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NCT00319176 · ClinicalTrials.gov registry record

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

A clinical trial of Pregnancy, sponsored by University of California, Irvine.

Completed
Registry status
15
Enrollment target
1
Study location

NCT00319176 is a study of Pregnancy that has completed, run by University of California, Irvine. The registered enrollment target is 15 participants, below the 873-participant average among 191 other Pregnancy trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT00319176, a study of Pregnancy, has completed, sponsored by University of California, Irvine.

COMPLETED
Registry status
15 participants
Enrollment target
1
Study location

Study 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 Studied

Study Locations (1)

California

  • Long Beach Memorial Medical Center - Long Beach

Trial Details

FieldValue
Enrollment Target 15 participants
Start Date 2004-04
Est. Completion 2007-12

Sponsor

University of California, Irvine

368 total trials

What the Registry Record Tells You About NCT00319176

The ClinicalTrials.gov registry entry for NCT00319176 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 873-participant average among 191 other Pregnancy trials with a reported enrollment target (98% lower). The listed sponsor is University of California, Irvine, which has 368 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Pregnancy appearing as the primary indexed condition, and to 0 interventions.

NCT00319176 reports 1 study location spanning 1 distinct geographic area - top geographies include California.

Frequently Asked Questions

What is clinical trial NCT00319176 about?

NCT00319176 is a clinical study titled "Evaluation of Pre-dose and Post-dose Anti-factor Xa Levels With Enoxaparin Use During Pregnancy". 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 blo...

What is the current status of trial NCT00319176?

This trial is currently completed. The enrollment target is 15 participants. The study started on 2004-04. Estimated completion is 2007-12.

What conditions does trial NCT00319176 study?

This clinical trial studies the following conditions: Pregnancy.

Who is sponsoring clinical trial NCT00319176?

This trial is sponsored by University of California, Irvine, which has 368 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00319176 being conducted?

This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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