Iron Parameters in Non-anemic First Trimester Gravidas

NCT ID: NCT03670537

Last Updated: 2019-06-26

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 102 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-02-07
• Study Completion Date: 2018-08-24

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.

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.

Conditions

Iron Deficiency (Without Anemia); Pregnancy

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

First trimester pregnant women

Iron parameters

Intervention Type: DIAGNOSTIC_TEST

Serum iron, total iron binding capacity, TSAT (Fe/TIBC), serum ferritin

Interventions

Iron parameters

Serum iron, total iron binding capacity, TSAT (Fe/TIBC), serum ferritin

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• Pregnant in first trimester
• Non-anemic

Exclusion Criteria

• anemia

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

MedStar Women's Care at Honeygo

UNKNOWN

Sponsor Role: collaborator

Auerbach Hematology Oncology Associates P C

OTHER

Sponsor Role: lead

Responsible Party

Michael Auerbach MD

President and Clinical Professor of Medicine, Georgetown

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Auerbach Hematology and Oncology

Baltimore, Maryland, United States

Countries

United States

References

Auerbach M, Abernathy J, Juul S, Short V, Derman R. Prevalence of iron deficiency in first trimester, nonanemic pregnant women. J Matern Fetal Neonatal Med. 2021 Mar;34(6):1002-1005. doi: 10.1080/14767058.2019.1619690. Epub 2019 Jun 3.

Reference Type: RESULT

PMID: 31154873 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Protocol 3

Identifier Type: -

Identifier Source: org_study_id