Prevention of Iron Deficiency Anemia Post-delivery (PRIORITY)

December 4, 2023 updated by: NICHD Global Network for Women's and Children's Health

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

PRIORITY is a 2-arm, randomized-controlled trial (RCT) that will be implemented at 8 sites in 7 countries: Bangladesh, Democratic Republic of the Congo, Guatemala, India (Nagpur and Belagavi), Kenya, Pakistan, and Zambia. The research team for each site will enroll approximately 600 women who deliver at a hospital or other facility such as a health center with delivery services. Participants will be randomized to receive a single-dose IV iron infusion between 6 and 48 hours after delivery prior to discharge from the facility or oral iron tablets taken twice daily for 6 weeks. They will then be assessed by research staff at an appropriate health facility at 6 weeks and 6 months post-delivery by providing a maternal blood sample that will be analyzed to determine Hb concentration. At each study visit, trained staff will also measure serum ferritin, serum transferrin receptor, C-reactive protein (CRP) and alpha 1 acid glycoprotein (AGP). Additionally, in the African research sites, a rapid diagnostic test (RDT) for malaria will be administered upon admission to the birthing facility, and at 6 weeks and 6 months postpartum. The Edinburgh Postnatal Depression Scale (EPDS), The World Health Organization Quality-of-Life (QOL) scale, The Maternal Fatigue Severity Scale (FSS-5R), and The Mother-to-infant Bonding Scale (MIBS) will also be used at the 6 weeks and 6 months postpartum follow up appointments to collect data for secondary study aims.The study hypothesizes that at 6 weeks post-delivery, the 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. Secondary study aims will look at the effects of postpartum depression on maternal quality of life, fatigue, and breastfeeding initiation and retention rates. Depression is also a risk factor for reducing infant-mother bonding.

The PRIORITY RCT will include an implementation research (IR) sub-study to complement the findings of the RCT trial and provide evidence about facilitators, barriers, and costs of implementation to inform global guidelines on the use of IV iron in postpartum women in Low-Middle Income Countries (LMIC). This Implementation Research (IR) sub-study will build upon the PRIORITY trial as well as other research projects to assess IV iron that are being conducted by the Jawaharlal Nehru Medical College research team in Belagavi, India, Thomas Jefferson University (TJU) and by the Aga Khan University team in Pakistan. The IR will utilize a mixed methods approach, employing both quantitative and qualitative data collection to better understand the potential barriers and facilitators to IV iron use in India and Pakistan. The implementation research will be harmonized with the timeline of the main PRIORITY trial, enabling the investigators to collect the IR data in parallel with the trial. The mixed methods IR study for the PRIORITY trial in India and Pakistan will be guided by the Consolidated Framework for Implementation Research (CFIR) and by Proctor's implementation outcomes framework. CFIR and Proctor's framework are complementary and provide a structure for guiding the types of questions and target groups for the implementation research data collection during the trial.

Study Type

Interventional

Enrollment (Estimated)

4800

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Elizabeth McClure, PhD
  • Phone Number: 919 316 3773
  • Email: mcclure@rti.org

Study Locations

  • Bangladesh
      • Dhaka, Bangladesh, 1212
        • Recruiting
        • ICDDRB
        • Contact:
        • Principal Investigator:
          • Rashidul Haque, MD
        • Principal Investigator:
          • William A Petri, MD
  • Congo, The Democratic Republic of the
      • Kinshasa, Congo, The Democratic Republic of the
        • Recruiting
        • Kinshasa School of Public Health
        • Contact:
        • Principal Investigator:
          • Antoinette Tshefu, MD
        • Principal Investigator:
          • Melissa Bauserman, MD
  • Guatemala
      • Guatemala City, Guatemala
        • Not yet recruiting
        • INCAP
        • Principal Investigator:
          • Manolo Mazariegos, MD
        • Contact:
        • Principal Investigator:
          • Nancy Krebs, MD
  • India
      • Nagpur, India
        • Recruiting
        • Lata Medical Research Foundation
        • Principal Investigator:
          • Archana Patel, MD, DNB, MSCE
        • Contact:
        • Principal Investigator:
          • Patricia L Hibberd, MD, PhD
    • Karnataka
      • Belgaum, Karnataka, India, 590 010
        • Recruiting
        • KLE Society's Jawaharlal Nehru Medical College
        • Contact:
        • Principal Investigator:
          • Richard J Derman, M.D.
        • Principal Investigator:
          • Shivaprasad S Goudar, M.D.
  • Kenya
      • Eldoret, Kenya, 30100
        • Not yet recruiting
        • Moi University School of Medicine
        • Contact:
        • Principal Investigator:
          • Fabian Esamai, MBChB, MMed, PhD
        • Principal Investigator:
          • Sherri Bucher, MD
  • Pakistan
      • Karachi, Pakistan, 74800
        • Not yet recruiting
        • The Aga Khan University
        • Principal Investigator:
          • Sarah Saleem, MD
        • Contact:
        • Principal Investigator:
          • Robert L Goldenberg, MD
  • Zambia
      • Lusaka, Zambia
        • Not yet recruiting
        • University Teaching Hospital
        • Contact:
        • Principal Investigator:
          • Elwyn Chomba, MD
        • Principal Investigator:
          • Wally A Carlo, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 49 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Drug: IV iron infusion
single-dose IV iron infusion
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.
Drug: Oral iron tablets
60 mg of elemental iron

