Postpartum AnemiaPhase 3PRIORITYNCT05590260
Prevention of Iron Deficiency Anemia Post-delivery
A Phase 3 study testing Ferric carboxymaltose (FCM) and folic acid tablets and Oral iron tablets and folic acid tablets in people with Postpartum Anemia, run by NICHD Global Network for Women's and Children's Health at 8 sites in 7 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 49 years, women only
- Conditions the study is for
- Postpartum Anemia
- What is being tested?
- Ferric carboxymaltose (FCM) and folic acid tablets and Oral iron tablets and folic acid tablets
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,857 participants
- Where
- 8 sitesin 7 countries
- Study dates
- 30 May 2023to 28 Jul 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 49 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
8 sites in 7 countries.
8 sites in 7 countries
India2 sites
KLE Society's Jawaharlal Nehru Medical College
Belagavi, Karnataka, 590 010
Lata Medical Research Foundation
Nagpur, India
Democratic Republic of the Congo1 site
Kinshasa School of Public Health
Kinshasa
About this study
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
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.
Read the 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. Following informed consent, women with moderate anemia, defined as Hb concentration 7-9.9 g/dL at enrollment, will be randomized to one of two study arms and subsequently receive a single-dose infusion of IV iron within 6-48 hours of delivery and prior to discharge or be given standard care consisting of the provision of tablets containing 60 mg of elemental iron to be taken twice daily for 6 weeks postpartum. Folic acid (400 mcg) will be given daily for 6 weeks postpartum to all participants as per WHO guidelines. The trial's primary endpoint is maternal non-anemic state (Hb ≥11 g/dL) at 6 weeks postpartum. Oral iron treatment with folic acid to 6 months postpartum will be dependent on maternal anemic state at 6 weeks postpartum.
Secondary endpoints include maternal functional outcomes and hematological/biochemical measures of iron status, and maternal and neonatal/infant clinical outcomes. Hb, as well as markers of iron status and inflammatory markers, will be measured at 6 weeks and 6 months postpartum. Other secondary endpoints of interest include intrapartum complications, post-discharge blood transfusions, maternal and neonatal/infant hospitalizations, and maternal and neonatal/infant mortality through 6 months postpartum, as well as rates of exclusive breastfeeding at 6 weeks, 3 months, and 6 months postpartum.
Validated instruments will be used to explore the possible impact of IV iron versus oral iron treatment for IDA on maternal functional outcomes at 6 weeks and 6 months postpartum. Maternal depression, based on the score on the Edinburgh Postnatal Depression Scale (EPDS), will be assessed at 6 weeks and 6 months postpartum. Fatigue is one of the most common symptoms of anemia and will be assessed at 6 weeks and 6 months postpartum using the modified 5-item version of the Maternal Fatigue Severity Scale (FSS-5R). Maternal quality of life will be measured at 6 weeks and 6 months postpartum with the World Health Organization Quality of Life (WHOQOL) score, an assessment tool developed to be applicable cross culturally. Maternal-infant bonding will be measured at 6 weeks postpartum using the Mother-to-Infant Bonding Scale (MIBS).
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.
- Conditions
- Postpartum Anemia
- Being tested
- Ferric carboxymaltose (FCM) and folic acid tablets, Oral iron tablets and folic acid tablets
- Keywords
- Postpartum anemia, Anemia, Postpartum, IV Iron, Iron Tablets, Iron, Pregnancy, Maternal, Infant, Hemaglobin
- Medical subject headings
- Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ferric carboxymaltose (FCM) and folic acid tabletsDrug
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.
Oral iron tablets and folic acid tabletsDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Oral iron tablets and folic acid tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal non-anemic state (Hb ≥11 g/dL)
Measured: 6 weeks post-delivery
Secondary outcomes (29)
Change from baseline in serum Hb concentration at 6-weeks postpartum
Serum Hb at baseline subtracted from serum Hb at 6 weeks. Key secondary outcome.
Measured: 6 weeks post-delivery
Maternal depression at 6-weeks postpartum
Measured by Edinburgh Postnatal Depression Scale score > 10. A score greater than 10 indicates a higher likelihood of depression. Key secondary outcome.
