Acid-suppressing Drugs Pregnancy Asthma Offspring Study

NCT ID: NCT01787435

Last Updated: 2015-04-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

10116 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-06-30

Study Completion Date

2014-12-31

Brief Summary

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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

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

Conditions

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Asthma in Offspring

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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

Risk of asthma in offspring

Intervention Type DRUG

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

Risk of asthma in offspring

Intervention Type DRUG

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

No interventions assigned to this group

Interventions

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Risk of asthma in offspring

Exposure to PPI or H2RA, respectively during pregnancy

No exposure to acid suppressing drugs during pregnancy

Intervention Type DRUG

Eligibility Criteria

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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)
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Luis A Garcia Rodriguez, MD

Role: PRINCIPAL_INVESTIGATOR

CEIFE (Centro Espanol de Investigacion Farmacoepidemiologica - Spanish Centre for Pharmacoepidemiologic Research )

Locations

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Research Site

Madrid, , Spain

Site Status

Countries

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Spain

Other Identifiers

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D9612N00018

Identifier Type: -

Identifier Source: org_study_id

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