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

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).

Study Overview

• Status: Completed
• Conditions: Pregnancy
• Intervention / Treatment: Drug: Intravaneous iron(low molecular weight iron dextran)

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 Type: Interventional
• Enrollment (Actual): 74
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21237
      • Auerbach Hematology Oncology Assoc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.	Drug: Intravaneous iron(low molecular weight iron dextran); 1000 mg of Iron dextran administered over one hour; Other Names: Iron Dextran(InFed)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage of Women Who Achieve Anemia Correction After a Single Dose of 1000mg of Low Molecular Weight Iron Dextran(INfeD).	4 weeks after infusion or post-partum

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum Ferritin		4 weeks post infusion or post-partum
Percent Transferrin Saturation		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.	4 weeks after infusion and 4 weeks post-partum

Collaborators and Investigators

• Sponsor: Auerbach Hematology Oncology Associates P C
• Collaborators: Pharmacosmos A/S
• Investigators: Principal Investigator: Michael Auerbach, MD, Auerbach Hematology Oncology

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (Actual): July 1, 2015
• Study Completion (Actual): August 1, 2015

Study Registration Dates

• First Submitted: January 9, 2014
• First Submitted That Met QC Criteria: January 15, 2014
• First Posted (Estimate): January 16, 2014

Study Record Updates

• Last Update Posted (Actual): June 28, 2018
• Last Update Submitted That Met QC Criteria: June 27, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: Iv iron in pregnant women; second and third trimester
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Trace Elements; Micronutrients; Anticoagulants; Hematinics; Plasma Substitutes; Blood Substitutes; Dextrans; Iron; Iron-Dextran Complex
• Other Study ID Numbers: Intravaneous Iron in Pregnancy; Infed (Other Grant/Funding Number: pharmacosmos)