Measured: 6 weeks post-delivery
Change from baseline in serum Hb concentration at 6-months postpartum
Serum Hb at baseline subtracted from serum Hb at 6 months. Key secondary outcome.
Measured: 6 months post-delivery
Maternal depression at 6-months postpartum
Measured by Edinburgh Postnatal Depression (EPDS) Scale score > 10. A score greater than 10 indicates a higher likelihood of depression. Key secondary outcome.
Measured: 6 months post-delivery
Maternal Fatigue Severity Scale Score > 4
Measured by the Maternal Fatigue Severity Scale (FSS-5R) > 4. A score > 4 indicates maternal fatigue.
Measured: 6 weeks and 6 months post-delivery
Mother-to-Infant Bonding Scale Score ≥ 4
Measured by the Mother-to-Infant Bonding Scale (MIBS) ≥ 4. A score ≥ 4 indicates worse mother to infant bonding.
Measured: 6 weeks post-delivery
WHOQOL-BREF Overall Perception of Quality of Life score
The WHOQOL-BREF overall perception of quality of life score is the response to question 1 from the WHOQOL-BREF survey. How would you rate your quality of life? (Very poor=1; Poor=2; Neither poor nor good=3; Good=4; Very good=5)
Measured: 6 weeks and 6 months post-delivery
WHOQOL-BREF Overall Perception of Health score
The WHOQOL-BREF overall perception of heath score is the response to question 2 from the WHOQOL-BREF survey. How satisfied are you with your health? (Very poor=1; Poor=2; Neither poor nor good=3; Good=4; Very good=5)
Measured: 6 weeks and 6 months post-delivery
WHOQOL-BREF Physical Domain Score
The WHOQOL-BREF physical domain score is calculated as:
((6-Q3) + (6-Q4) + Q10 + Q15 + Q16 + Q17 + Q18)/7 x 4. If a participant is missing 2 or more questions in the physical domain or 6 or more questions in the WHOQOL-BREF assessment, then the WHOQOL-BREF physical domain score is set to missing. In the case where up to two items are missing, the mean of other items in the domain is substituted for the missing question. The score is transformed to a 0-100 scale by applying the following formula: (Score-4)*(100/16).
Measured: 6 weeks and 6 months post-delivery
WHOQOL-BREF Psychological Domain Score
The WHOQOL-BREF psychological domain score is calculated as:
(Q5 + Q6 + Q7 + Q11 + Q19 + (6-Q26))/6 x 4. If a participant is missing 2 or more questions in the psychological domain or 6 or more questions in the WHOQOL-BREF assessment, then the WHOQOL-BREF psychological domain score is set to missing. In the case where up to two items are missing, the mean of other items in the domain is substituted for the missing question. The score is transformed to a 0-100 scale by applying the following formula: (Score-4)*(100/16).
Measured: 6 weeks and 6 months post-delivery
WHOQOL-BREF Social Relationships Domain Score
The WHOQOL-BREF social relationships domain score is calculated as:
(Q20 + Q21 + Q22)/3 x 4. If a participant is missing 2 or more questions in the social relationships domain or 6 or more questions in the WHOQOL-BREF assessment, then the WHOQOL-BREF social relationships domain score is set to missing. In the case where one item is missing, the mean of other items in the domain is substituted for the missing question. The score is transformed to a 0-100 scale by applying the following formula: (Score-4)*(100/16).
Measured: 6 weeks and 6 months post-delivery
WHOQOL-BREF Environment Domain Score
The WHOQOL-BREF environment domain score is calculated as:
(Q8 + Q9 + Q12 + Q13 + Q14 + Q23 + Q24 + Q25)/8 x 4. If a participant is missing 3 or more questions in the environment domain or 6 or more questions in the WHOQOL-BREF assessment, then the WHOQOL-BREF environment domain score is set to missing. In the case where up to two items are missing, the mean of other items in the domain is substituted for the missing questions. The score is transformed to a 0-100 scale by applying the following formula: (Score-4)*(100/16).
Measured: 6 weeks and 6 months post-delivery
Change from baseline in serum ferritin concentration
Serum ferritin concentration at baseline subtracted from serum ferritin concentration at 6 weeks and 6 months.
