Study type

Study topic

Disease /health condition
Human medicinal product

Study type

Non-interventional study

Scope of the study

Assessment of risk minimisation measure implementation or effectiveness

Data collection methods

Secondary use of data
Non-interventional study

Non-interventional study design

Cohort
Study drug and medical condition

Anatomical Therapeutic Chemical (ATC) code

(A02BA) H2-receptor antagonists
H2-receptor antagonists
(A02BC) Proton pump inhibitors
Proton pump inhibitors
Population studied

Short description of the study population

All women aged 18–45 years and with at least one pregnancy between 1 January 1995 and 31 December 2010 identified from THIN database 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.

Age groups

  • Adult and elderly population (≥18 years)
    • Adults (18 to < 65 years)
      • Adults (18 to < 46 years)

Special population of interest

Pregnant women

Estimated number of subjects

10116
Study design details

Main study objective

To estimate the association between prenatal exposure of acid suppressing drugs and the risk of asthma during childhood.

Outcomes

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

Data analysis plan

Among the matched infant cohorts, Cox proportional hazard models were used to estimate the hazard ratio (HR) and 95% confidence intervals (CIs) of developing asthma associated with maternal prenatal exposure to acid-suppressing drugs. For PPIs and H2RAs, exposure was assessed at any time during pregnancy and in each trimester of pregnancy. Different Cox regression models were used to adjust for various confounding factors.