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Determinants of Neonatal Anemia in Women Carrying Multiples

This study is ongoing, but not recruiting participants.
University of Rochester
Information provided by (Responsible Party):
Cornell University Identifier:
First received: April 12, 2012
Last updated: February 9, 2017
Last verified: February 2017
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.


Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Determinants of Neonatal Iron Homeostasis in Women Carrying Multiples

Resource links provided by NLM:

Further study details as provided by Cornell University:

Primary Outcome Measures:
  • Iron status [ Time Frame: Biochemical measures will be obtained whenever women have blood drawn across pregnancy (there are no fixed time points for sampling). These will be obtained over an approximate 36 week interval ]

Secondary Outcome Measures:
  • Effect of maternal Fe status on placental iron transporter expression [ Time Frame: Participants will be followed over the course of gestation from approximately week 12 of pregnancy until term ]
  • Maternal iron absorption and Fe57 enrichment in cord blood [ Time Frame: Participants will be given 10 mg of stable iron between week 27-32 of gestation. Blood will be drawn 2 weeks post-dosing and maternal and umbilical cord blood will be obtained at delivery ]

Biospecimen Retention:   Samples With DNA
maternal and cord blood, placental tissue and RNA

Estimated Enrollment: 350
Study Start Date: July 2011
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Pregnant women carrying multiples

Detailed Description:
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.

Ages Eligible for Study:   19 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Pregnant women (n = 100-125) carrying multiples (twins, triplets and quadruplets)

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01582802

United States, New York
Strong Memorial Hospital
Rochester, New York, United States, 14642
Sponsors and Collaborators
Cornell University
University of Rochester
Principal Investigator: Kimberly O'Brien, PhD Cornell University
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Cornell University Identifier: NCT01582802     History of Changes
Other Study ID Numbers: OSP 64155
Study First Received: April 12, 2012
Last Updated: February 9, 2017
Individual Participant Data  
Plan to Share IPD: No

Additional relevant MeSH terms:
Hematologic Diseases processed this record on March 28, 2017