Health Sciences Centre | |
Hamilton, Ontario, Canada | |
The Ottawa Hospital, Civic Campus | |
Ottawa, Ontario, Canada | |
Mount Sinai Hospital | |
Toronto, Ontario, Canada | |
Women's College Health Sciences Centre | |
Toronto, Ontario, Canada | |
Canada, Quebec | |
SMBD Jewish General Hospital | |
Montreal, Quebec, Canada | |
St Mary's Hospital Centre | |
Montreal, Quebec, Canada | |
Canada, Saskatchewan | |
Royal University Hospital | |
Saskatoon, Saskatchewan, Canada | |
Canada | |
CHA, Hopital Enfant Jesus | |
Quebec, Canada |
Principal Investigator: | Marc A Rodger, MD | Ottawa Hospital Research Institute, Ottawa, Canada | |
Principal Investigator: | William Hague, MD | Women's and Children's Hospital, Adelaide, Australia |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Ottawa Hospital Research Institute |
ClinicalTrials.gov Identifier: | NCT00967382 |
Other Study ID Numbers: |
1999210-01H IND 72,350 ( Other Identifier: Department of Health & Human Services, FDA ) ISRCTN 87441504 ( Registry Identifier: ISRCTN ) CIHR 200602MCT-157533-RFA ( Other Grant/Funding Number: Canadian Institutes of Health Research ) Trial number 2004/244 ( Other Identifier: Australian Government,Therapeutic Goods Administration ) 2007-000284-21 ( EudraCT Number ) |
First Posted: | August 27, 2009 Key Record Dates |
Last Update Posted: | May 19, 2014 |
Last Verified: | May 2014 |
Pregnancy Thrombophilia High-risk pregnancy LMWH prophylaxis Placenta mediated pregnancy complications |
Pregnancy Complications Thrombophilia Hematologic Diseases Dalteparin Tinzaparin |
Heparin, Low-Molecular-Weight Anticoagulants Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action |