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TIPPS: Thrombophilia in Pregnancy Prophylaxis Study

NCT00967382 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 292

Last updated 2014-05-19

No results posted yet for this study

Summary

The TIPPS trial seeks to determine the safety and effectiveness of low-molecular-weight heparin (LMWH), an anticoagulant, in preventing placenta mediated pregnancy complications and venous thromboembolism (VTE) in women with thrombophilia. Thus, the principal research question is: can LMWH prevent thrombosis in the leg veins, pulmonary arteries and placental vessels, thereby reducing the risk of deep vein thrombosis, pulmonary embolism (PE), intrauterine growth restriction (IUGR), preeclampsia, miscarriage and stillbirth?

Conditions

  • Pregnancy
  • Thrombophilia
  • Pregnancy Complications

Interventions

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

Sponsors & Collaborators

  • Canadian Institutes of Health Research (CIHR)

    collaborator OTHER_GOV

  • Ottawa Hospital Research Institute

    lead OTHER

Principal Investigators

  • Marc A Rodger, MD · Ottawa Hospital Research Institute, Ottawa, Canada

  • William Hague, MD · Women's and Children's Hospital, Adelaide, Australia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2000-07-31
Primary Completion
2014-03-31
Completion
2014-03-31

Countries

  • United States
  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00967382 on ClinicalTrials.gov