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Acid-suppressing Drugs Pregnancy Asthma Offspring Study

A Cohort Study on the Association Between Acid-suppressing Drugs in Pregnancy and Asthma in the Offspring

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01787435
Enrollment
10116
Registered
2013-02-08
Start date
2012-06-30
Completion date
2014-12-31
Last updated
2015-04-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma in Offspring

Keywords

Asthma,, acid-suppressing drugs,, pregnancy,, epidemiology

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

Interventions

DRUGRisk of asthma in offspring

Exposure to PPI or H2RA, respectively during pregnancy No exposure to acid suppressing drugs during pregnancy

Sponsors

AstraZeneca
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frame
Relative risk of first asthma diagnosis associated with prenatal exposure to proton pump inhibitorsFrom 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 antagonistsFrom 1 January 2005 till 31 December 2010, an expected average of 5 years

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 15, 2026