Consortium for the Study of Pregnancy Treatments (Co-OPT): An international birth cohort to study the effects of antenatal corticosteroids

Abstract

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.

Could the Trustworthiness in RAndomized Controlled Trials (TRACT) checklist be trusted?

“…'IUI in cervical factor 2007' [12] was the only trial classi ed as low risk, while no trial was classi ed as moderate risk. The TRACT lead developer coauthored 11 publications in the rst month of 2023 alone [13][14][15][16][17][18][19][20][21][22][23], leading us to consider the item "large number of RCTs published in a short time frame by one author/in one institute" to be ful lled in all reviewed trials. A total of 9 trials (56.25%) showed a discrepancy in reported ndings between the published abstract and the nal article [7-10, 24 -28].…”

Treatments for Ocular Diseases in Pregnancy and Breastfeeding: A Narrative Review

“…In addition, the teratogenicity of the exposure to systemic corticosteroids in humans is controversial and there have been conflicting reports in the literature in recent years [81,83].…”