Newborn Phosphocalcic Metabolism After Intravenous Iron Administration During Pregnancy

Completed

• Conditions: Iron Induced Hypophosphatemia
• Interventions: Drug: IV iron administration

• Registration Number: NCT06108258
• Lead Sponsor: University Hospital, Geneva

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 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-09-23
• Primary Completion: 2023-03-03
• Study Completion: 2023-03-03
• Status Verified: 2023-10
• Study First Submitted: 2023-10-19
• Study First Submitted QC: 2023-10-27
• Last Update Submitted: 2023-10-27
• Study First Posted: 2023-10-30
• Last Update Posted: 2023-10-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 43

Inclusion Criteria

• Single pregnancy
• Term (>37SA) pregnancy
• Oral or IV iron substitution from second trimester

Exclusion Criteria

• Multiple pregnancy
• Fetal anomalies
• Preterm birth

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
IV iron	IV iron administration	-

Primary Outcome Measures

Name	Time	Method
Concentration of cord blood phosphate in neonates	Single timepoint at delivery

Trial Locations

Locations (1)

Geneva University Hospitals; 🇨🇭 Geneva, Switzerland