Dose Adjusting Enoxaparin Thromboprophylaxis Dosage According to Anti-factor Xa Plasma Levels Improve Pregnancy Outcome
Primary Purpose
Fetal Demise, Fetal Growth Restriction, Preeclampsia
Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
enoxaparin
Sponsored by
About this trial
This is an interventional prevention trial for Fetal Demise focused on measuring placental syndrome, maternal thromboembolic event, enoxaparin, anti-factor Xa
Eligibility 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
Sites / Locations
- Dep. OB/GYN, HaEmek Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
enoxaparin fixed
enoxaparin adjusted
Arm Description
enoxaparin dosage will be fixed during pregnancy
enoxaparin dosage will be adjusted according to anti-factor Xa plasma levels
Outcomes
Primary Outcome Measures
placental syndrome or thromboembolic event
Secondary Outcome Measures
enoxaparin side effects
Full Information
NCT ID
NCT01068795
First Posted
January 20, 2010
Last Updated
February 20, 2016
Sponsor
HaEmek Medical Center, Israel
1. Study Identification
Unique Protocol Identification Number
NCT01068795
Brief Title
Dose Adjusting Enoxaparin Thromboprophylaxis Dosage According to Anti-factor Xa Plasma Levels Improve Pregnancy Outcome
Official Title
Dose Adjusting Enoxaparin Thromboprophylaxis Dosage According to Anti-factor Xa Plasma Levels Improve Pregnancy Outcome
Study Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
August 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
HaEmek Medical Center, Israel
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fetal Demise, Fetal Growth Restriction, Preeclampsia, Abruptio Placentae, Thromboembolism
Keywords
placental syndrome, maternal thromboembolic event, enoxaparin, anti-factor Xa
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
144 (Actual)
8. Arms, Groups, and Interventions
Arm Title
enoxaparin fixed
Arm Type
No Intervention
Arm Description
enoxaparin dosage will be fixed during pregnancy
Arm Title
enoxaparin adjusted
Arm Type
Experimental
Arm Description
enoxaparin dosage will be adjusted according to anti-factor Xa plasma levels
Intervention Type
Drug
Intervention Name(s)
enoxaparin
Intervention Description
enoxaparin dosage will be adjusted according to anti-factor Xa plasma levels
Primary Outcome Measure Information:
Title
placental syndrome or thromboembolic event
Time Frame
9 months
Secondary Outcome Measure Information:
Title
enoxaparin side effects
Time Frame
9 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raed Salim, MD
Organizational Affiliation
Dep. OB/GYN, HaEmek Medical Center, Afula, Israel
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dep. OB/GYN, HaEmek Medical Center
City
Afula
Country
Israel
12. IPD Sharing Statement
Citations:
PubMed Identifier
33779986
Citation
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.
Results Reference
derived
PubMed Identifier
27440463
Citation
Salim R, Nachum Z, Gavish I, Romano S, Braverman M, Garmi G. Adjusting enoxaparin dosage according to anti-FXa levels and pregnancy outcome in thrombophilic women. A randomised controlled trial. Thromb Haemost. 2016 Sep 27;116(4):687-95. doi: 10.1160/TH16-03-0221. Epub 2016 Jul 21.
Results Reference
derived
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Dose Adjusting Enoxaparin Thromboprophylaxis Dosage According to Anti-factor Xa Plasma Levels Improve Pregnancy Outcome
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