Prevention of Iron Deficiency Anemia Post-delivery

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.

Conditions

• Postpartum Anemia

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.

Sponsors & Collaborators

• Thomas Jefferson University

  collaborator OTHER

• University of North Carolina, Chapel Hill

  collaborator OTHER

• Kinshasa School of Public Health

  collaborator OTHER

• University of Alabama at Birmingham

  collaborator OTHER

• University Teaching Hospital, Lusaka, Zambia

  collaborator OTHER

• University of Colorado, Denver

  collaborator OTHER

• Institute of Nutrition of Central America and Panama

  collaborator OTHER

• University of Virginia

  collaborator OTHER

• International Centre for Diarrhoeal Disease Research, Bangladesh

  collaborator OTHER

• Columbia University

  collaborator OTHER

• Aga Khan University

  collaborator OTHER

• Boston University

  collaborator OTHER

• Lata Medical Research Foundation, Nagpur

  collaborator OTHER

• Indiana University

  collaborator OTHER

• Moi University

  collaborator OTHER

• RTI International

  collaborator OTHER

• Bill and Melinda Gates Foundation

  collaborator OTHER

• KLE University Jawaharlal Nehru Medical College

  collaborator UNKNOWN

• NICHD Global Network for Women's and Children's Health

  lead NETWORK

Principal Investigators

• Richard J Derman, MD, MPH · Thomas Jefferson University, Philadelphia, PA

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

15 Years

Max Age

49 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-05-30

Primary Completion

2025-03-10

Completion

2025-07-28

Countries

• Bangladesh
• Democratic Republic of the Congo
• Guatemala
• India
• Kenya
• Pakistan
• Zambia

Study Locations