Iron Deficiency AnemiaPhase 3IVIDA2NCT05462704
Intravenous Versus Oral Iron for Treating Iron-Deficiency Anemia in Pregnancy
A Phase 3 study testing Ferric derisomaltose and Ferrous sulfate in people with Iron Deficiency Anemia and Pregnancy, run by Women and Infants Hospital of Rhode Island at 8 sites in United States.
Trial summary
Double blind, placebo controlled, multicenter randomized trial in pregnant women in the U.S. (N=300) to test the central hypothesis that IV iron in pregnant women with IDA (Hb<11 g/dL and ferritin<30 ng/mL) at 13 - 30 weeks will be effective, safe and cost-effective in reducing severe maternal morbidity-as measured by… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Iron Deficiency Anemia, Pregnancy
- What is being tested?
- Ferric derisomaltose and Ferrous sulfate
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 8 sitesUnited States
- Study dates
- 17 Jan 2023to 31 Mar 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Pregnant women between the ages of 18-45
- Singleton gestation
- Iron-deficiency anemia (serum ferritin <30ng/mL and Hb<11 g/dL)
- At 13-30 weeks gestation
- Plan to deliver at participating hospital
Who cannot join
- Non-iron-deficiency anemia e.g thalassemia, sickle cell disease, B12 or folate deficiency, hypersplenism.
- Malabsorptive syndrome, inflammatory bowel disease, gastric bypass, or sensitivity to oral or IV iron
- Multiple gestation
- Inability or unwillingness to provide informed consent
- Inability to communicate with members of the study team, despite the presence of an interpreter
- Planned delivery at a non-study affiliated hospital
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
United States8 sites, 8 recruiting
- Recruiting
Michigan University Medical Center
Ann Arbor, Michigan, 48109
Molly Stout, MD, MSCI
- Recruiting
University of Alabama Medical Center
Birmingham, Alabama, 35401
Carolyn Webster, MD
- Recruiting
GNP Research at Heme-on-Call
Miami, Florida, 33143
Steven Fein, MD
- Recruiting
Oregon Health and Sciences Uiversity Medical Center
Portland, Oregon, 97239
Ashley Benson, MD
- Recruiting
Hasbro Children's Hospital
Providence, Rhode Island, 02905
Viren D'sa, MD
- Recruiting
Women & Infants Hospital of Rhode Island
Providence, Rhode Island, 02905
Methodius Tuuli, MD, MPH, MBA
- Recruiting
University of Utah Hospital
Salt Lake City, Utah, 84132
Ann Bruno, MD
- Recruiting
Washington University Medical Center
St Louis, Missouri, 65105
Ebony Carter, MD, MPH
About this study
Official title: Double-blind Placebo-controlled Multicenter Randomized Trial of Intravenous Versus Oral Iron for Treating Iron-Deficiency Anemia in Pregnancy
Double blind, placebo controlled, multicenter randomized trial in pregnant women in the U.S. (N=300) to test the central hypothesis that IV iron in pregnant women with IDA (Hb<11 g/dL and ferritin<30 ng/mL) at 13 - 30 weeks will be effective, safe and cost-effective in reducing severe maternal morbidity-as measured by maternal anemia at delivery-and will also improve offspring neurodevelopment.
Read the detailed description
Iron-deficiency anemia (IDA) is a common, undertreated problem in pregnancy. According to data from the U.S. National Health and Nutrition Examination Survey (NHANES), 25% of pregnant women in the U.S. have iron deficiency, with rates of 7%, 24%, and 39% in the first, second, and third trimesters, respectively. The prevalence of IDA is estimated at 16.2% overall and up to 30% at delivery. Iron deficiency is associated with significant adverse maternal and fetal outcomes including blood transfusion, cesarean delivery, depression, preterm birth, and low birth weight. Moreover, iron-deficient mothers are at risk of delivering iron-deficient neonates who, despite iron repletion, remain at risk for delayed growth and development. While treatment with iron supplementation is recommended during pregnancy, questions remain about the optimal route of delivery. Oral iron therapy, the current standard, is often suboptimal: up to 70% of patients experience significant gastrointestinal side effects (nausea, constipation, diarrhea, indigestion, and metallic taste) that prevent adherence to treatment, resulting in persistent anemia. Intravenous (IV) iron is an attractive alternative because it mitigates the adherence and absorption challenges of oral iron. However, IV iron costs more, and there are historical concerns about adverse reactions.
