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Selective Fetal Growth Restriction in Monochorionic Twins - an International Investigation
NCT05952583 · View on ClinicalTrials.gov ↗
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 Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 274 participants |
| Start Date | 2023-02-17 |
| Est. Completion | 2028-03-01 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05952583
The ClinicalTrials.gov registry entry for NCT05952583 describes a study currently listed as recruiting. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 274 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Leiden University Medical Center, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05952583 reports 6 study locations spanning 4 distinct geographic areas — top geographies include Other, Massachusetts, Ontario. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05952583?
The interventions under investigation include: Ultrasound (DIAGNOSTIC_TEST). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
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. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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