A prospective registry-based cohort study of the diagnosis and management of acute leukaemia in pregnancy: Study protocol

Northgraves, Matthew; Allsup, David; Cohen, Judith; Huang, Chao; Turgoose, John; Ali, Sahra

Abstract

Background
Acute leukaemias (AL) are aggressive but potentially curable blood cancers that can potentially affect women of childbearing age. When a pregnancy is complicated by a diagnosis of AL, clinicians face a complex dilemma: to balance risking the mother’s survival through delayed AL treatment, against the potential harm to the foetus through exposure to anti-cancer drugs. Up until now, all guidance and advice regarding the management of AL in pregnancy, have been based on expert opinion and small case studies. There is a pressing need for more studies in the subject to address this evidence gap.

Methods and analysis
This study is a registry-based observational cohort study which aims to monitor and record the treatment outcomes of patients diagnosed with AL during pregnancy. Additionally, the study aims to assess pregnancy outcomes in patients who become pregnant following successful treatment. Prospective and historical cases from August 2009 onwards will be identified from AL treating haematology units within the UK. Details of diagnosis, AL treatment delivered, antenatal and postnatal outcomes for mother and neonate will be collected. This study will establish a new research database for Leukaemia in Pregnancy.

Trial registration
The study was registered on Clinicaltrials.gov (NCT04182074) on the 2nd December 2019.

Citation

Northgraves, M., Allsup, D., Cohen, J., Huang, C., Turgoose, J., & Ali, S. (2022). A prospective registry-based cohort study of the diagnosis and management of acute leukaemia in pregnancy: Study protocol. PLoS ONE, 17(2), Article e0263195. https://doi.org/10.1371/journal.pone.0263195

• Journal Article Type: Article
• Acceptance Date: Jan 28, 2022
• Online Publication Date: Feb 7, 2022
• Publication Date: Feb 7, 2022
• Deposit Date: Feb 10, 2022
• Publicly Available Date: Feb 10, 2022
• Journal: PLOS ONE
• Print ISSN: 1932-6203
• Publisher: Public Library of Science
• Peer Reviewed: Peer Reviewed
• Volume: 17
• Issue: 2
• Article Number: e0263195
• DOI: https://doi.org/10.1371/journal.pone.0263195
• Keywords: Multidisciplinary
• Public URL: https://hull-repository.worktribe.com/output/3924672