Anemia, Iron DeficiencyPhase 4IVIRONMANNCT05047211
Intravenous Iron vs. Oral Iron Supplementation for Postpartum Anemia
A Phase 4 study testing Ferrous sulfate and Iron dextran in people with Anemia, Iron Deficiency and Delivery Complication, run by The University of Texas Medical Branch, Galveston at 1 site in United States.
Trial summary
This trial will be a comparative pragmatic open label feasibility randomized controlled trial of oral daily versus IV iron in anemic postpartum patients. Two randomly assigned groups will be compared during the postpartum period: 1. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Anemia, Iron Deficiency, Delivery Complication
- What is being tested?
- Ferrous sulfate and Iron dextran
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Oct 2021to 15 Apr 2023
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Delivery at our institution
- Hemoglobin below 9 g/dl in postpartum day 1
- Singleton gestation
Who cannot join
- Diagnosis of malabsorptive disorder or history of gastric bypass procedure
- Known diagnosis of anemia other than iron deficiency (thalassemia, macrocytic anemia, sickle cell, etc.)
- Significant cardiovascular disease, including but not limited to myocardial infarction or unstable angina within 6 months prior to study inclusion or current history of NYHA Class III or IV congestive heart failure
- Patient has received blood transfusion or there is a plan to transfuse
- Lactose intolerance
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Feasibility Trial of Intravenous Iron vs. Oral Iron Supplementation for the Treatment of Postpartum Anemia (IVIRONMAN)
This trial will be a comparative pragmatic open label feasibility randomized controlled trial of oral daily versus IV iron in anemic postpartum patients.
Two randomly assigned groups will be compared during the postpartum period:
Read more
- Oral Iron group: Ferrous sulfate 325 mg (65 mg elemental iron) by mouth for a total of 6 weeks TID. IV placebo in sodium chloride 0.9% 500mL IV infusion will be given before discharge home over 1 hour preceded by placebo test dose IV infusion of 100mL 0.9% sodium chloride.
- IV Iron group: Low molecular weight iron dextran (infed) 1000mg in sodium chloride 0.9% 500mL IV infusion over 1 hour preceded by test dose 25 mg IV low molecular weight iron dextran infusion in 100mL 0.9% sodium chloride.
2.1 Oral placebo will be given by mouth for a total of 6 weeks TID.
- Conditions
- Anemia, Iron Deficiency, Delivery Complication
- Being tested
- Ferrous sulfate, Iron dextran
- Keywords
- Postpartum, iron deficiency anemia, intravenous iron
- 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.
Ferrous sulfateDrug
one tablet 325 milligrams three times a day
Iron dextranDrug
1000 mg intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| Oral Iron group | Active comparator | Ferrous sulfate 325 mg (65 mg elemental iron) by mouth for a total of 6 weeks three times daily.
Intravenous placebo in sodium chloride 0.9% 500mL IV infusion will be given before discharge home over 1 hour preceded by placebo test dose IV infusion of 100mL 0.9% sodium chloride. Receives: Drug: Ferrous sulfate |
| IV Iron group | Experimental | Low molecular weight iron dextran (infed) 1000mg in sodium chloride 0.9% 500mL IV infusion over 1 hour preceded by test dose 25 mg IV low molecular weight iron dextran infusion in 100mL 0.9% sodium chloride.
Oral placebo will be given by mouth for a total of 6 weeks TID. Receives: Drug: Iron dextran |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin Level
hemoglobin in grams per deciliters
Measured: 6 weeks after delivery
Secondary outcomes (2)
Number of Participants With Nausea or Vomiting
feeling sick to vomit or vomit
Measured: up to 6 weeks after delivery
Myalgia
Generalized muscle pain
Measured: up to 6 weeks after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2021
- Study start7 Oct 2021
- Primary completion15 Mar 2023
- Study completion15 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anemia, Iron DeficiencyStudies of the same condition, open and under way.
- More trials run by The University of Texas Medical Branch, GalvestonThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized control trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05047211
- Sponsor's protocol ID
- 21-0127
- Acronym
- IVIRONMAN
- Status last verified
- Aug 2023
- First submitted
- 7 Sep 2021
- Last updated
- 29 Aug 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Saad AF, Stepanek R, Kothmann M, Wilson-Jimenez M, McCoy L, Aguillon B, Salazar A, Saade GR. Intravenous Iron Compared With Oral Iron Supplementation for the Treatment of Postpartum Anemia: A Randomized Controlled Trial. Obstet Gynecol. 2023 Jun 1;141(6):1052-1055. doi: 10.1097/AOG.0000000000005143. Epub 2023 May 3.
