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Selective Fetal Growth Restriction in Monochorionic Twins - an International Investigation

NCT05952583 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 274

Last updated 2024-04-15

No results posted yet for this study

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.

Conditions

  • Twin; Pregnancy, Affecting Fetus or Newborn
  • Fetal Growth Retardation
  • Twin Monochorionic Diamniotic Placenta
  • Twin Diseases

Interventions

DIAGNOSTIC_TEST

Ultrasound

Additional ultrasound measurements during pregnancy

Sponsors & Collaborators

  • Universitaire Ziekenhuizen KU Leuven

    collaborator OTHER

  • Karolinska University Hospital

    collaborator OTHER

  • BCNatal Fetal Medicine Research Center

    collaborator UNKNOWN

  • MOUNT SINAI HOSPITAL

    collaborator OTHER

  • Boston Children's Hospital

    collaborator OTHER

  • Leiden University Medical Center

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-17
Primary Completion
2025-03-01
Completion
2028-03-01

Countries

  • United States
  • Belgium
  • Canada
  • Netherlands
  • Spain
  • Sweden

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05952583 on ClinicalTrials.gov