Prevention of Iron Deficiency Anemia Post-delivery

NCT05590260 | Unknown Phase 3 DMC

• 1 other identifier: CP PRIORITY
• Study Type: interventional
• Target: 4,800
• 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 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.

Conditions

Postpartum Anemia

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Number of women with non-anemic hemaglobin levels (Hb >11 g/dL)

  Hemoglobin measure

  6 weeks post-delivery

Secondary Outcomes (16)

• Number of maternal deaths

  From delivery to 6 months post-delivery

• Number of women who receive a blood transfusion post-discharge

  through 6 months post-delivery

• Number of women who experience a postpartum hemorrhage requiring transfusion or major surgery

  from intervention through 6 weeks post-delivery

• Number of women with hospitalization

  through 6 months post-delivery

• Number of women with documentation of postpartum complications

  Randomization through 6 weeks post delivery

Study Arms (2)

IV iron arm

EXPERIMENTAL

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

Oral iron comparator arm

ACTIVE COMPARATOR

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

Interventions

IV iron infusion DRUG

single-dose IV iron infusion

IV iron arm

Oral iron tablets DRUG

60 mg of elemental iron

Oral iron comparator arm

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 \>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

You may not qualify if:

• 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

Sponsors & Collaborators

• NICHD Global Network for Women's and Children's Health: lead
• 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
• International Centre for Diarrhoeal Disease Research, Bangladesh: collaborator
• Columbia University: collaborator
• Aga Khan University: collaborator
• Boston 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

Study Sites (8)

ICDDRB

Dhaka, 1212, Bangladesh

RECRUITING

Kinshasa School of Public Health

Kinshasa, Democratic Republic of the Congo

RECRUITING

INCAP

Guatemala City, Guatemala

NOT YET RECRUITING

KLE Society's Jawaharlal Nehru Medical College

Belagavi, Karnataka, 590 010, India

RECRUITING

Lata Medical Research Foundation

Nagpur, India

RECRUITING

Moi University School of Medicine

Eldoret, 30100, Kenya

NOT YET RECRUITING

The Aga Khan University

Karachi, 74800, Pakistan

NOT YET RECRUITING

University Teaching Hospital

Lusaka, Zambia

NOT YET RECRUITING

Related Publications (27)

• Sultan P, Bampoe S, Shah R, Guo N, Estes J, Stave C, Goodnough LT, Halpern S, Butwick AJ. Oral vs intravenous iron therapy for postpartum anemia: a systematic review and meta-analysis. Am J Obstet Gynecol. 2019 Jul;221(1):19-29.e3. doi: 10.1016/j.ajog.2018.12.016. Epub 2018 Dec 19.

  PMID: 30578747 BACKGROUND

• Matsunaga A, Ohashi Y, Sakanashi K, Kitamura T. Factor structure of the Postpartum Bonding Questionnaire: Configural invariance and measurement invariance across postpartum time periods. J Psychiatr Res. 2021 Mar;135:1-7. doi: 10.1016/j.jpsychires.2020.11.017. Epub 2020 Nov 9.

  PMID: 33388520 BACKGROUND

• Taylor A, Atkins R, Kumar R, Adams D, Glover V. A new Mother-to-Infant Bonding Scale: links with early maternal mood. Arch Womens Ment Health. 2005 May;8(1):45-51. doi: 10.1007/s00737-005-0074-z. Epub 2005 May 4.

  PMID: 15868385 BACKGROUND

• Cox JL, Holden JM, Sagovsky R. Detection of postnatal depression. Development of the 10-item Edinburgh Postnatal Depression Scale. Br J Psychiatry. 1987 Jun;150:782-6. doi: 10.1192/bjp.150.6.782.

  PMID: 3651732 BACKGROUND

• Fellmeth G, Harrison S, Opondo C, Nair M, Kurinczuk JJ, Alderdice F. Validated screening tools to identify common mental disorders in perinatal and postpartum women in India: a systematic review and meta-analysis. BMC Psychiatry. 2021 Apr 20;21(1):200. doi: 10.1186/s12888-021-03190-6.

  PMID: 33879130 BACKGROUND

• Shrestha SD, Pradhan R, Tran TD, Gualano RC, Fisher JR. Reliability and validity of the Edinburgh Postnatal Depression Scale (EPDS) for detecting perinatal common mental disorders (PCMDs) among women in low-and lower-middle-income countries: a systematic review. BMC Pregnancy Childbirth. 2016 Apr 4;16:72. doi: 10.1186/s12884-016-0859-2.

  PMID: 27044437 BACKGROUND

• 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.

  PMID: 33256770 BACKGROUND

• Jessani S, Saleem S, Hoffman MK, Goudar SS, Derman RJ, Moore JL, Garces A, Figueroa L, Krebs NF, Okitawutshu J, Tshefu A, Bose CL, Mwenechanya M, Chomba E, Carlo WA, Das PK, Patel A, Hibberd PL, Esamai F, Liechty EA, Bucher S, Nolen TL, Koso-Thomas M, Miodovnik M, McClure EM, Goldenberg RL. Association of haemoglobin levels in the first trimester and at 26-30 weeks with fetal and neonatal outcomes: a secondary analysis of the Global Network for Women's and Children's Health's ASPIRIN Trial. BJOG. 2021 Aug;128(9):1487-1496. doi: 10.1111/1471-0528.16676. Epub 2021 Apr 12.

  PMID: 33629490 BACKGROUND

• 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.

  PMID: 30554474 BACKGROUND

• 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.

