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

Autor: Megan Riley, Dimitra Lambrelli, Sophie Graham, Ouzama Henry, Andrea Sutherland, Alexander Schmidt, Nicola Sawalhi-Leckenby, Robert Donaldson, Sonia K. Stoszek
Jazyk: angličtina
Rok vydání: 2022
Předmět:
Zdroj: BMC Pregnancy and Childbirth, Vol 22, Iss 1, Pp 1-15 (2022)
Druh dokumentu: article
ISSN: 1471-2393
DOI: 10.1186/s12884-022-04769-x
Popis: 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 pregnancies (AP) represented in the CPRD Pregnancy Register linked to HES (AP cohort; N = 298 155), (2) all pregnancies with a gestational age (GA) ≥ 24 weeks (AP24+ cohort; N = 208 328), and (3) low-risk pregnancies (LR cohort; N = 137 932) with a GA ≥ 24 weeks and no diagnosis of predefined high-risk medical conditions until 24 weeks GA. Results Miscarriage was the most common adverse pregnancy outcome in the AP cohort (1 379.5 per 10 000 pregnancies) but could not be assessed in the other cohorts because these only included pregnancies with a GA ≥ 24 weeks, and miscarriages with GA ≥ 24 weeks were reclassified as stillbirths. Preterm delivery (
Databáze: Directory of Open Access Journals
Nepřihlášeným uživatelům se plný text nezobrazuje