Low Molecular Weight Heparin for Blood Clot Prevention in Pregnancy

Overseen By Lizette Spears

Age: 18+

Sex: Female

Trial Phase: Phase 4

Sponsor: University of California, Irvine

Must be taking: Low molecular weight heparin

Disqualifiers: Multiples, Age under 18, HIT, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 5 days

12 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method of using Lovenox, a medication that prevents blood clots, during pregnancy. Pregnant women face a higher risk of blood clots, and the study aims to determine if taking Lovenox three times a day, instead of the usual two, maintains more stable medication levels. This approach could potentially offer better protection against clots. Women who are 18 or older, pregnant with one baby, and require this clot-preventing medication are suitable candidates for the trial. As a Phase 4 trial, it involves an FDA-approved treatment and seeks to understand how Lovenox can benefit more patients during pregnancy.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on adjusting the dosing schedule of Lovenox for pregnant women.

What is the safety track record for Lovenox?

Research has shown that Lovenox, also known as enoxaparin, is generally safe during pregnancy. Studies have found that using Lovenox is linked to fewer pregnancy losses compared to not using it, suggesting safety for pregnant women. However, some reports have noted heavy bleeding after childbirth in certain cases. Despite this, the risk of serious blood clots while using Lovenox remains low, indicating its effectiveness in preventing clots. Prospective trial participants should consider these safety details and discuss them with their healthcare provider. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about using Lovenox for blood clot prevention in pregnancy because it offers a new dosing approach. Unlike the standard once or twice daily dosing, this trial explores splitting the dose into three times a day, which could provide more consistent blood thinning and potentially improve safety for pregnant women. By more precisely controlling Factor Xa levels, this method might reduce the risk of clotting without increasing bleeding risks, making it a potentially safer option for managing blood clot prevention during pregnancy.

What is the effectiveness track record for Lovenox in preventing blood clots during pregnancy?

Research has shown that Lovenox, also known as enoxaparin, helps prevent blood clots during pregnancy. Studies found that Lovenox reduced blood clots to about 1.2% in pregnant women, indicating its effectiveness in clot prevention. It is also considered safe for use during pregnancy. In this trial, participants will receive therapeutic Lovenox dosing three times a day to maintain steady levels in the body, which is important due to changes in blood volume and kidney function during pregnancy. ^{1 2 3 4 5}

Who Is on the Research Team?

Afshan Hameed, MD

Principal Investigator

University of California, Irvine

Are You a Good Fit for This Trial?

This trial is for pregnant women aged 18 or older who need blood thinners to prevent clots and have a single baby in the womb. It's not for those under 18, with multiple babies, a history of bad reactions to heparin (HIT), or allergies to enoxaparin.

Inclusion Criteria

I am pregnant and need low molecular weight heparin for treatment.

Exclusion Criteria

I am pregnant with more than one baby.

I am a woman under 18 years old.

History of Heparin Induced Thrombocytopenia (HIT)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive therapeutic Lovenox dosing split into three times a day for 5 days

5 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Lovenox

Trial Overview The study tests if taking Lovenox three times daily instead of twice can maintain safer levels in pregnant women due to their body changes. The goal is consistent anticoagulation to reduce clot risks without over-thinning the blood.

How Is the Trial Designed?

Group I: Factor Xa levels in pregnant women with therapeutic Lovenox divided into three times a day dosing Experimental Treatment 1 Intervention

Therapeutic Lovenox dosing split into three times a day dosing for 5 day. Xa levels a measured.

Lovenox is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Lovenox for:

• Deep vein thrombosis
• Pulmonary embolism
• Acute coronary syndrome
• Heart attacks
• Prevention of blood clots in pregnancy

Approved in European Union as Clexane for:

• Deep vein thrombosis
• Pulmonary embolism
• Acute coronary syndrome
• Heart attacks
• Prevention of blood clots in pregnancy

Approved in Canada as Lovenox for:

• Deep vein thrombosis
• Pulmonary embolism
• Acute coronary syndrome
• Heart attacks
• Prevention of blood clots in pregnancy

Who Is Running the Clinical Trial?

University of California, Irvine

Lead Sponsor

Trials

580

Recruited

4,943,000+

Published Research Related to This Trial

In a prospective study of 10 pregnant patients with Factor V Leiden mutation, daily administration of low molecular weight heparin (enoxaparin) resulted in no recorded cases of thrombosis or hemorrhage during pregnancy or delivery, indicating its safety and efficacy.

All infants born to the mothers in the study were healthy, and the continuation of enoxaparin postpartum for 6 to 12 weeks further supports its role as a potential gold standard for obstetric thromboprophylaxis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Resistance to activated protein C and pregnancy: thromboprophylaxis with low molecular weight heparin]. Barjot, P., Beucher, G., Le Querrec, A., et al.[2006]

In a study of 61 high-risk pregnant women receiving enoxaparin for thromboprophylaxis, there were no cases of antenatal thromboembolism, indicating its safety and efficacy in preventing blood clots during pregnancy.

