Acid-suppressing Drugs Pregnancy Asthma Offspring Study

Completed

• Conditions: Asthma in Offspring
• Interventions: Drug: Risk of asthma in offspring

• Registration Number: NCT01787435
• Lead Sponsor: AstraZeneca

Brief Summary

The purpose of this study is

1. To estimate the association between prenatal exposure to proton pump inhibitors (PPIs) and the risk of asthma during childhood.

2. To estimate the association between prenatal exposure to H2-receptor antagonists (H2RAs) and the risk of asthma during childhood.

Detailed Description

A cohort study on the association between acid-suppressing drugs in pregnancy and asthma in the offspring

Study Timeline

• Study Start: 2012-06
• Study First Submitted: 2013-02-06
• Study First Submitted QC: 2013-02-06
• Study First Posted: 2013-02-08
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-03
• Last Update Posted: 2015-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 10116

Inclusion Criteria

• Females aged 18-45 years with at least one pregnancy between 1 January 1995 - 31 December 2010 (see study population description)

Exclusion Criteria

• Males, females below age 18 and 45 years and above (see study population description)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
All women exposed to PPI at any time during pregnancy	Risk of asthma in offspring	Exposure to PPI defined as presence of at least one prescription of a PPI any time between last menstrual period and delievry date
All women exposed to H2RA at any time during pregnancy	Risk of asthma in offspring	Exposure to H2RA defined as presence of at least one prescription of H2RA any time between last menstrual period and delivery date

Primary Outcome Measures

Name	Time	Method
Relative risk of first asthma diagnosis associated with prenatal exposure to proton pump inhibitors	From 1 January 2005 till 31 December 2010, an expected average of 5 years.
Relative risk of first asthma diagnosis associated with prenatal exposure to histamine-2 receptor antagonists	From 1 January 2005 till 31 December 2010, an expected average of 5 years

Trial Locations

Locations (1)

Research Site; 🇪🇸 Madrid, Spain