Iron Deficiency Anemia of PregnancyPhase 3NCT03657433
Intravenous Infusions of Ferumoxytol Compared to Oral Ferrous Sulfate for the Treatment of Anemia in Pregnancy
A Phase 3 study testing Ferrous sulfate 325mg and Ferumoxytol in people with Iron Deficiency Anemia of Pregnancy, run by University of Arizona at 1 site in United States.
Trial summary
This randomized controlled trial includes pregnant women with anemia. They are randomized to IV iron infusions or to oral iron supplementation. Pregnancy outcomes are assessed. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Iron Deficiency Anemia of Pregnancy
- What is being tested?
- Ferrous sulfate 325mg and Ferumoxytol
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Dec 2018to 1 Apr 2022
- 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 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Maternal age >/= 18
- Singleton gestation
- >/=20 weeks gestation, <37 weeks gestation
- Hemoglobin <11g/dL and/or hematocrit <33%
- Able to read/speak English or Spanish
Who cannot join
- Maternal age <18
- Multiple gestation
- <20 weeks gestation, </= 37 weeks gestation
- Hemoglobin >/=11g/dL and/or hematocrit >/=33%
- Unable to read or speak English or Spanish
- Incarcerated patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intravenous Infusions of Ferumoxytol Compared to Oral Ferrous Sulfate for the Treatment of Anemia in Pregnancy: A Randomized Controlled Trial
This randomized controlled trial includes pregnant women with anemia. They are randomized to IV iron infusions or to oral iron supplementation. Pregnancy outcomes are assessed.
Read the detailed description
This is a randomized controlled trial aimed at assessing whether IV Iron administration (Ferumoxytol x 2 infusions) is superior to oral ferrous sulfate for the treatment of iron-deficiency anemia in pregnancy.
140 patients will be randomized in a 1:1 ratio. Patients in the IV Iron group will receive two infusions of Ferumoxytol, one week apart. Patients in the oral Ferrous Sulfate group will receive medication to take at home during their pregnancy.
Patients will have iron studies performed at study entry, and again at presentation for delivery. Cord blood will also be sampled for iron studies.
- Conditions
- Iron Deficiency Anemia of Pregnancy
- Being tested
- Ferrous sulfate 325mg, Ferumoxytol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ferrous sulfate 325mgDietary supplement
Oral tablets supplied for home use
FerumoxytolDrug
Ferumoxytol will be administered in two infusions, one week apart
| Study group | Role | What they receive |
|---|---|---|
| Ferumoxyltol | Experimental | Patients will receive two infusions of Ferumoxyltol, 510mg, intravenously, one week apart.
Iron studies will be completed at study inclusion and again at presentation for delivery. Cord blood will also be assessed for iron studies. Receives: Drug: Ferumoxytol |
| Ferrous Sulfate | Active comparator | Patients will be provided with oral ferrous sulphate, 325mg, to take 2x daily at home.
Iron studies will be completed at study inclusion and again at presentation for delivery. Cord blood will also be assessed for iron studies. Receives: Dietary Supplement: Ferrous sulfate 325mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in hemoglobin
We will assess the increase in maternal hemoglobin during the study timeframe
Measured: 1 day - 22 weeks
Secondary outcomes (9)
Change in other laboratory values
Including hematocrit, serum iron, transferrin saturation, ferritin
Measured: 1 day - 22 weeks
Blood loss at delivery
Estimated or quantified blood loss at delivery
Measured: 1 day - 22 weeks
Hemoglobin change after delivery
Measured change in hemoglobin after delivery
Measured: 1 day - 22 weeks
Blood transfusion
Whether the mother requires a blood transfusion
Measured: 1 day - 22 weeks
Iron infusion
Whether the mother requires additional iron infusions
Measured: 1 day - 22 weeks
Concentration of substances in cord blood (iron studies)
Cord blood indices for iron, transferrin saturation and ferritin
Measured: 1 day - 22 weeks
Preterm delivery
Whether the delivery occurs at less than 37 weeks of gestation
Measured: 1 day - 22 weeks
Indication for delivery
Indication for delivery if not spontaneous
Measured: 1 day - 22 weeks
Birth weight
Neonatal weight immediately after delivery
Measured: 1 day - 22 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2018
- Study start17 Dec 2018
- Primary completion27 Aug 2021
- Study completion1 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Iron Deficiency Anemia of PregnancyStudies of the same condition, open and under way.
- More trials run by University of ArizonaThe sponsor's other registered studies.
- 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
- Model description
- Randomized Controlled Trial
- Masking
- None (open label)
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Collaborators
- AMAG Pharmaceuticals, Inc.
- Responsible party
- Principal investigator, Meghan Hill, University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03657433
- Sponsor's protocol ID
- 1807765944
- Status last verified
- Sep 2022
- First submitted
- 30 Aug 2018
- Last updated
- 7 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Awomolo AM, McWhirter A, Sadler LC, Coppola LM, Hill MG. Neonatal outcomes from a randomized controlled trial of maternal treatment of iron deficiency anemia with intravenous ferumoxytol vs oral ferrous sulfate. Am J Obstet Gynecol MFM. 2023 Sep;5(9):101063. doi: 10.1016/j.ajogmf.2023.101063. Epub 2023 Jun 20.
PubMed 37348817Awomolo AM, McWhirter A, Sadler LC, Coppola LM, Hill MG. Intravenous infusions of ferumoxytol compared to oral ferrous sulfate for the treatment of anemia in pregnancy: a randomized controlled trial. Am J Obstet Gynecol MFM. 2023 Sep;5(9):101064. doi: 10.1016/j.ajogmf.2023.101064. Epub 2023 Jun 20.
