Facilitating safety evaluation in maternal immunization trials: a retrospective cohort study to assess pregnancy outcomes and events of interest in low-risk pregnancies in England.

ABSTRACT:

Background

Maternal characteristics like medical history and health-related risk factors can influence the incidence of pregnancy outcomes and pregnancy-related events of interest (EIs). Data on the incidence of these endpoints in low-risk pregnant women are needed for appropriate external safety comparisons in maternal immunization trials. To address this need, this study estimated the incidence proportions of pregnancy outcomes and pregnancy-related EIs in different pregnancy cohorts (including low-risk pregnancies) in England, contained in the Clinical Practice Research Datalink (CPRD) Pregnancy Register linked to Hospital Episode Statistics (HES) between 2005 and 2017.

Methods

The incidence proportions of 7 pregnancy outcomes and 15 EIs were calculated for: (1) all pregn

SUBMITTER: Riley M 

PROVIDER: S-EPMC9157029 | biostudies-literature | 2022 Jun

REPOSITORIES: biostudies-literature