Cornish, R. P. http://orcid.org/0000-0002-2874-7646
Magnus, M. C.
Urhoj, S. K.
Santorelli, G.
Smithers, L. G.
Odd, D.
Fraser, A.
Håberg, S. E.
Nybo Andersen, A. M.
Birnie, K.
Lynch, J. W.
Tilling, K.
Lawlor, D. A.
Funding for this research was provided by:
Medical Research Council (MC_UU_00011/3, MC_UU_00011/6)
National Institutes of Health (R01 DK10324)
European Research Council (669545)
British Heart Foundation (AA/18/1/34219, PG/19/21/34190)
Norwegian Research Council (262700)
Article History
Received: 22 May 2023
Accepted: 13 December 2023
First Online: 5 January 2024
Declarations
:
: Collaborative Perinatal Project (CPP, USA): At the time of this study, there were no ethics review boards but informed consent was obtained from the women.Norwegian birth registry: The ethical committee provided a waiver of individual consent for this use of health register data for research in line with Norwegian legislation.Danish linked data: The processing and linkage of data were approved by the Danish Data Protection Agency (UCHP reference number: 514–0230/18–3000). Ethical approval or informed consent is not required for register-based studies in Denmark.Clinical Practice Research Datalink (CPRD): CPRD has National Research Ethics Service Committee (NRES) approval for research using the primary care and linked datasets. Individuals registered with participating GP practices are included in the CPRD dataset unless they specifically opt out. The CPRD study protocol was approved by the Independent Scientific Advisory Committee (ISAC; protocol number: 20_145R).South Australian Better Evidence Better Outcomes Linked Data (BEBOLD) platform: Approval for the BEBOLD platform was obtained from the South Australian Department of Health’s Human Research Ethics Committee, which included a waiver of individual consent for the use of de-identified administrative data.US National Center for Health Statistics vital statistics (birth registration) data: These publicly available datasets are anonymised and therefore patient consent and ethical approval were not required.Welsh linked data: Secure Anonymised Information Linkage (SAIL) Databank:Governance of the SAIL Databank was agreed in consultation with the Research Ethics Service and Health and Care Research Wales; individuals are able to opt out of their data being transferred to SAIL. Access to SAIL data requires approval from their Information Governance Review Panel (IGRP), which includes representatives from the Research Ethics Service.Bradford maternity data (UK): All data were anonymised and therefore patient consent and ethical approval were not required.
: Not applicable.
: DAL has received support from Roche Diagnostic and Medtronic Ltd for research unrelated to this study and that was completed more than 5 years ago. KT acted as expert witness to the High Court in England called by the UK MHRA, defendants in a case on hormonal pregnancy tests and congenital anomalies 2021/2022. All other authors declare that they have no competing interests.