Newborn Phosphocalcic Metabolism After Intravenous Iron Administration During Pregnancy

NCT ID: NCT06108258

Last Updated: 2023-10-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

43 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-09-23

Study Completion Date

2023-03-03

Brief Summary

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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

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Conditions

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Iron Induced Hypophosphatemia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Oral iron

No interventions assigned to this group

IV iron

IV iron administration

Intervention Type DRUG

IV iron administration during pregnancy

Interventions

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IV iron administration

IV iron administration during pregnancy

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Multiple pregnancy
* Fetal anomalies
* Preterm birth
Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Geneva

OTHER

Sponsor Role lead

Responsible Party

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Fanny Schumacher

resident doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Geneva University Hospitals

Geneva, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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2022-00197

Identifier Type: -

Identifier Source: org_study_id

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