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Prospective Analysis of Fetomaternal Risk Factors for the Development of a Risk Score for Pregnancy Complications

Prospective Analysis of Fetomaternal Risk Factors for the Development of a Risk Score for Pregnancy Complications - FeMaR

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00038627
Enrollment
223
Registered
2025-12-04
Start date
2026-02-02
Completion date
Unknown
Last updated
2026-03-30

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

Conditions

“Health complications that occur during pregnancy or childbirth and affect maternal and neonatal outcomes.

Interventions

Group 1: For patients: - Pregnant women = 14 years - Gestational age < 15+0 weeks - Participation in routine antenatal care according to the German Maternity Guidelines (Mutterschaftsrichtlinien) - S

Sponsors

Charité-Universitätsmedizin
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
14 Years to No maximum

Inclusion criteria

Inclusion criteria: - Gestational age < 15+0 weeks - Participation in routine antenatal care according to the German Maternity Guidelines (Mutterschaftsrichtlinien) - Statutory health insurance coverage

Exclusion criteria

Exclusion criteria: - Insufficient language proficiency - Privately insured pregnant women

Design outcomes

Primary

MeasureTime frame
The primary endpoint is the predictive accuracy (sensitivity and specificity) of the score recorded at the first point in time during pregnancy with regard to the occurrence of at least one pregnancy or birth complication between study inclusion and the postpartum period.

Secondary

MeasureTime frame
The secondary endpoint of the study focuses on the predictive performance of the new risk scores with regard to: (Feasibility of the new score, Comprehensibility, Applicability, Time required for assessment, Acceptance) From the health insurance billing data (GKV), including: - Costs - Type and frequency of healthcare utilization

Countries

Germany

Contacts

Public ContactSilke Wegener

Charité-Universitätsmedizin Berlin

silke.wegener@charite.de+49 30450664274

Outcome results

None listed

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