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

Phase 2

Completed

• Conditions: Pregnancy
• Interventions: Drug: Intravaneous iron(low molecular weight iron dextran)

• Registration Number: NCT02038023
• Lead Sponsor: Auerbach Hematology Oncology Associates P C

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.

Study Timeline

• Study Start: 2013-07
• Study First Submitted: 2014-01-09
• Study First Submitted QC: 2014-01-15
• Study First Posted: 2014-01-16
• Primary Completion: 2015-07
• Study Completion: 2015-08
• Status Verified: 2018-01
• Results First Submitted: 2018-01-11
• Results First Submitted QC: 2018-06-27
• Last Update Submitted: 2018-06-27
• Results First Posted: 2018-06-28
• Last Update Posted: 2018-06-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 74

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
IV iron	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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	4 weeks after infusion and 4 weeks post-partum	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.

Trial Locations

Locations (1)

Auerbach Hematology Oncology Assoc; 🇺🇸 Baltimore, Maryland, United States