In 2011, the prevalence of anemia in pregnant women worldwide was 38.2%, affecting 32.4 million pregnant women, of whom 0.8 million had severe anemia, defined as haemoglobin concentration <70 g/L. Iron deficiency is the most common nutritional deficiency and the most common cause of anemia globally, affecting around two billion individuals, or over 30% of the population. Similarly, iron deficiency accounts for almost 70% of anaemia in pregnancy. Adverse pregnancy outcomes believed to be associated with anemia include maternal and perinatal mortality, preterm birth, size small for gestational age. These adverse outcomes may extend into the postpartum period. Although preventing and treating postpartum anaemia would intuitively be associated with improved health and quality of life for women and infants, this has not been shown conclusively in large studies to date.
However, studies on the impact of IDA and iron supplementation on pregnancy outcomes have been limited by use of intermediary outcomes consisting of improvement of haematologic indices, at the expense of functional outcomes more reflective of clinical well-being.
The objective of this project is to produce a core outcome set for studies focusing on the identification, assessment and management of iron deficiency anaemia in pregnancy and postpartum.
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
Dr. Jahnavi Daru
NIHR Academic Clinical Fellow in O&G, Women’s Health Research Unit, Yvonne Carter Institute, Queen Mary University of London
Disease Category: Pregnancy & childbirth, Blood disorders
Disease Name: Iron Deficiency Anaemia, Anemia
Age Range: 16 - 55
Sex: Female
Nature of Intervention: Other
- 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 parameters used to identify iron deficiency, determine what outcomes (both laboratory and clinical) have been explored in studies of iron deficiency anaemia in pregnancy and postpartum, how these were measured, and for what type of intervention (i.e. intravenous vs. oral iron).
Key stakeholders including experts in the field (i.e. obstetricians, maternal-fetal medicine specialists, haematologists, obstetric medicine physicians, nurses, dieticians, 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 IDA 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 apriori.