While enoxaparin was effective in preventing thromboembolism, 32% of women showed reduced bone density post-partum, suggesting a need for further research on its long-term effects on bone health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low-molecular-weight heparin for obstetric thromboprophylaxis: experience of sixty-nine pregnancies in sixty-one women at high risk. Nelson-Piercy, C., Letsky, EA., de Swiet, M.[2019]

Lovenox (enoxaparin sodium) is considered safe and effective for pregnant women needing either preventive or treatment anticoagulation, based on its use in various clinical scenarios.

However, it is not recommended for pregnant women with prosthetic heart valves, and caution is advised when using it before epidural anesthesia during labor.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

ACOG Committee Opinion: safety of Lovenox in pregnancy. [2009]

Enoxaparin, a low-molecular-weight heparin, is the preferred anticoagulant during pregnancy, effectively preventing venous thromboembolism and pregnancy complications without crossing the placenta, making it safe for the fetus.

The medication has a low incidence of maternal side effects, primarily mild allergic reactions and increased bleeding, and its mechanisms of action include anti-factor Xa activity and anti-inflammatory effects, which contribute to its efficacy in pregnant women.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enoxaparin use in pregnancy: state of the art. Brenner, B.[2016]

Low molecular weight heparins (LMW heparins), like enoxaparin, are effective and safe for preventing thromboembolic complications in gynecologic surgery, with a reduced risk of bleeding and thrombocytopenia compared to standard heparin.

LMW heparins do not cross the placenta during any trimester and have no evidence of mutagenic or teratogenic effects, suggesting they are safe for use in pregnancy for thromboprophylaxis and treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low molecular weight heparins and their use in obstetrics and gynecology. Fejgin, MD., Lourwood, DL.[2019]

Lovenox (enoxaparin sodium) is considered safe and effective for pregnant women needing either preventive or treatment anticoagulation, based on its use in various clinical scenarios.

However, it is not recommended for pregnant women with prosthetic heart valves, and caution is advised when using it before epidural anesthesia during labor.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

ACOG committee opinion. Safety of Lovenox in pregnancy. Number 276, October 2002. Committee on Obstetric Practice. [2019]

Enoxaparin, a low molecular weight heparin, is effective for preventing venous thromboembolism (VTE) in nonsurgical patients with limited mobility due to acute illness, showing similar efficacy to unfractionated heparin but with the convenience of once-daily dosing.

Enoxaparin has a favorable tolerability profile, with lower incidences of local hematomas and increased liver enzymes compared to unfractionated heparin, making it a cost-effective option for short-term VTE prophylaxis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enoxaparin: a review of its use as thromboprophylaxis in acutely ill, nonsurgical patients. Siddiqui, MA., Wagstaff, AJ.[2018]

In critically ill trauma patients, particularly those with significant peripheral edema, the standard dose of enoxaparin (30 mg every 12 hours) resulted in significantly lower anti-Xa activity, indicating reduced efficacy in preventing venous thromboembolism (VTE).

The variability in anti-Xa activity was high, with many edematous patients showing barely quantifiable results, suggesting that the standard dosing may not be reliable for this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacokinetics and pharmacodynamics of enoxaparin in multiple trauma patients. Haas, CE., Nelsen, JL., Raghavendran, K., et al.[2019]

Recent clinical studies have shown that acutely ill medical patients are at a high risk for venous thromboembolism, a serious condition that can lead to blood clots.

Thromboprophylaxis using low molecular weight heparin, specifically enoxaparin, has been approved to effectively reduce this risk in bedridden patients due to acute illness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Thromboprophylaxis in medical patients. Hampton, KK.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6979442/

Safety and Efficacy of Enoxaparin in Pregnancy: A Systematic ... In terms of safety, enoxaparin was associated with a reduction in pregnancy loss in this analysis, which is an unexpected result, as a significant benefit of ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/31013386/

Effectiveness and safety of thromboprophylaxis with ... A single daily dose of 40 mg enoxaparin was used in 94.8% of pregnancies. Two breakthrough PA-VTEs occurred (1.2% [95% confidence interval, 0.32-4.14]).

3. sciencedirect.com sciencedirect.com/science/article/pii/S1538783622143564

Effectiveness and safety of thromboprophylaxis with ... A single daily dose of 40 mg enoxaparin was used in 94.8% of pregnancies. Two breakthrough PA‐VTEs occurred (1.2% [95% confidence interval, 0.32‐4.14]).

4. jamanetwork.com jamanetwork.com/journals/jama/fullarticle/2820391

A More Selective vs a Standard Risk-Stratified, Heparin ... A more selective protocol for postpartum enoxaparin was associated with decreased rates of wound hematomas without evidence of increased rates of postpartum ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2666572723000214

Anticoagulant prophylaxis in pregnant women with a ... The aim of this systematic review was to evaluate the risk of VTE recurrence during pregnancy for pregnant patients with prior personal history of VTE.