MoDi Twin Placental Imaging
Starting soon · Not applicable
Conditions studied: Monochorionic Diamniotic Placenta, Monochorial Monoamniotic Placenta, Monochorionic Twins, Ultrasound Doppler, Ultrasound, Pregnancy, Twin Pregnancy, Monochorionic, Twin Twin Transfusion Syndrome
In brief
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.
Key facts
- Study ID
- NCT07667647
- Run by
- Carilion Clinic
- People needed
- 10
- Starts
- 2026-07-01
- Expected to finish
- 2029-07-01
- Last updated by the study team
- 2026-06-25
Who can join
Age: 18 and older, up to 45. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Subject is 18 to 45 years of age at screening
- Non-anomalous, monochorionic, diamniotic (MoDi) or monochorionic, monoamniotic (MoMo) twin gestation without suspected genetic disorders
- Low-risk aneuploidy screening, if performed
- Intention to deliver at Carilion Roanoke Memorial Hospital (CRMH) or Carilion New River Valley Medical Center (CNRVMC)
- Anatomical survey has been performed
- 18 - 26 weeks gestational age
- Subject willing and able to provide/re-provide informed consent
You may not qualify if…
- Suspected fetal genetic disorder(s)
- Suspected fetal infection(s), twin-twin transfusion syndrome (TTTS), twin reversed arterial perfusion sequence (TRAPS), or maternal vascular disease
- Non-English reading and speaking
- Unstable housing or transportation
- Any other criterion which, in the clinical judgement of the investigator, would make the subject unsuitable for study enrollment
Where it is running
- Carilion Clinic, Community Medical Office Building — Roanoke, Virginia, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.