Ignite Creation Date:
2025-12-24 @ 7:24 PM
Ignite Modification Date:
2025-12-29 @ 2:09 PM
Study NCT ID:
NCT04861103
Status:
RECRUITING
Last Update Posted:
2025-10-29
First Post:
2021-04-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Anticoagulation Profile in Pregnant Women Treated With Three Times a Day of Low Molecular Weight Heparin (LMWH)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 12}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2027-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-27', 'studyFirstSubmitDate': '2021-04-22', 'studyFirstSubmitQcDate': '2021-04-22', 'lastUpdatePostDateStruct': {'date': '2025-10-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2021-04-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Factor Xa levels', 'timeFrame': '4 hours after injection'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pregnancy, High Risk', 'Anticoagulants']}, 'descriptionModule': {'briefSummary': "Pregnancy is associated with a increased risk of developing blood clots. There is nearly a 5 times greater risk of developing a blood clot in pregnancy. Lovenox is a medication that helps to prevent the body from developing clots. It is safe to use in pregnancy. Previous studies have demonstrated that despite recommendation of Lovenox, to prevent blood clots, the majority of patient's (70 to 90%) did not receive adequate levels of Lovenox at times throughout the day, which likely increases the risk of developing clots. The increase in blood volume and increase in kidney function that occurs in pregnancy may contribute to the inadequate levels. Currently the recommendation for pregnant and nonpregnant patients requiring Lovenox, is to calculate the daily dose of Lovenox and split the dose, giving half in the morning and the other half in the evening. This research study proposes that due to changes in the body during pregnancy that the daily Lovenox dosing be split into three times a day to achieve more consistent levels of Lovenox than twice a day in pregnant women."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Nulliparous or multiparous women with single intrauterine pregnancies who require therapeutic low molecular weight heparin during their pregnancy.\n* Participants must be age 18 or older.\n\nExclusion Criteria:\n\n* Women with multiples.\n* Women less than age 18\n* History of Heparin Induced Thrombocytopenia (HIT)\n* Allergy to enoxaparin'}, 'identificationModule': {'nctId': 'NCT04861103', 'briefTitle': 'Anticoagulation Profile in Pregnant Women Treated With Three Times a Day of Low Molecular Weight Heparin (LMWH)', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Irvine'}, 'officialTitle': 'Anticoagulation Profile in Pregnant Women Treated With Three Times a Day of Low Molecular Weight Heparin (LMWH)', 'orgStudyIdInfo': {'id': '20195544'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Factor Xa levels in pregnant women with therapeutic Lovenox divided into three times a day dosing', 'description': 'Therapeutic Lovenox dosing split into three times a day dosing for 5 day. Xa levels a measured.', 'interventionNames': ['Drug: Lovenox']}], 'interventions': [{'name': 'Lovenox', 'type': 'DRUG', 'description': 'Three times a day dosing and measuring Xa peak and trough levels', 'armGroupLabels': ['Factor Xa levels in pregnant women with therapeutic Lovenox divided into three times a day dosing']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92868', 'city': 'Orange', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Lizette Spears', 'role': 'CONTACT', 'email': 'lspiers@hs.uci.edu', 'phone': '714.456.5694'}, {'name': 'Phuong Linh L Huynh', 'role': 'CONTACT', 'email': 'plhuynh@hs.uci.edu', 'phone': '714.456.6155'}], 'facility': 'University of California Irvine', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}], 'centralContacts': [{'name': 'Lizette Spears', 'role': 'CONTACT', 'email': 'lspiers@hs.uci.edu', 'phone': '714.456.5694'}], 'overallOfficials': [{'name': 'Afshan Hameed', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, Irvine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Irvine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Maternal Fetal Medicine Physician', 'investigatorFullName': 'Afshan B. Hameed, M.D.', 'investigatorAffiliation': 'University of California, Irvine'}}}}