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NCT05952583 · ClinicalTrials.gov registry record

Selective Fetal Growth Restriction in Monochorionic Twins - an International Investigation

A clinical trial of Fetal Growth Retardation and Twin; Pregnancy, Affecting Fetus or Newborn, sponsored by Leiden University Medical Center.

Recruiting
Registry status
274
Enrollment target
6
Study locations

NCT05952583 is a study of Fetal Growth Retardation and Twin; Pregnancy, Affecting Fetus or Newborn that is actively recruiting participants, run by Leiden University Medical Center. The registered enrollment target is 274 participants, below the 414-participant average among 3 other Fetal Growth Retardation trials with a reported enrollment target (34% lower). The trial reports 6 study locations across 4 states.

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The verdict

NCT05952583, a study of Fetal Growth Retardation and Twin; Pregnancy, Affecting Fetus or Newborn, is actively recruiting participants, sponsored by Leiden University Medical Center.

RECRUITING
Registry status
274 participants
Enrollment target
6
Study locations

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.

Interventions

  • DIAGNOSTIC_TEST Ultrasound

Study Locations (6)

Other

  • Universitaire Ziekenhuizen Leuven - Leuven
  • BCNatal - Barcelona
  • Karolinska University Hospital - Stockholm

Massachusetts

  • Boston Children's Hospital - Boston

Ontario

  • Mount Sinai Hospital - Toronto

South Holland

  • Leiden University Medical Center - Leiden

Trial Details

FieldValue
Enrollment Target 274 participants
Start Date 2023-02-17
Est. Completion 2028-03-01

Sponsor

Leiden University Medical Center

2 total trials

What the Registry Record Tells You About NCT05952583

The ClinicalTrials.gov registry entry for NCT05952583 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 274 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 414-participant average among 3 other Fetal Growth Retardation trials with a reported enrollment target (34% lower). The listed sponsor is Leiden University Medical Center, which has 2 total studies on file at ClinicalTrials.gov.

The record links to 4 conditions, with Fetal Growth Retardation appearing as the primary indexed condition, and to 1 intervention - of which Ultrasound is the first listed.

NCT05952583 reports 6 study locations spanning 4 distinct geographic areas - top geographies include Other, Massachusetts, Ontario.

Frequently Asked Questions

What is clinical trial NCT05952583 about?

NCT05952583 is a clinical study titled "Selective Fetal Growth Restriction in Monochorionic Twins - an International Investigation". 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 patt...

What is the current status of trial NCT05952583?

This trial is currently recruiting. The enrollment target is 274 participants. The study started on 2023-02-17. Estimated completion is 2028-03-01.

What conditions does trial NCT05952583 study?

This clinical trial studies the following conditions: Fetal Growth Retardation, Twin; Pregnancy, Affecting Fetus or Newborn, Twin Monochorionic Diamniotic Placenta, Twin Diseases.

What interventions are being tested in trial NCT05952583?

The interventions under investigation include: Ultrasound (DIAGNOSTIC_TEST).

Who is sponsoring clinical trial NCT05952583?

This trial is sponsored by Leiden University Medical Center, which has 2 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05952583 being conducted?

This trial has 6 study locations across Massachusetts, Ontario, South Holland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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