Erythroferrone and Its Impact on Maternal and Neonatal Iron Homeostasis

Completed

• Conditions: Pregnancy Anemia; Newborn; Anemia

• Registration Number: NCT04517734
• Lead Sponsor: Cornell University

Brief Summary

Erythroferrone (ERFE) is a recently identified iron-regulatory hormone that couples iron homeostasis to erythropoiesis but at this time there are no human data on this hormone in pregnant women and their neonates. The investigators hypothesize that ERFE is a sensitive biomarker of iron deficiency and anemia in pregnancy and neonates, and that it mediates the feedback mechanism to correct iron deficiency and anemia. To address this research gap, the investigators will measure ERFE in maternal serum, umbilical cord serum and placental tissue using an existing biospecimen archive.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-04
• Primary Completion: 2017-12
• Study Completion: 2017-12
• Study First Submitted: 2020-08-11
• Study First Submitted QC: 2020-08-17
• Study First Posted: 2020-08-18
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-08
• Last Update Posted: 2022-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 338

Inclusion Criteria

• Healthy pregnant volunteers

Exclusion Criteria

• Hemoglobinopathies
• Pre-existing diabetes
• Malabsorption diseases
• Pregnancy induced hypertension
• Elevated diastolic blood pressure (>110)
• Previous treatment for lead exposure or elevated childhood lead concentrations.
• Preexisting medical conditions known to impact iron homeostasis

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Neonatal Erythroferrone at Birth	Measures will be obtained from umbilical cord blood collected at delivery
Maternal Erythroferrone During Pregnancy	Measures will be obtained from maternal blood collected throughout the 40 weeks of pregnancy
Maternal Erythroferrone at Delivery	Measures will be obtained from maternal blood collected at delivery
Placental Erythroferrone mRNA and Ferroportin protein Expression	Measures will be obtained from placental samples collected at delivery

Trial Locations

Locations (2)

Strong Memorial Hospital; 🇺🇸 Rochester, New York, United States

Rochester Adolescent Maternity Program; 🇺🇸 Rochester, New York, United States