Immune thrombocytopenia (ITP) is a clinical syndrome characterized by a low platelet count and increased risk of bleeding. It frequently occurs in women of childbearing age and is estimated to affect 1-10 of every 10,000 pregnancies. In pregnancy, platelet antibodies can cross the placenta resulting in neonatal thrombocytopenia. The literature to date contains studies that vary with regard to the reported outcomes and their measurement; limiting the ability to undertake rigorous meta-analysis that would enable extracting stronger conclusions, bolstered by larger sample sizes.
The objective of this project is to generate a core outcome set for studies focusing on the evolution and management of ITP in pregnancy.
Principal Investigator:
Dr. Ann Kinga Malinowski
Assistant Professor, University of Toronto
Clinical Investigator, Lunenfeld-Tanenbaum Research Institute
Maternal-Fetal Medicine Specialist, Mt. Sinai Hospital, Toronto
Collaborators
Dr. Nadine Shehata
Associate Professor, University of Toronto
Member, Institute of Health Policy, Management, and Evaluation, University of Toronto
Obstetric Haematologist, Mt. Sinai Hospital, Toronto
Head, Transfusion Medicine, Laboratory Medicine, and Pathology, Mt. Sinai Hospital, Toronto
Dr. Rohan D’Souza
Assistant Professor, University of Toronto
Maternal-Fetal Medicine Specialist, Mt. Sinai Hospital, Toronto
Dr. Kellie Murphy
Associate Professor, University of Toronto
Member, Institute of Health Policy, Management, and Evaluation, University of Toronto
Maternal-Fetal Medicine Specialist, Mt. Sinai Hospital, Toronto
Disease Category: Blood disorders, Pregnancy & childbirth
Disease Name: Immune thrombocytopenic purpura (ITP)
Age Range: 16 - 55
Sex: Female
Nature of Intervention: Drug
- Clinical experts
- Researchers
- COS for clinical trials or clinical research
- Delphi process
- Systematic review
A systematic review of RCTs and cohort studies will be completed to identify all reported outcomes and their definitions. More specifically, the systematic review will aim determine what maternal and fetal/neonatal outcomes (both laboratory, radiologic, and clinical) have been explored in studies of ITP in pregnancy and postpartum, how these were measured (i.e. evaluation of bleeding events, etc), and for what type of intervention (i.e. IVIg, corticosteroids, other).
Key stakeholders including experts in the field (i.e. obstetricians, maternal-fetal medicine specialists, haematologists, obstetric medicine physicians, nurses, neonatologists, and researchers), and health-care users will be identified and their input will be sought with respect to the composition of the COS for ITP in pregnancy and postpartum. Utilizing the Delphi technique, the results gathered in this manner will be collated and re-presented to the stakeholders alongside outcomes identified through the systematic review for round 2. At each round of this iterative process, participants will be provided with the analysis of the responses of that round and via pre-determined criteria will be able to add further outcomes or change the importance of the ones they previously identified. Criteria for consensus will be clearly defined a priori.