TY - JOUR
T1 - Consortium for the Study of Pregnancy Treatments (Co-OPT)
T2 - An international birth cohort to study the effects of antenatal corticosteroids
AU - Frier, Emily M
AU - Lin, Chun
AU - Reynolds, Rebecca M
AU - Allegaert, Karel
AU - Been, Jasper V
AU - Fraser, Abigail
AU - Gissler, Mika
AU - Einarsdóttir, Kristjana
AU - Florian, Lani
AU - Jacobsson, Bo
AU - Vogel, Joshua P
AU - Zoega, Helga
AU - Bhattacharya, Sohinee
AU - Krispin, Eyal
AU - Henning Pedersen, Lars
AU - Roberts, Devender
AU - Kuhle, Stefan
AU - Fahey, John
AU - Mol, Ben W
AU - Burgner, David
AU - Schuit, Ewoud
AU - Sheikh, Aziz
AU - Wood, Rachael
AU - Gyamfi-Bannerman, Cynthia
AU - Miller, Jessica E
AU - Duhig, Kate
AU - Lahti-Pulkkinen, Marius
AU - Hadar, Eran
AU - Wright, John
AU - Murray, Sarah R
AU - Stock, Sarah J
N1 - Funding Information:
The Co-OPT ACS study is funded through a Wellcome Trust Clinical Career Development Fellowship grant (Funding Reference number 209560/Z/17) awarded to Sarah J Stock. The funders had no role in study design, data collection, data analysis, decision to publish, or preparation of the manuscript. The Sponsor of the study is the University of Edinburgh (www.ed.ac. uk), Sponsor reference AC19119. For the purpose of open access, the author has applied a CC BY public copyright licence to any Author Accepted Manuscript version arising from this submission.
Publisher Copyright:
Copyright: © 2023 Frier et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
PY - 2023/3/2
Y1 - 2023/3/2
N2 - BACKGROUND: Antenatal corticosteroids (ACS) are widely prescribed to improve outcomes following preterm birth. Significant knowledge gaps surround their safety, long-term effects, optimal timing and dosage. Almost half of women given ACS give birth outside the "therapeutic window" and have not delivered over 7 days later. Overtreatment with ACS is a concern, as evidence accumulates of risks of unnecessary ACS exposure.METHODS: The Consortium for the Study of Pregnancy Treatments (Co-OPT) was established to address research questions surrounding safety of medications in pregnancy. We created an international birth cohort containing information on ACS exposure and pregnancy and neonatal outcomes by combining data from four national/provincial birth registers and one hospital database, and follow-up through linked population-level data from death registers and electronic health records.RESULTS AND DISCUSSION: The Co-OPT ACS cohort contains 2.28 million pregnancies and babies, born in Finland, Iceland, Israel, Canada and Scotland, between 1990 and 2019. Births from 22 to 45 weeks' gestation were included; 92.9% were at term (≥ 37 completed weeks). 3.6% of babies were exposed to ACS (67.0% and 77.9% of singleton and multiple births before 34 weeks, respectively). Rates of ACS exposure increased across the study period. Of all ACS-exposed babies, 26.8% were born at term. Longitudinal childhood data were available for 1.64 million live births. Follow-up includes diagnoses of a range of physical and mental disorders from the Finnish Hospital Register, diagnoses of mental, behavioural, and neurodevelopmental disorders from the Icelandic Patient Registers, and preschool reviews from the Scottish Child Health Surveillance Programme. The Co-OPT ACS cohort is the largest international birth cohort to date with data on ACS exposure and maternal, perinatal and childhood outcomes. Its large scale will enable assessment of important rare outcomes such as perinatal mortality, and comprehensive evaluation of the short- and long-term safety and efficacy of ACS.
AB - BACKGROUND: Antenatal corticosteroids (ACS) are widely prescribed to improve outcomes following preterm birth. Significant knowledge gaps surround their safety, long-term effects, optimal timing and dosage. Almost half of women given ACS give birth outside the "therapeutic window" and have not delivered over 7 days later. Overtreatment with ACS is a concern, as evidence accumulates of risks of unnecessary ACS exposure.METHODS: The Consortium for the Study of Pregnancy Treatments (Co-OPT) was established to address research questions surrounding safety of medications in pregnancy. We created an international birth cohort containing information on ACS exposure and pregnancy and neonatal outcomes by combining data from four national/provincial birth registers and one hospital database, and follow-up through linked population-level data from death registers and electronic health records.RESULTS AND DISCUSSION: The Co-OPT ACS cohort contains 2.28 million pregnancies and babies, born in Finland, Iceland, Israel, Canada and Scotland, between 1990 and 2019. Births from 22 to 45 weeks' gestation were included; 92.9% were at term (≥ 37 completed weeks). 3.6% of babies were exposed to ACS (67.0% and 77.9% of singleton and multiple births before 34 weeks, respectively). Rates of ACS exposure increased across the study period. Of all ACS-exposed babies, 26.8% were born at term. Longitudinal childhood data were available for 1.64 million live births. Follow-up includes diagnoses of a range of physical and mental disorders from the Finnish Hospital Register, diagnoses of mental, behavioural, and neurodevelopmental disorders from the Icelandic Patient Registers, and preschool reviews from the Scottish Child Health Surveillance Programme. The Co-OPT ACS cohort is the largest international birth cohort to date with data on ACS exposure and maternal, perinatal and childhood outcomes. Its large scale will enable assessment of important rare outcomes such as perinatal mortality, and comprehensive evaluation of the short- and long-term safety and efficacy of ACS.
KW - Adrenal Cortex Hormones/therapeutic use
KW - Birth Cohort
KW - Child
KW - Child Health
KW - Child, Preschool
KW - Family
KW - Female
KW - Humans
KW - Infant
KW - Infant, Newborn
KW - Pregnancy
KW - Premature Birth/epidemiology
UR - http://www.scopus.com/inward/record.url?scp=85149279482&partnerID=8YFLogxK
U2 - 10.1371/journal.pone.0282477
DO - 10.1371/journal.pone.0282477
M3 - Article
C2 - 36862657
SN - 1932-6203
JO - PLoS ONE
JF - PLoS ONE
M1 - e0282477
ER -