Prevention of Iron Deficiency Anemia Post-delivery (PRIORITY)
Primary Purpose
Postpartum Anemia
Status
Not yet recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
IV iron infusion
Oral iron tablets
Sponsored by
About this trial
This is an interventional treatment trial for Postpartum Anemia focused on measuring Postpartum anemia, Anemia, Postpartum, IV Iron, Iron Tablets, Iron, Pregnancy, Maternal, Infant, Hemaglobin
Eligibility 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
Sites / Locations
- ICDDRB
- Kinshasa School of Public Health
- INCAP
- KLE Society's Jawaharlal Nehru Medical College
- Lata Medical Research Foundation
- Moi University School of Medicine
- The Aga Khan University
- University Teaching Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
IV iron arm
Oral iron comparator arm
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Number of women with non-anemic hemaglobin levels (Hb >11 g/dL)
Hemoglobin measure
Secondary Outcome Measures
Number of maternal deaths
Maternal death from any cause
Number of women who receive a blood transfusion post-discharge
Blood transfusion given to mother enrolled in study after randomization
Number of women who experience a postpartum hemorrhage requiring transfusion or major surgery
PPH defined as those requiring transfusion of surgery
Number of women with hospitalization
Hospital admission for any reason after randomization until 6 months postpartum
Number of women with documentation of postpartum complications
Maternal postpartum clinical complications
Number of women screening positive for postpartum depression
EPDS will be used as post-partum depression screening tool
Number of women with severe fatigue
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)
Differences between treatment groups in infant-mother bonding scale scores
Will utilize mother-infant (MIBS) tool
Differences in quality of life assessment scores
Will utilize WHO QOL tool
Prevalence of severe/moderate/mild anemia among women
Use Hemocue hemoglobin measure to categorize anemia
Maternal - Change resulting in severe/moderate/mild anemia by treatment arm
Evaluate individual changes in maternal anemia levels from randomization to 6 months
Maternal - Hemoglobin concentration by mode of delivery
Evaluate hemoglobin stratified by Cesarean delivery vs. Vaginal delivery
Maternal - Differences in ferritin and inflammatory markers by treatment group
Using centralized testing, evaluate differences by treatment group
Number of neonatal infant deaths
Neonatal or infant death from any cause post-randomization
Number of infants with hospitalization
Neonatal or infant hospitalization for any reason
Number of women exclusive breastfeeding rate and intend to continue breastfeeding through 12 months post-delivery
Self report of breastfeeding
Full Information
NCT ID
NCT05590260
First Posted
September 29, 2022
Last Updated
April 25, 2023
Sponsor
NICHD Global Network for Women's and Children's Health
Collaborators
Thomas Jefferson University, University of North Carolina, Kinshasa School of Public Health, University of Alabama at Birmingham, University Teaching Hospital, Lusaka, Zambia, University of Colorado, Denver, Institute of Nutrition of Central America and Panama, University of Virginia, International Centre for Diarrhoeal Disease Research, Bangladesh, Columbia University, Aga Khan University, Boston University, Lata Medical Research Foundation, Nagpur, Indiana University, Moi University, RTI International, Bill and Melinda Gates Foundation, KLE University Jawaharlal Nehru Medical College
1. Study Identification
Unique Protocol Identification Number
NCT05590260
Brief Title
Prevention of Iron Deficiency Anemia Post-delivery
Acronym
PRIORITY
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 1, 2023 (Anticipated)
Primary Completion Date
October 1, 2025 (Anticipated)
Study Completion Date
December 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NICHD Global Network for Women's and Children's Health
Collaborators
Thomas Jefferson University, University of North Carolina, Kinshasa School of Public Health, University of Alabama at Birmingham, University Teaching Hospital, Lusaka, Zambia, University of Colorado, Denver, Institute of Nutrition of Central America and Panama, University of Virginia, International Centre for Diarrhoeal Disease Research, Bangladesh, Columbia University, Aga Khan University, Boston University, Lata Medical Research Foundation, Nagpur, Indiana University, Moi University, RTI International, Bill and Melinda Gates Foundation, KLE University Jawaharlal Nehru Medical College
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
Detailed Description
PRIORITY is a 2-arm, randomized-controlled trial 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 LMICs. This 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postpartum Anemia
Keywords
Postpartum anemia, Anemia, Postpartum, IV Iron, Iron Tablets, Iron, Pregnancy, Maternal, Infant, Hemaglobin
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Model Description
Study participation will be individually randomized and allocated 1:1 to one of two arms stratified by site. A computer algorithm generated by the data coordinating center (DCC) will create the random assignment to one of the treatment arms based on randomly permuted block design with randomly varied block sizes. Randomization will be stratified based on delivery mode (Cesarean section vs. vaginal birth) and site. The block sizes will be known only by the DCC personnel
Masking
None (Open Label)
Allocation
Randomized
Enrollment
4800 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
IV iron arm
Arm Type
Experimental
Arm Description
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.
