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Clinical trialNCT07667647Not, yet, recruitingInterventional

MoDi Twin Placental Imaging

SponsorCarilion ClinicEnrollment10Monochorial Monoamniotic PlacentaMonochorionic Diamniotic PlacentaMonochorionic TwinsPregnancyTwin Pregnancy, MonochorionicTwin Twin Transfusion Syndrome+2 more conditions
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

Twin-twin transfusion syndrome (TTTS) can arise in monochorionic, diamniotic (MoDi), those identical twins arising from division of a single fertilized ovum at 4-8 days gestational age (GA) or monochorionic, monoamniotic (MoMo or Mono-Mono) twins, arising from division on day 8-13 GA. In monochorionic twin pregnancies sharing a single placenta often unevenly, anastomoses \[connections\] artery to artery (AA), vein to vein (VV), and artery to vein (AV) can occur. AV anastomoses usually flow unilaterally, shunting blood unevenly towards one twin and away from the other. This can lead to fluid overload and polyhydramnios along with many other pathologies in one twin while the other twin suffers from inadequate blood flow and oligohydramnios, along with secondary pathologies arising from these conditions. TTTS will affect approximately 8-10% of MoDi twins while 6% of MoMo twins will suffer with this condition. Treatment for TTTS is necessary, with the donor or 'pump' twin having around an 80% chance of death without medical intervention. The aim of this single arm, unblinded, feasibility study of the Verasonics Vantage 256 device is to leverage the devices ultrafast power Doppler imaging (uPDI) to perform microvascular mapping of the placenta in healthy, non-anomalous, 18-26 week gestational age (GA), monochorionic, diamniotic (MoDi) or monochorionic, monoamniotic (MoMo/MonoMono) pregnancies without TTTS, twin reversed arterial perfusion sequence (TRAP), or maternal vascular disease. Participants will be recruited in the Maternal Fetal Medicine department of Carilion Clinic, which specializes in high risk or complicated pregnancies. Pregnant subjects carrying monochorionic twins and scheduled for appointments at the clinic, who meet study eligibility criteria, will be approached between weeks 18 and 26 for study enrollment. Those providing informed consent will undergo a single, transabdominal ultrasound examination by a licensed ultrasonographer or obstetrician with the Verasonics Vantage 256 ultrasound machine, with imaging focused on mapping the vasculature of the placenta with ultrafast power Doppler imaging (uPDI). The ultrasound exam will last about 15 minutes and occur immediately after the subject's standard-of-care appointment at the clinic so as not to inconvenience subjects more than necessary. Similar to commercially marketable ultrasounds in the US, the Verasonics ultrasound will use the principle of 'As Low As Reasonably Achievable (ALARA) to output the lowest acoustic waves possible to achieve the ultrasound imaging. After the single ultrasound scan, subjects' electronic medical records will be used to source demographic, medical, obstetric, and other historical datapoints to better characterize the 10-subject study population and their babies. No follow-up contact with subjects is expected after the single research ultrasound visit.

Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

1 registered facility, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States
  • Carilion Clinic, Community Medical Office Building

    Roanoke, Virginia, United States

    Allison Durica, MDCynthia Matos Molina, MDMegan D Whitham, MD

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

No drug or biological interventions are in our data for this study. It may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
1 Jul 2026
Primary completion
1 Jul 2028
Completion
1 Jul 2029
Last update posted
25 Jun 2026
Registered enrollment
10
Registry id
NCT07667647

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 4 Nov 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.