Obstetric Labor ComplicationsEarly Phase 1NCT05763043
Monoferric for Prenatal Iron Deficiency
A Early Phase 1 study testing Ferric derisomaltose in people with Obstetric Labor Complications, run by Oregon Health and Science University at 1 site in United States.
Trial summary
A prospective observational study of pregnant women with iron deficiency anemia and oral iron intolerance or advanced gestational age. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obstetric Labor Complications
- What is being tested?
- Ferric derisomaltose
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jan 2024to Oct 2028
- Phase
- Early Phase 1
- 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 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants 18 years of age or older between 14 to 42 weeks gestation who are deemed appropriate for IV iron by their treating provider as part of their standard of care treatment.
- Iron deficiency anemia, defined as second or third trimester (14 weeks or more) hemoglobin less than or equal to 10.5 g/dL or less than or equal to11 g/dL, respectively, and ferritin less than 50 μg/L
- Experience intolerance to oral iron or are greater than 28 weeks gestation
- Willing to participate in the study
Who cannot join
- Known infectious, inflammatory, or malignant conditions that may confound iron repletion and outcome analysis
- Prior IV iron intolerance or hypersensitivity reaction
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Oregon Health & Science Univerity
Portland, Oregon, 97239
Women's Health Research Unit, 503-494-3666, whru@ohsu.edu
About this study
A prospective observational study of pregnant women with iron deficiency anemia and oral iron intolerance or advanced gestational age.
Read the detailed description
Intravenous therapy (IV) Monoferric (ferric derisomaltose), is a single-dose, rapid infusion formulation that has the potential to reduce both time and cost barriers, though its efficacy and safety in pregnant women has not been well studied. Thus, we propose to study the safety and efficacy of single dose, monoferric 1,000 mg IV in a cohort of pregnant participants with iron deficiency.
- Conditions
- Obstetric Labor Complications
- Being tested
- Ferric derisomaltose
- Medical subject headings
- Obstetric Labor Complications
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 between the gestational ages of 14 to 42 weeks with iron deficiency will receive IV Ferric derisomaltose at a routine prenatal visit.
| Study group | Role | What they receive |
|---|---|---|
| Ferric derisomaltose | Experimental | Not described Receives: Drug: Ferric derisomaltose |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of participants who experienced a resolution of iron deficiency anemia
The proportion of participants who experienced a resolution of iron deficiency anemia, defined as a 1 g/dL increase in Hgb at a follow up assessment at 6 weeks postpartum following IV Monoferric administration
Measured: From enrollment to 6 weeks post partum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2023
- Study start18 Jan 2024
- Primary completionOct 2028 (estimated)
- Study completionOct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstetric Labor ComplicationsStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ashley Benson, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05763043
- Sponsor's protocol ID
- OHSU IRB 25397
- Status last verified
- Sep 2024
- First submitted
- 28 Feb 2023
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monoferric for Prenatal Iron Deficiency
- ClinicalTrials.gov ID
- NCT05763043
- Acronym / sponsor ID
- OHSU IRB 25397
- Conditions
- Obstetric Labor Complications
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- 18 Jan 2024 (actual)
- Primary completion
- Oct 2028 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 10 Mar 2023 (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.
A prospective observational study of pregnant women with iron deficiency anemia and oral iron intolerance or advanced gestational age.
Detailed description
Intravenous therapy (IV) Monoferric (ferric derisomaltose), is a single-dose, rapid infusion formulation that has the potential to reduce both time and cost barriers, though its efficacy and safety in pregnant women has not been well studied. Thus, we propose to study the safety and efficacy of single dose, monoferric 1,000 mg IV in a cohort of pregnant participants with iron deficiency.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ferric derisomaltose | Experimental | Drug: Ferric derisomaltose |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participants 18 years of age or older between 14 to 42 weeks gestation who are deemed appropriate for IV iron by their treating provider as part of their standard of care treatment.
- Iron deficiency anemia, defined as second or third trimester (14 weeks or more) hemoglobin less than or equal to 10.5 g/dL or less than or equal to11 g/dL, respectively, and ferritin less than 50 μg/L
- Experience intolerance to oral iron or are greater than 28 weeks gestation
- Willing to participate in the study
Key exclusion criteria (2 listed)
- Known infectious, inflammatory, or malignant conditions that may confound iron repletion and outcome analysis
- Prior IV iron intolerance or hypersensitivity reaction
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 between the gestational ages of 14 to 42 weeks with iron deficiency will receive IV Ferric derisomaltose at a routine prenatal visit. | Drug | Ferric derisomaltose |
Primary outcome
The proportion of participants who experienced a resolution of iron deficiency anemia
Time frame: From enrollment to 6 weeks post partum
The proportion of participants who experienced a resolution of iron deficiency anemia, defined as a 1 g/dL increase in Hgb at a follow up assessment at 6 weeks postpartum following IV Monoferric administration
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 19 Sep 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Ferric derisomaltose in people with Obstetric Labor Complications, run by Oregon Health and Science University 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 4 inclusion and 2 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 19 Sep 2024. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 Women's Health Research Unit Research Unit Department of OB/Gyn (503-494-3666, whru@ohsu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of participants who experienced a resolution of iron deficiency anemia (time frame: From enrollment to 6 weeks post partum). 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 19 Sep 2024; AzTrials last refreshed its copy on 31 Oct 2026.