PubMed 37486650
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Trial of Intravenous Iron vs. Oral Iron Supplementation for the Treatment of Postpartum Anemia (IVIRONMAN)
- ClinicalTrials.gov ID
- NCT05047211
- Acronym / sponsor ID
- IVIRONMAN / 21-0127
- Conditions
- Anemia, Iron Deficiency, Delivery Complication
- Keywords
- Postpartum, iron deficiency anemia, intravenous iron
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- The University of Texas Medical Branch, GalvestonUniversity, hospital or other
- Study start
- 7 Oct 2021 (actual)
- Primary completion
- 15 Mar 2023 (actual)
- Study completion
- 15 Apr 2023 (actual)
- First posted
- 17 Sep 2021 (actual)
- Results
- Posted 29 Aug 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial will be a comparative pragmatic open label feasibility randomized controlled trial of oral daily versus IV iron in anemic postpartum patients.
Two randomly assigned groups will be compared during the postpartum period:
- Oral Iron group: Ferrous sulfate 325 mg (65 mg elemental iron) by mouth for a total of 6 weeks TID. IV placebo in sodium chloride 0.9% 500mL IV infusion will be given before discharge home over 1 hour preceded by placebo test dose IV infusion of 100mL 0.9% sodium chloride.
- IV Iron group: Low molecular weight iron dextran (infed) 1000mg in sodium chloride 0.9% 500mL IV infusion over 1 hour preceded by test dose 25 mg IV low molecular weight iron dextran infusion in 100mL 0.9% sodium chloride.
2.1 Oral placebo will be given by mouth for a total of 6 weeks TID.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized control trial
| Arm | Type | Receives |
|---|---|---|
| Oral Iron group | Active comparator | Drug: Ferrous sulfateFerrous sulfate 325 mg (65 mg elemental iron) by mouth for a total of 6 weeks three times daily. Intravenous placebo in sodium chloride 0.9% 500mL IV infusion will be given before discharge home over 1 hour preceded by placebo test dose IV infusion of 100mL 0.9% sodium chloride. |
| IV Iron group | Experimental | Drug: Iron dextranLow molecular weight iron dextran (infed) 1000mg in sodium chloride 0.9% 500mL IV infusion over 1 hour preceded by test dose 25 mg IV low molecular weight iron dextran infusion in 100mL 0.9% sodium chloride. Oral placebo will be given by mouth for a total of 6 weeks TID. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Delivery at our institution
- Hemoglobin below 9 g/dl in postpartum day 1
- Singleton gestation
Key exclusion criteria (5 listed)
- Diagnosis of malabsorptive disorder or history of gastric bypass procedure
- Known diagnosis of anemia other than iron deficiency (thalassemia, macrocytic anemia, sickle cell, etc.)
- Significant cardiovascular disease, including but not limited to myocardial infarction or unstable angina within 6 months prior to study inclusion or current history of NYHA Class III or IV congestive heart failure
- Patient has received blood transfusion or there is a plan to transfuse
- Lactose intolerance
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 sulfateone tablet 325 milligrams three times a day | Drug | Oral Iron group |
| Iron dextran1000 mg intravenous infusion | Drug | IV Iron group |
Primary outcome
Hemoglobin Level
Time frame: 6 weeks after delivery
hemoglobin in grams per deciliters
2 secondary outcomes
Number of Participants With Nausea or Vomiting
Time frame: up to 6 weeks after delivery
Myalgia
Time frame: up to 6 weeks after delivery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37486650Saad AF, Stepanek R, Kothmann M, Wilson-Jimenez M, McCoy L, Aguillon B, Salazar A, Saade GR. Intravenous Iron Compared With Oral Iron Supplementation for the Treatment of Postpartum Anemia: A Randomized Controlled Trial. Obstet Gynecol. 2023 Jun 1;141(6):1052-1055. doi: 10.1097/AOG.0000000000005143. Epub 2023 May 3.
- 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.
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 4 study testing Ferrous sulfate and Iron dextran in people with Anemia, Iron Deficiency and Delivery Complication, run by The University of Texas Medical Branch, Galveston 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 3 inclusion and 5 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 29 Aug 2023. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Aug 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Hemoglobin Level (time frame: 6 weeks after 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 NCT05047211, which also lists 1 linked publication.
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 29 Aug 2023.