Acid-suppressing Drugs Pregnancy Asthma Offspring Study

Study identifier:D9612N00018

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

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

Medical condition

Asthma in offspring

Phase

N/A

Healthy volunteers

Study drug

Risk of asthma in offspring

Sex

Female

Actual Enrollment

10116

Study type

Observational

Age

N/A

Date

Study Start Date: 01 Jun 2012

Primary Completion Date: 01 Dec 2014

Study Completion Date: 01 Dec 2014

Study design

Allocation: -
Endpoint Classification: -
Intervention Model: -
Masking: -
Primary Purpose: -

Verification:

Verified 01 Dec 2015 by AstraZeneca

Collaborators

Inclusion and exclusion criteria

Location

Research Site

Madrid, Spain

Arms	Assigned Interventions
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	Drug: Risk of asthma in offspring 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	Drug: Risk of asthma in offspring 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	-

"There is no result for the study"

Documents available

D9612N00018 Clinical Report Synopsis
Download
Redacted and IP approved protocol
Download
Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

information.center@astrazeneca.com

Contact Backup

Saga Johansson

+46 31 7761526

saga.johansson@astrazeneca.com

Investigators

Principal Investigator

Luis A Garcia Rodriguez

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