Clinical trial NCT02038023: Intravaneous Iron(1000 mg Low Molecular Weight Iron Dextran Over 60 Minutes) for Pregnant Women
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pregnancy
Keywords: Iv iron in pregnant women
second and third trimester
Lead sponsor: Auerbach Hematology Oncology Associates P C
Sponsor class: OTHER
Collaborators: name: Pharmacosmos A/S
First posted: 2014-01-16
Enrollment: 74
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

* pregnant women intolerable to oral iron. hbg \<10.9 g/dl during second or third trimester.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Percentage of Women Who Achieve Anemia Correction After a Single Dose of 1000mg of Low Molecular Weight Iron Dextran(INfeD).
timeFrame: 4 weeks after infusion or post-partum
Secondary outcomes:
measure: Serum Ferritin
timeFrame: 4 weeks post infusion or post-partum
measure: Percent Transferrin Saturation
timeFrame: 4 weeks post infusion or post-partum
measure: Safety as Measured by Number of Adverse Events
timeFrame: 4 weeks after infusion and 4 weeks post-partum
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Auerbach Hematology Oncology Assoc
state: Maryland
Study officials:
affiliation: Auerbach Hematology Oncology
name: Michael Auerbach, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.