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

This study has been completed.
Sponsor:
Collaborator:
Long Beach Memorial Medical Center
Information provided by (Responsible Party):
University of California, Irvine
ClinicalTrials.gov Identifier:
NCT00319176
First received: April 26, 2006
Last updated: February 6, 2013
Last verified: February 2013
  Purpose

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
Pregnancy

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective

Further study details as provided by University of California, Irvine:

Estimated Enrollment: 15
Study Start Date: April 2004
Study Completion Date: December 2007
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Obstetrics clinic

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00319176

Locations
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
Investigators
Principal Investigator: Afshan B Hameed, MD University of California, Irvine
  More Information

No publications provided by University of California, Irvine

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of California, Irvine
ClinicalTrials.gov Identifier: NCT00319176     History of Changes
Other Study ID Numbers: 162-04
Study First Received: April 26, 2006
Last Updated: February 6, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Irvine:
Pregnancy
Enoxaparin
Anticoagulation

ClinicalTrials.gov processed this record on October 23, 2014