Clinical Trials Directory

Trials / Completed

CompletedNCT06108258

Newborn Phosphocalcic Metabolism After Intravenous Iron Administration During Pregnancy

Status
Completed
Phase
Study type
Observational
Enrollment
43 (actual)
Sponsor
University Hospital, Geneva · Academic / Other
Sex
Female
Age
Healthy volunteers
Accepted

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 newborn's 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 1.3 mmol/L.

Conditions

Interventions

TypeNameDescription
DRUGIV iron administrationIV iron administration during pregnancy

Timeline

Start date
2022-09-23
Primary completion
2023-03-03
Completion
2023-03-03
First posted
2023-10-30
Last updated
2023-10-30

Locations

1 site across 1 country: Switzerland

Source: ClinicalTrials.gov record NCT06108258. Inclusion in this directory is not an endorsement.