Determinants of Neonatal Anemia in Women Carrying Multiples

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Cornell University
Sponsor:
Collaborator:
University of Rochester
Information provided by (Responsible Party):
Cornell University
ClinicalTrials.gov Identifier:
NCT01582802
First received: April 12, 2012
Last updated: March 18, 2014
Last verified: March 2014
  Purpose

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.


Condition
Anemia

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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

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 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

  Eligibility

Ages Eligible for Study:   19 Years to 45 Years
Genders 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)

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01582802

Contacts
Contact: Kimberly O'Brien, PhD 607-255-3743 koo4@cornell.edu

Locations
United States, New York
Strong Memorial Hospital Recruiting
Rochester, New York, United States, 14642
Contact: Eva Pressman, MD       Eva_Pressman@URMC.Rochester.edu   
Principal Investigator: Kimberly O'Brien, PhD         
Principal Investigator: Eva Pressman, MD         
Sub-Investigator: Ronnie Guillet, MD, PhD         
Sub-Investigator: Philip Katzman, MD         
Sponsors and Collaborators
Cornell University
University of Rochester
Investigators
Principal Investigator: Kimberly O'Brien, PhD Cornell University
  More Information

No publications provided

Responsible Party: Cornell University
ClinicalTrials.gov Identifier: NCT01582802     History of Changes
Other Study ID Numbers: OSP 64155
Study First Received: April 12, 2012
Last Updated: March 18, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Anemia
Hematologic Diseases

ClinicalTrials.gov processed this record on July 20, 2014