Actively Recruiting
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
52 weeks
Total Duration
On this page
Sponsors
C
Caroline Lilliecreutz
Lead Sponsor
U
Uppsala University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying adults with Fontan circulation, a condition where the heart has a single ventricle pumping blood. This research aims to understand how this circulation affects reproductive health, fertility, pregnancy outcomes, parenthood experiences, fatigue, and cognitive functions. The study includes about 200 adults and their partners from Sweden and seeks to improve medical and psychosocial care for people living with complex congenital heart defects. Participants will provide data through questionnaires and functional tests. The study includes different groups: males and females with Fontan circulation, their partners, and control groups without congenital heart disease. The study collects information on sexual dysfunction, infertility, pregnancy outcomes, delivery choices, complications, parenthood perceptions, fatigue, and cognitive abilities such as memory, attention, and executive functions. Participants will engage in data collection including medical records, obstetrical history, and responses to questionnaires. The study measures primary outcomes like sexual dysfunction and infertility prevalence, and secondary outcomes such as obstetric and cardiological variables, parenthood experiences, and cognitive function. The research involves multiple national centers in Sweden and aims to provide detailed insights over several hours of assessment and follow-up, enhancing care for adults living with Fontan circulation.
CONDITIONS
Brief Title
Fontan Circulation and Reproductive Health in a National Swedish Cohort
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Fontan circulation
- Age 18 years or older at inclusion
- Follow-up at specialist clinics
- Ability to fill in questionnaires in Swedish
- Partner of a person with Fontan circulation
- Age 18 years or older at inclusion
- Ability to fill in questionnaires in Swedish
- Age- and gender-matched individuals without congenital heart disease recruited via population registry
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single assessment lasting approximately 3 to 4 hours
Participants complete questionnaires and undergo functional tests to assess reproductive health, cognitive function, and related factors.
1 visit (in-person)
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
Research Team
C
Caroline Lilliecreutz, PhD, Docent
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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