Abstract
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. 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. The study was registered on Clinicaltrials.gov (NCT04182074) on the 2nd December 2019.
Highlights
Peer Review History: PLOS recognizes the benefits of transparency in the peer review process; we enable the publication of all of the content of peer review and author responses alongside final, published articles
On the basis of certain conditions relating to dissent procedures that were requested by the Confidentiality Advisory Group (CAG) and the addition of collecting information regarding any further pregnancies, REC Substantial amendment (SA) 1 was approved on the 9th October 2019
Despite the presence of a number of ongoing cancer and leukaemia registries [17,18,19, 26], only one [20], captures information relating to patients either receiving treatment during their pregnancy or the effects of previous treatment on subsequent pregnancies
Summary
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. 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
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