Arm Title
Oral iron comparator arm
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
IV iron infusion
Intervention Description
single-dose IV iron infusion
Intervention Type
Drug
Intervention Name(s)
Oral iron tablets
Intervention Description
60 mg of elemental iron
Primary Outcome Measure Information:
Title
Number of women with non-anemic hemaglobin levels (Hb >11 g/dL)
Description
Hemoglobin measure
Time Frame
6 weeks post-delivery
Secondary Outcome Measure Information:
Title
Number of maternal deaths
Description
Maternal death from any cause
Time Frame
From delivery to 6 months post-delivery
Title
Number of women who receive a blood transfusion post-discharge
Description
Blood transfusion given to mother enrolled in study after randomization
Time Frame
through 6 months post-delivery
Title
Number of women who experience a postpartum hemorrhage requiring transfusion or major surgery
Description
PPH defined as those requiring transfusion of surgery
Time Frame
from intervention through 6 weeks post-delivery
Title
Number of women with hospitalization
Description
Hospital admission for any reason after randomization until 6 months postpartum
Time Frame
through 6 months post-delivery
Title
Number of women with documentation of postpartum complications
Description
Maternal postpartum clinical complications
Time Frame
Randomization through 6 weeks post delivery
Title
Number of women screening positive for postpartum depression
Description
EPDS will be used as post-partum depression screening tool
Time Frame
6 weeks and 6 months
Title
Number of women with severe fatigue
Description
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)
Time Frame
6 weeks, 6 months
Title
Differences between treatment groups in infant-mother bonding scale scores
Description
Will utilize mother-infant (MIBS) tool
Time Frame
6 weeks
Title
Differences in quality of life assessment scores
Description
Will utilize WHO QOL tool
Time Frame
6 weeks, 6 months
Title
Prevalence of severe/moderate/mild anemia among women
Description
Use Hemocue hemoglobin measure to categorize anemia
Time Frame
At 6 weeks and 6 months
Title
Maternal - Change resulting in severe/moderate/mild anemia by treatment arm
Description
Evaluate individual changes in maternal anemia levels from randomization to 6 months
Time Frame
6 months
Title
Maternal - Hemoglobin concentration by mode of delivery
Description
Evaluate hemoglobin stratified by Cesarean delivery vs. Vaginal delivery
Time Frame
6 months
Title
Maternal - Differences in ferritin and inflammatory markers by treatment group
Description
Using centralized testing, evaluate differences by treatment group
Time Frame
6 weeks, 6 months
Title
Number of neonatal infant deaths
Description
Neonatal or infant death from any cause post-randomization
Time Frame
birth to 6 months
Title
Number of infants with hospitalization
Description
Neonatal or infant hospitalization for any reason
Time Frame
birth to 6 months
Title
Number of women exclusive breastfeeding rate and intend to continue breastfeeding through 12 months post-delivery
Description
Self report of breastfeeding
Time Frame
6 weeks, 6 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elizabeth McClure, PhD
Phone
919 316 3773
Email
mcclure@rti.org
First Name & Middle Initial & Last Name or Official Title & Degree
Tracy Nolen, DrPH
Phone
919 541 7467
Email
tnolen@rti.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard J Derman, MD, MPH
Organizational Affiliation
Thomas Jefferson University, Philadelphia, PA
Official's Role
Principal Investigator
Facility Information:
Facility Name
ICDDRB
City
Dhaka
ZIP/Postal Code
1212
Country
Bangladesh
Facility Name
Kinshasa School of Public Health
City
Kinshasa
Country
Congo, The Democratic Republic of the
Facility Name
INCAP
City
Guatemala City
Country
Guatemala
Facility Name
KLE Society's Jawaharlal Nehru Medical College
City
Belgaum
State/Province
Karnataka
ZIP/Postal Code
590 010
Country
India
Facility Name
Lata Medical Research Foundation
City
Nagpur
Country
India
Facility Name
Moi University School of Medicine
City
Eldoret
ZIP/Postal Code
30100
Country
Kenya
Facility Name
The Aga Khan University
City
Karachi
ZIP/Postal Code
74800
Country
Pakistan
Facility Name
University Teaching Hospital
City
Lusaka
Country
Zambia
12. IPD Sharing Statement
Plan to Share IPD
No
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World Health Organization. Prevalence of anaemia in women of reproductive age (aged 15-49) (%)
URL
http://www.who.int/publications/i/item/WHO-HIS-HSI-Rev.2012.03
Description
World Health Organization. The World Health Organization Quality of Life (WHOQOL). 2012.
URL
http://apps.who.int/iris/bitstream/handle/10665/113048/WHO_NMH_NHD_14.1_eng.pdf;jsessionid=639F57F1C9B591D01291EECF0D9E632A?sequence=1
Description
World Health Organization. WHA65.6. Comprehensive implementation plan on maternal, infant and young child nutrition as passed by the World Health Assembly at the Sixty-fifth World Health Assembly meeting.2012.
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Prevention of Iron Deficiency Anemia Post-delivery
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