Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2026-01-08 @ 2:15 AM
Study NCT ID:
NCT06484634
Status:
COMPLETED
Last Update Posted:
2024-07-03
First Post:
2024-06-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Role of Low-Molecular-Weight Heparin in Unexplained Recurrent Pregnancy Loss
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 175}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2024-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-26', 'studyFirstSubmitDate': '2024-06-26', 'studyFirstSubmitQcDate': '2024-06-26', 'lastUpdatePostDateStruct': {'date': '2024-07-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy of Low-Molecular-Weight Heparin', 'timeFrame': '32 weeks', 'description': 'Efficacy was labeled as yes in terms of live births after the age of viability, i.e., 24 weeks of gestation.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pregnancy Loss']}, 'descriptionModule': {'briefSummary': 'Using low-molecular-weight heparin (LMWH), outcomes such as live birth rate and the occurrence of pregnancy complications are some of the variables reported in some studies, with varying degrees of success. The present study aimed to compare the role of LMWH in unexplained recurrent pregnancy loss.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '44 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pregnant females between 18 and 44 years of age\n* Gestational age above 8 weeks\n* A history of ≥3 consecutive first trimester pregnancy losses\n\nExclusion Criteria:\n\n* Patients with systemic lupus erythematosus\n* Positive IgG and IgM anticardiolipin antibodies\n* Positive for thrombophilia screening\n* Any platelet function abnormality or a previous thromboembolic event requiring anticoagulant therapy (including heparin, aspirin or warfarin)\n* Sensitive to acetylsalicylic acid, heparin, or warfarin\n* Patients with any genetic, anatomical, or hormonal cause of recurrent pregnancy loss'}, 'identificationModule': {'nctId': 'NCT06484634', 'briefTitle': 'Role of Low-Molecular-Weight Heparin in Unexplained Recurrent Pregnancy Loss', 'organization': {'class': 'OTHER', 'fullName': 'RESnTEC, Institute of Research'}, 'officialTitle': 'Role of Low-Molecular-Weight Heparin in Unexplained Recurrent Pregnancy Loss', 'orgStudyIdInfo': {'id': 'LMWHDGKHAN'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LMWH Group', 'description': 'Women received a daily dose of 40 mg of Low Molecular Weight Heparin subcutaneously.', 'interventionNames': ['Drug: Low molecular weight heparin']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Women received the placebo in the form of a multivitamin tablet.'}], 'interventions': [{'name': 'Low molecular weight heparin', 'type': 'DRUG', 'description': 'A daily dose of 40 mg of low-molecular-weight heparin (LMWH) subcutaneously was given to the patients.', 'armGroupLabels': ['LMWH Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32200', 'city': 'Dera Ghazi Khan', 'state': 'Punjab Province', 'country': 'Pakistan', 'facility': 'DG Khan Hospital', 'geoPoint': {'lat': 30.04587, 'lon': 70.64029}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Data can be shared with other researchers on a reasonable request'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'RESnTEC, Institute of Research', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}