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 post-delivery, prevalence of the non-anemic state in women in that received a single-dose IV iron infusion between 6 and 48 hours after delivery and prior to discharge from the facility will be greater than that of women given a supply of oral iron tablets taken twice daily for 6 weeks.

Conditions

• Postpartum Anemia

Interventions

DRUG

IV iron infusion

single-dose IV iron infusion

DRUG

Oral iron tablets

60 mg of elemental iron

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

2025-10-01

Completion

2025-12-01

Countries

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

Study Locations