Iron Deficiency Anemia of PregnancyPICCOLINONCT07083492
Non-invasive Detection of Iron Deficiency in Obstetrics
An observational study of Iron Deficiency Anemia of Pregnancy and Iron-deficiency, run by Wuerzburg University Hospital at 1 site in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Iron Deficiency Anemia of Pregnancy, Iron-deficiency, Restless Leg Syndrome in Pregnancy
- What is being tested?
- non-invasive measurement of zink protoporphyrin
- How many people
- 500 participants
- Where
- 1 siteGermany
- Study dates
- 15 Nov 2022to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: pregnant women ≥ 18 years
Who may be able to join
- any timepoint during or up to 3 months after pregnancy
- age ≥ 18 years
- written informed consent
Who cannot join
- previous participation in this study
- refusal of blood sampling
- incapacity to give informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
University Hospital Würzburg
Würzburg, Bavaria, 97080
Peter Kranke, MD, MBA, MME, +49-931 ext. 20130050, kranke_p@ukw.de
Eva-Maria Kranke, RN, +49-931 ext. 20130024, kranke_e@ukw.de
About this study
Official title: Point-of-care Transcutaneous Longitudinal Non-invasive Detection of Iron Deficiency in Obstetrics (PICCOLINO-Trial)
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.
Read the detailed description
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
- Conditions
- Iron Deficiency Anemia of Pregnancy, Iron-deficiency, Restless Leg Syndrome in Pregnancy, Restless Leg Syndrome Due to Iron Deficiency Anaemia, Postpartum Hemorrhage, Postpartum Depression
- Being tested
- non-invasive measurement of zink protoporphyrin
- Keywords
- Zinc protoporphyrin, Non-invasive detection, Obstetric anesthesia, Patient blood management
- Medical subject headings
- Anemia, Iron-Deficiency, Postpartum Hemorrhage, Depression, Postpartum, Iron Deficiencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non-invasive measurement of zink protoporphyrinDiagnostic test
Also called blood samples, questionnaires
validation of non-invasive measurement of zink protoporphyrin
| Study group | Role | What they receive |
|---|---|---|
| pregnant women | Not described Receives: Diagnostic Test: non-invasive measurement of zink protoporphyrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of non-invasive zinc protoporphyrin for the detection of iron deficiency in pregnancy
To validate accuracy of non-invasively measured ZnPP for detection of iron deficiency in pregnancy at prespecified timepoints
Measured: through study completion, up to 3 months postpartum
Secondary outcomes (4)
Influence of iron status on quality of life of pregnant women
To evaluate whether iron deficiency has an impact on the risk of impaired quality of life in pregnancy. Questionnaire: Short Form 12 (SF-12)
Measured: through study completion, up to 3 months postpartum
Influence of iron status on incidence of postpartum depression
To evaluate whether iron deficiency has an impact on the risk of postpartum depression. Questionnaire: Edinburgh Postnatal Depression Scala (EPDS)
Measured: through study completion, up to 3 months postpartum
Influence of iron status on incidence of restless legs syndrome among pregnant women
To evaluate whether iron deficiency has an impact on the risk of restless legs syndrome in pregnancy. Questionnaire: International Restless Legs Scale (IRLS)
Measured: through study completion, up to 3 months postpartum
Influence of iron status on incidence of preterm birth
To evaluate whether iron deficiency has an impact on the risk of preterm delivery
Measured: peripartum ( about 20 weeks of pregnancy until approximately 6 weeks after delivery. )
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2025
- Study start15 Nov 2022
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iron Deficiency Anemia of PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wuerzburg University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Univ.-Prof. Dr. P. Kranke, Wuerzburg University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07083492
- Sponsor's protocol ID
- 115/21-sc
- Acronym
- PICCOLINO
- Status last verified
- Jul 2025
- First submitted
- 12 Nov 2022
- Last updated
- 24 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Point-of-care Transcutaneous Longitudinal Non-invasive Detection of Iron Deficiency in Obstetrics (PICCOLINO-Trial)
- ClinicalTrials.gov ID
- NCT07083492
- Acronym / sponsor ID
- PICCOLINO / 115/21-sc
- Conditions
- Iron Deficiency Anemia of Pregnancy, Iron-deficiency, Restless Leg Syndrome in Pregnancy, Restless Leg Syndrome Due to Iron Deficiency Anaemia, Postpartum Hemorrhage, Postpartum Depression
- Keywords
- Zinc protoporphyrin, Non-invasive detection, Obstetric anesthesia, Patient blood management
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Wuerzburg University HospitalUniversity, hospital or other
- Study start
- 15 Nov 2022 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 24 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pregnant women | – | Diagnostic Test: non-invasive measurement of zink protoporphyrin |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- pregnant women ≥ 18 years
Key inclusion criteria (3 listed)
- any timepoint during or up to 3 months after pregnancy
- age ≥ 18 years
- written informed consent
Key exclusion criteria (3 listed)
- previous participation in this study
- refusal of blood sampling
- incapacity to give informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| non-invasive measurement of zink protoporphyrinAlso: blood samples, questionnairesvalidation of non-invasive measurement of zink protoporphyrin | Diagnostic test | pregnant women |
Primary outcome
Accuracy of non-invasive zinc protoporphyrin for the detection of iron deficiency in pregnancy
Time frame: 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
4 secondary outcomes
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. )
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Iron Deficiency Anemia of Pregnancy and Iron-deficiency, run by Wuerzburg University Hospital at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Peter Kranke, MD, MBA (+4993120130050, kranke_p@ukw.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of non-invasive zinc protoporphyrin for the detection of iron deficiency in pregnancy (time frame: through study completion, up to 3 months postpartum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2025.