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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00319176
Recruitment Status : Completed
First Posted : April 27, 2006
Last Update Posted : February 8, 2013
Long Beach Memorial Medical Center
Information provided by (Responsible Party):
University of California, Irvine

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.

Condition or disease

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 15 participants
Observational Model: Case-Only
Time Perspective: Prospective
Study Start Date : April 2004
Actual Study Completion Date : December 2007

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Obstetrics clinic

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT00319176

United States, California
Long Beach Memorial Medical Center
Long Beach, California, United States, 90806
Sponsors and Collaborators
University of California, Irvine
Long Beach Memorial Medical Center
Principal Investigator: Afshan B Hameed, MD University of California, Irvine

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: University of California, Irvine Identifier: NCT00319176     History of Changes
Other Study ID Numbers: 162-04
First Posted: April 27, 2006    Key Record Dates
Last Update Posted: February 8, 2013
Last Verified: February 2013

Keywords provided by University of California, Irvine: