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

Status: Recruiting
Location: See all (8) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 15
Maximum Age: 49
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Bangladesh
ICDDRB
RECRUITING
Dhaka
Democratic Republic of the Congo
Kinshasa School of Public Health
RECRUITING
Kinshasa
Guatemala
INCAP
NOT_YET_RECRUITING
Guatemala City
India
KLE Society's Jawaharlal Nehru Medical College
RECRUITING
Belagavi
Lata Medical Research Foundation
RECRUITING
Nagpur
Kenya
Moi University School of Medicine
NOT_YET_RECRUITING
Eldoret
Pakistan
The Aga Khan University
NOT_YET_RECRUITING
Karachi
Zambia
University Teaching Hospital
NOT_YET_RECRUITING
Lusaka
Contact Information
Primary
Elizabeth McClure, PhD
mcclure@rti.org
919 316 3773
Time Frame
Start Date: 2023-05-30
Estimated Completion Date: 2025-12-01
Participants
Target number of participants: 4800
Treatments
Experimental: IV iron arm
Which will result in receipt of a single-dose IV iron infusion between 6 and 48 hours after delivery and prior to discharge from the facility; folate tablets per local guidelines.
Active_comparator: Oral iron comparator arm
Oral iron tablets (containing 60 mg of elemental iron (± folate as per local guidelines)) to be taken at a treatment dose of twice daily for 6 weeks.
Related Therapeutic Areas
Sponsors
Collaborators: Indiana University, Bill and Melinda Gates Foundation, Lata Medical Research Foundation, Nagpur, Institute of Nutrition of Central America and Panama, Boston University, University Teaching Hospital, Lusaka, Zambia, KLE University Jawaharlal Nehru Medical College, Kinshasa School of Public Health, Columbia University, RTI International, International Centre for Diarrhoeal Disease Research, Bangladesh, Moi University, Thomas Jefferson University, Aga Khan University, University of Virginia, University of Alabama at Birmingham, University of Colorado, Denver, University of North Carolina, Chapel Hill
Leads: NICHD Global Network for Women's and Children's Health

This content was sourced from clinicaltrials.gov