Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT05952583

Selective Fetal Growth Restriction in Monochorionic Twins - an International Investigation

Sponsor: Leiden University Medical Center

View on ClinicalTrials.gov

Summary

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.

Key Details

Gender

All

Age Range

18 Years - 50 Years

Study Type

OBSERVATIONAL

Enrollment

274

Start Date

2023-02-17

Completion Date

2028-03-01

Last Updated

2024-04-15

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

Ultrasound

Additional ultrasound measurements during pregnancy

Locations (6)

Boston Children's Hospital

Boston, Massachusetts, United States

Universitaire Ziekenhuizen Leuven

Leuven, Belgium

Mount Sinai Hospital

Toronto, Ontario, Canada

Leiden University Medical Center

Leiden, South Holland, Netherlands

BCNatal

Barcelona, Spain

Karolinska University Hospital

Stockholm, Sweden