Acid-suppressing Drugs Pregnancy Asthma Offspring Study

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.

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Key information

Conditions

Asthma in Offspring Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Sex eligibility

Female

Study type

Observational

Primary location

Research Site

Madrid, Spain

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Risk of asthma in offspring

Drug

Exposure to PPI or H2RA, respectively during pregnancy

No exposure to acid suppressing drugs during pregnancy

Primary outcomes

Relative risk of first asthma diagnosis associated with prenatal exposure to proton pump inhibitors

Time frame: 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

Time frame: From 1 January 2005 till 31 December 2010, an expected average of 5 years

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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

Important dates

Study start: 2012
Primary completion: 2014
Study completion: 2014
First posted: Feb 8, 2013
Registry last updated: Apr 6, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed