Prevention of Iron Deficiency Anemia Post-Delivery (PRIORITY)
New approaches for treating postpartum anemia and reducing maternal mortality in low- and middle-income countries
Anemia remains a major contributor to maternal illness and mortality, and, despite numerous efforts, rates of anemia have not decreased in low- and middle-income countries. The most common cause of anemia worldwide is iron deficiency (IDA). IDA during pregnancy increases the risk of adverse maternal, fetal, and neonatal outcomes; women are also susceptible to IDA immediately after delivery, when maternal hemoglobin values often drop precipitously.
To reduce anemia among women of reproductive age, new interventions are needed. Intravenous iron has been demonstrated to be a safe, effective intervention to reduce anemia during pregnancy but has not been adequately assessed during the postpartum period. The PRIORITY trial will determine if postpartum women who receive a single-dose iron infusion are more likely to achieve a state of non-anemia than women who receive the standard-of-care oral iron.
In addition to comparing the two study populations for the prevalence of anemia, the trial will assess both groups for significant secondary outcomes, such as maternal mortality, postpartum hemorrhaging requiring blood transfusion or surgery, hospitalization of mother or infant, and other complications. Determining postpartum depression at six weeks post-delivery has been included as an important secondary outcome. Postpartum depression can affect other secondary outcomes, including maternal quality of life, fatigue, breastfeeding initiation and retention rates, and infant-mother bonding.
The intended outcome of the study is publicly disseminated knowledge to inform policy and practice in treating postpartum anemia globally. It is expected that the results will be used to inform national health policies and practices, improving care of women.
- Compare the effects of two approaches for early diagnosis of postpartum anemia
- Explore findings related to secondary outcomes to better understand scope and duration of anemia in the postpartum period as well as health-related consequences
- Compare the effects of two approaches for treatment of maternal depression
- Assess if differences between two study arms continue for as long as one year post-delivery
- Assess specific clinical outcomes in the infant due to differences in a mother’s postpartum anemia status
- Define whether iron levels in blood or inflammatory markers are associated with study outcomes
FNIH Newsletter (November 30, 2022): Summary of PRIORITY Launch
FNIH Announcement (November 10, 2022): New Trial Will Evaluate Iron Infusions to Treat Postpartum Anemia Globally
NIH Media Advisory (November 10, 2022): NIH-funded researchers to begin study of intravenous iron treatment for post-pregnancy anemia
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Global Network for Women’s and Children’s Research
*Provided financial support
- Boston University—with Lata Medical Research Foundation, Nagpur, India
- Columbia University—with Aga Khan University, Karachi, Pakistan
- Indiana University School of Medicine—with Moi University School of Medicine, Eldoret, Kenya
- Thomas Jefferson University—with KLE University’s Jawaharlal Nehru Medical College, Belgaum, India
- University of Alabama at Birmingham—with University Teaching Hospital, Lusaka, Zambia
- University of Colorado Denver—with Instituto de Nutrición de Centroamérica y Panamá (INCAP), Guatemala City, Guatemala
- University of North Carolina School of Medicine—with Kinshasa School of Public Health, Kinshasa, Democratic Republic of Congo
- University of Virginia—with International Centre for Diarrhoeal Disease Research, Dhaka, Bangladesh
- Susan Wiener, Senior Project Manager, firstname.lastname@example.org
- Renata Hoffstetter, Senior Project Manager, email@example.com