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CompletedNCT06108258Updated Oct 30, 2023

Newborn Phosphocalcic Metabolism After Intravenous Iron Administration During Pregnancy

An observational study in Iron Induced Hypophosphatemia, sponsored by University Hospital, Geneva. Completed at 1 site in Switzerland. Open to female participants, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-10-30.

Sponsored by University Hospital, Geneva · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
43
Sex
Female
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Study 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.

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Conditions studied

  • Iron Induced Hypophosphatemia

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In context

Hypophosphatemia

53 studies on the registry are indexed under Hypophosphatemia; 16 are open to participants now.

This study's enrollment of 43 is below the median of 105 across 26 observational studies indexed under Hypophosphatemia.

Browse Hypophosphatemia studies →

Lead sponsor

University Hospital, Geneva is the lead sponsor of 379 studies on the registry; 70 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Female
Accepts healthy volunteers
Yes
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Multiple pregnancy
  • Fetal anomalies
  • Preterm birth
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
43 participants (actual)
Patient registry
No

Groups and cohorts

  • Oral iron
  • IV iron

    Drug: IV iron administration

Interventions

  • DrugIV iron administration

    IV iron administration during pregnancy

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What researchers measure

Primary outcomes

  1. Concentration of cord blood phosphate in neonates

    Time frame: Single timepoint at delivery

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Study locations

1 site
  • Geneva University Hospitals
    Geneva, Switzerland
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Sep 2022 to primary completion in Mar 2023, 5 months.

Of 14 observational studies under Hypophosphatemia, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 24. This study's 5 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 19, 2023
First posted
Oct 30, 2023
StartActual
Sep 23, 2022
Primary completionActual
Mar 3, 2023
CompletionActual
Mar 3, 2023
Last update
Oct 30, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 30, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06108258
Responsible party
Fanny Schumacher (resident doctor, University Hospital, Geneva) — Principal investigator
First posted
Oct 30, 2023
Start date
Sep 23, 2022
Primary completion
Mar 3, 2023
Completion
Mar 3, 2023
Last update
Oct 30, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.

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Discussion

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