Measured: 6 weeks and 6 months post-delivery
Change from baseline in serum soluble transferrin receptor concentration
Serum soluble transferrin receptor at baseline subtracted from serum soluble transferrin receptor at 6 weeks and 6 months.
Measured: 6 weeks and 6 months post-delivery
Maternal non-anemic state (Hb ≥11.5 g/dL)
Measured: 6 weeks and 6 months post-delivery
Maternal non-anemic state (Hb ≥12.0 g/dL)
Measured: 6 weeks and 6 months post-delivery
Anemic state
Anemic state at 6 weeks postpartum defined as no anemia for Hb ≥ 11.0 g/dL, mild anemia for Hb 10.0-10.9 g/dL, moderate anemia for 7.0-9.9 g/dL and severe anemia for Hb < 7.0 g/dL. Anemic state at 6 months postpartum defined as no anemia for Hb ≥ 12.0 g/dL, mild anemia for Hb 10.0-11.9 g/dL, moderate anemia for 7.0-9.9 g/dL and severe anemia for Hb < 7.0 g/dL.
Measured: 6 weeks and 6 months post-delivery
Change from baseline in anemic state
Defined as 'Better' if the participant's Hb measurement is > 9.9 g/dL, 'No change' if the participant's Hb measurement is 7.0-9.9 g/dL, and 'Worse' if the participant's Hb measurement is < 7.0 g/dL.
Measured: 6 weeks and 6 months post-delivery
Maternal mortality
Maternal death from any cause
Measured: randomization to 6 months post-delivery
Post-discharge blood transfusion
Blood transfusion given to mother after delivery facility discharge
Measured: discharge from delivery facility to 6 months post-delivery
Postpartum hemorrhage requiring blood transfusion or major surgery
Measured: randomization to 6 weeks post-delivery
Post-discharge maternal hospitalization
Maternal admission to facility after delivery facility discharge
Measured: discharge from delivery facility to 6 months post-delivery
Neonatal/infant mortality
Neonatal/infant death from any cause
Measured: randomization to 6 months
Post-discharge neonatal/infant hospitalization
Neonatal/infant admission to facility after delivery facility discharge
Measured: discharge from delivery facility to 6 months post-delivery
Exclusive breastfeeding
Based on WHO/UNICEF definition that measures exclusive feeding with breast milk during the previous day.
Measured: 6 weeks, 3 months and 6 months post-delivery
Hypophosphatemia at 6-weeks postpartum
Measured by serum phosphate concentration < 2.5 mg/dL.
Measured: 6 weeks post-delivery
Hypophosphatemia at 6-months postpartum
Measured by serum phosphate concentration < 2.5 mg/dL at 6 months among participants with hypophosphatemia at 6 weeks.
Measured: 6 months post-delivery
Short-term safety outcomes
Measured by at least one serious adverse event reported.
Measured: randomization to 6 weeks post-delivery
All Safety outcomes
Measured by at least one serious adverse event reported.
Measured: randomization to 6 months post-delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2022
- Study start30 May 2023
- Primary completion10 Mar 2025
- Study completion28 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (27)Papers the sponsor has linked to this study.
- Other trials for Postpartum AnemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- 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. The block sizes will be known only by the Data Coordinating Center's personnel.
- Masking
- None (open label)
- Enrolment
- 4,857 participants (actual)
Sponsor and investigators
- Lead sponsor
- NICHD Global Network for Women's and Children's Health
- Sponsor type
- Research network
- Collaborators
- Thomas Jefferson University, University of North Carolina, Chapel Hill, 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
- Responsible party
- Sponsor
- Investigators
- Richard J Derman, MD, MPH, Principal investigator, Thomas Jefferson University, Philadelphia, PA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05590260
- Sponsor's protocol ID
- CP PRIORITY
- Acronym
- PRIORITY
- Status last verified
- Jun 2026
- First submitted
- 29 Sep 2022
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30578747Matsunaga 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.
PubMed 33388520Taylor 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.
PubMed 15868385Cox 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.
PubMed 3651732Fellmeth 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.
PubMed 33879130Shrestha 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.
PubMed 27044437Ali 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.
PubMed 33256770Jessani 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.
