Venous thromboembolism (VTE), a well-described complication of pregnancy. Despite its low absolute numbers in pregnancy of 1-2/1000, it persists as a leading cause of maternal mortality in the developed world, and a significant source of morbidity. Investigations conducted thus far have addressed diverse outcomes, with varying definitions; restricting the capacity to compare, contrast, and combine results in an effort to generate stronger conclusions, supported by larger sample sizes.
The objective of this project is to produce a core outcome set for studies focusing on the identification, assessment and management of VTE 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
Ms. Alexandria King
Graduate Student (MSc) University of Toronto, Canada
Ms. Rachel Dadouch
Graduate Student (PhD) University of Toronto, Canada
Disease Category: Heart & circulation, Pregnancy & childbirth
Disease Name: Venous thromboembolism , Deep venous thrombosis (DVT) and/or pulmonary embolism (PE)
Age Range: 16 - 55
Sex: Female
Nature of Intervention: Drug
- Clinical experts
- Consumers (patients)
- Researchers
- COS for clinical trials or clinical research
- Delphi process
- Systematic review
A systematic review of RCTs and cohort studies will be carried out to ascertain all reported outcomes and their definitions.
More specifically, the systematic review will aim to identify the laboratory and imaging studies relevant for diagnosis of VTE in pregnancy, determine what outcomes (both laboratory, radiologic, and clinical) have been explored in studies of VTE in pregnancy and postpartum, how these were measured, and for what type of intervention (i.e. unfractionated heparin, LMWH, warfarin, novel oral anticoagulants).
Key stakeholders including experts in the field (i.e. Obstetricians, maternal-fetal medicine specialists, haematologists, obstetric medicine physicians, nurses, and researchers), and health-care users will be identified and their input will be sought with respect to the composition of the COS for VTE 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.