Ignite Creation Date:
2025-12-25 @ 2:10 AM
Ignite Modification Date:
2026-03-07 @ 10:56 PM
Study NCT ID:
NCT04153760
Status:
COMPLETED
Last Update Posted:
2023-09-13
First Post:
2019-11-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pilot PARTUM Trial: Postpartum Aspirin to Reduce Thromboembolism Undue Morbidity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Denmark'], 'submissionTracking': {'submissionInfos': [{'resetDate': '2025-12-23', 'releaseDate': '2025-12-08'}], 'estimatedResultsFirstSubmitDate': '2025-12-08'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D054556', 'term': 'Venous Thromboembolism'}, {'id': 'D020246', 'term': 'Venous Thrombosis'}, {'id': 'D011655', 'term': 'Pulmonary Embolism'}, {'id': 'D019851', 'term': 'Thrombophilia'}, {'id': 'D011225', 'term': 'Pre-Eclampsia'}, {'id': 'D006473', 'term': 'Postpartum Hemorrhage'}], 'ancestors': [{'id': 'D013923', 'term': 'Thromboembolism'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D013927', 'term': 'Thrombosis'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D004617', 'term': 'Embolism'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D046110', 'term': 'Hypertension, Pregnancy-Induced'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007744', 'term': 'Obstetric Labor Complications'}, {'id': 'D011644', 'term': 'Puerperal Disorders'}, {'id': 'D014592', 'term': 'Uterine Hemorrhage'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001241', 'term': 'Aspirin'}], 'ancestors': [{'id': 'D012459', 'term': 'Salicylates'}, {'id': 'D062385', 'term': 'Hydroxybenzoates'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 257}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-10-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2023-09-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-08', 'studyFirstSubmitDate': '2019-11-04', 'studyFirstSubmitQcDate': '2019-11-04', 'lastUpdatePostDateStruct': {'date': '2023-09-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recruitment Rate', 'timeFrame': '6 months', 'description': 'Mean recruitment rate per center per month'}], 'secondaryOutcomes': [{'measure': 'Consent Rate', 'timeFrame': '6 months', 'description': 'Proportion of eligible subjects who provide consent'}, {'measure': 'Withdrawals/Loss to Follow-up', 'timeFrame': '9 months', 'description': 'Proportion of withdrawals/loss to follow-up among participants'}, {'measure': 'Study Drug Compliance', 'timeFrame': '6 months', 'description': 'Level of compliance with study drug through participant recall and medication diary'}, {'measure': 'Time Required to Obtain Site Institutional Approvals', 'timeFrame': '24 months', 'description': 'Proportion of sites requiring \\>18 months to obtain all required approvals/contracts from time of delivery of all study documents.'}, {'measure': 'VTE Event Rate', 'timeFrame': '6 months', 'description': 'A more precise estimate of the VTE event rate'}, {'measure': 'Bleeding Event Rate', 'timeFrame': '6 months', 'description': 'A more precise estimate of the major and clinically relevant non-major bleeding event rate'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['deep vein thrombosis', 'pulmonary embolism', 'postpartum', 'pregnancy', 'thrombophilia', 'cesarean delivery', 'pre-eclampsia', 'postpartum hemorrhage'], 'conditions': ['Venous Thromboembolism', 'Postpartum Period', 'Aspirin']}, 'referencesModule': {'references': [{'pmid': '39827892', 'type': 'DERIVED', 'citation': 'Skeith L, Malinowski AK, El-Chaar D, Chan WS, Donnelly J, Chauleur C, Ganzevoort W, Wood S, Dubois S, McCarthy C, Buchmuller A, Wiegers H, Gibson PS, Ni Ainle F, Middeldorp S, Duffett L, Bates SM, Garven A, Baxter J, Lethebe BC, Rodger MA; Pilot PARTUM Group. Low-dose aspirin versus placebo in postpartum venous thromboembolism: a multi-national, pilot, randomised, placebo-controlled trial. Lancet Haematol. 2025 Feb;12(2):e109-e119. doi: 10.1016/S2352-3026(24)00338-7. Epub 2025 Jan 16.'}, {'pmid': '39238110', 'type': 'DERIVED', 'citation': 'Blondon M, Claver M, Celetta E, Righini M, de Tejada BM. Preventing Postpartum Venous Thromboembolism With Low-Molecular-Weight Heparin: The PP-HEP Pilot Randomised Controlled Trial. BJOG. 2025 Jan;132(1):35-43. doi: 10.1111/1471-0528.17943. Epub 2024 Sep 5.'}, {'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.'}]}, 'descriptionModule': {'briefSummary': 'The pilot PARTUM trial is a randomized, multicenter, placebo-controlled trial. Women who are at modest risk of VTE (as defined by the inclusion criteria) will be identified during pregnancy, labor and delivery and up to 48 hours postpartum. Eligible and consenting participants will be randomly assigned to one of two study arms: aspirin 81 mg daily or placebo daily for 6 weeks.', 'detailedDescription': 'The purpose of the pilot PARTUM trial is to determine whether it is feasible to conduct a larger randomized controlled trial to determine whether low-dose aspirin is efficacious and safe at preventing postpartum venous thromboembolism (VTE) in women at increased risk of VTE, compared to placebo.\n\nGiven the large sample size needed to adequately power a large multicenter trial that assesses the efficacy of aspirin 81 mg versus placebo, the investigators first need to determine if it is possible to recruit enough women. If the pilot trial is successful and there are no major changes to the study design, then the secondary clinical outcomes collected in the pilot trial will be used in the analysis of the full multicenter trial.