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Completed NCT05590260

Prevention of Iron Deficiency Anemia Post-delivery

Conditions: Postpartum Anemia

Sex: Female
Ages: 15 Years – 49 Years
Healthy volunteers: No
Phase: PHASE3
Enrollment: 4857
Sponsor: NICHD Global Network for Women's and Children's Health

Location: ICDDRB Dhaka

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.

Eligibility Criteria

Inclusion Criteria: * Established pregnancy ≥28 weeks gestational age by last menstrual period and/or clinical assessment and/or ultrasonography * Age: 18 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 at least 6 months postpartum Exclusion Criteria: * IV Iron infusion received in past 3 weeks * Prior reaction to IV iron or oral iron or folic acid * Contraindication to iron supplementation (some examples may include severe allergic states including asthma, hemolytic anemia, allergy, or severe infection) * Blood transfusion already received or scheduled during the current hospital admission * Known diagnosis of pre-existing depression or other psychiatric illness * Major congenital anomaly prior to randomization * Stillbirth or neonatal loss prior to randomization * Presenting with symptomatic anemia with dyspnea or fatigue and need for immediate correction * Known hemoglobinopathy (sickle cell disease or thalassemia) * Positive malaria RDT prior to randomization (sub-Saharan African sites only) * Any illness/condition requiring immediate medical care per physician's assessment

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05590260). StuddyBuddy aggregates publicly available trial information.