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

This study is currently recruiting participants.
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

January 20, 2010
April 8, 2014
July 2009
September 2014   (final data collection date for primary outcome measure)
placental syndrome or thromboembolic event [ Time Frame: 9 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01068795 on ClinicalTrials.gov Archive Site
enoxaparin side effects [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Dose Adjusting Enoxaparin Thromboprophylaxis Dosage According to Anti-factor Xa Plasma Levels Improve Pregnancy Outcome
Dose Adjusting Enoxaparin Thromboprophylaxis Dosage According to Anti-factor Xa Plasma Levels Improve Pregnancy Outcome

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Fetal Demise
  • Fetal Growth Restriction
  • Preeclampsia
  • Abruptio Placentae
  • Thromboembolism
Drug: enoxaparin
enoxaparin dosage will be adjusted according to anti-factor Xa plasma levels
  • 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
    Intervention: Drug: enoxaparin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
144
December 2014
September 2014   (final data collection date for primary outcome measure)

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
Female
18 Years to 45 Years
No
Contact: Raed Salim, MD 97246494031 salim_ra@clalit.org.il
Israel
 
NCT01068795
0048-09-EMC ANTIXA-02, 0048-09-EMC
Yes
Raed Salim, HaEmek Medical Center, Israel
HaEmek Medical Center, Israel
Not Provided
Principal Investigator: Raed Salim, MD Dep. OB/GYN, HaEmek Medical Center, Afula, Israel
HaEmek Medical Center, Israel
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP