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

Preeclampsia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01068795
• Other study ID #: 0048-09-EMC ANTIXA-02
• Secondary ID: 0048-09-EMC
• Status: Completed
• Phase: N/A
• First received: January 20, 2010
• Last updated: February 20, 2016
• Start date: July 2009
• Est. completion date: August 2015

Study information

• Verified date: February 2016
• Source: HaEmek Medical Center, Israel
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: The Israel National Institute for Health Policy Research and Health Services Research
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 144
• Est. completion date: August 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Abruptio Placentae
• Fetal Death
• Fetal Demise
• Fetal Growth Restriction
• Fetal Growth Retardation
• Preeclampsia
• Thromboembolism

Intervention

Drug:
• enoxaparin
enoxaparin dosage will be adjusted according to anti-factor Xa plasma levels

Locations

Country	Name	City	State
Israel	Dep. OB/GYN, HaEmek Medical Center	Afula

Sponsors (1)

Lead Sponsor	Collaborator
HaEmek Medical Center, Israel

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	placental syndrome or thromboembolic event		9 months	No
Secondary	enoxaparin side effects		9 months	Yes