Prophylactic Enoxaparin Dosing for Prevention of Venous Thromboembolism in Pregnancy.

NCT00878826 | Completed Phase 2 Results

• 2 other identifiers: SU-03172009-200315957
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

Enoxaparin is a type of low molecular weight heparin (LMWH), or anticoagulant, used to prevent and treat blood clots. Formation of blood clots, or venous thromboemboli (VTE) in pregnancy can have dangerous and even life-threatening effects on the mother and fetus. Enoxaparin is the preferred medicine to prevent clotting in pregnant patients who are at risk for VTE, because it has been studied to be safe and effective in pregnancy without any harms to the fetus. Although this medication is routinely used and is recommended by several prominent medical groups, the optimal dosing for prevention of VTE is still unclear. The range of standardly prescribed dosing regimens of Enoxaparin includes 40mg daily and 1mg/kg daily, but these two dosing strategies have never been compared in a head to head fashion.

Conditions

Venous Thrombosis

Outcome Measures

Primary Outcomes (1)

• Peak Anti-Xa Level

  Goal peak anti-Xa level is 0.2 to 0.4 u/ml. We compared peak drug levels between different dosing arms.

  One measurement per trimester of pregnancy, up to 36 weeks

Secondary Outcomes (3)

• Thromboembolic Events

  Enrollment through 6 weeks postpartum

• Bleeding Events

  Enrollment through 6 weeks postpartum

• Side Effect - Bruising

  Enrollment through 6 weeks postpartum

Study Arms (3)

Enoxaparin 40 mg per day

ACTIVE COMPARATOR

Drug: Enoxaparin

Enoxaparin 1 mg per kg daily

ACTIVE COMPARATOR

Drug: Enoxaparin

Pre prescribed regimen of Enoxaparin

ACTIVE COMPARATOR

Current enoxaparin dose at time of first prenatal visit.

Drug: Enoxaparin

Interventions

Enoxaparin DRUG

Drug: Enoxaparin 40 mg every morning until 36 weeks gestation. Drug: Enoxaparin 1 mg per kg every morning until 36 weeks gestation. Dose will increase at wt. increases. Drug: Enoxaparin dose taken by patient when enrolled until 36 weeks gestation.

Enoxaparin 1 mg per kg daily; Enoxaparin 40 mg per day; Pre prescribed regimen of Enoxaparin

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \>18 years of age
• Warrants prophylaxis against venous thromboembolism in pregnancy according to American College of
• Obstetrics and Gynecology Practice Bulletin 2000, reaffirmed in 2008:
• history of idiopathic thrombosis
• history of thrombosis related to pregnancy or oral contraceptive use
• history of thrombosis accompanied by an underlying thrombophilia other than homozygous for the factor V Leiden mutation, heterozygous for both the factor V Leiden and the prothrombin G20210A mutation, or AT-III deficiency
• without a history of thrombosis but who have an underlying thrombophilia and a strong family history of thrombosis
• Known thrombophilia except for those listed above, with a history of adverse pregnancy outcome (APO) as defined by: ¡Ý3 pregnancy losses in the 1st trimester, ¡Ý2 pregnancy losses/stillbirth in 2nd trimester, ¡Ý1 pregnancy loss/intrauterine fetal demise (IUFD) in the 3rd trimester, intrauterine growth restriction (IUGR), abruptio placentae, or severe pre-Eclampsia prior to 34 weeks gestation.

You may not qualify if:

• Need for therapeutic-level anticoagulation as determined by physician
• Renal disease as defined by serum creatinine \>1.0
• Weight \>90kg
• Allergy to enoxaparin

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

Related Publications (1)

• Middleton P, Shepherd E, Gomersall JC. Venous thromboembolism prophylaxis for women at risk during pregnancy and the early postnatal period. Cochrane Database Syst Rev. 2021 Mar 29;3(3):CD001689. doi: 10.1002/14651858.CD001689.pub4.

  PMID: 33779986 DERIVED

MeSH Terms

Conditions

Venous Thrombosis

Interventions

Enoxaparin

Condition Hierarchy (Ancestors)

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Heparin, Low-Molecular-Weight; Heparin; Glycosaminoglycans; Polysaccharides; Carbohydrates

Limitations and Caveats

Small numbers of subjects

Results Point of Contact

• Title: Dr. Deirdre Lyell
• Organization: Stanford University

dlyell@stanford.edu

650-736-1191

Study Officials

• Deirdre Judith Lyell

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Obstetrics and Gynecology

Study Record Dates

• First Submitted: April 7, 2009
• First Posted: April 9, 2009
• Study Start: May 1, 2009
• Primary Completion: August 1, 2011
• Study Completion: October 1, 2014
• Last Updated: December 16, 2016
• Results First Posted: September 5, 2013

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)