Fontan Circulation and Reproductive Health in a National Swedish Cohort
ConditionFontan Circulation
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCaroline Lilliecreutz
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
Fontan circulation,
Age ≥18 years at inclusion,
Follow-up at specialist clinics,
Ability to fill in questionnaires in the Swedish language (no other alternative available) or
Disqualifiers
None
Trial population
Approximately 200 patients with fontan circulation and their potential partners. Age and gender matched control groups.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Questionnaires and functional test
Other interventionData will be collected from different sources. Questinnaires, Medical journal, Obstetrical records and functional tests
Treatment groups
600 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Group A: Male with Fontan circulation1 intervention
Group B: Female with Fontan circulation1 intervention
Group C: Partner to male with Fontan circulation1 intervention
Group D: Partner to female with Fontan circulation1 intervention
Group E: Male control group1 intervention
Group F: Female control group1 intervention
Trial outcomes
Primary outcomes
1
Prevalence and explanatory factors for sexual dysfunction and infertility in women and men with Fontan circulation
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.
Time frame
3 hoursSecondary outcomes
1
Obstetric, neonatal and cardiological variables before, during, and after pregnancy
Cardiological complications during pregnancy, at delivery, first 6 months Pregnancy,Obstetric and Neonatal complications e.g.Gestational diabetes, Pregnancy-induced hypertension, Preeclampsia, Anemia,Thromboembolic event, hepatosis, Chorioamnionitis-other Relevant medication. Gestational week at partus Premature delivery Induction with indication, Delivery method; uncomplicated vaginal delivery, instrumental vaginal delivery, Cesarean section,Bleeding (ml) at partus, Birth trauma Placental retention, Maternal death. Admission to neonatal ward, Neonatal complications, Child malformations- Type-, Neonatal death, Birth weight, small for gestational age (SGA), large for gestational age (LGA), average for gestational age (AGA) Apgar
Time frame
4 hours2
Experiences and perceptions of parenthood
Thoughts, fears, and hopes,Information and knowledge before and during pregnancy, Follow-ups during pregnancy and their extent, Need for special contact at the clinic for congenital heart defects during pregnancy, Physical and mental well-being during and after childbirth ,Describe experiences and perceptions of parenthood in men Long-term follow-up; additional pregnancy, intervention, hospitalization for heart failure/arrhythmia/FALD/endocarditis/infection/stroke, transplantation, cardiovascular death, non-cardiovascular death after 2.5, 10, and 15 years . Control group: As control subjects, 200 age- and gender-matched individuals are recruited via the population registry. They must not have congenital heart disease. They will complete the same questionnaires as the study participants and will be asked questions about health status.
Time frame
4 hours3
Cognitive function
Multidimensional Fatigue Inventory (MFI-20) Montreal Cognitive Assessment (MoCA) SDMT - Symbol Digit Modalities Test. . TMT A and B - Trail Making Test. BVMT-R - Brief Visuospatial Memory Test. CWIT - Color Word Interference Test. M. FAS - Verbal Fluency Test. DEX - Dysexecutive Questionnaire. . HADs- Hospital Anxiety and Depression Scale BDI II- Beck Depression Inventory
Time frame
4 hoursSponsors and contacts
Click on the lead sponsor to view all of their trials.
Caroline Lilliecreutz
Lead sponsor
Linkoeping University
Sponsor institution
Uppsala University
Collaborator
Umeå University
Collaborator
Lund University
Collaborator
Göteborg University
Collaborator
Karolinska Institutet
Collaborator
Source ClinicalTrials.gov