Newborn Phosphocalcic Metabolism After Intravenous Iron Administration During Pregnancy

NCT06108258 | Completed

• 1 other identifier: 2022-00197
• Study Type: observational
• Target: 43
• Locations: 1 country
• Sites: 1

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.

Conditions

Iron Induced Hypophosphatemia

Outcome Measures

Primary Outcomes (1)

• Concentration of cord blood phosphate in neonates

  Single timepoint at delivery

Study Arms (2)

Oral iron

IV iron

Drug: IV iron administration

Interventions

IV iron administration DRUG

IV iron administration during pregnancy

IV iron

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women with an uncomplicated term (≥ 37 weeks) single pregnancy who received IV iron or oral iron substitution from the 2nd trimester of pregnancy (\>12 weeks of pregnancy) to the day of delivery

You may qualify if:

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

You may not qualify if:

• Multiple pregnancy
• Fetal anomalies
• Preterm birth

Sponsors & Collaborators

• University Hospital, Geneva: lead

Study Sites (1)

Geneva University Hospitals

Geneva, Switzerland

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: resident doctor

Study Record Dates

• First Submitted: October 19, 2023
• First Posted: October 30, 2023
• Study Start: September 23, 2022
• Primary Completion: March 3, 2023
• Study Completion: March 3, 2023
• Last Updated: October 30, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)