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria: Study inclusion criteria includes one (or more) first order criterion or two (or more) second order criteria. A patient is still eligible if they have multiple criteria met, at the discretion of the local investigator.\n\nONE (or more) First Order Criteria:\n\n1. Known inherited thrombophilia diagnosed prior to enrolment:\n\n i) Heterozygous factor V Leiden, OR ii) Heterozygous prothrombin gene variant, OR iii) Protein C deficiency, OR iv) Protein S deficiency\n2. Immobilization (90% of waking hours spent in bed) for ≥7 days anytime during the antepartum period\n\nTWO (or more) Second Order Criteria:\n\n1. Postpartum infection\n2. Postpartum hemorrhage (\\>1000 mL of blood loss, regardless of delivery mode)\n3. Pre-pregnancy BMI ≥30 kg/m2\n4. Emergency or unplanned cesarean delivery\n5. Smoking ≥5 cigarettes/day before pregnancy\n6. Pre-eclampsia\n7. Current pregnancy ending in stillbirth (pregnancy loss \\>20 weeks gestation)\n8. Small-for-gestational-age infant (\\<3rd percentile adjusted for gestational age and sex).\n9. Previous history of superficial vein thrombosis\n\nExclusion Criteria:\n\n1. More than 48 hours since delivery\n2. Received more than 2 doses of low-molecular-weight heparin (LMWH) since delivery\n3. Need for postpartum LMWH prophylaxis or systemic anticoagulation as judged by the local investigator. May include but is not limited to:\n\n 1. Documented history of provoked or unprovoked VTE\n 2. Mechanical heart valve(s)\n 3. Known antiphospholipid syndrome\n 4. Known high-risk inherited thrombophilia i) Antithrombin deficiency; ii) Homozygous factor V Leiden; iii) Homozygous prothrombin gene mutation; iv) Compound heterozygosity factor V Leiden and prothrombin gene mutation; v) More than one inherited thrombophilia\n4. Need for postpartum aspirin as judged by the local investigator. May include but is not limited to:\n\n 1. Documented history of myocardial infarction\n 2. Documented history of ischemic stroke or transient ischemic attack (TIA)\n5. Contraindication to aspirin including:\n\n 1. History of known aspirin allergy\n 2. Documented history of a gastrointestinal ulcer\n 3. Known platelet count \\<50 x 109/L at any time during the current pregnancy or postpartum\n 4. Active bleeding at any site, excluding normal vaginal bleeding, at the time of randomization\n 5. Most recent known hemoglobin ≤70 g/L documented during the current pregnancy or postpartum\n 6. Known severe hypertension (SBP \\>200mm/hg and/or DBP \\>120mm/hg) during the current pregnancy or postpartum\n6. \\<18 years of age\n7. Unable or refused consent'}, 'identificationModule': {'nctId': 'NCT04153760', 'acronym': 'PARTUM', 'briefTitle': 'Pilot PARTUM Trial: Postpartum Aspirin to Reduce Thromboembolism Undue Morbidity', 'organization': {'class': 'OTHER', 'fullName': 'University of Calgary'}, 'officialTitle': 'A Pilot Study Assessing the Feasibility of a Randomized Controlled Trial Evaluating Aspirin in Postpartum Women at Risk of Developing Venous Thromboembolism', 'orgStudyIdInfo': {'id': 'REB19-1237'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Aspirin', 'description': 'Aspirin 81 mg daily for six weeks post-randomization (postpartum)', 'interventionNames': ['Drug: Aspirin 81 mg']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo daily for six weeks post-randomization (postpartum)', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Aspirin 81 mg', 'type': 'DRUG', 'otherNames': ['acetylsalicylic acid', 'ASA'], 'description': 'Aspirin 81 mg p.o. daily', 'armGroupLabels': ['Aspirin']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo p.o. daily', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'T2N 2T9', 'city': 'Calgary', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Foothills Medical Centre', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'zip': 'V6H 3N1', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': "British Columbia Women's Hospital & Health Centre", 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'zip': 'K1H 8L6', 'city': 'Ottawa', 'state': 'Ontario', 'country': 'Canada', 'facility': 'The Ottawa Hospital - General Campus', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}, {'zip': 'M5G 1Z5', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Mount Sinai Hospital', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': '42270', 'city': 'Saint-Étienne-de-Montluc', 'state': 'Pays de la Loire Region', 'country': 'France', 'facility': 'Centre Hospitalier Universitaire de Saint-Etienne', 'geoPoint': {'lat': 47.27622, 'lon': -1.78013}}, {'zip': 'D01 P5W9', 'city': 'Dublin', 'country': 'Ireland', 'facility': 'Rotunda Hospital', 'geoPoint': {'lat': 53.33306, 'lon': -6.24889}}, {'zip': '1105', 'city': 'Amsterdam', 'state': 'North Holland', 'country': 'Netherlands', 'facility': 'The Amsterdam Medical Centre', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}], 'overallOfficials': [{'name': 'Leslie Skeith, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Calgary'}, {'name': 'Marc Rodger, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'McGill University Health Centre/Research Institute of the McGill University Health Centre'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Calgary', 'class': 'OTHER'}, 'collaborators': [{'name': 'Canadian Institutes of Health Research (CIHR)', 'class': 'OTHER_GOV'}, {'name': 'Canadian Venous Thromboembolism Clinical Trials and Outcomes Research (CanVECTOR) Network', 'class': 'NETWORK'}], 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2025-12-08', 'type': 'RELEASE'}, {'date': '2025-12-23', 'type': 'RESET'}], 'unpostedResponsibleParty': 'University of Calgary'}}}}