Ignite Creation Date:
2025-12-24 @ 1:28 PM
Ignite Modification Date:
2025-12-28 @ 1:09 AM
Study NCT ID:
NCT01068795
Status:
COMPLETED
Last Update Posted:
2016-02-23
First Post:
2010-01-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dose Adjusting Enoxaparin Thromboprophylaxis Dosage According to Anti-factor Xa Plasma Levels Improve Pregnancy Outcome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005313', 'term': 'Fetal Death'}, {'id': 'D005317', 'term': 'Fetal Growth Retardation'}, {'id': 'D011225', 'term': 'Pre-Eclampsia'}, {'id': 'D000037', 'term': 'Abruptio Placentae'}, {'id': 'D013923', 'term': 'Thromboembolism'}], 'ancestors': [{'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D003643', 'term': 'Death'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D005315', 'term': 'Fetal Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D006130', 'term': 'Growth Disorders'}, {'id': 'D046110', 'term': 'Hypertension, Pregnancy-Induced'}, {'id': 'D007744', 'term': 'Obstetric Labor Complications'}, {'id': 'D010922', 'term': 'Placenta Diseases'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017984', 'term': 'Enoxaparin'}], 'ancestors': [{'id': 'D006495', 'term': 'Heparin, Low-Molecular-Weight'}, {'id': 'D006493', 'term': 'Heparin'}, {'id': 'D006025', 'term': 'Glycosaminoglycans'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 144}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'completionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-02-20', 'studyFirstSubmitDate': '2010-01-20', 'studyFirstSubmitQcDate': '2010-02-12', 'lastUpdatePostDateStruct': {'date': '2016-02-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-02-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'placental syndrome or thromboembolic event', 'timeFrame': '9 months'}], 'secondaryOutcomes': [{'measure': 'enoxaparin side effects', 'timeFrame': '9 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['placental syndrome', 'maternal thromboembolic event', 'enoxaparin', 'anti-factor Xa'], 'conditions': ['Fetal Demise', 'Fetal Growth Restriction', 'Preeclampsia', 'Abruptio Placentae', 'Thromboembolism']}, 'referencesModule': {'references': [{'pmid': '33779986', 'type': 'DERIVED', '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.'}, {'pmid': '27440463', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nPregnant 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.\n\nLow 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.\n\nPhysiologic 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".\n\nTwo 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.\n\nOur 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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nWOMEN WITH\n\n* Singleton gestation\n* A history of fetal demise, fetal growth restriction, placental abruption, preeclampsia, recurrent abortions or maternal thromboembolic event.\n* Acquired or congenital thrombophilia treated with low molecular weight heparin\n\nExclusion Criteria:\n\n* Women treated empirically with low molecular weight heparin\n* Women with a history of pregestational diabetes.\n* Significant polyhydramnios or oligohydramnios, major fetal structural, generic or chromosomal malformations'}, 'identificationModule': {'nctId': 'NCT01068795', 'briefTitle': 'Dose Adjusting Enoxaparin Thromboprophylaxis Dosage According to Anti-factor Xa Plasma Levels Improve Pregnancy Outcome', 'organization': {'class': 'OTHER', 'fullName': 'HaEmek Medical Center, Israel'}, 'officialTitle': 'Dose Adjusting Enoxaparin Thromboprophylaxis Dosage According to Anti-factor Xa Plasma Levels Improve Pregnancy Outcome', 'orgStudyIdInfo': {'id': '0048-09-EMC ANTIXA-02'}, 'secondaryIdInfos': [{'id': '0048-09-EMC'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'enoxaparin fixed', 'description': 'enoxaparin dosage will be fixed during pregnancy'}, {'type': 'EXPERIMENTAL', 'label': 'enoxaparin adjusted', 'description': 'enoxaparin dosage will be adjusted according to anti-factor Xa plasma levels', 'interventionNames': ['Drug: enoxaparin']}], 'interventions': [{'name': 'enoxaparin', 'type': 'DRUG', 'description': 'enoxaparin dosage will be adjusted according to anti-factor Xa plasma levels', 'armGroupLabels': ['enoxaparin adjusted']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Afula', 'country': 'Israel', 'facility': 'Dep. OB/GYN, HaEmek Medical Center', 'geoPoint': {'lat': 32.60907, 'lon': 35.2892}}], 'overallOfficials': [{'name': 'Raed Salim, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dep. OB/GYN, HaEmek Medical Center, Afula, Israel'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'HaEmek Medical Center, Israel', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Raed Salim', 'investigatorAffiliation': 'HaEmek Medical Center, Israel'}}}}