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

Pregnancy Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02038023
• Other study ID #: Intravaneous Iron in Pregnancy
• Secondary ID: Infed
• Status: Completed
• Phase: Phase 2
• Start date: July 2013
• Est. completion date: August 2015

Study information

• Verified date: January 2018
• Source: Auerbach Hematology Oncology Associates P C
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To determine the percentage of women who achieve anemia correction after a single dose of 1000mg of low molecular weight iron dextran(infed).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: August 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pregnancy

Intervention

Drug:
• Intravaneous iron(low molecular weight iron dextran)
1000 mg of Iron dextran administered over one hour

Locations

Country	Name	City	State
United States	Auerbach Hematology Oncology Assoc	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Auerbach Hematology Oncology Associates P C	Pharmacosmos A/S

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Serum Ferritin		4 weeks post infusion or post-partum
Secondary	Percent Transferrin Saturation		4 weeks post infusion or post-partum
Secondary	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