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COMPLETED
NCT05590260
PHASE3

Prevention of Iron Deficiency Anemia Post-delivery

Sponsor: NICHD Global Network for Women's and Children's Health

View on ClinicalTrials.gov

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

Interventions

DRUG

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.

DRUG

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