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of women with non-anemic hemaglobin levels (Hb >11 g/dL)
Time Frame: 6 weeks post-delivery
Hemoglobin measure
6 weeks post-delivery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of maternal deaths
Time Frame: From delivery to 6 months post-delivery
Maternal death from any cause
From delivery to 6 months post-delivery
Number of women who receive a blood transfusion post-discharge
Time Frame: through 6 months post-delivery
Blood transfusion given to mother enrolled in study after randomization
through 6 months post-delivery
Number of women with hospitalization
Time Frame: through 6 months post-delivery
Hospital admission for any reason after randomization until 6 months postpartum
through 6 months post-delivery
Number of women with documentation of postpartum complications
Time Frame: Randomization through 6 weeks post delivery
Maternal postpartum clinical complications
Randomization through 6 weeks post delivery
Differences between treatment groups in infant-mother bonding scale scores
Time Frame: 6 weeks
Will utilize mother-infant (MIBS) tool
6 weeks
Maternal - Change resulting in severe/moderate/mild anemia by treatment arm
Time Frame: 6 months
Evaluate individual changes in maternal anemia levels from randomization to 6 months
6 months
Maternal - Hemoglobin concentration by mode of delivery
Time Frame: 6 months
Evaluate hemoglobin stratified by Cesarean delivery vs. Vaginal delivery
6 months
Maternal - Differences in ferritin and inflammatory markers by treatment group
Time Frame: 6 weeks, 6 months
Using centralized testing, evaluate differences by treatment group
6 weeks, 6 months
Number of neonatal infant deaths
Time Frame: birth to 6 months
Neonatal or infant death from any cause post-randomization
birth to 6 months
Number of infants with hospitalization
Time Frame: birth to 6 months
Neonatal or infant hospitalization for any reason
birth to 6 months
Number of women who experience a postpartum hemorrhage requiring transfusion or major surgery
Time Frame: from intervention through 6 weeks post-delivery
Postpartum hemorrhaging defined as those requiring transfusion of surgery
from intervention through 6 weeks post-delivery
Number of women screening positive for postpartum depression
Time Frame: 6 weeks and 6 months
Edinburgh Postnatal Depression Scale (EPDS) will be used as post-partum depression screening tool
6 weeks and 6 months
Number of women with severe fatigue
Time Frame: 6 weeks and 6 months
Fatigue severity score (utilizing 9 question survey with a scale from 1-7 for each item; the lower the total score is the better the outcome)
6 weeks and 6 months
Prevalence of severe/moderate/mild anemia among women
Time Frame: 6 weeks and 6 months
Use Hemocue hemoglobin measure to categorize anemia
6 weeks and 6 months
Number of women exclusive breastfeeding rate and intend to continue breastfeeding through 12 months post-delivery
Time Frame: 6 weeks and 6 months
Self report of breastfeeding
6 weeks and 6 months
Differences in quality of life assessment scores
Time Frame: 6 weeks and 6 months
Will utilize WHO Quality of Life (QOL) - BREF tool. The minimum is 0 (bad QOL) and maximum is 100 (good QOL).
6 weeks and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NICHD Global Network for Women's and Children's Health

Collaborators

Boston University
University of Colorado, Denver
University of Alabama at Birmingham
Columbia University
Bill and Melinda Gates Foundation
University of North Carolina, Chapel Hill
Aga Khan University
University of Virginia
International Centre for Diarrhoeal Disease Research, Bangladesh
Indiana University
Thomas Jefferson University
RTI International
University Teaching Hospital, Lusaka, Zambia
Kinshasa School of Public Health
Institute of Nutrition of Central America and Panama
Lata Medical Research Foundation, Nagpur
Moi University
KLE University Jawaharlal Nehru Medical College

Investigators

  • Principal Investigator: Richard J Derman, MD, MPH, Thomas Jefferson University, Philadelphia, PA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 30, 2023

Primary Completion (Estimated)

October 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

September 29, 2022

First Submitted That Met QC Criteria

October 19, 2022

First Posted (Actual)

October 21, 2022

Study Record Updates

Last Update Posted (Estimated)

December 11, 2023

Last Update Submitted That Met QC Criteria

December 4, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CP PRIORITY

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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