PubMed 33629490Parks 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.
PubMed 30554474Patel 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.
PubMed 30093518Rioux 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.
PubMed 16759433Babu 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.
PubMed 29770322Tsai 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.
PubMed 24340036Say 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.
PubMed 25103301Khaskheli 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.
PubMed 27375704
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05590260
- Acronym / sponsor ID
- PRIORITY / CP PRIORITY
- Conditions
- Postpartum Anemia
- Keywords
- Postpartum anemia, Anemia, Postpartum, IV Iron, Iron Tablets, Iron, Pregnancy, Maternal
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,857 participants (actual)
- Lead sponsor
- NICHD Global Network for Women's and Children's HealthResearch network
- Collaborators
- Thomas Jefferson University, University of North Carolina, Chapel Hill, 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
- Study start
- 30 May 2023 (actual)
- Primary completion
- 10 Mar 2025 (actual)
- Study completion
- 28 Jul 2025 (actual)
- First posted
- 21 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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. Following informed consent, women with moderate anemia, defined as Hb concentration 7-9.9 g/dL at enrollment, will be randomized to one of two study arms and subsequently receive a single-dose infusion of IV iron within 6-48 hours of delivery and prior to discharge or be given standard care consisting of the provision of tablets containing 60 mg of elemental iron to be taken twice daily for 6 weeks postpartum. Folic acid (400 mcg) will be given daily for 6 weeks postpartum to all participants as per WHO guidelines. The trial's primary endpoint is maternal non-anemic state (Hb ≥11 g/dL) at 6 weeks postpartum. Oral iron treatment with folic acid to 6 months postpartum will be dependent on maternal anemic state at 6 weeks postpartum.
Secondary endpoints include maternal functional outcomes and hematological/biochemical measures of iron status, and maternal and neonatal/infant clinical outcomes. Hb, as well as markers of iron status and inflammatory markers, will be measured at 6 weeks and 6 months postpartum. Other secondary endpoints of interest include intrapartum complications, post-discharge blood transfusions, maternal and neonatal/infant hospitalizations, and maternal and neonatal/infant mortality through 6 months postpartum, as well as rates of exclusive breastfeeding at 6 weeks, 3 months, and 6 months postpartum.
Validated instruments will be used to explore the possible impact of IV iron versus oral iron treatment for IDA on maternal functional outcomes at 6 weeks and 6 months postpartum. Maternal depression, based on the score on the Edinburgh Postnatal Depression Scale (EPDS), will be assessed at 6 weeks and 6 months postpartum. Fatigue is one of the most common symptoms of anemia and will be assessed at 6 weeks and 6 months postpartum using the modified 5-item version of the Maternal Fatigue Severity Scale (FSS-5R). Maternal quality of life will be measured at 6 weeks and 6 months postpartum with the World Health Organization Quality of Life (WHOQOL) score, an assessment tool developed to be applicable cross culturally. Maternal-infant bonding will be measured at 6 weeks postpartum using the Mother-to-Infant Bonding Scale (MIBS).
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- 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. The block sizes will be known only by the Data Coordinating Center's personnel.
