An interventional study of enoxaparin in Fetal Demise, Fetal Growth Restriction and Preeclampsia, sponsored by HaEmek Medical Center, Israel. Completed at 1 site in Israel. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2016-02-23.
Sponsored by HaEmek Medical Center, Israel · Not applicable, Interventional, and Prevention
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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.
33 studies on the registry are indexed under Fetal Death; 8 are open to participants now.
This study's enrollment of 144 is above the median of 95 across 14 interventional studies indexed under Fetal Death.
Browse Fetal Death studies →HaEmek Medical Center, Israel is the lead sponsor of 237 studies on the registry; 11 are open to participants now.
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WOMEN WITH
Exclusion Criteria:
enoxaparin dosage will be fixed during pregnancy
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
placental syndrome or thromboembolic event
Time frame: 9 months
enoxaparin side effects
Time frame: 9 months
The record gives a start of Jul 2009, a primary completion of Jan 2015 and a completion of Aug 2015. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Feb 2016. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Enoxaparin
HaEmek Medical Center, Israel →