The American College of Obstetricians and Gynecologists (ACOG) recommends oral iron for the treatment of IDA in pregnancy, with IV iron reserved for the restricted group of patients. Our preliminary data show that this approach leads to 30% of patients with persistent IDA at delivery and an associated 3 to 6-fold increased risk of peripartum blood transfusion. ACOG's preferential recommendation of oral iron is based on paucity of data on the benefits and safety of IV iron, compared with oral iron, in pregnancy. Our published systematic review and meta-analysis showed that IV iron is associated with greater increase in maternal hemoglobin (Hb), but most of the primary trials were conducted in developing countries, included small sample sizes (50 - 252), and did not assess meaningful maternal and neonatal outcomes. The current Cochrane review noted that despite the high incidence and disease burden associated with IDA in pregnancy, there is paucity of quality trials assessing clinical maternal and neonatal effects of iron administration in women with anemia. The authors called for "large, good quality trials assessing clinical outcomes." The only large randomized trial of IV versus oral iron, conducted in India, showed no difference in a maternal composite outcome, but it is limited by use of iron sucrose which required five infusions, resulting in a wide range of iron doses (200 - 1600 mg). In addition, the primary composite outcome included some components not directly related to anemia. In contrast, our pilot trial of a single infusion of 1000 mg of IV low molecular weight iron dextran in pregnant women in the U.S. with moderate-to-severe IDA significantly reduced the rate of maternal anemia at delivery and showed promise for improving maternal morbidity by reducing rates of blood transfusion.
This is the first definitive double blind, placebo controlled, multicenter randomized trial in pregnant women in the U.S. (N=300) to test the central hypothesis that IV iron in pregnant women with IDA (Hb<11 g/dL and ferritin<30 ng/mL) at 13 - 30 weeks will be effective, safe and cost-effective in reducing severe maternal morbidity-as measured by maternal anemia at delivery-and will also improve offspring neurodevelopment. A multidisciplinary team of investigators in the U.S., will pursue the following specific aims:
Primary Aim: Evaluate the effectiveness and safety of IV iron, compared with oral iron, in reducing the rate of anemia at delivery in pregnant women with IDA.
Secondary Aim 1: Estimate the cost-effectiveness of IV iron , compared with oral iron, in pregnant women with IDA as measured by incremental cost per Quality Adjusted Life-year (QALY).
Secondary Aim 2: Assess the effect of IV iron, compared with oral iron, on offspring brain myelin content and neurodevelopment.
- Conditions
- Iron Deficiency Anemia, Pregnancy
- Being tested
- Ferric derisomaltose, Ferrous sulfate
- Medical subject headings
- Anemia, Iron-Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ferric derisomaltoseDrug
Also called Monoferric
Participants assigned to the IV iron group will receive a single IV infusion of 1000 mg ferric derisomaltose (Monoferric, Pharmacosmos Therapeutics Inc., Morristown, NJ) in 250 mL given over 20 minutes.
Ferrous sulfateDrug
Also called Ferosul
325mg ferrous sulfate tablets (65 mg of elemental iron), 1 to 3 orally per day.
