Intravenous Infusions of Ferumoxytol Compared to Oral Ferrous Sulfate for the Treatment of Anemia in Pregnancy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

124 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-17

Study Completion Date

2022-04-01

Brief Summary

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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.

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Detailed Description

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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

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Iron Deficiency Anemia of Pregnancy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized Controlled Trial

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Ferumoxyltol

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.

Group Type EXPERIMENTAL

Ferumoxytol

Intervention Type DRUG

Ferumoxytol will be administered in two infusions, one week apart

Ferrous Sulfate

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.

Group Type ACTIVE_COMPARATOR

Ferrous sulfate 325mg

Intervention Type DIETARY_SUPPLEMENT

Oral tablets supplied for home use

Interventions

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Ferrous sulfate 325mg

Oral tablets supplied for home use

Intervention Type DIETARY_SUPPLEMENT

Ferumoxytol

Ferumoxytol will be administered in two infusions, one week apart

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No