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

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ClinicalTrials.gov Identifier: NCT02038023
Recruitment Status : Completed
First Posted : January 16, 2014
Results First Posted : June 28, 2018
Last Update Posted : June 28, 2018
Sponsor:
Collaborator:
Pharmacosmos A/S
Information provided by (Responsible Party):
Auerbach Hematology Oncology Associates P C

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Pregnancy
Intervention Drug: Intravaneous iron(low molecular weight iron dextran)
Enrollment 74
Recruitment Details Standard referrals from obstetricians and gynecologists
Pre-assignment Details Oral iron intolerance plus iron deficiency anemia as defined by a serum ferritin of <20 ng/mL or transferrin saturation of <19% in the 2nd or 3rd trimester plus the ACOG guidelines of <10/.5 g/dL and 11.0 g/dl respectively. 73/74 enrolled received the planned dose.
Arm/Group Title IV Iron
Hide Arm/Group Description

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.

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

Period Title: Overall Study
Started 74
Completed 73
Not Completed 1
Arm/Group Title Intravenous Iron
Hide Arm/Group Description As oral iron intolerant iron deficient 2nd and 3rd trimester gravidas defined by a ferritin of <20 ng/mL and TSAT ,19%. All were anemic by ACOG criteria of Hb <10.5 g/dL in 2nd trimester or, 11g/dL in 3rd, who received 1000 mg IV low molecular weight iron dextran in one hour
Overall Number of Baseline Participants 74
Hide Baseline Analysis Population Description
Iron deficient gravidas in 2nd and 3rd trimesters
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 74 participants
24
(18 to 42)
Sex/Gender, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
All female Number Analyzed 74 participants
74
 100.0%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 74 participants
74
Pretreatment Hb  
Mean (Standard Deviation)
Unit of measure:  g/dL
Number Analyzed 74 participants
9.65  (0.70)
Iron Deficient Pregnant Gravidas  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 74 participants
74
 100.0%
Serum ferritin  
Mean (Standard Deviation)
Unit of measure:  ng/mL
Number Analyzed 74 participants
14.53  (24.61)
Percent Transferrin Saturation  
Mean (Standard Deviation)
Unit of measure:  Percent saturation (Fe/TIBC)
Number Analyzed 74 participants
11.72  (9.14)
1.Primary Outcome
Title Percentage of Women Who Achieve Anemia Correction After a Single Dose of 1000mg of Low Molecular Weight Iron Dextran(INfeD).
Hide Description [Not Specified]
Time Frame 4 weeks after infusion or post-partum
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 73 who received the infusion, 5 were lost to followup and 8 did not return for 4-week posttreatment bloodwork. Pretreatment (initial) and 4-week posttreatment laboratory studies are available for 60
Arm/Group Title Iron Deficient Gravidas
Hide Arm/Group Description:
This has been described twice before. Iron deficient pregnant women in the 2nd and 3rd trimester
Overall Number of Participants Analyzed 60
Measure Type: Count of Participants
Unit of Measure: Participants
Improvement of > or equal to 1 g/dL
35
  58.3%
Improvement of > or equal to 2 g/dL
11
  18.3%
2.Secondary Outcome
Title Serum Ferritin
Hide Description [Not Specified]
Time Frame 4 weeks post infusion or post-partum
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 73 who received the infusion, 5 were lost to followup and 8 did not return for 4-week posttreatment bloodwork. Pretreatment (initial) and 4-week posttreatment laboratory studies are available for 60
Arm/Group Title Intravenous Iron
Hide Arm/Group Description:
As oral iron intolerant iron deficient 2nd and 3rd trimester gravidas defined by a ferritin of <20 ng/mL and TSAT, 19%. All were anemic by ACOG criteria of Hb <10.5 g/dL in 2nd trimester or, 11g/dL in 3rd, who received 1000 mg IV low molecular weight iron dextran in one hour
Overall Number of Participants Analyzed 60
Mean (Standard Deviation)
Unit of Measure: ng/mL
126.29  (88.48)
3.Secondary Outcome
Title Percent Transferrin Saturation
Hide Description [Not Specified]
Time Frame 4 weeks post infusion or post-partum
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 73 who received the infusion, 5 were lost to followup and 8 did not return for 4-week posttreatment bloodwork. Pretreatment (initial) and 4-week posttreatment laboratory studies are available for 60
Arm/Group Title Iron Deficient Gravidas
Hide Arm/Group Description:
This has been described twice before. Iron deficient pregnant women in the 2nd and 3rd trimester
Overall Number of Participants Analyzed 60
Mean (Standard Deviation)
Unit of Measure: percent saturation (Fe/TIBC)
22.64  (12.14)
4.Secondary Outcome
Title Safety as Measured by Number of Adverse Events
Hide Description 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.
Time Frame 4 weeks after infusion and 4 weeks post-partum
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Only One Group[
Hide Arm/Group Description:
Post treatment hemoglobin in 73/74 gravidas
Overall Number of Participants Analyzed 74
Measure Type: Number
Unit of Measure: minor adverse events
6
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title IV Iron
Hide Arm/Group Description

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.

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

All-Cause Mortality
IV Iron
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
IV Iron
Affected / at Risk (%)
Total   0/74 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
IV Iron
Affected / at Risk (%)
Total   0/74 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr Michael AUERBACH
Organization: AUERBACH HEMATOLOGY ONCOLOGY ASSOC
Phone: 410-780-4050
Responsible Party: Auerbach Hematology Oncology Associates P C
ClinicalTrials.gov Identifier: NCT02038023     History of Changes
Other Study ID Numbers: Intravaneous Iron in Pregnancy
Infed ( Other Grant/Funding Number: pharmacosmos )
First Submitted: January 9, 2014
First Posted: January 16, 2014
Results First Submitted: January 11, 2018
Results First Posted: June 28, 2018
Last Update Posted: June 28, 2018