Acid-suppressing Drugs Pregnancy Asthma Offspring Study
Study identifier:D9612N00018
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A cohort study on the association between acid-suppressing drugs in pregnancy and asthma in the offspring
Medical condition
Asthma in offspring
Phase
N/A
Healthy volunteers
No
Study drug
Risk of asthma in offspring
Sex
Female
Actual Enrollment
10116
Study type
Observational
Age
N/A
Date
Study Start Date: 01 Jun 2012
Primary Completion Date: 01 Dec 2014
Study Completion Date: 01 Dec 2014
Study design
Allocation: -
Endpoint Classification: -
Intervention Model: -
Masking: -
Primary Purpose: -
Verification:
Verified 01 Dec 2015 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| All women exposed to PPI at any time during pregnancy Exposure to PPI defined as presence of at least one prescription of a PPI any time between last menstrual period and delievry date | Drug: Risk of asthma in offspring Exposure to PPI or H2RA, respectively during pregnancy No exposure to acid suppressing drugs during pregnancy |
| All women exposed to H2RA at any time during pregnancy Exposure to H2RA defined as presence of at least one prescription of H2RA any time between last menstrual period and delivery date | Drug: Risk of asthma in offspring Exposure to PPI or H2RA, respectively during pregnancy No exposure to acid suppressing drugs during pregnancy |
| Pregnant women with no recorded use of acid suppressing drugs Pregnant women with no recorded use of acid suppressing drugs at any time during pregnancy | - |
Contacts
Investigators
Principal Investigator
Luis A Garcia Rodriguez
CEIFE (Centro Espanol de Investigacion Farmacoepidemiologica - Spanish Centre for Pharmacoepidemiologic Research )
