Status:

COMPLETED

Non-invasive Optical Detection of Iron Deficiency

Lead Sponsor:

Klinikum der Universitaet Muenchen, Grosshadern

Conditions:

Anemia, Iron-Deficiency

Eligibility:

FEMALE

18+ years

Brief Summary

This study aims to evaluate a prototype device detecting zinc protoporphyrin-IX fluorescence non-invasively from the intact oral mucosa. Zinc protoporphyrin-IX is an established indicator of iron defi...

Detailed Description

This trial is a proof-of-concept study using a prototype fiber optic fluorometer to acquire autofluorescence spectra from women after delivery and determine the erythrocyte zinc protoporphyrin-IX fluo...

Eligibility Criteria

Inclusion

  • Women after delivery of term infants
  • Pregnancy and delivery without study-relevant complications
  • Hb value pre-partum greater or equal 12 g/dL or less or equal 11 g/dL
  • Regular blood withdrawal before and after delivery for clinical indications
  • Informed consent to participation in the study
  • Age 18 or older

Exclusion

  • Patients who are not legally competent
  • Transfusion of blood products in the course of delivery
  • Thalassemia and sickle cell anemia
  • Any acute or chronic infectious or inflammatory disease
  • Insufficient amount of residual blood in the clinically indicated post partum sample

Key Trial Info

Start Date :

June 1 2013

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

February 1 2015

Estimated Enrollment :

96 Patients enrolled

Trial Details

Trial ID

NCT02310607

Start Date

June 1 2013

End Date

February 1 2015

Last Update

April 8 2015

Active Locations (1)

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1

Department of Obstetrics and Gynecology, Klinikum der Universitaet Muenchen, Grosshadern

Munich, Germany, D-81377