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Psychosocial Pregnancy Outcomes in Women with Congenital Heart Disease

Psychosocial Pregnancy Outcomes in Women with Congenital Heart Disease - PROTE-CHD

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00025868
Enrollment
500
Registered
2021-07-14
Start date
2021-08-02
Completion date
Unknown
Last updated
2026-02-02

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

Conditions

Q20 Q21 Q22 Q23 Q24 Q25 Q26

Interventions

Group 1: All patients presenting to the Outpatient Clinic for Congenital Heart Defects and Pediatric Cardiology of the German Heart Institute Munich and fulfilling the inclusion criteria will be infor

Sponsors

Klinik für angeborene Herzfehler und KinderkardiologieDeutsches Herzzentrum München
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: - Female sex (biological) - Age >= 18 years - Presence of an CHD - Patient at the German Heart Center - one or more pregnancies - Ability to give consent - Written consent

Exclusion criteria

Exclusion criteria: Failure to meet an inclusion criterion. Mental, cognitive, or language impairment that prevents the patient from participating in the study

Design outcomes

Primary

MeasureTime frame
The primary endpoint of the study is to identify potentially modifiable risk factors for the development of additional psychological stress in expectant mothers with CHD and thus to prevent unfavorable effects in the long-term course. Psychometric diagnostics in the study will be performed using the following empirically validated and standardized instruments: Postpartum Depression - EPDS Anxiety/Depression - HADS-D Quality of life - EQ-5D-5L Illness identity - IIQ-D Trauma Diagnostics - IES-R General health status - PHQ-D

Secondary

MeasureTime frame
Attachment characteristics - AAS Parent-child relationship - PBQ Control beliefs - FEGK Social support - F-SozU Sense of coherence - SOC Self-compassion - SCS-D-12 Gratitude - GQ-6-G Resilience - RS-13 Mindfulness - FFA-14

Countries

Germany

Contacts

Public ContactHarald Kaemmerer

Klinik für angeborene Herzfehler und KinderkardiologieDeutsches Herzzentrum München

kaemmerer@dhm.mhn.de00498912183025

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 7, 2026