Non-invasive Detection of Iron Deficiency in Obstetrics

NCT07083492 | Recruiting

• 1 other identifier: 115/21-sc
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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.

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; Pregnancy Anemia; Iron Deficiency (Without Anemia)

Keywords

Zinc protoporphyrin; Non-invasive detection; Obstetric anesthesia; Patient blood management

Outcome Measures

Primary Outcomes (1)

• 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

  through study completion, up to 3 months postpartum

Secondary Outcomes (4)

• 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. )

Study Arms (1)

pregnant women

Diagnostic Test: non-invasive measurement of zink protoporphyrin

Interventions

non-invasive measurement of zink protoporphyrin DIAGNOSTIC_TEST

validation of non-invasive measurement of zink protoporphyrin

Also known as: blood samples, questionnaires

pregnant women

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

pregnant women ≥ 18 years

You may qualify if:

• any timepoint during or up to 3 months after pregnancy
• age ≥ 18 years
• written informed consent

You may not qualify if:

• previous participation in this study
• refusal of blood sampling
• incapacity to give informed consent

Sponsors & Collaborators

• Wuerzburg University Hospital: lead

Study Sites (1)

University Hospital Würzburg

Würzburg, Bavaria, 97080, Germany

RECRUITING

Biospecimen

Retention: NONE RETAINED

blood samples

MeSH Terms

Conditions

Anemia, Iron-Deficiency; Postpartum Hemorrhage; Depression, Postpartum; Iron Deficiencies

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

Peter Kranke, MD, MBA

CONTACT

+4993120130050; kranke_p@ukw.de

Tobias Schlesinger, MD

CONTACT

+4993120130380; schlesinge_t@ukw.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. P. Kranke

Study Record Dates

• First Submitted: November 12, 2022
• First Posted: July 24, 2025
• Study Start: November 15, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: July 24, 2025

Record last verified: 2025-07

Locations

DE (1)