A Phase 3 interventional study of Ferric carboxymaltose (FCM) and folic acid tablets and Oral iron tablets and folic acid tablets in Postpartum Anemia, sponsored by NICHD Global Network for Women's and Children's Health. Completed at 8 sites in 7 countries. Open to female participants aged 15 Years to 49 Years. Per ClinicalTrials.gov, last updated 2026-07-01.
Sponsored by NICHD Global Network for Women's and Children's Health · Phase 3, Interventional, and Treatment
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.
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.
1,810 studies on the registry are indexed under Anemia; 215 are open to participants now.
This study's enrollment of 4,857 is above the median of 117 across 1,336 interventional studies indexed under Anemia.
Browse Anemia studies →NICHD Global Network for Women's and Children's Health is the lead sponsor of 33 studies on the registry; 3 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
Drug pages: Ferric carboxymaltose · Folic Acid
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.
Drug pages: Iron · Folic Acid
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.
Maternal non-anemic state (Hb ≥11 g/dL)
Time frame: 6 weeks post-delivery
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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)
Time frame: 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)
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
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
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.
Time frame: 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.
Time frame: 6 weeks and 6 months post-delivery
Maternal mortality
Maternal death from any cause
Time frame: randomization to 6 months post-delivery
Post-discharge blood transfusion
Blood transfusion given to mother after delivery facility discharge
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
Maternal admission to facility after delivery facility discharge
Time frame: discharge from delivery facility to 6 months post-delivery
Neonatal/infant mortality
Neonatal/infant death from any cause
Time frame: randomization to 6 months
Post-discharge neonatal/infant hospitalization
Neonatal/infant admission to facility after delivery facility discharge
Time frame: 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.
Time frame: 6 weeks, 3 months and 6 months post-delivery
Hypophosphatemia at 6-weeks postpartum
Measured by serum phosphate concentration \< 2.5 mg/dL.
Time frame: 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.
Time frame: 6 months post-delivery
Short-term safety outcomes
Measured by at least one serious adverse event reported.
Time frame: randomization to 6 weeks post-delivery
All Safety outcomes
Measured by at least one serious adverse event reported.
Time frame: randomization to 6 months post-delivery
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Studies of the drugs tested here: Ferric carboxymaltose · Folic Acid
NICHD Global Network for Women's and Children's Health