NCT01416454 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Bates SM, Greer IA, Pabinger I, Sofaer S, Hirsh J; American College of Chest Physicians
Venous thromboembolism, thrombophilia, antithrombotic therapy, and pregnancy: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th Edition). Chest. 2008 Jun;133(6 Suppl):844S-886S. doi: 10.1378/chest.08-0761.
James AH
Venous thromboembolism in pregnancy. Arterioscler Thromb Vasc Biol. 2009 Mar;29(3):326-31. doi: 10.1161/ATVBAHA.109.184127. Review.
Morris JM, Algert CS, Roberts CL
Incidence and risk factors for pulmonary embolism in the postpartum period. J Thromb Haemost. 2010 May;8(5):998-1003. doi: 10.1111/j.1538-7836.2010.03794.x. Epub 2010 Feb 1.
Ng KF
Changes in thrombelastograph variables associated with aging. Anesth Analg. 2004 Aug;99(2):449-54, table of contents.
Saha P, Stott D, Atalla R
Haemostatic changes in the puerperium '6 weeks postpartum' (HIP Study) - implication for maternal thromboembolism. BJOG. 2009 Nov;116(12):1602-12. doi: 10.1111/j.1471-0528.2009.02295.x. Epub 2009 Aug 14.
Sharma SK, Philip J, Wiley J
Thromboelastographic changes in healthy parturients and postpartum women. Anesth Analg. 1997 Jul;85(1):94-8.

Thromboelastography to Assess Age-Related Coagulation Differences in Patients Undergoing Elective Cesarean Delivery.

Clinical trial NCT01416454 - References