Prevention of Iron Deficiency Anemia Post-delivery (NCT05590260) | Clinical Trial Compass
UnknownPhase 3
Prevention of Iron Deficiency Anemia Post-delivery
Bangladesh, Democratic Republic of the Congo, Guatemala4,800 participantsStarted 2023-05-30
Plain-language 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.
Who can participate
Age range15 Years – 49 Years
SexFEMALE
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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
What they're measuring
1
Number of women with non-anemic hemaglobin levels (Hb >11 g/dL)
Timeframe: 6 weeks post-delivery
Trial details
NCT IDNCT05590260
SponsorNICHD Global Network for Women's and Children's Health