| Arm | Type | Receives |
|---|---|---|
| IV iron infusion | Experimental | Drug: Ferric carboxymaltose (FCM) and folic acid tabletsParticipants 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. |
| Oral iron tablets | Active comparator | Drug: Oral iron tablets and folic acid tabletsParticipants 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. |
Who may qualify
- Ages
- 15 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ferric carboxymaltose (FCM) and folic acid tabletsFCM 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. | Drug | IV iron infusion |
| Oral iron tablets and folic acid tablets60 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. | Drug | Oral iron tablets |
Primary outcome
Maternal non-anemic state (Hb ≥11 g/dL)
Time frame: 6 weeks post-delivery
29 secondary outcomes
Change from baseline in serum Hb concentration at 6-weeks postpartum
Time frame: 6 weeks post-delivery
Maternal depression at 6-weeks postpartum
Time frame: 6 weeks post-delivery
Change from baseline in serum Hb concentration at 6-months postpartum
Time frame: 6 months post-delivery
Maternal depression at 6-months postpartum
Time frame: 6 months post-delivery
Maternal Fatigue Severity Scale Score > 4
Time frame: 6 weeks and 6 months post-delivery
Mother-to-Infant Bonding Scale Score ≥ 4
Time frame: 6 weeks post-delivery
WHOQOL-BREF Overall Perception of Quality of Life score
Time frame: 6 weeks and 6 months post-delivery
WHOQOL-BREF Overall Perception of Health score
Time frame: 6 weeks and 6 months post-delivery
WHOQOL-BREF Physical Domain Score
Time frame: 6 weeks and 6 months post-delivery
WHOQOL-BREF Psychological Domain Score
Time frame: 6 weeks and 6 months post-delivery
WHOQOL-BREF Social Relationships Domain Score
Time frame: 6 weeks and 6 months post-delivery
WHOQOL-BREF Environment Domain Score
Time frame: 6 weeks and 6 months post-delivery
Change from baseline in serum ferritin concentration
Time frame: 6 weeks and 6 months post-delivery
Change from baseline in serum soluble transferrin receptor concentration
Time frame: 6 weeks and 6 months post-delivery
Maternal non-anemic state (Hb ≥11.5 g/dL)
Time frame: 6 weeks and 6 months post-delivery
Maternal non-anemic state (Hb ≥12.0 g/dL)
Time frame: 6 weeks and 6 months post-delivery
Anemic state
Time frame: 6 weeks and 6 months post-delivery
Change from baseline in anemic state
Time frame: 6 weeks and 6 months post-delivery
Maternal mortality
Time frame: randomization to 6 months post-delivery
Post-discharge blood transfusion
Time frame: discharge from delivery facility to 6 months post-delivery
Postpartum hemorrhage requiring blood transfusion or major surgery
Time frame: randomization to 6 weeks post-delivery
Post-discharge maternal hospitalization
Time frame: discharge from delivery facility to 6 months post-delivery
Neonatal/infant mortality
Time frame: randomization to 6 months
Post-discharge neonatal/infant hospitalization
Time frame: discharge from delivery facility to 6 months post-delivery
Exclusive breastfeeding
Time frame: 6 weeks, 3 months and 6 months post-delivery
Hypophosphatemia at 6-weeks postpartum
Time frame: 6 weeks post-delivery
Hypophosphatemia at 6-months postpartum
Time frame: 6 months post-delivery
Short-term safety outcomes
Time frame: randomization to 6 weeks post-delivery
All Safety outcomes
Time frame: randomization to 6 months post-delivery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
- Background: PubMed 30578747Sultan 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.
- Background: PubMed 33388520Matsunaga 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.
- Background: PubMed 15868385Taylor 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.
- Background: PubMed 3651732Cox 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.
- Background: PubMed 33879130Fellmeth 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.
- Background: PubMed 27044437Shrestha 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.
- Background: PubMed 33256770Ali 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.
- Background: PubMed 33629490Jessani 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.
- Background: PubMed 30554474Parks 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.
- Background: PubMed 30093518Patel 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.
- Background: PubMed 16759433Rioux 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.
- Background: PubMed 29770322Babu 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.
- Sison G. The Morisky Medication Adherence Scale: An Overview. 2018Link provided by the sponsor.
- Auerbach M. Treatment of iron deficiency anemia in adults. 2020Link provided by the sponsor.
- Electronic Medicines Compendium (eMC). Monofer 100mg/ml solution for injection/infusion.Link provided by the sponsor.
- Electronic Medicines Compendium (eMC). Ferinject (ferric carboxymaltose).Link provided by the sponsor.
- World Health Organization. AnemiaLink provided by the sponsor.
- World Health Organization. Maternal healthLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard J Derman, MD, MPH principal investigator
Thomas Jefferson University, Philadelphia, PA
8 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ferric carboxymaltose (FCM) and folic acid tablets and Oral iron tablets and folic acid tablets in people with Postpartum Anemia, run by NICHD Global Network for Women's and Children's Health at 8 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in India, Bangladesh, Democratic Republic of the Congo, Guatemala, Kenya and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maternal non-anemic state (Hb ≥11 g/dL) (time frame: 6 weeks post-delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05590260, which also lists 27 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2026.