PregnancyPhase 2NCT02038023
Intravaneous Iron(1000 mg Low Molecular Weight Iron Dextran Over 60 Minutes) for Pregnant Women
A Phase 2 study testing Intravaneous iron(low molecular weight iron dextran) in people with Pregnancy, run by Auerbach Hematology Oncology Associates P C at 1 site in United States.
Trial summary
To determine the percentage of women who achieve anemia correction after a single dose of 1000mg of low molecular weight iron dextran(infed). Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Pregnancy
- What is being tested?
- Intravaneous iron(low molecular weight iron dextran)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2013to Aug 2015
- Phase
- Phase 2
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- pregnant women intolerable to oral iron. hbg <10.9 g/dl during second or third trimester.
Who cannot join
- known sensitivity to IV iron. hemoglobinopathies. hemolytic anemia. women who have received or will receive blood transfusions. women with significant vaginal bleeding(>200 cc blood loss)prior to delivery. women with documented history of allergy to more than one class of drug clinically significant anemia requiring therapy in the opinion of the obstetrician, in the first trimester.
Trial locations and contacts
1 site in 1 country.
United States1 site
Auerbach Hematology Oncology Assoc
Baltimore, Maryland, 21237
About this study
Official title: Intravaneous Iron(1000 mg Low Molecular Weight Iron Dextran Over 60 Minutes) for Moderate to Severe Iron Deficient Anemia of Pregnancy in Women Intolerant of or Responsive to Oral Iron.
To determine the percentage of women who achieve anemia correction after a single dose of 1000mg of low molecular weight iron dextran(infed).
Read the detailed description
To determine the percentage of women who achieve anemia correction after a single dose of 1000mg of low molecular weight iron dextran(infed).
To determine whether IV iron supplementation has a higher satisfaction with treatment as compared to oral supplementation in a population previously intolerant of or unresponsive to oral iron.
To evaluate the safety of IV low molecular weight iron dextran in pregnant women.
To assess maternal and fetal outcomes-preterm delivery, low birth weight deliveries, ER visits and hospitalizations related to preterm labor, preterm contractions, ante-partum and post-partum transfusions, maternal hemoglobin at post-partum visit after IV iron supplementation groups.
- Conditions
- Pregnancy
- Being tested
- Intravaneous iron(low molecular weight iron dextran)
- Keywords
- Iv iron in pregnant women, second and third trimester
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravaneous iron(low molecular weight iron dextran)Drug
Also called Iron Dextran(InFed)
1000 mg of Iron dextran administered over one hour
| Study group | Role | What they receive |
|---|---|---|
| IV iron | Other | Intravaneous iron(1000 mg low molecular weight iron dextran over 60 minutes) for moderate to severe iron deficient anemia of pregnancy in women intolerant of or unresponsive to oral iron. Receives: Drug: Intravaneous iron(low molecular weight iron dextran) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Women Who Achieve Anemia Correction After a Single Dose of 1000mg of Low Molecular Weight Iron Dextran(INfeD).
Measured: 4 weeks after infusion or post-partum
Secondary outcomes (3)
Serum Ferritin
Measured: 4 weeks post infusion or post-partum
Percent Transferrin Saturation
Measured: 4 weeks post infusion or post-partum
Safety as Measured by Number of Adverse Events
To evaluate the safety of IV low molecular weight iron dextran in pregnant women. Also to asses maternal and fetal outcomes-preterm delivery, low-birth weight deliveries, ER visits and hospitalizations related to preterm labor, preterm contractions, ante-partum and post partum transfusions, maternal hemoglobin at post-partum visit after IV iron supplementation groups. A questionaire with a list of symptoms to include nausea, dizziness, hypotension, edema, headache, abdominal pain, chest pain, cough, itching, fever, back pain, muscle cramps and rash are asked immediately after administration and phone calls at 24, 48 hours and 7 days.
Measured: 4 weeks after infusion and 4 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 posted16 Jan 2014 (estimated)
- Study startJul 2013
- Primary completionJul 2015
- Study completionAug 2015
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 PregnancyStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Auerbach Hematology Oncology Associates P C
- Sponsor type
- University, hospital or other
- Collaborators
- Pharmacosmos A/S
- Responsible party
- Sponsor
- Investigators
- Michael Auerbach, MD, Principal investigator, Auerbach Hematology Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02038023
- Sponsor's protocol ID
- Intravaneous Iron in Pregnancy
- Other IDs
- Infed
- Status last verified
- Jan 2018
- First submitted
- 9 Jan 2014
- Last updated
- 28 Jun 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Auerbach M, James SE, Nicoletti M, Lenowitz S, London N, Bahrain HF, Derman R, Smith S. Results of the First American Prospective Study of Intravenous Iron in Oral Iron-Intolerant Iron-Deficient Gravidas. Am J Med. 2017 Dec;130(12):1402-1407. doi: 10.1016/j.amjmed.2017.06.025. Epub 2017 Jul 21.
