Ignite Creation Date:
2025-12-24 @ 2:22 PM
Ignite Modification Date:
2026-02-20 @ 6:20 PM
Study NCT ID:
NCT02856295
Status:
COMPLETED
Last Update Posted:
2022-11-15
First Post:
2016-07-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
anti10a Levels in Women Treated With LMWH in the Postpartum Period
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054556', 'term': 'Venous Thromboembolism'}], 'ancestors': [{'id': 'D013923', 'term': 'Thromboembolism'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017984', 'term': 'Enoxaparin'}, {'id': 'D006495', 'term': 'Heparin, Low-Molecular-Weight'}], 'ancestors': [{'id': 'D006493', 'term': 'Heparin'}, {'id': 'D006025', 'term': 'Glycosaminoglycans'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 136}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-11-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2022-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-11-10', 'studyFirstSubmitDate': '2016-07-13', 'studyFirstSubmitQcDate': '2016-08-03', 'lastUpdatePostDateStruct': {'date': '2022-11-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-08-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-08-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'clexane dosing method in order to achieve anti 10a level >0.2', 'timeFrame': '4 hour after the women receive the drug'}], 'secondaryOutcomes': [{'measure': 'incidence of anti 10a level of >0.6', 'timeFrame': '4 hour after the women receive the drug'}, {'measure': 'incidence of vein thromboembolism', 'timeFrame': 'during the six weeks after delivery'}, {'measure': 'incidence of bleeding events', 'timeFrame': 'during the six weeks after delivery'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['postpartum venous thromboembolism', 'prophylactic dose of low molecular weight heparin', 'anti 10a'], 'conditions': ['Venous Thromboembolism']}, 'referencesModule': {'references': [{'pmid': '12763484', 'type': 'RESULT', 'citation': 'Bremme KA. Haemostatic changes in pregnancy. Best Pract Res Clin Haematol. 2003 Jun;16(2):153-68. doi: 10.1016/s1521-6926(03)00021-5.'}, {'pmid': '12709915', 'type': 'RESULT', 'citation': 'Hellgren M. Hemostasis during normal pregnancy and puerperium. Semin Thromb Hemost. 2003 Apr;29(2):125-30. doi: 10.1055/s-2003-38897.'}, {'pmid': '21860314', 'type': 'RESULT', 'citation': 'Practice bulletin no. 124: inherited thrombophilias in pregnancy. Obstet Gynecol. 2011 Sep;118(3):730-740. doi: 10.1097/AOG.0b013e3182310c6f.'}, {'pmid': '18572147', 'type': 'RESULT', 'citation': 'Scifres CM, Macones GA. The utility of thrombophilia testing in pregnant women with thrombosis: fact or fiction? Am J Obstet Gynecol. 2008 Oct;199(4):344.e1-7. doi: 10.1016/j.ajog.2008.04.051. Epub 2008 Jun 24.'}, {'pmid': '10546719', 'type': 'RESULT', 'citation': 'Gherman RB, Goodwin TM, Leung B, Byrne JD, Hethumumi R, Montoro M. Incidence, clinical characteristics, and timing of objectively diagnosed venous thromboembolism during pregnancy. Obstet Gynecol. 1999 Nov;94(5 Pt 1):730-4. doi: 10.1016/s0029-7844(99)00426-3.'}, {'pmid': '12825542', 'type': 'RESULT', 'citation': 'Chang J, Elam-Evans LD, Berg CJ, Herndon J, Flowers L, Seed KA, Syverson CJ. Pregnancy-related mortality surveillance--United States, 1991--1999. MMWR Surveill Summ. 2003 Feb 21;52(2):1-8.'}, {'pmid': '16287790', 'type': 'RESULT', 'citation': 'Heit JA, Kobbervig CE, James AH, Petterson TM, Bailey KR, Melton LJ 3rd. Trends in the incidence of venous thromboembolism during pregnancy or postpartum: a 30-year population-based study. Ann Intern Med. 2005 Nov 15;143(10):697-706. doi: 10.7326/0003-4819-143-10-200511150-00006.'}, {'pmid': '18248600', 'type': 'RESULT', 'citation': 'Pomp ER, Lenselink AM, Rosendaal FR, Doggen CJ. Pregnancy, the postpartum period and prothrombotic defects: risk of venous thrombosis in the MEGA study. J Thromb Haemost. 2008 Apr;6(4):632-7. doi: 10.1111/j.1538-7836.2008.02921.x. Epub 2008 Jan 31.'}, {'pmid': '10453824', 'type': 'RESULT', 'citation': 'McColl MD, Walker ID, Greer IA. The role of inherited thrombophilia in venous thromboembolism associated with pregnancy. Br J Obstet Gynaecol. 1999 Aug;106(8):756-66. doi: 10.1111/j.1471-0528.1999.tb08395.x.'}, {'pmid': '22315276', 'type': 'RESULT', 'citation': 'Bates SM, Greer IA, Middeldorp S, Veenstra DL, Prabulos AM, Vandvik PO. VTE, thrombophilia, antithrombotic therapy, and pregnancy: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest. 2012 Feb;141(2 Suppl):e691S-e736S. doi: 10.1378/chest.11-2300.'}, {'pmid': '12387283', 'type': 'RESULT', 'citation': 'American College of Obstetricians and Gynecologists. ACOG Committee Opinion: safety of Lovenox in pregnancy. Obstet Gynecol. 