| Study group | Role | What they receive |
|---|---|---|
| IV Iron | Experimental | Participants assigned to the IV iron group will receive a single IV infusion of 1000 mg ferric derisomaltose (Monoferric, Pharmacosmos Therapeutics Inc., Morristown, NJ) in 250 mL given over 20 minutes and daily placebo tablets until delivery. Receives: Drug: Ferric derisomaltose |
| Oral Iron | Active comparator | Participants assigned to the oral iron group will receive a single 250 mL IV normal saline infusion given over 20 minutes and 325mg tablets of ferrous sulfate (65 mg of elemental iron) to be taken until delivery. Receives: Drug: Ferrous sulfate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of maternal anemia (hgb<11mg/dL) at delivery
Hemoglobin <11mg/dL on admission to inpatient obstetrics unit for labor and delivery
Measured: Within 24 hours of admission to inpatient obstetrics unit for delivery of infant
Secondary outcomes (25)
Concentration of maternal hemoglobin at delivery
Hemoglobin on admission to inpatient obstetrics unit for labor and delivery
Measured: Within 24 hours of admission to inpatient obstetrics unit for delivery of infant
Rate of maternal blood transfusion at delivery
Maternal blood transfusion from delivery to 7 days postpartum
Measured: Delivery to 7 days postpartum
Concentration of maternal ferritin at delivery
Maternal ferritin on admission to inpatient obstetrics unit for labor and delivery
Measured: Within 24 hours of admission to inpatient obstetrics unit for delivery of infant
Concentration of maternal hemoglobin postpartum day 1
Maternal hemoglobin on postpartum day 1
Measured: On day after participant delivered her infant; postpartum day 1
Rate of cesarean delivery
Cesarean delivery for any indication in patients without prior cesarean deliveries
Measured: Once at infant delivery
Rate of severe infusion adverse events
Safety and tolerability
Measured: 2 days after intravenous iron or placebo infusion
Rate of mild medication adverse events
Safety and tolerability
Measured: 4 weeks after initiation of oral iron or placebo
Edinburgh Perinatal Depression Scale score
Edinburgh Perinatal Depression Scale score. Minimum score 0, maximum score 30, higher scores indicate worse depressive symptoms.
Measured: At randomization (baseline) and at 4-6 weeks postpartum
Maternal EuroQol Group Quality-of-Life Questionnaire score
Maternal EuroQol Group Quality-of-Life Questionnaire (EQ-5D-5L). Minimum score 11111 (full health), maximum score 55555 (worst health), higher scores indicate worse quality of life.
Measured: At 6 weeks postpartum by phone or in person
Rate of Maternal infection
Any infection diagnosed from initiation of treatment until 6 weeks postpartum
Measured: From initiation of treatment until 6 weeks postpartum
Rate of Composite Maternal Complications
Maternal mortality or any one of several maternal morbidities
Measured: At 6 weeks postpartum
Gestational age at delivery
Gestational age at delivery
Measured: At delivery
Rate of preterm birth at less then 37 weeks
Preterm birth; gestational age at delivery at less than 37 weeks (spontaneous or indicated)
Measured: At delivery
Rate of Neonatal Intensive Care Unit Admission
Admission to the neonatal intensive care unit for any indication
Measured: At birth through through 30 days from birth
Neonatal birth weight
Infant birth weight
Measured: At birth
Concentration of umbilical artery pH
Concentration of umbilical artery pH from umbilical cord gases from infant umbilical cord segment at birth
Measured: At birth
Concentration of umbilical artery bicarbonate
Concentration of umbilical artery bicarbonate from umbilical cord gases from infant umbilical cord segment at birth
Measured: At birth
Concentration of umbilical artery base excess
Concentration of base excess from umbilical cord gases from infant umbilical cord segment at birth
Measured: At birth
Concentration of umbilical artery lactate
Concentration of umbilical artery lactate from umbilical cord gases from infant umbilical cord segment at birth
Measured: At birth
Concentration of neonatal hemoglobin
Concentration of neonatal hemoglobin from umbilical cord blood at birth or first neonatal complete blood count
Measured: At birth
Concentration of neonatal ferritin
Concentration of neonatal ferritin from umbilical cord blood at birth or first neonatal blood draw
Measured: At birth
Neonatal Apgar scores
Apgar scores at 1 and 5 minutes of life. Minimum score 0, maximum score 10, higher scores indicate better well being.
