Dose Adjusting Enoxaparin Thromboprophylaxis Dosage According to Anti-factor Xa Plasma Levels Improve Pregnancy Outcome

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2013 by HaEmek Medical Center, Israel
Sponsor:
Information provided by (Responsible Party):
Raed Salim, HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier:
NCT01068795
First received: January 20, 2010
Last updated: April 8, 2014
Last verified: March 2013
  Purpose

The risk of venous thromboembolism increases in pregnancy. Thrombophilia whether genetic or acquired, is a hypercoagulable disorder that may increase the risk of venous thromboembolic events. Clinically, these events are presented as maternal deep vein thrombosis and pulmonary emboli. Thrombophilias are also associated with adverse fetal outcomes including intrauterine growth restriction, intrauterine fetal death, severe preeclampsia, placental abruption and recurrent abortions.

Pregnant women who experienced one or more of the above complications are advised to be examined for the presence of the genetic or the acquired form of thrombophilia.

Low molecular weight heparin prophylaxis, an anticoagulant, is advised for pregnant women with a history of thromboembolism, and many experts recommend prophylaxis for pregnant patients with a known thrombophilia and history of adverse pregnancy outcomes associated with these hypercoagulable states.

Physiologic changes in normal pregnancy, including weight gain, increased renal clearance and volume of distribution, may decrease the availability of low molecular weight heparin (Enoxaparin or Dalteparin), or produce a less predictable response in pregnant women compared with nonpregnant women. There are no clear recommendations for use of prophylactic low molecular weight heparin in pregnancy. Clinicians tend to use doses suggested for nonpregnant patients. Regarding pregnant patients taking enoxaparin or dalteparin, the American College of Obstetricians and Gynecologists states that "because of the lack of data regarding adequate dosing during pregnancy, anti-factor Xa levels may be monitored".

Two recently published studies demonstrated that plasma anti-factor Xa levels during pregnancy were lower than expected, indicating that many pregnant patients may receive a subprophylactic dosing.

Our objective is to check pregnancy outcome among thrombophilic women treated with an adjusted enoxaparin thromboprophylaxis dosage according to anti-factor Xa plasma levels compared to women with fixed dosage.


Condition Intervention
Fetal Demise
Fetal Growth Restriction
Preeclampsia
Abruptio Placentae
Thromboembolism
Drug: enoxaparin

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Dose Adjusting Enoxaparin Thromboprophylaxis Dosage According to Anti-factor Xa Plasma Levels Improve Pregnancy Outcome

Resource links provided by NLM:


Further study details as provided by HaEmek Medical Center, Israel:

Primary Outcome Measures:
  • placental syndrome or thromboembolic event [ Time Frame: 9 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • enoxaparin side effects [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 144
Study Start Date: July 2009
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: enoxaparin fixed
enoxaparin dosage will be fixed during pregnancy
Experimental: enoxaparin adjusted
enoxaparin dosage will be adjusted according to anti-factor Xa plasma levels
Drug: enoxaparin
enoxaparin dosage will be adjusted according to anti-factor Xa plasma levels

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

WOMEN WITH

  • Singleton gestation
  • A history of fetal demise, fetal growth restriction, placental abruption, preeclampsia, recurrent abortions or maternal thromboembolic event.
  • Acquired or congenital thrombophilia treated with low molecular weight heparin

Exclusion Criteria:

  • Women treated empirically with low molecular weight heparin
  • Women with a history of pregestational diabetes.
  • Significant polyhydramnios or oligohydramnios, major fetal structural, generic or chromosomal malformations
  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: NCT01068795

Contacts
Contact: Raed Salim, MD 97246494031 salim_ra@clalit.org.il

Locations
Israel
Dep. OB/GYN, HaEmek Medical Center Recruiting
Afula, Israel
Contact: Raed Salim, MD       salim_ra@clalit.org.il   
Principal Investigator: Raed Salim, MD         
Sponsors and Collaborators
HaEmek Medical Center, Israel
Investigators
Principal Investigator: Raed Salim, MD Dep. OB/GYN, HaEmek Medical Center, Afula, Israel
  More Information

No publications provided

Responsible Party: Raed Salim, MD, HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier: NCT01068795     History of Changes
Other Study ID Numbers: 0048-09-EMC ANTIXA-02, 0048-09-EMC
Study First Received: January 20, 2010
Last Updated: April 8, 2014
Health Authority: Israel: The Israel National Institute for Health Policy Research and Health Services Research

Keywords provided by HaEmek Medical Center, Israel:
placental syndrome
maternal thromboembolic event
enoxaparin
anti-factor Xa

Additional relevant MeSH terms:
Abruptio Placentae
Fetal Growth Retardation
Pre-Eclampsia
Thromboembolism
Obstetric Labor Complications
Pregnancy Complications
Placenta Diseases
Fetal Diseases
Growth Disorders
Pathologic Processes
Hypertension, Pregnancy-Induced
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Thrombosis
Enoxaparin
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on July 22, 2014