Point-of-care Transcutaneous Longitudinal Non-invasive Detection of Iron Deficiency in Obstetrics (PICCOLINO-Trial)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Accuracy of non-invasive zinc protoporphyrin for the detection of iron deficiency in pregnancy
研究概览
简要总结
Validation of non-invasive measurement of zinc protoporphyrin for detection of iron deficiency in pregnancy.
In addition, the impact of iron deficiency on the incidence of postpartum depression, restless legs syndrome, obstetric complications and quality of life will be examined.
详细描述
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:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •any timepoint during or up to 3 months after pregnancy
- •age ≥ 18 years
- •written informed consent
排除标准
- •previous participation in this study
- •refusal of blood sampling
- •incapacity to give informed consent
结局指标
主要结局
Accuracy of non-invasive zinc protoporphyrin for the detection of iron deficiency in pregnancy
时间窗: through study completion, up to 3 months postpartum
To validate accuracy of non-invasively measured ZnPP for detection of iron deficiency in pregnancy at prespecified timepoints
次要结局
- Influence of iron status on quality of life of pregnant women(through study completion, up to 3 months postpartum)
- Influence of iron status on incidence of postpartum depression(through study completion, up to 3 months postpartum)
- Influence of iron status on incidence of restless legs syndrome among pregnant women(through study completion, up to 3 months postpartum)
- Influence of iron status on incidence of preterm birth(peripartum ( about 20 weeks of pregnancy until approximately 6 weeks after delivery. ))
研究者
Univ.-Prof. Dr. P. Kranke
Prof. Dr. P. Kranke
Wuerzburg University Hospital