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OpenTrials
Completed

NCT Number: NCT06108258

Newborn Phosphocalcic Metabolism After Intravenous Iron Administration During Pregnancy

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.

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Key information

Sex eligibility

Female

Study type

Observational

Primary location

Geneva University Hospitals

Geneva, Switzerland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Multiple pregnancy
  • Fetal anomalies
  • Preterm birth

Treatment and study plan

IV iron administration

Drug

IV iron administration during pregnancy

Primary outcomes

  1. Concentration of cord blood phosphate in neonates

    Time frame: Single timepoint at delivery

Sponsors and collaborators

Lead sponsor

University Hospital, Geneva

Other

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Oct 30, 2023
Registry last updated
Oct 30, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.