Delphi Method Consensus on Statistical Analysis and Reporting Recommendations for Single-Arm Pregnancy Medication Safety Studies Investigating Pregnancy, Birth and Neonatal Health Outcomes: A Contribution from IMI-ConcePTION

Jonathan L. Richardson (), Alan Moore, Michael Stellfeld, Yvonne Geissbühler, Ursula Winterfeld, Guillaume Favre, Christina Chambers, Evelin Beck, Marlies Onken, Katarina Dathe, Michael Ceulemans, Orna Diav-Citrin, Svetlana Shechtman, Alison M. Oliver, Kenneth K. Hodson, Dee-Dee Shiller, Amalia Alexe, Eugène P. Puijenbroek, David J. Lewis and Laura M. Yates
Additional contact information
Jonathan L. Richardson: Newcastle upon Tyne Hospitals NHS Foundation Trust
Alan Moore: Novartis Pharma AG
Michael Stellfeld: Novo Nordisk A/S
Yvonne Geissbühler: Novartis Pharma AG
Ursula Winterfeld: University Hospital
Guillaume Favre: University Hospital
Christina Chambers: University of California, San Diego
Evelin Beck: Charité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin
Marlies Onken: Charité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin
Katarina Dathe: Charité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin
Michael Ceulemans: KU Leuven
Orna Diav-Citrin: Ministry of Health
Svetlana Shechtman: Ministry of Health
Alison M. Oliver: Newcastle upon Tyne Hospitals NHS Foundation Trust
Kenneth K. Hodson: Newcastle upon Tyne Hospitals NHS Foundation Trust
Dee-Dee Shiller: AbbVie Inc.
Amalia Alexe: Novartis Pharma AG
Eugène P. Puijenbroek: Pharmacovigilance Centre Lareb
David J. Lewis: Novartis Pharma AG
Laura M. Yates: Newcastle upon Tyne Hospitals NHS Foundation Trust

Drug Safety, 2025, vol. 48, issue 6, No 4, 643-654

Abstract: Abstract Background and Objective Standardised procedures for performing and reporting safety monitoring studies investigating medications use in pregnancy may help improve data quality and the speed of data generation. The objective of this study was to provide recommendations on the statistical analysis and reporting of single-arm pregnancy medication safety studies using primary source datasets. Methods A Delphi consensus-setting protocol was used to acquire agreement on recommendations from experts with extensive knowledge and experience in conducting studies investigating medication safety in pregnancy. A series of recommendations, along with their scientific justifications and examples of how to calculate and describe exposure and outcome incidences, were critiqued and improved through a series of online Delphi review rounds. Agreement to inclusion scoring was assessed using a five-point Likert scale. Recommendations with a median Likert-scale score of at least 4, where ≥ 80% of the expert panel scored the recommendation at level 4 or higher, was used as the threshold for inclusion. Results The Delphi consensus methodology produced a set of 30 recommendations spread over five themes. These included descriptions of (1) study sample, (2) medication exposure, (3) maternal outcomes, (4) pregnancy and birth outcomes, and (5) fetal and neonatal outcomes. Of the 30 recommendations, 19 were strongly advised while 11 were included for consideration where their implementation may be beneficial for supplementing data communication. Conclusion Use of the finalised set of recommendations should be encouraged to help standardise published evidence around medication use in pregnancy.

Date: 2025
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DOI: 10.1007/s40264-025-01521-0

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