Acid-suppressing Drugs Pregnancy Asthma Offspring Study
3. april 2015 opdateret af: AstraZeneca
A Cohort Study on the Association Between Acid-suppressing Drugs in Pregnancy and Asthma in the Offspring
The purpose of this study is
- 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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
A cohort study on the association between acid-suppressing drugs in pregnancy and asthma in the offspring
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
10116
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
-
Madrid, Spanien
- Research Site
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Kvinde
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
All women aged 18-45 years and with at least one pregnancy between 1 January 1995 and 31 December 2010 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.
The final study population will include pregnancies that can be unequivocally linked with live birth(s) and only the first pregnancy ascertained during the study period for each woman will be retained
Beskrivelse
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)
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
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
|
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
|
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
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Relative risk of first asthma diagnosis associated with prenatal exposure to proton pump inhibitors
Tidsramme: From 1 January 2005 till 31 December 2010, an expected average of 5 years.
|
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
Tidsramme: From 1 January 2005 till 31 December 2010, an expected average of 5 years
|
From 1 January 2005 till 31 December 2010, an expected average of 5 years
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. juni 2012
Primær færdiggørelse (Faktiske)
1. december 2014
Studieafslutning (Faktiske)
1. december 2014
Datoer for studieregistrering
Først indsendt
6. februar 2013
Først indsendt, der opfyldte QC-kriterier
6. februar 2013
Først opslået (Skøn)
8. februar 2013
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
6. april 2015
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
3. april 2015
Sidst verificeret
1. april 2015
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- D9612N00018
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .