Prevention of Iron Deficiency Anemia Post-delivery

• Status: Not yet recruiting
• Trial end date: 2025-12-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: NICHD Global Network for Women's and Children's Health
• Collaborators: Aga Khan University; Bill and Melinda Gates Foundation; Boston University; Columbia University; Indiana University; Institute of Nutrition of Central America and Panama; International Centre for Diarrhoeal Disease Research, Bangladesh; Kinshasa School of Public Health; KLE University Jawaharlal Nehru Medical College; Lata Medical Research Foundation, Nagpur; Moi University; RTI International; Thomas Jefferson University; University of Alabama at Birmingham; University of Colorado, Denver; University of North Carolina; University of Virginia; University Teaching Hospital, Lusaka, Zambia
• Treatments: Iron

Criteria

Inclusion Criteria:

• Established pregnancy >20 weeks gestation by LMP and/or clinical assessment and/ Or USG

• Age: 15 years (or lower limit age eligible*) to 49 years

• Confirmed moderate anemia (Hb 7.0 to 9.9 g/dL, 6-48 hour after delivery based on a venous blood sample on Hemocue®)

• Deliver in participating study hospital or health facility

• Able to provide informed consent

• Plans to remain in study area for duration of the study

Exclusion Criteria:

• IV Iron infusion received in past 3 weeks

• Contraindication to iron supplementation (some examples may include hemolytic anemia, allergy, severe infection)

• Blood transfusion already received or scheduled during the current hospital admission

• Known diagnosis of pre-existing depression or other psychiatric illness

• Stillbirth, major congenital anomaly, or neonatal loss prior to randomization

• Women testing positive and previously untreated for malaria

• Presenting with symptomatic anemia with dyspnea or fatigue and need for immediate correction

• Women with known hemoglobinopathy (sickle cell disease or thalassemia)

• Presence of severe allergic conditions such as severe asthma or known drug allergies

• Women presenting with any illness/condition requiring immediate medical care per physician's assessment