Selective Fetal Growth Restriction in Monochorionic Twins - an International Investigation

Status: Recruiting
Location: See all (6) locations...
Intervention Type: Diagnostic test
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 50
Healthy Volunteers: f
View:

• MCDA twin pregnancy

• Diagnosis of sFGR before 28+0 weeks of GA (independent of Doppler flows)

• Pregnant woman ≥ 18 years and able to consent

• Partner (who has (future) parental responsibility - if applicable) ≥ 18 years and able to consent

• Written informed consent of both parents (if applicable) for participation in the longitudinal follow-up until 2 years after birth)

Locations
United States
Massachusetts
Boston Children's Hospital
RECRUITING
Boston
Other Locations
Belgium
Universitaire Ziekenhuizen Leuven
RECRUITING
Leuven
Canada
Mount Sinai Hospital
RECRUITING
Toronto
Netherlands
Leiden University Medical Center
RECRUITING
Leiden
Spain
BCNatal
RECRUITING
Barcelona
Sweden
Karolinska University Hospital
NOT_YET_RECRUITING
Stockholm
Contact Information
Primary
Anne Noll, MD
a.t.r.noll@lumc.nl
+32 16 34 47 50
Time Frame
Start Date: 2023-02-17
Estimated Completion Date: 2028-03-01
Participants
Target number of participants: 274
Treatments
sFGR cohort
Monochorionic diamniotic twin pregnancies complicated by sFGR (diagnosed before 28 weeks of gestational age)
Related Therapeutic Areas
Sponsors
Leads: Leiden University Medical Center
Collaborators: Boston Children's Hospital, Karolinska University Hospital, Universitaire Ziekenhuizen KU Leuven, BCNatal Fetal Medicine Research Center, MOUNT SINAI HOSPITAL

This content was sourced from clinicaltrials.gov