Non-invasive Detection of Iron Deficiency in Obstetrics

Study Title Point-of-care transcutaneous longitudinal non-invasive detection of iron deficiency in obstetrics (PICCOLINO Trial)

\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ Brief Summary Iron deficiency is a common condition during pregnancy and is associated with maternal fatigue, increased need for blood transfusion during delivery, and adverse neonatal outcomes. However, current screening practices are inconsistent and often rely on imprecise laboratory parameters like hemoglobin and ferritin. The PICCOLINO trial is a prospective, longitudinal observational study investigating the feasibility and diagnostic value of a novel non-invasive fluorescence-based device to measure zinc protoporphyrin (ZnPP) at the lower lip as a screening tool for iron deficiency in pregnant women.

This study compares non-invasive ZnPP measurements with conventional blood-based markers for iron deficiency and anemia at five time points: once in each trimester, at the time of delivery, and approximately 2-3 months postpartum. The study further examines correlations between iron status and maternal well-being, postpartum depression, restless legs syndrome (RLS), and pregnancy complications.

\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ Detailed Description The study enrolls up to 500 pregnant women, aiming to start inclusion as early as the first trimester. In each participant, ZnPP will be measured non-invasively at the lower lip using an optical sensor. Concurrently, venous blood samples will be drawn (where possible during routine care) to assess standard hematological and iron-related parameters (Hb, MCV, MCH, ferritin, transferrin saturation, Ret-Hb, RDW, and serum zinc).

Validated questionnaires will be used to assess:

* General health-related quality of life (SF-12) * Postpartum depression (EPDS) * Restless legs syndrome (IRLS) * Nutrition and supplement intake * Birth experience (SCIB) The primary aim is to validate the diagnostic performance of non-invasive ZnPP measurements as a screening tool for iron deficiency in pregnancy. Receiver operating characteristic (ROC) analysis will be conducted to compare non-invasive measurements with expert opinion diagnoses and blood-based markers. Secondary outcomes include the relationship between iron deficiency and maternal fatigue, mood disorders, pregnancy outcomes, and neonatal parameters.

Study Design

* Type: Observational (Longitudinal Cohort) * Duration per participant: Up to 12 months * Estimated Enrollment: 500 participants * Timepoints: 1st, 2nd, 3rd trimester, peripartum, and 60-90 days postpartum * Location: University Hospital Würzburg, Germany

Eligibility Criteria

Inclusion Criteria:

* Pregnant women aged ≥18 years * Any gestational age or shortly postpartum * Written informed consent

Exclusion Criteria:

* Previous participation in the study * Decline of blood sampling for study purposes * Inability to provide informed consent

Outcome Measures

Primary Outcome:

• Diagnostic performance (ROC/AUC) of non-invasive ZnPP in detecting iron deficiency

Secondary Outcomes:

* Correlation of iron status with quality of life, postpartum depression, and RLS * Relationship between iron deficiency and pregnancy/neonatal complications

• Influence of iron status on quality of life of pregnant women [Time frame: through study completion, up to 3 months postpartum]
• Influence of iron status on incidence of postpartum depression [Time frame: through study completion, up to 3 months postpartum]
• Influence of iron status on incidence of restless legs syndrome among pregnant women [Time frame: through study completion, up to 3 months postpartum]
• Influence of iron status on incidence of preterm birth [Time frame: peripartum ( about 20 weeks of pregnancy until approximately 6 weeks after delivery. )]