Non-invasive zinc protoporphyrin screening for iron deficiency in pregnancy
Official title: Point-of-care Transcutaneous Longitudinal Non-invasive Detection of Iron Deficiency in Obstetrics (PICCOLINO-Trial)
Run by Wuerzburg University Hospital · NCT07083492 · Data updated 2026-11-12
This project tests a handheld device that measures zinc protoporphyrin through the lower lip to detect iron deficiency in pregnant and recently postpartum people.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 500 (estimated) |
| Sponsor | Wuerzburg University Hospital Academic / other |
| Locations | 1 site (Würzburg, Bavaria) |
| Status | Recruiting |
| Started | November 15, 2022 |
| Main results expected | December 31, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | July 24, 2025 |
| Trial ID | NCT07083492 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Pregnant people aged 18 or older (including up to 3 months postpartum) who can give informed consent and are willing to undergo blood sampling and non-invasive ZnPP measurements are ideal candidates.
✕Probably not a fit
Those who refuse blood sampling, cannot provide informed consent, or have already participated are not eligible and therefore will not benefit from the study procedures.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective, longitudinal observational study enrolling up to 500 participants to test a fluorescence-based device that measures zinc protoporphyrin (ZnPP) transcutaneously at the lower lip. Measurements will be taken once per trimester, at delivery, and about 2–3 months postpartum and compared with conventional blood-based iron markers. The study will analyze diagnostic agreement between non-invasive ZnPP and laboratory tests and track associations between iron status and outcomes such as postpartum depression, restless legs syndrome, obstetric complications, transfusion need, and quality of life. The protocol focuses on feasibility and diagnostic value of point-of-care non-invasive screening in an obstetric population.
Why it matters
Potential benefit: If successful, this could offer a quick, painless screening tool to identify iron deficiency in pregnancy and postpartum without routine blood draws.
How similar studies have gone: Blood ZnPP has a history as an iron-status marker, but transcutaneous ZnPP measurement is a relatively new technique with limited prior clinical validation.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * any timepoint during or up to 3 months after pregnancy * age ≥ 18 years * written informed consent Exclusion Criteria: * previous participation in this study * refusal of blood sampling * incapacity to give informed consent
Where it's running
-
University Hospital Würzburg
Würzburg, Bavaria, Germany Recruiting
Study contacts
- Study coordinator: Peter Kranke, MD, MBA
- Email: kranke_p@ukw.de
- Phone: +4993120130050
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.