Fontan Circulation and Reproductive Health in a National Swedish Cohort

Condition(s) studied

Investigational drug(s) / intervention(s)

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

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.

Eligibility

Primary outcome measure(s)

• Prevalence and explanatory factors for sexual dysfunction and infertility in women and men with Fontan circulation — 3 hours
  Reproductive health questionnaire for Woman/reproductive health questionnaire for Man, and a questionnaire for the potential partner, designed for this study. International Index of Erectile Function (IIEF5) Female Sexual Function Index (FSFI) EQ-5D is an instrument to describe and measure health and health-related quality of life.

Trial sites (15)