2002 Oct;100(4):845-6.'}, {'pmid': '24519568', 'type': 'RESULT', 'citation': 'Bain E, Wilson A, Tooher R, Gates S, Davis LJ, Middleton P. Prophylaxis for venous thromboembolic disease in pregnancy and the early postnatal period. Cochrane Database Syst Rev. 2014 Feb 11;(2):CD001689. doi: 10.1002/14651858.CD001689.pub3.'}, {'pmid': '15383488', 'type': 'RESULT', 'citation': 'Bates SM, Greer IA, Hirsh J, Ginsberg JS. Use of antithrombotic agents during pregnancy: the Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy. Chest. 2004 Sep;126(3 Suppl):627S-644S. doi: 10.1378/chest.126.3_suppl.627S.'}, {'pmid': '21923455', 'type': 'RESULT', 'citation': 'Shapiro NL, Kominiarek MA, Nutescu EA, Chevalier AB, Hibbard JU. Dosing and monitoring of low-molecular-weight heparin in high-risk pregnancy: single-center experience. Pharmacotherapy. 2011 Jul;31(7):678-85. doi: 10.1592/phco.31.7.678.'}, {'pmid': '18827132', 'type': 'RESULT', 'citation': 'Fox NS, Laughon SK, Bender SD, Saltzman DH, Rebarber A. Anti-factor Xa plasma levels in pregnant women receiving low molecular weight heparin thromboprophylaxis. Obstet Gynecol. 2008 Oct;112(4):884-9. doi: 10.1097/AOG.0b013e31818638dc.'}, {'pmid': '37156466', 'type': 'DERIVED', 'citation': 'Haj R, Massalha M, Eitam H, Kassabri R, Yefet E, Nachum Z. Comparison of postpartum anti-Xa levels following enoxaparin administration to prevent venous thromboembolism using 2 weight-based protocols: a randomized controlled trial. Am J Obstet Gynecol MFM. 2023 Aug;5(8):100988. doi: 10.1016/j.ajogmf.2023.100988. Epub 2023 May 6.'}]}, 'descriptionModule': {'briefSummary': "The aim of this study is to compare between anti-10a levels in postpartum women receiving different prophylactic doses of LMWH: one group with LMWH doses adjusted by the women's weight and the second group receiving 1mg/kg to a maximum dose of 120 mg", 'detailedDescription': 'pregnancy and postpartum period are associated with increased risk of thromboembolism. this risk is further increased in women with thrombophilia.\n\nThis risk is higher in the postpartum period compared with pregnancy period, especially the risk for pulmonary embolism (PE). The American College Of Obstetrics and Gynecologists, The American college of chest physicians and The Royal College of obstetricians and gynecologists recommend using low molecular weight heparin during the postpartum period in women with thrombophilia and women with risk factor for developing thromboembolism. there is no specific guidelines regarding the best protocol based on the level of anti-10 a.\n\nThis study will compare between two protocols based on anti-10a levels.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* postpartum women supposed to receive LMWH according to obstetric indications\n\nExclusion Criteria:\n\n* known allergy to clexane\n* active bleeding postpartum\n* thrombocytopenia \\< 75000\n* recent cerebrovascular accident / transient ischemic attack (\\<4 weeks)\n* glomerular filtration rate) \\< 30 ml/min)\n* active liver disease\n* malignant hypertension (systolic \\> 200 mmHg, diastolic\\> 120 mmHg)'}, 'identificationModule': {'nctId': 'NCT02856295', 'briefTitle': 'anti10a Levels in Women Treated With LMWH in the Postpartum Period', 'organization': {'class': 'OTHER', 'fullName': 'HaEmek Medical Center, Israel'}, 'officialTitle': 'anti10a Levels in Women Treated With LMWH in the Postpartum Period for Preventing Vein Thrombosis Events: A Comparison of Two Doses', 'orgStudyIdInfo': {'id': 'EMC59-12'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'clexane according to weight group', 'description': "clexane dose adjusted for woman's weight according to: weight \\< 90 kg - 40mg, 91-130kg - 60 mg, 131-170kg - 80mg, \\>170kg-100mg.", 'interventionNames': ['Drug: clexane (LMWH)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'clexane mg per kg', 'description': 'clexane dose of 1mg/kg up to 120 mg', 'interventionNames': ['Drug: clexane (LMWH)']}], 'interventions': [{'name': 'clexane (LMWH)', 'type': 'DRUG', 'description': 'to compare tow doses of clexane for preventing VTE in postpartum women', 'armGroupLabels': ['clexane according to weight group', 'clexane mg per kg']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Afula', 'country': 'Israel', 'facility': 'Emek medical center', 'geoPoint': {'lat': 32.60907, 'lon': 35.2892}}], 'overallOfficials': [{'name': 'Zohar Nachum, M.D', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Emek Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'HaEmek Medical Center, Israel', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Zohar Nachum', 'investigatorAffiliation': 'HaEmek Medical Center, Israel'}}}}