Pregnancy Clinical Trial
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.
Status | Completed |
Enrollment | 15 |
Est. completion date | December 2007 |
Est. primary completion date | |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 45 Years |
Eligibility |
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. |
Observational Model: Case-Only, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
United States | Long Beach Memorial Medical Center | Long Beach | California |
Lead Sponsor | Collaborator |
---|---|
University of California, Irvine | Long Beach Memorial Medical Center |
United States,
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03442582 -
Afluria Pregnancy Registry
|
||
Terminated |
NCT02161861 -
Improvement of IVF Fertilization Rates, by the Cyclic Tripeptide FEE - Prospective Randomized Study
|
N/A | |
Not yet recruiting |
NCT05934318 -
L-ArGinine to pRevent advErse prEgnancy Outcomes (AGREE)
|
N/A | |
Enrolling by invitation |
NCT05415371 -
Persistent Poverty Counties Pregnant Women With Medicaid
|
N/A | |
Completed |
NCT04548102 -
Effects of Fetal Movement Counting on Maternal and Fetal Outcome Among High Risk Pregnant Woman
|
N/A | |
Completed |
NCT03218956 -
Protein Requirement During Lactation
|
N/A | |
Completed |
NCT02191605 -
Computer-delivered Screening & Brief Intervention for Marijuana Use in Pregnancy
|
N/A | |
Completed |
NCT02223637 -
Meningococcal Quadrivalent CRM-197 Conjugate Vaccine Pregnancy Registry
|
||
Recruiting |
NCT06049953 -
Maternal And Infant Antipsychotic Study
|
||
Completed |
NCT02577536 -
PregSource: Crowdsourcing to Understand Pregnancy
|
||
Not yet recruiting |
NCT06336434 -
CREATE - Cabotegravir & Rilpivirine Antiretroviral Therapy in Pregnancy
|
Phase 1/Phase 2 | |
Not yet recruiting |
NCT05412238 -
Formulation and Evaluation of the Efficacy of Macro- and Micronutrient Sachets on Pregnant Mothers and Children Aged 6-60 Months
|
N/A | |
Not yet recruiting |
NCT04786587 -
Alcohol Self-reporting During Pregnancy. AUTOQUEST Study.
|
||
Not yet recruiting |
NCT05028387 -
Telemedicine Medical Abortion Service Using the "No-test" Protocol in Ukraine and Uzbekistan.
|
||
Completed |
NCT02683005 -
Study of Hepatitis C Treatment During Pregnancy
|
Phase 1 | |
Completed |
NCT02783170 -
Safety and Immunogenicity of Simultaneous Tdap and IIV in Pregnant Women
|
Phase 4 | |
Recruiting |
NCT02564250 -
Maternal Metabolism and Pregnancy Outcomes in Obese Pregnant Women
|
N/A | |
Recruiting |
NCT02619188 -
Nutritional Markers in Normal and Hyperemesis Pregnancies
|
N/A | |
Recruiting |
NCT02507180 -
Safely Ruling Out Deep Vein Thrombosis in Pregnancy With the LEFt Clinical Decision Rule and D-Dimer
|
||
Completed |
NCT02520687 -
Effects of Dietary Nitrate in Hypertensive Pregnant Women
|
Phase 1 |