Prevention of Iron Deficiency Anemia Post-delivery

NCT05590260 | Completed Phase 3 DMC

• 1 other identifier: CP PRIORITY
• Study Type: interventional
• Target: 4,857
• Locations: 7 countries
• Sites: 8

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 postpartum, the incidence of achieving a non-anemic state (defined as Hb ≥11 g/dL) will be greater among women receiving a single-dose infusion of IV iron than among women receiving standard care with oral iron.

Conditions

Postpartum Anemia

Keywords

Postpartum anemia; Anemia; Postpartum; IV Iron; Iron Tablets; Iron; Pregnancy; Maternal; Infant; Hemaglobin

Outcome Measures

Primary Outcomes (1)

• Maternal non-anemic state (Hb ≥11 g/dL)

  6 weeks post-delivery

Secondary Outcomes (29)

• Change from baseline in serum Hb concentration at 6-weeks postpartum

  6 weeks post-delivery

• Maternal depression at 6-weeks postpartum

  6 weeks post-delivery

• Change from baseline in serum Hb concentration at 6-months postpartum

  6 months post-delivery

• Maternal depression at 6-months postpartum

  6 months post-delivery

• Maternal Fatigue Severity Scale Score > 4

  6 weeks and 6 months post-delivery

Study Arms (2)

IV iron infusion

EXPERIMENTAL

Participants randomized to the IV iron arm will receive a single-dose infusion of IV FCM, to be initiated between 6-48 hours after delivery. All randomized participants will receive 400 mcg of folic acid daily for 6 months postpartum.

Drug: Ferric carboxymaltose (FCM) and folic acid tablets

Oral iron tablets

ACTIVE COMPARATOR

Participants randomized to the oral iron arm will receive 60 mg elemental iron twice daily. Treatment will be initiated between 6-48 hours after delivery and prior to discharge from the facility. After discharge, each participant will take a treatment dose of twice daily for 6 weeks postpartum. At 6 weeks postpartum, serum Hb will be assessed and participants with Hb \< 7.0 g/dL will stop treatment, participants with Hb 7.0-11.9 g/dL will continue taking 60 mg elemental iron twice daily and participants with Hb \> 11.9 g/dL will take 60 mg elemental iron once daily. All randomized participants will receive 400 mcg of folic acid daily for 6 months postpartum.

Drug: Oral iron tablets and folic acid tablets

Interventions

Ferric carboxymaltose (FCM) and folic acid tablets DRUG

FCM 50 mg iron/mL will be in a solution of 20 mL vials for infusion, using a dosage of 20 mg elemental iron per kg body weight, up to a maximum of 1 g, in a single IV infusion over 20-30 minutes. 400 mcg of folic acid daily to 6 months.

IV iron infusion

Oral iron tablets and folic acid tablets DRUG

60 mg elemental iron twice daily to 6-weeks with then once or twice daily (based on Hb at 6-weeks) to 6-months. 400 mcg of folic acid daily to 6 months.

Oral iron tablets

Eligibility Criteria

• Age: 15 Years - 49 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Established pregnancy ≥28 weeks gestational age by last menstrual period and/or clinical assessment and/or ultrasonography
• Age: 18 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 at least 6 months postpartum

You may not qualify if:

• IV Iron infusion received in past 3 weeks
• Prior reaction to IV iron or oral iron or folic acid
• Contraindication to iron supplementation (some examples may include severe allergic states including asthma, hemolytic anemia, allergy, or severe infection)
• Blood transfusion already received or scheduled during the current hospital admission
• Known diagnosis of pre-existing depression or other psychiatric illness
• Major congenital anomaly prior to randomization
• Stillbirth or neonatal loss prior to randomization
• Presenting with symptomatic anemia with dyspnea or fatigue and need for immediate correction
• Known hemoglobinopathy (sickle cell disease or thalassemia)
• Positive malaria RDT prior to randomization (sub-Saharan African sites only)
• Any illness/condition requiring immediate medical care per physician's assessment

Sponsors & Collaborators

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

Study Sites (8)

ICDDRB

Dhaka, 1212, Bangladesh

Location

Kinshasa School of Public Health

Kinshasa, Democratic Republic of the Congo

Location

INCAP

Guatemala City, Guatemala

Location

Lata Medical Research Foundation

Nagpur, India, India

Location

KLE Society's Jawaharlal Nehru Medical College

Belagavi, Karnataka, 590 010, India

Location

Moi University School of Medicine

Eldoret, 30100, Kenya

Location

The Aga Khan University

Karachi, Pakistan, 74800, Pakistan

Location

University Teaching Hospital

Lusaka, Zambia

Location

Related Publications (27)

