Actively Recruiting
Selective Fetal Growth Restriction in Monochorionic Twins - an International Investigation
Led by Leiden University Medical Center · Updated on 2024-04-15
274
Participants Needed
6
Research Sites
262 weeks
Total Duration
On this page
Sponsors
L
Leiden University Medical Center
Lead Sponsor
U
Universitaire Ziekenhuizen KU Leuven
Collaborating Sponsor
AI-Summary
What this Trial Is About
Optimal diagnostic management and underlying pathophysiological mechanisms of selective fetal growth restriction (sFGR) in monochorionic diamniotic (MCDA) twin pregnancies have not been fully clarified. The current diagnostic classification system based on three different umbilical artery flow patterns has no increasing scale of severity and the predictive value is limited. Since there is no treatment available for sFGR, predicting fetal deterioration is key in preventing single or double fetal demise. Outcome prediction is furthermore important in the selection of cases that will be offered selective reduction (to provide the larger twin with better prospects), as well as determining monitor frequency and possible hospital admission. As outcome prediction is clinically challenging, patient counselling is too, and parents often encounter a great deal of uncertainty during the pregnancy. Furthermore, little is known about the brain development of sFGR children (both during pregnancy and after birth). Moreover, the psychological impact of an sFGR pregnancy of the future parent)s) has not been studied before. The impact of these factors should be taken into account during patient counseling, which is currently not the case. By our knowledge, this is the first international, multicenter, prospective cohort study on that will address the abovementioned questions and knowledge gaps in MCDA pregnancies complicated by selective fetal growth restriction.
CONDITIONS
Official Title
Selective Fetal Growth Restriction in Monochorionic Twins - an International Investigation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pregnant with monochorionic diamniotic (MCDA) twins
- Diagnosed with selective fetal growth restriction (sFGR) before 28 weeks of gestational age
- Pregnant woman aged 18 years or older and able to give consent
- Partner aged 18 years or older and able to give consent, if applicable
- Written informed consent obtained from both parents if applicable for follow-up until 2 years after birth
You will not qualify if you...
- Presence of lethal anomalies in one or both fetuses
- Multiple pregnancy beyond twins
- Twin-to-twin transfusion syndrome (TTTS) or twin anemia-polycythemia sequence (TAPS) present at the time of sFGR diagnosis
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
2
Universitaire Ziekenhuizen Leuven
Leuven, Belgium, 3000
Actively Recruiting
3
Mount Sinai Hospital
Toronto, Ontario, Canada, ON M5G 1X5
Actively Recruiting
4
Leiden University Medical Center
Leiden, South Holland, Netherlands, 2333 ZA
Actively Recruiting
5
BCNatal
Barcelona, Spain, 08028
Actively Recruiting
6
Karolinska University Hospital
Stockholm, Sweden, 17164 Solna
Not Yet Recruiting
Research Team
A
Anne Noll, MD
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
1
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