Selective Fetal Growth Restriction in Monochorionic Twins - an International Investigation

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-50
SponsorLeiden University Medical Center

About this trial

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 criteria

Qualifiers

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

Disqualifiers

The presence of lethal anomalies (one or both fetuses)

Multiple pregnancy higher order than twins;

TTTS/TAPS present at moment of sFGR diagnosis.

Trial design

Treatments tested in this trial

  • Ultrasound

Treatment groups

274 Participants
are divided into 1 treatment group

Sponsors and collaborators

Leiden University Medical Center

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Collaborator

Karolinska University Hospital

Collaborator

BCNatal Fetal Medicine Research Center

Collaborator

MOUNT SINAI HOSPITAL

Collaborator

Boston Children's Hospital

Collaborator