Intravaneous Iron(1000 mg Low Molecular Weight Iron Dextran Over 60 Minutes) for Pregnant Women

NCT ID: NCT02038023

Last Updated: 2018-06-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 74 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-07-31
• Study Completion Date: 2015-08-31

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.

Conditions

Pregnancy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

IV iron

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.

Group Type: OTHER

Intravaneous iron(low molecular weight iron dextran)

Intervention Type: DRUG

1000 mg of Iron dextran administered over one hour

Interventions

Intravaneous iron(low molecular weight iron dextran)

1000 mg of Iron dextran administered over one hour

Intervention Type: DRUG

Other Intervention Names

Iron Dextran(InFed)

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Pharmacosmos A/S

INDUSTRY

Sponsor Role: collaborator

Auerbach Hematology Oncology Associates P C

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Auerbach, MD

Role: PRINCIPAL_INVESTIGATOR

Auerbach Hematology Oncology

Locations

Auerbach Hematology Oncology Assoc

Baltimore, Maryland, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 28739199 (View on PubMed)

Other Identifiers

Infed

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

Intravaneous Iron in Pregnancy

Identifier Type: -

Identifier Source: org_study_id