- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04517734
Erythroferrone and Its Impact on Maternal and Neonatal Iron Homeostasis
March 8, 2022 updated by: Cornell University
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.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
338
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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New York
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Rochester, New York, United States, 14609
- Rochester Adolescent Maternity Program
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Rochester, New York, United States, 14620
- Strong Memorial Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
9 years to 43 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
Pregnant women carrying multiple fetuses (twins, triplets and quadruplets) or pregnant adolescents carrying a single fetus
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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Pregnant Adolescents
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Pregnant Women Carrying Multiple Fetuses
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Maternal Erythroferrone During Pregnancy
Time Frame: Measures will be obtained from maternal blood collected throughout the 40 weeks of pregnancy
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Measures will be obtained from maternal blood collected throughout the 40 weeks of pregnancy
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Maternal Erythroferrone at Delivery
Time Frame: Measures will be obtained from maternal blood collected at delivery
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Measures will be obtained from maternal blood collected at delivery
|
Neonatal Erythroferrone at Birth
Time Frame: Measures will be obtained from umbilical cord blood collected at delivery
|
Measures will be obtained from umbilical cord blood collected at delivery
|
Placental Erythroferrone mRNA and Ferroportin protein Expression
Time Frame: Measures will be obtained from placental samples collected at delivery
|
Measures will be obtained from placental samples collected at delivery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Elizabeta Nemeth, PhD, University of California, Los Angeles
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2006
Primary Completion (Actual)
December 1, 2017
Study Completion (Actual)
December 1, 2017
Study Registration Dates
First Submitted
August 11, 2020
First Submitted That Met QC Criteria
August 17, 2020
First Posted (Actual)
August 18, 2020
Study Record Updates
Last Update Posted (Actual)
March 22, 2022
Last Update Submitted That Met QC Criteria
March 8, 2022
Last Verified
March 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0911001050
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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-
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