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Iron Parameters in Non-anemic First Trimester Gravidas

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03670537
Recruitment Status : Completed
First Posted : September 13, 2018
Results First Posted : October 15, 2018
Last Update Posted : June 26, 2019
MedStar Women's Care at Honeygo
Information provided by (Responsible Party):
Michael Auerbach MD, Auerbach Hematology Oncology Associates P C

Brief Summary:
The purpose of the study is to see the percentage of non-anemic, first trimester gravidas presenting to their obstetricians, who are iron deficient.

Condition or disease Intervention/treatment
Iron Deficiency (Without Anemia) Pregnancy Diagnostic Test: Iron parameters

Detailed Description:

The 2015 United States Preventive Services Task Force (USPSTF) stated "there is insufficient evidence to recommend the routine screening for iron deficiency in non-anemic gravidas". The basis for this recommendation is the lack maternal or fetal outcome data in this population. To date, there are no guidelines for the treatment of non-anemic, iron deficiency pregnancy women with or without anemia. Obstetricians and gynecologists often do not screen for iron deficiency unless the mean corpuscular volume (MCV) is reduced even in the presence of a reduced hemoglobin. Iron deficiency occurs prior to a decrement in hemoglobin concentration, followed by a decrease in the MCV which occurs after. Subsequently, if these recommendation are followed up to 50% of iron deficient pregnant women remain undiagnosed.

While prospective studies may be absent proving that routine screening and supplementation is beneficial, there is ample evidence that iron deficiency in mothers and infants results in significant morbidity, even in the absence of anemia. Fetal, neonatal and childhood brain growth and development require iron, with deficiencies resulting with adverse effects on myelination, neurotransmitter synthesis and brain programming. There is a two-fold incidence of preterm birth, three-fold increase in low birth weight and small for gestational age infants. In addition to negative effects on the fetus, maternal iron deficiency is associated with an increased risk for caesarean delivery, transfusion, perinatal bleeding, pre-eclampsia, placental abruption, poor wound healing, cardiac failure and even death. Of note, using existing guidelines infants are not screened for iron deficiency even if they are at high risk (preterm, infants of diabetic mothers, smokers or those with intrauterine growth restriction.

Published evidence suggests that when iron deficiency is present later in pregnancy in the mother, adequate iron delivery to the fetus does not occur. In a prospective study of 2400 urban women with iron deficiency in the second and third trimesters, while supplementation resulted in a significant improvement in maternal hemoglobin concentrations and iron parameters, over 45% of infants were iron deficient at birth.

Subsequently, while prospective studies are lacking supporting routine screening and iron supplementation, high quality published evidence imputing a litany of morbid events associated with iron deficiency, calls into question the recommendations of the USPSTF. Until such evidence is available based on the preponderance of evidence supporting absence of harm with either screening or supplementation we believe all gravidas presenting to their obstetricians should be screened for iron deficiency.

We propose a prospective observation study of one hundred consecutive, non-selected, non-anemic, first trimester pregnant women to have iron parameters added to their routine laboratory tests. While we realize this is not standard, many practices already have adopted this screening process. We intend to redact all demographic patient information and expect to incur no uncovered costs. As a result we believe neither investigational review board or informed consent is necessary. In hundreds of patients so screened we have encountered no insurance pushback. The additional tests will include only serum iron, total iron binding capacity (TIBC), percent transferrin saturation (Fe/TIBC) and serum ferritin. The data will be stratified by parity.

We anticipate to find an incidence of iron deficiency of 30-40% based on either a low TSAT or low serum ferritin. Such a finding should motivate properly powered, prospective outcome analyses supporting a new paradigm that incorporating the low cost screening for iron deficiency accompany standard screening tests at the beginning of pregnancy irrespective of the presence or absence of anemia.

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Study Type : Observational
Actual Enrollment : 102 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Iron Parameters in Non-anemic First Trimester Gravidas
Actual Study Start Date : February 7, 2018
Actual Primary Completion Date : August 24, 2018
Actual Study Completion Date : August 24, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Iron

Group/Cohort Intervention/treatment
First trimester pregnant women Diagnostic Test: Iron parameters
Serum iron, total iron binding capacity, TSAT (Fe/TIBC), serum ferritin

Primary Outcome Measures :
  1. Percent of Non-anemic Patients With Iron Deficiency Stratified by Gravidity [ Time Frame: Day 1 presentation to obstetrician ]
    Either low serum ferritin or low percent transferrin saturation (TSAT)

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Pregnant women presenting to their obstetricians

Inclusion Criteria:

  • Pregnant in first trimester
  • Non-anemic

Exclusion Criteria:

  • anemia

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03670537

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United States, Maryland
Auerbach Hematology and Oncology
Baltimore, Maryland, United States, 21237
Sponsors and Collaborators
Auerbach Hematology Oncology Associates P C
MedStar Women's Care at Honeygo
  Study Documents (Full-Text)

Documents provided by Michael Auerbach MD, Auerbach Hematology Oncology Associates P C:

Publications of Results:
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Responsible Party: Michael Auerbach MD, President and Clinical Professor of Medicine, Georgetown, Auerbach Hematology Oncology Associates P C Identifier: NCT03670537     History of Changes
Other Study ID Numbers: Protocol 3
First Posted: September 13, 2018    Key Record Dates
Results First Posted: October 15, 2018
Last Update Posted: June 26, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Michael Auerbach MD, Auerbach Hematology Oncology Associates P C:
Iron deficiency, Non-anemic
Additional relevant MeSH terms:
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Anemia, Iron-Deficiency
Anemia, Hypochromic
Hematologic Diseases
Iron Metabolism Disorders
Metabolic Diseases
Trace Elements
Growth Substances
Physiological Effects of Drugs