Actively Recruiting

Age: 18Years +
All Genders
Healthy Volunteers
NCT06258382

Fontan Circulation and Reproductive Health in a National Swedish Cohort

Led by Caroline Lilliecreutz · Updated on 2024-10-16

600

Participants Needed

15

Research Sites

152 weeks

Total Duration

On this page

Sponsors

C

Caroline Lilliecreutz

Lead Sponsor

U

Uppsala University

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Fontan Circulation and Reproductive Health in a National Swedish Cohort

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 years or older
  • Diagnosed with Fontan circulation
  • Under follow-up at specialist clinics
  • Able to complete questionnaires in Swedish
  • Partners of persons with Fontan circulation aged 18 years or older
  • Age- and gender-matched individuals without congenital heart disease recruited via the population registry
Not Eligible

You will not qualify if you...

  • None specified

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 15 locations

1

Lund University Skåne University Hospital

Lund, Skåne County, Sweden

Actively Recruiting

2

Sahlgrenska Academy, University of Gothenburg Sahlgrenska University Hospital

Gothenburg, Sweden

Not Yet Recruiting

3

Sahlgrenska University Hospital,

Gothenburg, Sweden

Not Yet Recruiting

4

University Hospital, Linköping

Linköping, Sweden

Not Yet Recruiting

5

Skåne University Hospital, Lund University

Lund, Sweden

Not Yet Recruiting

6

Karolinska University Hospital

Stockholm, Sweden

Not Yet Recruiting

7

Karolinska University Hospital

Stockholm, Sweden

Not Yet Recruiting

8

Karolinska University Hospital

Stockholm, Sweden

Not Yet Recruiting

9

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

Trollhättan, Sweden

Not Yet Recruiting

10

Umeå University, Norrland University Hospital

Umeå, Sweden

Not Yet Recruiting

11

Umeå University, Norrlands University Hospital

Umeå, Sweden

Not Yet Recruiting

12

Umeå University, Norrlands University Hospital

Umeå, Sweden

Not Yet Recruiting

13

Akademiska Hospital Uppsala.Uppsala University.

Uppsala, Sweden

Actively Recruiting

14

Uppsala University, Akademiska Hospital

Uppsala, Sweden

Actively Recruiting

15

Linköping University, University Hospital

Linköping, Östergötland County, Sweden, 58158 Linköping

Not Yet Recruiting

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Research Team

C

Caroline Lilliecreutz, PhD, Docent

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

6

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