Ignite Creation Date:
2025-12-25 @ 2:18 AM
Ignite Modification Date:
2026-01-07 @ 2:15 PM
Study NCT ID:
NCT01352234
Status:
COMPLETED
Last Update Posted:
2018-11-13
First Post:
2011-04-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Doses of Acetylsalicylic Acid in Women With Previous History of Preeclampsia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011225', 'term': 'Pre-Eclampsia'}, {'id': 'D005317', 'term': 'Fetal Growth Retardation'}, {'id': 'D047928', 'term': 'Premature Birth'}, {'id': 'D010927', 'term': 'Placental Insufficiency'}], 'ancestors': [{'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': 'D005315', 'term': 'Fetal Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D006130', 'term': 'Growth Disorders'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D007752', 'term': 'Obstetric Labor, Premature'}, {'id': 'D007744', 'term': 'Obstetric Labor Complications'}, {'id': 'D010922', 'term': 'Placenta Diseases'}]}, '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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 104}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-11-08', 'studyFirstSubmitDate': '2011-04-01', 'studyFirstSubmitQcDate': '2011-05-10', 'lastUpdatePostDateStruct': {'date': '2018-11-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-05-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Placental function', 'timeFrame': '22nd week of gestation', 'description': 'We chose a continuous intermediate variable focused on the aetiology, the placental function, assessed by Doppler ultrasound: the average pulsatility index of uterine arteries (UTAP - primary outcome) at 22 weeks of gestation'}], 'secondaryOutcomes': [{'measure': 'Rates of pregnancy complications related to placental insufficiency (preeclampsia, IUGR, premature birth)', 'timeFrame': 'At delivery', 'description': 'The effectiveness of treatment on the rate of preterm delivery, hypertensive disorders of pregnancy and IUGR will also be measured by reviewing medical records. All cases with a diagnosis of preterm labor, gestational hypertension or IUGR \\<10th percentile will be reviewed by a specialist in maternal fetal medicine at blindness for allocation.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Pre-Eclampsia', 'Fetal Growth Retardation', 'Premature Birth', 'Placental Insufficiency']}, 'descriptionModule': {'briefSummary': 'Placental insufficiency is the source of preeclampsia (PE) and intrauterine growth retardation (IUGR). Current data demonstrate a significant beneficial effect of prophylactic use of aspirin on the recurrence of placental insufficiency and its complications, mainly preeclampsia, when started early in pregnancy. However, there is a significant heterogeneity in medical practice in Canada and around the world in terms of the dose of aspirin used.\n\nThe objectives of this study are: 1) Evaluate whether a dose of 160 mg of aspirin is associated with greater improvement in placental function assessed by biochemistry (sFlt-1 and endoglin) and ultrasound (uterine artery Doppler) than a dose of 80 mg in women with a history of PE, 2) Assess whether the change is dependent on platelet aggregation measured by a test used in several Canadian centers (PFA-100).', 'detailedDescription': 'Many studies suggest that aspirin (acetylsalicylic acid) at low dose significantly reduces the incidence of preeclampsia. More recent data have shown that, when administered before 16 weeks of pregnancy, aspirin can prevent over 50% of preeclampsia, severe preeclampsia, and IUGR but also a significant proportion of the rate of preterm births. Current data also demonstrate a beneficial effect of prophylactic use of aspirin when started early in pregnancy in populations composed of high-risk patients with a history of preeclampsia and / or other pregnancy complications related to poor placental function.\n\nBeside, many clinicians are already using aspirin in the context of a proven benefit. However, the usual dose prescribed in Canada today is 80 mg while the most favorable studies have used a slightly higher dose of aspirin (100 mg).\n\nMoreover, it has been demonstrated that the time of day during which aspirin was administered was also a very important factor regarding the effect on blood pressure and adverse outcomes of the majority of pregnancy. Yet the majority of studies in this context have not specified the time of day at which aspirin was or had been taken, possibly underestimating the effect thereof.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Gestational age between 10 0 / 7 and 13 6 / 7 weeks\n* History of preeclampsia (as defined by The Society of Obstetricians and Gynaecologists of Canada) confirmed by medical records\n\nExclusion Criteria:\n\n* Negative Fetal Heart\n* Multiple pregnancy\n* Anaphylactic allergy to lactose\n* Kown coagulopathy (antithrombin III deficiency, factor V Leiden, antiphospholipid syndrome, the prothrombin mutation, deficiency of protein S or protein C)\n* Use of heparin or other anticoagulants.\n* Contraindications to aspirin\n* Severe fetal abnormality (cystic hygroma, nuchal translucency\\> 95th percentile, anencephaly, etc.)\n* History or active peptic ulcer'}, 'identificationModule': {'nctId': 'NCT01352234', 'briefTitle': 'Comparison of Doses of Acetylsalicylic Acid in Women With Previous History of Preeclampsia', 'organization': {'class': 'OTHER', 'fullName': 'CHU de Quebec-Universite Laval'}, 'officialTitle': 'Evaluation of Dose-response Effect of Acetylsalicylic Acid on Placental Development, Preterm Birth, Fetal Growth and Hypertension in Pregnancy in Women With Previous History of Preeclampsia', 'orgStudyIdInfo': {'id': 'C10-11-108'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A', 'description': 'Acetylsalicylic Acid 160mg administered at bedtime', 'interventionNames': ['Drug: Acetylsalicylic Acid 160 mg']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group B', 'description': 'Acetylsalicylic Acid 80mg administered at bedtime', 'interventionNames': ['Drug: Acetylsalicylic Acid 80 mg']}], 'interventions': [{'name': 'Acetylsalicylic Acid 160 mg', 'type': 'DRUG', 'otherNames': ['Asaphen', 'Aspirin', 'ASA'], 'description': 'Capsule containing Acetylsalicylic Acid 160mg pill with lactose', 'armGroupLabels': ['Group A']}, {'name': 'Acetylsalicylic Acid 80 mg', 'type': 'DRUG', 'otherNames': ['Asaphen', 'Aspirin', 'ASA'], 'description': 'Capsule containing Acetylsalicylic Acid 80mg pill with lactose', 'armGroupLabels': ['Group B']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'G1V 4G2', 'city': 'Québec', 'country': 'Canada', 'facility': 'Centre Hospitalier Universitaire de Québec (CHUQ)/Pavillon CHUL', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}], 'overallOfficials': [{'name': 'Emmanuel Bujold, MD, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU de Quebec-Universite Laval'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CHU de Quebec-Universite Laval', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}