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Fontan Circulation and Reproductive Health in a National Swedish Cohort

NCT06258382 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 600

Last updated 2024-10-16

No results posted yet for this study

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.

Conditions

  • Fontan Circulation

Interventions

OTHER

Questionnaires and functional test

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

Sponsors & Collaborators

  • Uppsala University

    collaborator OTHER

  • Umeå University

    collaborator OTHER

  • Lund University

    collaborator OTHER

  • Göteborg University

    collaborator OTHER

  • Karolinska Institutet

    collaborator OTHER

  • Caroline Lilliecreutz

    lead OTHER_GOV

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-11-01
Primary Completion
2025-10-01
Completion
2026-10-01

Countries

  • Sweden

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06258382 on ClinicalTrials.gov