Measured: At 1 minute and 5 minutes of life
Rate of composite neonatal complication
Neonatal mortality or any one of several neonatal morbidities
Measured: Through 30 days from birth
Concentration of child brain myelin
Concentration of infant brain myelin from magnetic resonance imaging
Measured: At an average of 6 months and 36 months
Child Mullen Scale of Early Learning Score
Mullen Scale of Early Learning Score as percentile. Minimum score 1, maximum score 99, higher scores indicate better neurodevelopment.
Measured: At an average of 6 months and 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2022
- Study start17 Jan 2023
- Primary completion30 Mar 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iron Deficiency 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Women and Infants Hospital of Rhode Island
- Sponsor type
- University, hospital or other
- Collaborators
- Hasbro Children's Hospital, University of Michigan, Washington University School of Medicine, University of Utah, University of Alabama at Birmingham, Oregon Health and Science University, GNP Research at Heme-on-Call
- Responsible party
- Principal investigator, Methodius Tuuli, Women and Infants Hospital of Rhode Island
- Investigators
- Methodius Tuuli, MD, MPH, MBA, Principal investigator, Women and Infants Hospital of Rhode Island
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05462704
- Sponsor's protocol ID
- Pro00060930
- Acronym
- IVIDA2
- Status last verified
- Jun 2025
- First submitted
- 15 May 2022
- Last updated
- 10 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be collected from human subjects and will be shared according to NIH guidelines. The investigators are committed to the sharing of final data, being mindful that the rights and privacy of people who participate in research must be protected at all times. The investigators will make a complete study dataset available for sharing. The investigators will have a description of study dataset, including code books, meta-data related to the dataset, and documented programming code used for creating the final study population, for creating variables, and for conducting all outcomes analyses. The investigators will remain HIPAA compliant, and therefore any datasets resulting from participants will be free of any identifiers that would permit linkages to individual research participants and variables that could lead to deductive disclosure of individual subjects.
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind Placebo-controlled Multicenter Randomized Trial of Intravenous Versus Oral Iron for Treating Iron-Deficiency Anemia in Pregnancy
- ClinicalTrials.gov ID
- NCT05462704
- Acronym / sponsor ID
- IVIDA2 / Pro00060930
- Conditions
- Iron Deficiency Anemia, Pregnancy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Women and Infants Hospital of Rhode IslandUniversity, hospital or other
- Collaborators
- Hasbro Children's Hospital, University of Michigan, Washington University School of Medicine, University of Utah, University of Alabama at Birmingham, Oregon Health and Science University, GNP Research at Heme-on-Call
- Study start
- 17 Jan 2023 (actual)
- Primary completion
- 30 Mar 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 18 Jul 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.
Double blind, placebo controlled, multicenter randomized trial in pregnant women in the U.S. (N=300) to test the central hypothesis that IV iron in pregnant women with IDA (Hb<11 g/dL and ferritin<30 ng/mL) at 13 - 30 weeks will be effective, safe and cost-effective in reducing severe maternal morbidity-as measured by maternal anemia at delivery-and will also improve offspring neurodevelopment.
Detailed description
Iron-deficiency anemia (IDA) is a common, undertreated problem in pregnancy. According to data from the U.S. National Health and Nutrition Examination Survey (NHANES), 25% of pregnant women in the U.S. have iron deficiency, with rates of 7%, 24%, and 39% in the first, second, and third trimesters, respectively. The prevalence of IDA is estimated at 16.2% overall and up to 30% at delivery. Iron deficiency is associated with significant adverse maternal and fetal outcomes including blood transfusion, cesarean delivery, depression, preterm birth, and low birth weight. Moreover, iron-deficient mothers are at risk of delivering iron-deficient neonates who, despite iron repletion, remain at risk for delayed growth and development. While treatment with iron supplementation is recommended during pregnancy, questions remain about the optimal route of delivery. Oral iron therapy, the current standard, is often suboptimal: up to 70% of patients experience significant gastrointestinal side effects (nausea, constipation, diarrhea, indigestion, and metallic taste) that prevent adherence to treatment, resulting in persistent anemia. Intravenous (IV) iron is an attractive alternative because it mitigates the adherence and absorption challenges of oral iron. However, IV iron costs more, and there are historical concerns about adverse reactions.
