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RECRUITING
NCT06258382

Fontan Circulation and Reproductive Health in a National Swedish Cohort

Sponsor: Caroline Lilliecreutz

View on ClinicalTrials.gov

Summary

In the Swedish registry for congenital heart defects, SWEDCON, over 230 patients with single-ventricle circulation are registered in the adult section. Congenital heart defects affect career choices, family planning, and leisure activities. Questions regarding heredity and pregnancy are common. The impact of Fontan circulation on reproductive health and fertility needs to be illuminated, and additional studies are required from both medical and psychosocial perspectives.Cognitive impairment is common among patients with congenital heart defects but is likely an overlooked cause of long-term illness. Objective To study a large national population (n=200) of adults with Fontan circulation and their potential partners regarding. * the prevalence and explanatory factors for sexual dysfunction and infertility in women and men with Fontan circulation (Study A). * the outcomes of pregnancy, choice of delivery mode, and complications in patients with Fontan circulation (Study B). * the experiences and perceptions of becoming parents among women (n=20) and men (n=20), as well as elucidate reasoning and family planning among women and men (n=20) who have not become parents (Study C). * Investigate the prevalence and explanatory factors for (Sub-study D): * Fatigue * In-depth cognitive screening to describe specific cognitive functions such as auditory memory, visuospatial memory, attention, cognitive speed, and executive functions. The aim of this research is to gain more knowledge in an area that has been relatively underexplored, thus improving care for women and men with congenital heart defects.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

600

Start Date

2023-11-01

Completion Date

2026-10-01

Last Updated

2024-10-16

Healthy Volunteers

Yes

Interventions

OTHER

Questionnaires and functional test

Data will be collected from different sources. Questinnaires, Medical journal, Obstetrical records and functional tests

Locations (15)

Lund University Skåne University Hospital

Lund, Skåne County, Sweden

Sahlgrenska Academy, University of Gothenburg Sahlgrenska University Hospital

Gothenburg, Sweden

Sahlgrenska University Hospital,

Gothenburg, Sweden

University Hospital, Linköping

Linköping, Sweden

Skåne University Hospital, Lund University

Lund, Sweden

Karolinska University Hospital

Stockholm, Sweden

Karolinska University Hospital

Stockholm, Sweden

Karolinska University Hospital

Stockholm, Sweden

University West, Drottning Silvia's Children's Hospital/Sahlgrenska University Hospital,

Trollhättan, Sweden

Umeå University, Norrland University Hospital

Umeå, Sweden

Umeå University, Norrlands University Hospital

Umeå, Sweden

Umeå University, Norrlands University Hospital

Umeå, Sweden

Akademiska Hospital Uppsala.Uppsala University.

Uppsala, Sweden

Uppsala University, Akademiska Hospital

Uppsala, Sweden

Linköping University, University Hospital

Linköping, Östergötland County, Sweden