Determinants of Neonatal Anemia in Women Carrying Multiples

NCT01582802 | Unknown

• 1 other identifier: OSP 64155
• Study Type: observational
• Target: 350
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anemia

Outcome Measures

Primary Outcomes (3)

• Maternal iron status

  Maternal hematological measures will be evaluated

  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

• Neonatal iron status at birth

  Cord blood hematological measures will be evaluated

  Umbilical cord blood will be collected at birth

• Determinants of inter- and intra-uterine variance of neonatal iron status

  ICC will be evaluated for iron status biomarkers

  Umbilical cord blood will be collected at birth

Secondary Outcomes (2)

• Effect of maternal Fe status on placental iron transporter expression

  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

  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

Study Arms (1)

Pregnant women carrying multiples

Healthy pregnant women carrying twins, triplets and quadruplets will be recruited.

Eligibility Criteria

• Age: 19 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant women (n = 100-125) carrying multiples (twins, triplets and quadruplets)

You may qualify if:

• 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

You may not qualify if:

• Hemoglobinopathies,
• Preexisting diabetes,
• Malabsorption diseases

Sponsors & Collaborators

• Cornell University: lead
• University of Rochester: collaborator

Study Sites (1)

Strong Memorial Hospital

Rochester, New York, 14642, United States

Location

Related Publications (7)

• Ru Y, Pressman EK, Cooper EM, Guillet R, Katzman PJ, Kent TR, Bacak SJ, O'Brien KO. Iron deficiency and anemia are prevalent in women with multiple gestations. Am J Clin Nutr. 2016 Oct;104(4):1052-1060. doi: 10.3945/ajcn.115.126284. Epub 2016 Aug 31.

  PMID: 27581469 BACKGROUND

• Ru Y, Pressman EK, Guillet R, Katzman PJ, Bacak SJ, O'Brien KO. Predictors of anemia and iron status at birth in neonates born to women carrying multiple fetuses. Pediatr Res. 2018 Aug;84(2):199-204. doi: 10.1038/s41390-018-0044-6. Epub 2018 Jun 15.

  PMID: 29907852 BACKGROUND

• Ru Y, Pressman EK, Guillet R, Katzman PJ, Vermeylen F, O'Brien KO. Umbilical Cord Hepcidin Concentrations Are Positively Associated with the Variance in Iron Status among Multiple Birth Neonates. J Nutr. 2018 Nov 1;148(11):1716-1722. doi: 10.1093/jn/nxy151.

  PMID: 30247706 BACKGROUND

• Barad A, Guillet R, Pressman EK, Katzman PJ, Ganz T, Nemeth E, O'Brien KO. Placental ferroportin protein abundance is associated with neonatal erythropoietic activity and iron status in newborns at high risk for iron deficiency and anemia. Am J Clin Nutr. 2024 Jan;119(1):76-86. doi: 10.1016/j.ajcnut.2023.10.022. Epub 2023 Oct 27.

  PMID: 37890671 DERIVED

• Delaney KM, Barad A, Castillo LF, Hasund CM, Guillet R, Pressman EK, Katzman PJ, Ganz T, Nemeth E, O'Brien KO. Placental Erythroferrone and Erythropoietin mRNA Expression is not Associated with Maternal or Neonatal Iron Status in Adolescents Carrying Singletons and Adult Women Carrying Multiples. J Nutr. 2023 Jul;153(7):1950-1958. doi: 10.1016/j.tjnut.2023.05.023. Epub 2023 May 28.

  PMID: 37253412 DERIVED

• Delaney KM, Guillet R, Pressman EK, Caulfield LE, Zavaleta N, Abrams SA, O'Brien KO. Iron absorption during pregnancy is underestimated when iron utilization by the placenta and fetus is ignored. Am J Clin Nutr. 2020 Sep 1;112(3):576-585. doi: 10.1093/ajcn/nqaa155.

  PMID: 32614379 DERIVED

• Delaney KM, Guillet R, Fleming RE, Ru Y, Pressman EK, Vermeylen F, Nemeth E, O'Brien KO. Umbilical Cord Serum Ferritin Concentration is Inversely Associated with Umbilical Cord Hemoglobin in Neonates Born to Adolescents Carrying Singletons and Women Carrying Multiples. J Nutr. 2019 Mar 1;149(3):406-415. doi: 10.1093/jn/nxy286.

  PMID: 30770543 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

maternal and cord blood, placental tissue and RNA

MeSH Terms

Conditions

Anemia

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Kimberly O'Brien, PhD

  Cornell University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2012
• First Posted: April 23, 2012
• Study Start: July 1, 2011
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2023
• Last Updated: July 12, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)