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"Mamilla 1" Feasibility analysis of hyperspectral imaging for the assessment of nipple perfusion parameters in the early postpartum period under routine clinical conditions: an exploratory observational study

"Mamilla 1" Feasibility analysis of hyperspectral imaging for the assessment of nipple perfusion parameters in the early postpartum period under routine clinical conditions: an exploratory observational study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00041041
Enrollment
30
Registered
2026-07-27
Start date
2026-10-01
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Physiological nipple perfusion during the early postpartum period and feasibility of hyperspectral imaging (HSI) for assessing perfusion-related tissue parameters. S20.1

Interventions

Group 1: Breastfeeding women (=18 years) in the early postpartum period undergo a single assessment during a regular breastfeeding session. Hyperspectral imaging (HSI) is used non-invasively to assess

Sponsors

Universitätsklinikum Tübingen, Department für Frauengesundheit
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: • Written informed consent • Breastfeeding women in the early postpartum period receiving inpatient care at the University Women’s Hospital • Active breastfeeding according to the newborn’s needs

Exclusion criteria

Exclusion criteria: • Expected noncompliance by the patient or the patient’s inability to understand the purpose of the clinical trial • Lack of patient consent • Acute systemic infections • Insufficient knowledge of German

Design outcomes

Primary

MeasureTime frame
Endpoint: Change in nipple perfusion-related hyperspectral imaging (HSI) parameters during a regular breastfeeding session. Assessment time: Once per day during the participant's inpatient stay on the mother–infant unit. Assessment method: Non-invasive hyperspectral imaging (HSI)

Secondary

MeasureTime frame
Inter- and intraindividual variability of HSI-derived perfusion parameters. Association between HSI parameters and maternal pain intensity (VAS). Association between HSI parameters and clinical nipple status (Nipple Trauma Score). Feasibility of HSI measurements under routine clinical conditions.

Countries

Germany

Contacts

Public ContactMartin Weiß

Universitätsklinikum Tübingen, Department für Frauengesundheit

Martin.Weiss@med.uni-tuebingen.de070712982211

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Aug 10, 2026