  PMID: 30093518 BACKGROUND

• Rioux FM, Savoie N, Allard J. Is there a link between postpartum anemia and discontinuation of breastfeeding? Can J Diet Pract Res. 2006 Summer;67(2):72-6. doi: 10.3148/67.2.2006.72.

  PMID: 16759433 BACKGROUND

• Babu GR, Murthy GVS, Singh N, Nath A, Rathnaiah M, Saldanha N, Deepa R, Kinra S. Sociodemographic and Medical Risk Factors Associated With Antepartum Depression. Front Public Health. 2018 May 2;6:127. doi: 10.3389/fpubh.2018.00127. eCollection 2018.

  PMID: 29770322 BACKGROUND

• 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.

  PMID: 24340036 BACKGROUND

• 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.

  PMID: 25103301 BACKGROUND

• 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.

  PMID: 27375704 BACKGROUND

• 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.

  PMID: 21846436 BACKGROUND

• Markova V, Norgaard A, Jorgensen KJ, Langhoff-Roos J. Treatment for women with postpartum iron deficiency anaemia. Cochrane Database Syst Rev. 2015 Aug 13;2015(8):CD010861. doi: 10.1002/14651858.CD010861.pub2.

  PMID: 26270434 BACKGROUND

• Vanobberghen F, Lweno O, Kuemmerle A, Mwebi KD, Asilia P, Issa A, Simon B, Mswata S, Schmidlin S, Glass TR, Abdulla S, Daubenberger C, Tanner M, Meyer-Monard S. Efficacy and safety of intravenous ferric carboxymaltose compared with oral iron for the treatment of iron deficiency anaemia in women after childbirth in Tanzania: a parallel-group, open-label, randomised controlled phase 3 trial. Lancet Glob Health. 2021 Feb;9(2):e189-e198. doi: 10.1016/S2214-109X(20)30448-4. Epub 2020 Nov 24.

  PMID: 33245866 BACKGROUND

• Skevington SM. Measuring quality of life in Britain: introducing the WHOQOL-100. J Psychosom Res. 1999 Nov;47(5):449-59. doi: 10.1016/s0022-3999(99)00051-3.

  PMID: 10624843 BACKGROUND

• Young CA, Mills R, Al-Chalabi A, Burke G, Chandran S, Dick DJ, Ealing J, Hanemann CO, Harrower T, Mcdermott CJ, Majeed T, Pinto A, Talbot K, Walsh J, Williams TL, Tennant A; TONiC study group. Measuring quality of life in ALS/MND: validation of the WHOQOL-BREF. Amyotroph Lateral Scler Frontotemporal Degener. 2020 Jun 27;21(5-6):364-372. doi: 10.1080/21678421.2020.1752244.

  PMID: 32597226 BACKGROUND

• Auerbach M, Macdougall I. The available intravenous iron formulations: History, efficacy, and toxicology. Hemodial Int. 2017 Jun;21 Suppl 1:S83-S92. doi: 10.1111/hdi.12560. Epub 2017 Mar 29.

  PMID: 28371203 BACKGROUND

• Chertow GM, Mason PD, Vaage-Nilsen O, Ahlmen J. Update on adverse drug events associated with parenteral iron. Nephrol Dial Transplant. 2006 Feb;21(2):378-82. doi: 10.1093/ndt/gfi253. Epub 2005 Nov 11.

  PMID: 16286429 BACKGROUND

• Gomez-Ramirez S, Shander A, Spahn DR, Auerbach M, Liumbruno GM, Vaglio S, Munoz M. Prevention and management of acute reactions to intravenous iron in surgical patients. Blood Transfus. 2019 Mar;17(2):137-145. doi: 10.2450/2018.0156-18. Epub 2018 Oct 16.

  PMID: 30418128 BACKGROUND

• Rampton D, Folkersen J, Fishbane S, Hedenus M, Howaldt S, Locatelli F, Patni S, Szebeni J, Weiss G. Hypersensitivity reactions to intravenous iron: guidance for risk minimization and management. Haematologica. 2014 Nov;99(11):1671-6. doi: 10.3324/haematol.2014.111492.

  PMID: 25420283 BACKGROUND

• Tolkien Z, Stecher L, Mander AP, Pereira DI, Powell JJ. Ferrous sulfate supplementation causes significant gastrointestinal side-effects in adults: a systematic review and meta-analysis. PLoS One. 2015 Feb 20;10(2):e0117383. doi: 10.1371/journal.pone.0117383. eCollection 2015.

  PMID: 25700159 BACKGROUND

• Auerbach M, Macdougall IC. Safety of intravenous iron formulations: facts and folklore. Blood Transfus. 2014 Jul;12(3):296-300. doi: 10.2450/2014.0094-14. No abstract available.

  PMID: 25074787 BACKGROUND

• Rebecca Giallo, Catherine Wade & Mandy Kienhuis (2014) Fatigue in mothers of infants and young children: factor structure of the fatigue assessment scale, Fatigue: Biomedicine, Health & Behavior, 2:3, 119-131, DOI: 10.1080/21641846.2014.925326

  BACKGROUND

Related Links

• 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
• 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

Iron

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Metals, Heavy; Elements; Inorganic Chemicals; Transition Elements; Metals

Study Officials

• Richard J Derman, MD, MPH

  Thomas Jefferson University, Philadelphia, PA

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elizabeth McClure, PhD

CONTACT

919 316 3773; mcclure@rti.org

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. 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.

Study Record Dates

• First Submitted: September 29, 2022
• First Posted: October 21, 2022
• Study Start: May 30, 2023
• Primary Completion: October 1, 2025
• Study Completion: December 1, 2025
• Last Updated: December 11, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

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