PubMed 37348816
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravenous Infusions of Ferumoxytol Compared to Oral Ferrous Sulfate for the Treatment of Anemia in Pregnancy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03657433
- Acronym / sponsor ID
- 1807765944
- Conditions
- Iron Deficiency Anemia of Pregnancy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Collaborators
- AMAG Pharmaceuticals, Inc.
- Study start
- 17 Dec 2018 (actual)
- Primary completion
- 27 Aug 2021 (actual)
- Study completion
- 1 Apr 2022 (actual)
- First posted
- 5 Sep 2018 (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.
This randomized controlled trial includes pregnant women with anemia. They are randomized to IV iron infusions or to oral iron supplementation. Pregnancy outcomes are assessed.
Detailed description
This is a randomized controlled trial aimed at assessing whether IV Iron administration (Ferumoxytol x 2 infusions) is superior to oral ferrous sulfate for the treatment of iron-deficiency anemia in pregnancy.
140 patients will be randomized in a 1:1 ratio. Patients in the IV Iron group will receive two infusions of Ferumoxytol, one week apart. Patients in the oral Ferrous Sulfate group will receive medication to take at home during their pregnancy.
Patients will have iron studies performed at study entry, and again at presentation for delivery. Cord blood will also be sampled for iron studies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Ferumoxyltol | Experimental | Drug: FerumoxytolPatients will receive two infusions of Ferumoxyltol, 510mg, intravenously, one week apart. Iron studies will be completed at study inclusion and again at presentation for delivery. Cord blood will also be assessed for iron studies. |
| Ferrous Sulfate | Active comparator | Dietary Supplement: Ferrous sulfate 325mgPatients will be provided with oral ferrous sulphate, 325mg, to take 2x daily at home. Iron studies will be completed at study inclusion and again at presentation for delivery. Cord blood will also be assessed for iron studies. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Maternal age >/= 18
- Singleton gestation
- >/=20 weeks gestation, <37 weeks gestation
- Hemoglobin <11g/dL and/or hematocrit <33%
- Able to read/speak English or Spanish
Key exclusion criteria (6 listed)
- Maternal age <18
- Multiple gestation
- <20 weeks gestation, </= 37 weeks gestation
- Hemoglobin >/=11g/dL and/or hematocrit >/=33%
- Unable to read or speak English or Spanish
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 |
|---|---|---|
| Ferrous sulfate 325mgOral tablets supplied for home use | Dietary supplement | Ferrous Sulfate |
| FerumoxytolFerumoxytol will be administered in two infusions, one week apart | Drug | Ferumoxyltol |
Primary outcome
Change in hemoglobin
Time frame: 1 day - 22 weeks
We will assess the increase in maternal hemoglobin during the study timeframe
9 secondary outcomes
Change in other laboratory values
Time frame: 1 day - 22 weeks
Blood loss at delivery
Time frame: 1 day - 22 weeks
Hemoglobin change after delivery
Time frame: 1 day - 22 weeks
Blood transfusion
Time frame: 1 day - 22 weeks
Iron infusion
Time frame: 1 day - 22 weeks
Concentration of substances in cord blood (iron studies)
Time frame: 1 day - 22 weeks
Preterm delivery
Time frame: 1 day - 22 weeks
Indication for delivery
Time frame: 1 day - 22 weeks
Birth weight
Time frame: 1 day - 22 weeks
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 7 Sep 2022.
- Derived from this study: PubMed 37348817Awomolo AM, McWhirter A, Sadler LC, Coppola LM, Hill MG. Neonatal outcomes from a randomized controlled trial of maternal treatment of iron deficiency anemia with intravenous ferumoxytol vs oral ferrous sulfate. Am J Obstet Gynecol MFM. 2023 Sep;5(9):101063. doi: 10.1016/j.ajogmf.2023.101063. Epub 2023 Jun 20.
- Derived from this study: PubMed 37348816Awomolo AM, McWhirter A, Sadler LC, Coppola LM, Hill MG. Intravenous infusions of ferumoxytol compared to oral ferrous sulfate for the treatment of anemia in pregnancy: a randomized controlled trial. Am J Obstet Gynecol MFM. 2023 Sep;5(9):101064. doi: 10.1016/j.ajogmf.2023.101064. Epub 2023 Jun 20.
- Individual participant dataSharing planned: No
Related trials for Iron Deficiency Anemia of Pregnancy
Active, not recruiting
Iron Absorption From IFA and MMS Supplements in Kenyan Women During the Second Trimester of Pregnancy
Pregnancy
RecruitingPhase 2
Probiotic Supplementation in Optimizing Iron and Hematological Status Among Pregnant Females
Iron Deficiency (ID), Pregnancy
Active, not recruitingPhase 2
Management of Iron Deficiency Anemia in Hemodialysis Patients
Iron Deficiency Anemia (IDA), ESRD (End Stage Renal Disease)
Recruiting
Safety and Efficacy of Iron Prophylaxis With on Iron Homeostasis in Healthy Pregnant Women
Iron Deficiency Anemia in Pregnancy, Iron Deficiency in Pregnancy
RecruitingObservational study
Maternal Iron Deficiency and Childhood Health
Iron Deficiency Anaemia in Childbirth, Iron Deficiency
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ferrous sulfate 325mg and Ferumoxytol in people with Iron Deficiency Anemia of Pregnancy, run by University of Arizona at 1 site 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: finished, as of the sponsor's last update on 7 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
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?
Change in hemoglobin (time frame: 1 day - 22 weeks). 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 NCT03657433, which also lists 2 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 7 Sep 2022.