Selective Fetal Growth Restriction in Monochorionic Twins - an International Investigation

Recruiting now

Conditions studied: Twin; Pregnancy, Affecting Fetus or Newborn, Fetal Growth Retardation, Twin Monochorionic Diamniotic Placenta, Twin Diseases

In brief

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 facts

Study ID

NCT05952583

Run by

Leiden University Medical Center

People needed

274

Starts

2023-02-17

Expected to finish

2028-03-01

Last updated by the study team

2024-04-15

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• The presence of lethal anomalies (one or both fetuses)
• Multiple pregnancy higher order than twins;
• TTTS/TAPS present at moment of sFGR diagnosis.

Where it is running

• Boston Children's Hospital — Boston, Massachusetts, United States (enrolling)
• Universitaire Ziekenhuizen Leuven — Leuven, Belgium (enrolling)
• Mount Sinai Hospital — Toronto, Ontario, Canada (enrolling)
• Leiden University Medical Center — Leiden, South Holland, Netherlands (enrolling)
• BCNatal — Barcelona, Spain (enrolling)
• Karolinska University Hospital — Stockholm, Sweden

Full record on ClinicalTrials.gov

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