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Iron Parameters in Non-anemic First Trimester Gravidas

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ClinicalTrials.gov Identifier: NCT03670537
Recruitment Status : Completed
First Posted : September 13, 2018
Results First Posted : October 15, 2018
Last Update Posted : June 26, 2019
Sponsor:
Collaborator:
MedStar Women's Care at Honeygo
Information provided by (Responsible Party):
Michael Auerbach MD, Auerbach Hematology Oncology Associates P C

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Conditions Iron Deficiency (Without Anemia)
Pregnancy
Intervention Diagnostic Test: Iron parameters
Enrollment 102
Recruitment Details  
Pre-assignment Details  
Arm/Group Title First Trimester Pregnant Women
Hide Arm/Group Description Iron parameters: Serum iron, total iron binding capacity, TSAT (Fe/TIBC), serum ferritin
Period Title: Overall Study
Started 102
Completed 101
Not Completed 1
Reason Not Completed
Protocol Violation             1
Arm/Group Title First Trimester Pregnant Women
Hide Arm/Group Description Iron parameters: Serum iron, total iron binding capacity, TSAT (Fe/TIBC), serum ferritin
Overall Number of Baseline Participants 101
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 101 participants
<=18 years
0
   0.0%
Between 18 and 65 years
101
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 101 participants
Female
101
 100.0%
Male
0
   0.0%
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: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 101 participants
101
 100.0%
Gravidity (number of pregnancies)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 101 participants
Gravida 1
29
  28.7%
Gravida 2
30
  29.7%
Gravida 3
23
  22.8%
Gravida 4
11
  10.9%
Gravida 5
6
   5.9%
Gravida 6 or more
2
   2.0%
1.Primary Outcome
Title Percent of Non-anemic Patients With Iron Deficiency Stratified by Gravidity
Hide Description Either low serum ferritin or low percent transferrin saturation (TSAT)
Time Frame Day 1 presentation to obstetrician
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title First Trimester Pregnant Women
Hide Arm/Group Description:
Iron parameters: Serum iron, total iron binding capacity, TSAT (Fe/TIBC), serum ferritin
Overall Number of Participants Analyzed 101
Measure Type: Count of Participants
Unit of Measure: Participants
Serum ferritin 25-30ng/ml
9
   8.9%
Serum ferritin 20-25ng/ml
3
   3.0%
Serum ferritin <20ng/ml
6
   5.9%
TSAT <19%
38
  37.6%
Time Frame During blood draw
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title First Trimester Pregnant Women
Hide Arm/Group Description Iron parameters: Serum iron, total iron binding capacity, TSAT (Fe/TIBC), serum ferritin
All-Cause Mortality
First Trimester Pregnant Women
Affected / at Risk (%)
Total   0/102 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
First Trimester Pregnant Women
Affected / at Risk (%)
Total   0/102 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
First Trimester Pregnant Women
Affected / at Risk (%)
Total   0/102 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Michael Auerbach
Organization: Auerbach Hematology and Oncology
Phone: 4107804050
Responsible Party: Michael Auerbach MD, Auerbach Hematology Oncology Associates P C
ClinicalTrials.gov Identifier: NCT03670537     History of Changes
Other Study ID Numbers: Protocol 3
First Submitted: September 12, 2018
First Posted: September 13, 2018
Results First Submitted: October 10, 2018
Results First Posted: October 15, 2018
Last Update Posted: June 26, 2019