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Prevention of Iron Deficiency Anemia Post-delivery
Sponsor: NICHD Global Network for Women's and Children's Health
Summary
PRIORITY is designed as a 2-arm, randomized-controlled trial focused on postpartum women. The trial will recruit women who are diagnosed with moderate anemia based on a blood sample taken 6-48 hours after childbirth. A total of 4,800 eligible women, or 600 women per research site, will be consented and enrolled in the trial. The study hypothesizes that at 6 weeks postpartum, the incidence of achieving a non-anemic state (defined as Hb ≥11 g/dL) will be greater among women receiving a single-dose infusion of IV iron than among women receiving standard care with oral iron.
Official title: Prevention of Iron Deficiency Anemia Post-delivery (PRIORITY Trial): A Randomized Controlled Trial of the Global Network for Women's and Children's Health Research
Key Details
Gender
FEMALE
Age Range
15 Years - 49 Years
Study Type
INTERVENTIONAL
Enrollment
4857
Start Date
2023-05-30
Completion Date
2025-07-28
Last Updated
2026-07-01
Healthy Volunteers
No
Conditions
Interventions
Ferric carboxymaltose (FCM) and folic acid tablets
FCM 50 mg iron/mL will be in a solution of 20 mL vials for infusion, using a dosage of 20 mg elemental iron per kg body weight, up to a maximum of 1 g, in a single IV infusion over 20-30 minutes. 400 mcg of folic acid daily to 6 months.
Oral iron tablets and folic acid tablets
60 mg elemental iron twice daily to 6-weeks with then once or twice daily (based on Hb at 6-weeks) to 6-months. 400 mcg of folic acid daily to 6 months.
Locations (8)
ICDDRB
Dhaka, Bangladesh
Kinshasa School of Public Health
Kinshasa, Democratic Republic of the Congo
INCAP
Guatemala City, Guatemala
Lata Medical Research Foundation
Nagpur, India, India
KLE Society's Jawaharlal Nehru Medical College
Belagavi, Karnataka, India
Moi University School of Medicine
Eldoret, Kenya
The Aga Khan University
Karachi, Pakistan, Pakistan
University Teaching Hospital
Lusaka, Zambia