Ignite Creation Date:
2024-05-06 @ 7:42 PM
Last Modification Date:
2024-10-26 @ 3:12 PM
Study NCT ID:
NCT06108258
Status:
COMPLETED
Last Update Posted:
2023-10-30
First Post:
2023-10-19
Brief Title:
Newborn Phosphocalcic Metabolism After Intravenous Iron Administration During Pregnancy
Sponsor:
University Hospital Geneva
Organization:
University Hospital Geneva
Study Overview
Official Title:
Newborn Phosphocalcic Metabolism After Intravenous Iron Administration During Pregnancy
Status:
COMPLETED
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Iron deficiency anemia IDA is a very common health problem during pregnancy and intravenous IV iron substitution has become part of routine management Recent studies have raised concerns about association of IV iron infusion and development of secondary transitory hypophosphatemia HP in adults including pregnant women The study aimed to evaluate the impact of IV iron administration during pregnancy on newborns phosphatemia
The investigators conducted a prospective single-center observational study in the Geneva University Hospitals HUG from September 2022 to March 2023 Pregnant women treated either with IV iron or with oral iron during pregnancy were included At delivery a maternal blood sample to assess hemoglobin hematocrit ferritin phosphate and calcium and an umbilical cord blood sample to assess levels of phosphate and calcium were collected Difference in demographics and clinical characteristics between the two groups were explored using univariate analyses Multivariate analyses were performed to test the contribution of IV iron substitution on cord blood phosphatemia and calcemia considering potential confounding factors Neonatal HP was defined as a phosphate level lower than 13 mmolL
The investigators conducted a prospective single-center observational study in the Geneva University Hospitals HUG from September 2022 to March 2023 Pregnant women treated either with IV iron or with oral iron during pregnancy were included At delivery a maternal blood sample to assess hemoglobin hematocrit ferritin phosphate and calcium and an umbilical cord blood sample to assess levels of phosphate and calcium were collected Difference in demographics and clinical characteristics between the two groups were explored using univariate analyses Multivariate analyses were performed to test the contribution of IV iron substitution on cord blood phosphatemia and calcemia considering potential confounding factors Neonatal HP was defined as a phosphate level lower than 13 mmolL
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None