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eNav 2.0 Mama Care - Optimization and evaluation of a family-centered, digital navigator for the cross-professional, cross-sectoral needs coordination of families

eNav 2.0 Mama Care - Optimization and evaluation of a family-centered, digital navigator for the cross-professional, cross-sectoral needs coordination of families - eNav2

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00036995
Enrollment
500
Registered
2025-05-21
Start date
2024-11-30
Completion date
Unknown
Last updated
2025-10-06

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

Conditions

F53.0

Interventions

Group 1: Intervention group: Patient data provided in the app is collected. After registration at one of the participating centers, the medical history and obstetric outcome are recorded in a digital

Sponsors

Universitätsklinik und Poliklinik für Geburtshilfe und Pränatalmedizin
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: - Capacity to consent - Internet access (tablet or smartphone) - Sufficient knowledge of German - Confirmed pregnancy between the 12th and 35th week of pregnancy at the time of study inclusion - Planned delivery at one of the study centers

Exclusion criteria

Exclusion criteria: - Patients who are unable to provide informed consent and cooperation due to mental or cognitive impairments. - Patients who have not provided informed consent or who do not agree to the data protection regulations or who withdraw their consent. - Patients without internet access - Insufficient German language skills - Patients who are not giving birth at one of the participating centers.

Design outcomes

Primary

MeasureTime frame
Correlation between duration of use (high user/low user) of the study application and differences in self-assessment of knowledge and utilization of support services in the areas of: a) psychosocial, b) family/partnership, c) exercise/nutrition, measured using a 5-point Likert scale at the start of app use, at 36+0 weeks of gestation, and 3 months postpartum.

Secondary

MeasureTime frame
- Improvement in health-related parameters over the course of the study (T1-T5) and group comparison depending on duration of use (high user/low user) - Prediction of premature birth (<37+0 weeks of gestation), early premature rupture of membranes (<37+0 weeks of gestation), preeclampsia. The test quality criteria are calculated. - Traceability of the AI-generated information regarding the indication for the "Early Help" support service after delivery, as well as regarding recommendations for or against VBAC (vaginal birth after cesarean) – there are no defined outcome measures for this question.

Countries

Germany

Contacts

Public ContactStephanie Wallwiener

Universitätsklinik und Poliklinik für Geburtshilfe und Pränatalmedizini

stephanie.wallwiener@uk-halle.de03455573245

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026