Determinants of Neonatal Anemia in Women Carrying Multiples



Status:Active, not recruiting
Conditions:Anemia
Therapuetic Areas:Hematology
Healthy:No
Age Range:19 - 45
Updated:2/7/2019
Start Date:July 2011
End Date:December 2019

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Determinants of Neonatal Iron Homeostasis in Women Carrying Multiples

Multiple births in the United States are rapidly increasing in large part due to assisted
reproductive technologies. Recent data indicate that multiple births now comprise 3-4.5% of
all births in the United States. Pregnant women are at risk for iron (Fe) deficiency anemia
yet there are virtually no data on Fe status in women carrying multiples and current
recommendations do not necessitate Fe screening among this high risk group. Maternal anemia
is known to increase the risk of adverse birth outcomes including preterm birth and low birth
weight. Moreover, the developing brain is increasingly recognized to be susceptible to Fe
insufficiency in utero and growing data support that suboptimal Fe stores at birth are
associated with long-term irreversible cognitive deficits in the offspring. To address these
gaps in knowledge the investigators will monitor weight gain, hematological measures, Fe
status indicators and serum hepcidin across pregnancy in approximately 120 women carrying
twins and triplets. Determinants of maternal anemia will be identified. Neonatal
hematological measures will be assessed in cord blood from each neonate at birth for
assessment of hematological measures, Fe status and hepcidin. Determinants of neonatal anemia
will be identified. Inflammatory markers will be measured in all blood samples and related to
outcomes. Stable iron isotopes will be given to a subset of women to assess maternal Fe
absorption and fetal Fe uptake.

Pregnant women (n=100-125) carrying multiples (twins and triplets) will be identified when
entering prenatal care. Women will be invited to participate in a longitudinal study of Fe
homeostasis across pregnancy and at delivery in the maternal / neonatal dyad. In all maternal
and cord blood samples obtained, whole blood will be analyzed for hemoglobin, hematocrit,
reticulocyte count, erythrocyte count, mean corpuscular hemoglobin, mean corpuscular Hb
concentration, mean corpuscular volume, and red cell distribution width using standard
procedures. Circulating Fe status indicators (serum iron, ferritin, C-reactive protein, IL-6,
erythropoietin, transferrin receptor and hepcidin) and serum folate and vitamin B12 will be
measured. Distributions of each variable will be examined and associations among variables
will be explored. Multiple linear regression models will be constructed to examine specific
relations between a) determinants of Fe deficiency anemia in the mother; b) Fe status
indicators in the mother vs. those in the neonate; c) Fe status indicators in the mother and
neonate with placental Fe binding proteins; and d) neonatal Fe status between siblings.

Inclusion Criteria:

- The investigators anticipate that the majority of these women will be recruited early
in gestation because many of these pregnancies are a result of assisted reproductive
technology.

- Eligible volunteers will be otherwise healthy and have no diagnosed, preexisting
medical conditions known to impact iron homeostasis

Exclusion Criteria:

- Hemoglobinopathies,

- Preexisting diabetes,

- Malabsorption diseases
We found this trial at
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Rochester, New York 14642
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Rochester, NY
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