Ignite Creation Date:
2025-12-25 @ 3:23 AM
Ignite Modification Date:
2026-01-12 @ 12:59 PM
Study NCT ID:
NCT01890005
Status:
UNKNOWN
Last Update Posted:
2013-07-01
First Post:
2013-06-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Low Dose Aspirin for the Prevention 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': 'D066087', 'term': 'Perinatal Death'}, {'id': 'D050497', 'term': 'Stillbirth'}, {'id': 'D000037', 'term': 'Abruptio Placentae'}], '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': 'D003643', 'term': 'Death'}, {'id': 'D005313', 'term': 'Fetal Death'}, {'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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 476}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2013-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-06', 'completionDateStruct': {'date': '2014-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-06-28', 'studyFirstSubmitDate': '2013-06-26', 'studyFirstSubmitQcDate': '2013-06-28', 'lastUpdatePostDateStruct': {'date': '2013-07-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-07-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevention of preeclampsia', 'timeFrame': '6 months', 'description': 'The number of cases of preeclampsia that appear in both groups before 34 weeks of pregnancy'}], 'secondaryOutcomes': [{'measure': 'Prevention of preeclampsia at term', 'timeFrame': '6 months', 'description': 'The number of cases of preeclampsia that appear in both groups between 37 and 41 weeks of pregnancy.'}, {'measure': 'Stillbirth', 'timeFrame': '6 months', 'description': 'The number of cases of stillbirths that appear in both groups at any given time during pregnancy.'}, {'measure': 'Neonatal deaths', 'timeFrame': '6 months', 'description': 'The number of cases of neonatal deaths that appear in both groups, regardless of the cause.'}, {'measure': 'Neonatal intensive care unit admissions.', 'timeFrame': '28 days', 'description': 'The number of cases that require admittance to the Neonatal Intensive Care Unit in both groups in the first 28 days after birth.'}, {'measure': 'Abruptio placenta', 'timeFrame': '6 months', 'description': 'The number of cases of abruptio placenta that appear in both groups at any given time during pregnancy.'}, {'measure': 'Fetal Growth Restriction', 'timeFrame': '6 months', 'description': 'The number of cases of fetal growth restriction, defined as a fetal weight below the 10th percentile and an abnormal umbilical cord doppler that appear in both groups at any given time during pregnancy.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Preeclampsia', 'Low dose aspirin', 'Fetal growth restriction', 'Neonatal death', 'Stillbirth', 'Abruptio placenta'], 'conditions': ['Preeclampsia']}, 'descriptionModule': {'briefSummary': 'Preeclampsia is one of the three leading causes of maternal morbidity and mortality all over the world. The use of low dose aspirin has been mentioned in several studies with promising results. The investigators decided to evaluate the use of low dose aspirin, starting between 13 and 16 weeks of pregnancy, based on clinical characteristics only to reduce the incidence of preeclampsia.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Gestational age between 13 and 16 weeks of pregnancy\n* High risk of preeclampsia, based in clinical risk factors as:\n\nPreeclampsia in a previous pregnancy Mother or sister that developed preeclampsia in a previous pregnancy Diabetes Mellitus (insulin dependant) Chronic Hypertension (with/without proteinuria) Body Mass Index \\> 32 Multiple pregnancy Lupus or other autoimmune disorder Chronic Renal Disease.\n\nExclusion Criteria:\n\n* Blood coagulation disorders of any kind\n* Peptic ulcers\n* Allergy to aspirin\n* Chronic use of anti-inflammatory drugs\n* Fetus with mayor anomalies'}, 'identificationModule': {'nctId': 'NCT01890005', 'briefTitle': 'Low Dose Aspirin for the Prevention of Preeclampsia', 'organization': {'class': 'OTHER', 'fullName': 'Saint Thomas Hospital, Panama'}, 'officialTitle': 'Low Dose Aspirin Between 13 and 16 Weeks of Pregnancy for the Prevention of Preeclampsia. Double Blind, Randomized, Controlled Trial.', 'orgStudyIdInfo': {'id': 'MHST2013-05'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Aspirin', 'description': 'Low dose aspirin (100 mg) starting between 13 and 16 weeks of pregnancy until 36 weeks of pregnancy, taken at night.', 'interventionNames': ['Drug: Aspirin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo (identical to low dose aspirin (100 mg)) starting between 13 and 16 weeks of pregnancy until 36 weeks of pregnancy, taken at night.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Aspirin', 'type': 'DRUG', 'description': 'Low dose aspirin (100 mg) starting between 13 and 16 weeks of pregnancy until 36 weeks of pregnancy, taken at night.', 'armGroupLabels': ['Aspirin']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo starting between 13 and 16 weeks of pregnancy until 36 weeks of pregnancy, taken at night.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Panama City', 'country': 'Panama', 'contacts': [{'name': 'Rodrigo Velarde, MD', 'role': 'CONTACT', 'email': 'revelarde_14@yahoo.es'}, {'name': 'Osvaldo Reyes, MD', 'role': 'CONTACT', 'email': 'oreyespanama@yahoo.es'}, {'name': 'Osvaldo Reyes, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Rodrigo Velarde, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Saint Thomas Maternity Hospital', 'geoPoint': {'lat': 8.9936, 'lon': -79.51973}}], 'centralContacts': [{'name': 'Rodrigo Velarde, MD', 'role': 'CONTACT', 'email': 'revelarde_14@yahoo.es'}, {'name': 'Osvaldo Reyes, MD', 'role': 'CONTACT', 'email': 'oreyespanama@yahoo.es'}], 'overallOfficials': [{'name': 'Osvaldo Reyes, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Saint Thomas Maternity Hospital'}, {'name': 'Rodrigo Velardee, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Saint Thomas Maternity Hospital'}, {'name': 'Ameth Hawkins, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Saint Thomas Maternity Hospital'}, {'name': 'Ana Moreno, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Saint Thomas Maternity Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Saint Thomas Hospital, Panama', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Coordinator of Research', 'investigatorFullName': 'Osvaldo A. Reyes T.', 'investigatorAffiliation': 'Saint Thomas Hospital, Panama'}}}}