Actively Recruiting
Point-of-care Transcutaneous Longitudinal Non-invasive Detection of Iron Deficiency in Obstetrics (PICCOLINO-Trial)
Led by Wuerzburg University Hospital · Updated on 2025-07-24
500
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a new, non-invasive way to detect iron deficiency in pregnant women using a device that measures zinc protoporphyrin (ZnPP) through the skin of the lower lip. This study aims to compare this method with traditional blood tests and assess how iron deficiency during pregnancy affects postpartum depression, restless legs syndrome, pregnancy complications, and quality of life. The study is observational and follows participants over time to understand these relationships better. The study involves up to 500 pregnant women who will be assessed up to five times: once in each trimester, at delivery, and 2-3 months after giving birth. During these visits, the ZnPP levels will be measured non-invasively with an optical sensor, and blood samples will be taken when possible to check standard iron and blood health markers. Participants will also complete questionnaires about their health, mood, restless legs symptoms, nutrition, supplement intake, and birth experience. Participants will be involved for up to 12 months, with assessments at key pregnancy and postpartum stages. Researchers will monitor the accuracy of the non-invasive ZnPP test compared to blood tests and expert diagnoses. They will also study how iron levels relate to fatigue, mood disorders, pregnancy outcomes, and newborn health. Safety and well-being are tracked through validated questionnaires and blood tests throughout the study period.
CONDITIONS
Brief Title
Non-invasive Detection of Iron Deficiency in Obstetrics
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pregnant women or women up to 3 months postpartum
- Age 18 years or older
- Able to provide written informed consent
You will not qualify if you...
- Previous participation in this study
- Refusal to provide blood samples
- Unable to give informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - From 1st trimester through delivery
Participants undergo non-invasive zinc protoporphyrin measurements and blood sampling to assess iron deficiency at specified pregnancy stages.
5 visits (once in each trimester, at delivery, and postpartum)
Duration - Up to 3 months postpartum
Participants are observed for correlations between iron status and maternal health outcomes including quality of life, postpartum depression, restless legs syndrome, and pregnancy complications.
1 visit (postpartum follow-up)
Trial Site Locations
Total: 1 location
1
University Hospital Würzburg
Würzburg, Bavaria, Germany, 97080
Actively Recruiting
Research Team
P
Peter Kranke, MD, MBA
T
Tobias Schlesinger, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here