Non-invasive zinc protoporphyrin screening for iron deficiency in pregnancy
Point-of-care Transcutaneous Longitudinal Non-invasive Detection of Iron Deficiency in Obstetrics (PICCOLINO-Trial)
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 |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Wuerzburg University Hospital Academic / other |
| Locations | 1 site (Würzburg, Bavaria) |
| Trial ID | NCT07083492 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: Blood ZnPP has a history as an iron-status marker, but transcutaneous ZnPP measurement is a relatively new technique with limited prior clinical validation.
Eligibility criteria
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 this trial is running
Würzburg, Bavaria
- University Hospital Würzburg — Würzburg, Bavaria, Germany (Recruiting)
Study contacts
- Study coordinator: Peter Kranke, MD, MBA
- Email: kranke_p@ukw.de
- Phone: +4993120130050
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.