The American College of Obstetricians and Gynecologists (ACOG) recommends oral iron for the treatment of IDA in pregnancy, with IV iron reserved for the restricted group of patients. Our preliminary data show that this approach leads to 30% of patients with persistent IDA at delivery and an associated 3 to 6-fold increased risk of peripartum blood transfusion. ACOG's preferential recommendation of oral iron is based on paucity of data on the benefits and safety of IV iron, compared with oral iron, in pregnancy. Our published systematic review and meta-analysis showed that IV iron is associated with greater increase in maternal hemoglobin (Hb), but most of the primary trials were conducted in developing countries, included small sample sizes (50 - 252), and did not assess meaningful maternal and neonatal outcomes. The current Cochrane review noted that despite the high incidence and disease burden associated with IDA in pregnancy, there is paucity of quality trials assessing clinical maternal and neonatal effects of iron administration in women with anemia. The authors called for "large, good quality trials assessing clinical outcomes." The only large randomized trial of IV versus oral iron, conducted in India, showed no difference in a maternal composite outcome, but it is limited by use of iron sucrose which required five infusions, resulting in a wide range of iron doses (200 - 1600 mg). In addition, the primary composite outcome included some components not directly related to anemia. In contrast, our pilot trial of a single infusion of 1000 mg of IV low molecular weight iron dextran in pregnant women in the U.S. with moderate-to-severe IDA significantly reduced the rate of maternal anemia at delivery and showed promise for improving maternal morbidity by reducing rates of blood transfusion.
This is the first definitive double blind, placebo controlled, multicenter randomized trial in pregnant women in the U.S. (N=300) to test the central hypothesis that IV iron in pregnant women with IDA (Hb<11 g/dL and ferritin<30 ng/mL) at 13 - 30 weeks will be effective, safe and cost-effective in reducing severe maternal morbidity-as measured by maternal anemia at delivery-and will also improve offspring neurodevelopment. A multidisciplinary team of investigators in the U.S., will pursue the following specific aims:
Primary Aim: Evaluate the effectiveness and safety of IV iron, compared with oral iron, in reducing the rate of anemia at delivery in pregnant women with IDA.
Secondary Aim 1: Estimate the cost-effectiveness of IV iron , compared with oral iron, in pregnant women with IDA as measured by incremental cost per Quality Adjusted Life-year (QALY).
Secondary Aim 2: Assess the effect of IV iron, compared with oral iron, on offspring brain myelin content and neurodevelopment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IV Iron | Experimental | Drug: Ferric derisomaltoseParticipants assigned to the IV iron group will receive a single IV infusion of 1000 mg ferric derisomaltose (Monoferric, Pharmacosmos Therapeutics Inc., Morristown, NJ) in 250 mL given over 20 minutes and daily placebo tablets until delivery. |
| Oral Iron | Active comparator | Drug: Ferrous sulfateParticipants assigned to the oral iron group will receive a single 250 mL IV normal saline infusion given over 20 minutes and 325mg tablets of ferrous sulfate (65 mg of elemental iron) to be taken until delivery. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Pregnant women between the ages of 18-45
- Singleton gestation
- Iron-deficiency anemia (serum ferritin <30ng/mL and Hb<11 g/dL)
- At 13-30 weeks gestation
- Plan to deliver at participating hospital
Key exclusion criteria (6 listed)
- Non-iron-deficiency anemia e.g thalassemia, sickle cell disease, B12 or folate deficiency, hypersplenism.
