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