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• Ali SA, Tikmani SS, Saleem S, Patel AB, Hibberd PL, Goudar SS, Dhaded S, Derman RJ, Moore JL, McClure EM, Goldenberg RL. Hemoglobin concentrations and adverse birth outcomes in South Asian pregnant women: findings from a prospective Maternal and Neonatal Health Registry. Reprod Health. 2020 Nov 30;17(Suppl 2):154. doi: 10.1186/s12978-020-01006-6.

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• Parks S, Hoffman MK, Goudar SS, Patel A, Saleem S, Ali SA, Goldenberg RL, Hibberd PL, Moore J, Wallace D, McClure EM, Derman RJ. Maternal anaemia and maternal, fetal, and neonatal outcomes in a prospective cohort study in India and Pakistan. BJOG. 2019 May;126(6):737-743. doi: 10.1111/1471-0528.15585. Epub 2019 Jan 24.

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• Patel A, Prakash AA, Das PK, Gupta S, Pusdekar YV, Hibberd PL. Maternal anemia and underweight as determinants of pregnancy outcomes: cohort study in eastern rural Maharashtra, India. BMJ Open. 2018 Aug 8;8(8):e021623. doi: 10.1136/bmjopen-2018-021623.

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• Tsai AC, Scott JA, Hung KJ, Zhu JQ, Matthews LT, Psaros C, Tomlinson M. Reliability and validity of instruments for assessing perinatal depression in African settings: systematic review and meta-analysis. PLoS One. 2013 Dec 10;8(12):e82521. doi: 10.1371/journal.pone.0082521. eCollection 2013.

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• Say L, Chou D, Gemmill A, Tuncalp O, Moller AB, Daniels J, Gulmezoglu AM, Temmerman M, Alkema L. Global causes of maternal death: a WHO systematic analysis. Lancet Glob Health. 2014 Jun;2(6):e323-33. doi: 10.1016/S2214-109X(14)70227-X. Epub 2014 May 5.

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• Khaskheli MN, Baloch S, Sheeba A, Baloch S, Khaskheli FK. Iron deficiency anaemia is still a major killer of pregnant women. Pak J Med Sci. 2016 May-Jun;32(3):630-4. doi: 10.12669/pjms.323.9557.

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• Kramer MS, Dahhou M, Vallerand D, Liston R, Joseph KS. Risk factors for postpartum hemorrhage: can we explain the recent temporal increase? J Obstet Gynaecol Can. 2011 Aug;33(8):810-819. doi: 10.1016/S1701-2163(16)34984-2.

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  BACKGROUND

Related Links

• Sison G. The Morisky Medication Adherence Scale: An Overview. 2018
• Auerbach M. Treatment of iron deficiency anemia in adults. 2020
• Electronic Medicines Compendium (eMC). Monofer 100mg/ml solution for injection/infusion.
• Electronic Medicines Compendium (eMC). Ferinject (ferric carboxymaltose).
• World Health Organization. Anemia
• World Health Organization. Maternal health
• Number of non-pregnant women (aged 15-49 years) with anaemia (thousands)
• World Health Organization. Prevalence of anaemia in pregnant women (aged 15-49) (%).
• World Health Organization. Prevalence of anaemia in women of reproductive age (aged 15-49) (%)
• World Health Organization. The World Health Organization Quality of Life (WHOQOL). 2012.
• 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.

MeSH Terms

Conditions

Anemia

Interventions

ferric carboxymaltose; Fosfomycin; Folic Acid; Iron

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Metals, Heavy; Elements; Inorganic Chemicals; Transition Elements; Metals

Study Officials

• Richard J Derman, MD, MPH

  Thomas Jefferson University, Philadelphia, PA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Model Details: 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. The block sizes will be known only by the Data Coordinating Center's personnel.

Study Record Dates

• First Submitted: September 29, 2022
• First Posted: October 21, 2022
• Study Start: May 30, 2023
• Primary Completion: March 10, 2025
• Study Completion: July 28, 2025
• Last Updated: July 1, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

BA (1); IN (2); PA (1); KE (1); ZA (1); GU (1); DE (1)