Preventing iron deficiency anemia in postpartum women
Prevention of Iron Deficiency Anemia Post-delivery (PRIORITY Trial): A Randomized Controlled Trial of the Global Network for Women's and Children's Health Research
This study is testing whether a single IV iron infusion right after childbirth can help new moms with moderate anemia feel better compared to taking iron tablets for six weeks.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 4800 (estimated) |
| Ages | 15 Years to 49 Years |
| Sex | Female |
| Sponsor | NICHD Global Network for Women's and Children's Health Research network |
| Locations | 8 sites (Dhaka and 7 other locations) |
| Trial ID | NCT05590260 on ClinicalTrials.gov |
What this trial studies
This trial, known as PRIORITY, is a randomized-controlled study aimed at postpartum women diagnosed with moderate anemia shortly after childbirth. It will enroll 4,800 women across 8 sites in 7 countries, comparing the effectiveness of a single-dose IV iron infusion given within 48 hours of delivery to a regimen of oral iron tablets taken for 6 weeks. Participants will be monitored for hemoglobin levels and other health indicators at 6 weeks and 6 months postpartum to assess the prevalence of anemia. The study also includes assessments of maternal mental health and quality of life.
Who should consider this trial
Good fit: Ideal candidates are postpartum women aged 15 to 49 who have been diagnosed with moderate anemia after delivery.
Not a fit: Patients who have received IV iron in the past 3 weeks or have contraindications to iron supplementation will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly reduce the incidence of postpartum anemia, improving maternal health outcomes.
How similar studies have performed: Previous studies have shown promising results with IV iron infusions for treating anemia, suggesting this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Dhaka and 7 other locations
- Icddrb — Dhaka, Bangladesh (Recruiting)
- Kinshasa School of Public Health — Kinshasa, Congo, The Democratic Republic of the (Recruiting)
- Incap — Guatemala City, Guatemala (Not_yet_recruiting)
- KLE Society's Jawaharlal Nehru Medical College — Belgaum, Karnataka, India (Recruiting)
- Lata Medical Research Foundation — Nagpur, India (Recruiting)
- Moi University School of Medicine — Eldoret, Kenya (Not_yet_recruiting)
- The Aga Khan University — Karachi, Pakistan (Not_yet_recruiting)
- University Teaching Hospital — Lusaka, Zambia (Not_yet_recruiting)
Study contacts
- Principal investigator: Richard J Derman, MD, MPH — Thomas Jefferson University, Philadelphia, PA
- Study coordinator: Elizabeth McClure, PhD
- Email: mcclure@rti.org
- Phone: 919 316 3773
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.