Clinical trial NCT05590260: Prevention of Iron Deficiency Anemia Post-delivery
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
Overall status: RECRUITING
Phase: PHASE3
Conditions: Postpartum Anemia
Keywords: Postpartum anemia
Anemia
Postpartum
IV Iron
Iron Tablets
Iron
Pregnancy
Maternal
Infant
Hemaglobin
Lead sponsor: NICHD Global Network for Women's and Children's Health
Sponsor class: NETWORK
Collaborators: name: Thomas Jefferson University
name: University of North Carolina, Chapel Hill
name: Kinshasa School of Public Health
name: University of Alabama at Birmingham
name: University Teaching Hospital, Lusaka, Zambia
name: University of Colorado, Denver
name: Institute of Nutrition of Central America and Panama
name: University of Virginia
name: International Centre for Diarrhoeal Disease Research, Bangladesh
name: Columbia University
name: Aga Khan University
name: Boston University
name: Lata Medical Research Foundation, Nagpur
name: Indiana University
name: Moi University
name: RTI International
name: Bill and Melinda Gates Foundation
name: KLE University Jawaharlal Nehru Medical College
First posted: 2022-10-21
Enrollment: 4800
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 49
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention 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 Data Coordinating Center's personnel.
Primary purpose: TREATMENT

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 (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.

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

Primary outcomes:
measure: Number of women with non-anemic hemaglobin levels (Hb >11 g/dL)
timeFrame: 6 weeks post-delivery
Secondary outcomes:
measure: Number of maternal deaths
timeFrame: From delivery to 6 months post-delivery
measure: Number of women who receive a blood transfusion post-discharge
timeFrame: through 6 months post-delivery
measure: Number of women who experience a postpartum hemorrhage requiring transfusion or major surgery
timeFrame: from intervention through 6 weeks post-delivery
measure: Number of women with hospitalization
timeFrame: through 6 months post-delivery
measure: Number of women with documentation of postpartum complications
timeFrame: Randomization through 6 weeks post delivery
measure: Number of women screening positive for postpartum depression
timeFrame: 6 weeks and 6 months
measure: Number of women with severe fatigue
timeFrame: 6 weeks and 6 months
measure: Differences between treatment groups in infant-mother bonding scale scores
timeFrame: 6 weeks
measure: Differences in quality of life assessment scores
timeFrame: 6 weeks and 6 months
measure: Prevalence of severe/moderate/mild anemia among women
timeFrame: 6 weeks and 6 months
measure: Maternal - Change resulting in severe/moderate/mild anemia by treatment arm
timeFrame: 6 months
measure: Maternal - Hemoglobin concentration by mode of delivery
timeFrame: 6 months
measure: Maternal - Differences in ferritin and inflammatory markers by treatment group
timeFrame: 6 weeks, 6 months
measure: Number of neonatal infant deaths
timeFrame: birth to 6 months
measure: Number of infants with hospitalization
timeFrame: birth to 6 months
measure: Number of women exclusive breastfeeding rate and intend to continue breastfeeding through 12 months post-delivery
timeFrame: 6 weeks and 6 months
Other outcomes:
Locations:
city: Dhaka
country: Bangladesh
facility: ICDDRB
city: Kinshasa
country: Congo, The Democratic Republic of the
facility: Kinshasa School of Public Health
city: Guatemala City
country: Guatemala
facility: INCAP
city: Belgaum
country: India
facility: KLE Society's Jawaharlal Nehru Medical College
state: Karnataka
city: Nagpur
country: India
facility: Lata Medical Research Foundation
city: Eldoret
country: Kenya
facility: Moi University School of Medicine
city: Karachi
country: Pakistan
facility: The Aga Khan University
city: Lusaka
country: Zambia
facility: University Teaching Hospital
Study officials:
affiliation: Thomas Jefferson University, Philadelphia, PA
name: Richard J Derman, MD, MPH
role: PRINCIPAL_INVESTIGATOR
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