Evaluation of Pre-dose and Post-dose Anti-factor Xa Levels With Enoxaparin Use During Pregnancy

NCT00319176 | Completed

• 1 other identifier: 162-04
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

Venous thromboembolism is a condition that causes formation of blood clots in the body. It may have life threatening consequences if the leg veins, lungs or the brain blood vessels are involved. In pregnancy, a woman's baseline risk for forming blood clots is increased. Women with a known prior blood clot during pregnancy, artificial heart valves or other genetic conditions are at a very high risk for these complications during their pregnancy. It has been well established that these women benefit from medical treatment with a blood thinning medication in their pregnancies to prevent further formation of blood clots. These medications are called Heparins and are given as shots. Prior studies have suggested that a type of Heparin called "low molecular weight heparin" (Enoxaparin=Lovenox®) is well suited for use in pregnancy as it does not affect the baby and has a very low complication rate. The standard dose given for treatment of these patients has been established previously. However, there is a concern that complications may occur if the concentration of this medication falls below its effective level. It is of particular importance in pregnancy, as the rate of breakdown of this medication increases in pregnancy and may lead to lowering of its effective levels. Our study will evaluate the blood levels of enoxaparin before and after administration of this medication in pregnant women who are receiving this drug for treatment. This will determine whether an increase in the dose or an increase in the frequency of dosing might further improve the standard of care.

Conditions

Pregnancy

Keywords

Pregnancy; Enoxaparin; Anticoagulation

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Obstetrics clinic

You may qualify if:

• Nulliparous or multiparous women with intrauterine pregnancies who are receiving twice daily treatment doses of enoxaparin (1 mg/kg ± 20% SC BID).
• Subjects who consent to the study.

You may not qualify if:

• Women who are not pregnant.
• Women who are receiving enoxaparin at prophylactic doses (i.e., 30 mg twice daily or 40 mg daily).
• Women who are currently receiving another LMWH or UFH.
• Women who are receiving other concomitant anticoagulant medications, such as warfarin, lepirudin, or argatroban.
• Subjects who are unable or unwilling to give informed consent.
• Women who, in the judgment of the investigators, would not be in the best interest of the patient to participate in the study.

Sponsors & Collaborators

• University of California, Irvine: lead
• Long Beach Memorial Medical Center: collaborator

Study Sites (1)

Long Beach Memorial Medical Center

Long Beach, California, 90806, United States

Location

Related Publications (1)

• Friedrich E, Hameed AB. Fluctuations in anti-factor Xa levels with therapeutic enoxaparin anticoagulation in pregnancy. J Perinatol. 2010 Apr;30(4):253-7. doi: 10.1038/jp.2009.164. Epub 2009 Oct 15.

  PMID: 19829297 DERIVED

Study Officials

• Afshan B Hameed, MD

  University of California, Irvine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2006
• First Posted: April 27, 2006
• Study Start: April 1, 2004
• Study Completion: December 1, 2007
• Last Updated: February 8, 2013

Record last verified: 2013-02

Locations

US (1)