PubMed 28739199
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravaneous Iron(1000 mg Low Molecular Weight Iron Dextran Over 60 Minutes) for Moderate to Severe Iron Deficient Anemia of Pregnancy in Women Intolerant of or Responsive to Oral Iron.
- ClinicalTrials.gov ID
- NCT02038023
- Acronym / sponsor ID
- Intravaneous Iron in Pregnancy
- Conditions
- Pregnancy
- Keywords
- Iv iron in pregnant women, second and third trimester
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Auerbach Hematology Oncology Associates P CUniversity, hospital or other
- Collaborators
- Pharmacosmos A/S
- Study start
- Jul 2013
- Primary completion
- Jul 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 16 Jan 2014 (estimated)
- Results
- Posted 28 Jun 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine the percentage of women who achieve anemia correction after a single dose of 1000mg of low molecular weight iron dextran(infed).
Detailed description
To determine the percentage of women who achieve anemia correction after a single dose of 1000mg of low molecular weight iron dextran(infed).
To determine whether IV iron supplementation has a higher satisfaction with treatment as compared to oral supplementation in a population previously intolerant of or unresponsive to oral iron.
To evaluate the safety of IV low molecular weight iron dextran in pregnant women.
To assess maternal and fetal outcomes-preterm delivery, low birth weight deliveries, ER visits and hospitalizations related to preterm labor, preterm contractions, ante-partum and post-partum transfusions, maternal hemoglobin at post-partum visit after IV iron supplementation groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IV iron | Other | Drug: Intravaneous iron(low molecular weight iron dextran)Intravaneous iron(1000 mg low molecular weight iron dextran over 60 minutes) for moderate to severe iron deficient anemia of pregnancy in women intolerant of or unresponsive to oral iron. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- pregnant women intolerable to oral iron. hbg <10.9 g/dl during second or third trimester.
Key exclusion criteria (1 listed)
- known sensitivity to IV iron. hemoglobinopathies. hemolytic anemia. women who have received or will receive blood transfusions. women with significant vaginal bleeding(>200 cc blood loss)prior to delivery. women with documented history of allergy to more than one class of drug clinically significant anemia requiring therapy in the opinion of the obstetrician, in the first trimester.
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 |
|---|---|---|
| Intravaneous iron(low molecular weight iron dextran)Also: Iron Dextran(InFed)1000 mg of Iron dextran administered over one hour | Drug | IV iron |
Primary outcome
Percentage of Women Who Achieve Anemia Correction After a Single Dose of 1000mg of Low Molecular Weight Iron Dextran(INfeD).
Time frame: 4 weeks after infusion or post-partum
3 secondary outcomes
Serum Ferritin
Time frame: 4 weeks post infusion or post-partum
Percent Transferrin Saturation
Time frame: 4 weeks post infusion or post-partum
Safety as Measured by Number of Adverse Events
Time frame: 4 weeks after infusion and 4 weeks post-partum
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 28739199Auerbach M, James SE, Nicoletti M, Lenowitz S, London N, Bahrain HF, Derman R, Smith S. Results of the First American Prospective Study of Intravenous Iron in Oral Iron-Intolerant Iron-Deficient Gravidas. Am J Med. 2017 Dec;130(12):1402-1407. doi: 10.1016/j.amjmed.2017.06.025. Epub 2017 Jul 21.
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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.
Michael Auerbach, MD principal investigator
Auerbach Hematology Oncology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Intravaneous iron(low molecular weight iron dextran) in people with Pregnancy, run by Auerbach Hematology Oncology Associates P C 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 1 inclusion and 1 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 28 Jun 2018. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 28 Jun 2018). 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?
Percentage of Women Who Achieve Anemia Correction After a Single Dose of 1000mg of Low Molecular Weight Iron Dextran(INfeD). (time frame: 4 weeks after infusion or post-partum). 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 NCT02038023, 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 28 Jun 2018.