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 range
15 Years – 49 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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