- Malabsorptive syndrome, inflammatory bowel disease, gastric bypass, or sensitivity to oral or IV iron
- Multiple gestation
- Inability or unwillingness to provide informed consent
- Inability to communicate with members of the study team, despite the presence of an interpreter
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 derisomaltoseAlso: MonoferricParticipants assigned to the IV iron group will receive a single IV infusion of 1000 mg ferric derisomaltose (Monoferric, Pharmacosmos Therapeutics Inc., Morristown, NJ) in 250 mL given over 20 minutes. | Drug | IV Iron |
| Ferrous sulfateAlso: Ferosul325mg ferrous sulfate tablets (65 mg of elemental iron), 1 to 3 orally per day. | Drug | Oral Iron |
Primary outcome
Rate of maternal anemia (hgb<11mg/dL) at delivery
Time frame: Within 24 hours of admission to inpatient obstetrics unit for delivery of infant
Hemoglobin <11mg/dL on admission to inpatient obstetrics unit for labor and delivery
25 secondary outcomes
Concentration of maternal hemoglobin at delivery
Time frame: Within 24 hours of admission to inpatient obstetrics unit for delivery of infant
Rate of maternal blood transfusion at delivery
Time frame: Delivery to 7 days postpartum
Concentration of maternal ferritin at delivery
Time frame: Within 24 hours of admission to inpatient obstetrics unit for delivery of infant
Concentration of maternal hemoglobin postpartum day 1
Time frame: On day after participant delivered her infant; postpartum day 1
Rate of cesarean delivery
Time frame: Once at infant delivery
Rate of severe infusion adverse events
Time frame: 2 days after intravenous iron or placebo infusion
Rate of mild medication adverse events
Time frame: 4 weeks after initiation of oral iron or placebo
Edinburgh Perinatal Depression Scale score
Time frame: At randomization (baseline) and at 4-6 weeks postpartum
Maternal EuroQol Group Quality-of-Life Questionnaire score
Time frame: At 6 weeks postpartum by phone or in person
Rate of Maternal infection
Time frame: From initiation of treatment until 6 weeks postpartum
Rate of Composite Maternal Complications
Time frame: At 6 weeks postpartum
Gestational age at delivery
Time frame: At delivery
Rate of preterm birth at less then 37 weeks
Time frame: At delivery
Rate of Neonatal Intensive Care Unit Admission
Time frame: At birth through through 30 days from birth
Neonatal birth weight
Time frame: At birth
Concentration of umbilical artery pH
Time frame: At birth
Concentration of umbilical artery bicarbonate
Time frame: At birth
Concentration of umbilical artery base excess
Time frame: At birth
Concentration of umbilical artery lactate
Time frame: At birth
Concentration of neonatal hemoglobin
Time frame: At birth
Concentration of neonatal ferritin
Time frame: At birth
Neonatal Apgar scores
Time frame: At 1 minute and 5 minutes of life
Rate of composite neonatal complication
Time frame: Through 30 days from birth
Concentration of child brain myelin
Time frame: At an average of 6 months and 36 months
Child Mullen Scale of Early Learning Score
Time frame: At an average of 6 months and 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2025.
- Individual participant dataSharing planned: Yes. Data will be collected from human subjects and will be shared according to NIH guidelines. The investigators are committed to the sharing of final data, being mindful that the rights and privacy of people who participate in research must be protected at all times. The investigators will make a complete study dataset available for sharing. The investigators will have a description of study dataset, including code books, meta-data related to the dataset, and documented programming code used for creating the final study population, for creating variables, and for conducting all outcomes analyses. The investigators will remain HIPAA compliant, and therefore any datasets resulting from participants will be free of any identifiers that would permit linkages to individual research participants and variables that could lead to deductive disclosure of individual subjects.
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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.
Methodius Tuuli, MD, MPH, MBA principal investigator
Women and Infants Hospital of Rhode Island
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ferric derisomaltose and Ferrous sulfate in people with Iron Deficiency Anemia and Pregnancy, run by Women and Infants Hospital of Rhode Island at 8 sites in United States.
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 5 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 10 Jun 2025. 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Crystal Ware, BSN, CCRP (401-274-1122, cware@wihri.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of maternal anemia (hgb<11mg/dL) at delivery (time frame: Within 24 hours of admission to inpatient obstetrics unit for delivery of infant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Jun 2025; AzTrials last refreshed its copy on 8 Nov 2026.