Ignite Creation Date:
2025-12-24 @ 10:14 PM
Ignite Modification Date:
2026-01-02 @ 6:15 PM
Study NCT ID:
NCT01787435
Status:
COMPLETED
Last Update Posted:
2015-04-06
First Post:
2013-02-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Acid-suppressing Drugs Pregnancy Asthma Offspring Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001249', 'term': 'Asthma'}], 'ancestors': [{'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10116}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-04-03', 'studyFirstSubmitDate': '2013-02-06', 'studyFirstSubmitQcDate': '2013-02-06', 'lastUpdatePostDateStruct': {'date': '2015-04-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-02-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Relative risk of first asthma diagnosis associated with prenatal exposure to proton pump inhibitors', 'timeFrame': 'From 1 January 2005 till 31 December 2010, an expected average of 5 years.'}, {'measure': 'Relative risk of first asthma diagnosis associated with prenatal exposure to histamine-2 receptor antagonists', 'timeFrame': 'From 1 January 2005 till 31 December 2010, an expected average of 5 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Asthma,', 'acid-suppressing drugs,', 'pregnancy,', 'epidemiology'], 'conditions': ['Asthma in Offspring']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is\n\n1. To estimate the association between prenatal exposure to proton pump inhibitors (PPIs) and the risk of asthma during childhood.\n2. To estimate the association between prenatal exposure to H2-receptor antagonists (H2RAs) and the risk of asthma during childhood.', 'detailedDescription': 'A cohort study on the association between acid-suppressing drugs in pregnancy and asthma in the offspring'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All women aged 18-45 years and with at least one pregnancy between 1 January 1995 and 31 December 2010 who have been enrolled with their PCP (Primary Care Physician) for at least 1 year and have had a health contact in the year prior to the last menstrual period (LMP) of the respective pregnancy. The final study population will include pregnancies that can be unequivocally linked with live birth(s) and only the first pregnancy ascertained during the study period for each woman will be retained', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Females aged 18-45 years with at least one pregnancy between 1 January 1995 - 31 December 2010 (see study population description)\n\nExclusion Criteria:\n\n\\- Males, females below age 18 and 45 years and above (see study population description)'}, 'identificationModule': {'nctId': 'NCT01787435', 'briefTitle': 'Acid-suppressing Drugs Pregnancy Asthma Offspring Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Cohort Study on the Association Between Acid-suppressing Drugs in Pregnancy and Asthma in the Offspring', 'orgStudyIdInfo': {'id': 'D9612N00018'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'All women exposed to PPI at any time during pregnancy', 'description': 'Exposure to PPI defined as presence of at least one prescription of a PPI any time between last menstrual period and delievry date', 'interventionNames': ['Drug: Risk of asthma in offspring']}, {'label': 'All women exposed to H2RA at any time during pregnancy', 'description': 'Exposure to H2RA defined as presence of at least one prescription of H2RA any time between last menstrual period and delivery date', 'interventionNames': ['Drug: Risk of asthma in offspring']}, {'label': 'Pregnant women with no recorded use of acid suppressing drugs', 'description': 'Pregnant women with no recorded use of acid suppressing drugs at any time during pregnancy'}], 'interventions': [{'name': 'Risk of asthma in offspring', 'type': 'DRUG', 'description': 'Exposure to PPI or H2RA, respectively during pregnancy\n\nNo exposure to acid suppressing drugs during pregnancy', 'armGroupLabels': ['All women exposed to H2RA at any time during pregnancy', 'All women exposed to PPI at any time during pregnancy']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Madrid', 'country': 'Spain', 'facility': 'Research Site', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}], 'overallOfficials': [{'name': 'Luis A Garcia Rodriguez, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CEIFE (Centro Espanol de Investigacion Farmacoepidemiologica - Spanish Centre for Pharmacoepidemiologic Research )'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}