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Healthy Monochorionic Diamniotic Twin Microvasculature and Placental Imaging
Sponsor study identifier
interventional
10
1 country
1
Study Start
July 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
July 1, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
July 1, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 1, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 11, 2026
Actual (reported)June 25, 2026
Actual (reported)July 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
July 1, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
July 1, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Ultrafast Power Doppler Imaging (uPDI) Achieved with the Verasonics Vantage 256 System
Obtain 10 subjects' ultrafast power Doppler imaging (uPDI) with the Verasonics Vantage 256 research ultrasound machine that successfully visualize the placenta's microvasculature. The ability to appreciate the placental microvasculature will be determined \[Y/N\] by perinatologists working as investigators on the study.
24 months
Comparison of uPDI Ultrasound Image Resolution, Quality, and Visualization of Tertiary Villous Capillary Doppler Signals Versus Standard-of-Care Philips Ultrasound Imaging
24 months
Feasibility of High-Quality Placental Vascular Mapping in MoDi/MoMo Twin Pregnancies Using the Verasonics Vantage 256 Ultrasound System
Healthy monochorionic twin pregnancies of 18-26 weeks gestational age (GA) will undergo a single transabdominal ultrasound evaluation of the placenta using the Verasonics 256 device and ultrafast power Doppler imaging (uPDI) as well as quantitative ultrasound (QUS).
Healthy, pregnant subjects with nonanomalous, monochorionic twins will undergo a single transabdominal ultrasound evaluation of the placenta using the Verasonics 256 device which uses ultrafast power Doppler imaging (uPDI) as well as quantitative ultrasound (QUS) to take detailed images of the placental microvasculature.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Carilion Clinic, Community Medical Office Building
Roanoke, Virginia, 24013, United States
Society for Maternal-Fetal Medicine (SMFM); Miller RS, Miller JL, Monson MA, Porter TF, Obican SG, Simpson LL; SMFM Publications Committee. Electronic address: pubs@smfm.org. Society for Maternal-Fetal Medicine Consult Series #72: Twin-twin transfusion syndrome and twin anemia-polycythemia sequence. Am J Obstet Gynecol. 2024 Oct;231(4):B16-B37. doi: 10.1016/j.ajog.2024.07.017. Epub 2024 Jul 18.
Leung KY, Wan YL. Update on Color Flow Imaging in Obstetrics. Life (Basel). 2022 Jan 31;12(2):226. doi: 10.3390/life12020226.
Megan D Whitham, MD
Carilion Clinic
Aiguo Han, PhD
Virginia Polytechnic Institute and State University
First Submitted
June 11, 2026
First Posted
June 25, 2026
Study Start
July 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
July 1, 2028
Estimated24 months
Ability of the Verasonics Vantage 256 Ultrasound System to Distinguish Individual Twin Placental Vasculature
24 months
Contact the study team to confirm eligibility.
Li, Y. L. et al. in 2020 IEEE International Ultrasonics Symposium (IUS). 1-4.
Deeba F, Ma M, Pesteie M, Terry J, Pugash D, Hutcheon JA, Mayer C, Salcudean S, Rohling R. Attenuation Coefficient Estimation of Normal Placentas. Ultrasound Med Biol. 2019 May;45(5):1081-1093. doi: 10.1016/j.ultrasmedbio.2018.10.015. Epub 2019 Jan 23.
Han A, Zhang YN, Boehringer AS, Montes V, Andre MP, Erdman JW Jr, Loomba R, Valasek MA, Sirlin CB, O'Brien WD Jr. Assessment of Hepatic Steatosis in Nonalcoholic Fatty Liver Disease by Using Quantitative US. Radiology. 2020 Apr;295(1):106-113. doi: 10.1148/radiol.2020191152. Epub 2020 Feb 4.
Sainz JA, Carrera J, Borrero C, Garcia-Mejido JA, Fernandez-Palacin A, Robles A, Sosa F, Arroyo E. Study of the Development of Placental Microvascularity by Doppler SMI (Superb Microvascular Imaging): A Reality Today. Ultrasound Med Biol. 2020 Dec;46(12):3257-3267. doi: 10.1016/j.ultrasmedbio.2020.08.017. Epub 2020 Sep 11.
Hata T, Kanenishi K, Yamamoto K, AboEllail MAM, Mashima M, Mori N. Microvascular imaging of thick placenta with fetal growth restriction. Ultrasound Obstet Gynecol. 2018 Jun;51(6):837-839. doi: 10.1002/uog.18837. No abstract available.
Roberts D, Gates S, Kilby M, Neilson JP. Interventions for twin-twin transfusion syndrome: a Cochrane review. Ultrasound Obstet Gynecol. 2008 Jun;31(6):701-11. doi: 10.1002/uog.5328.
Society for Maternal-Fetal Medicine; Simpson LL. Twin-twin transfusion syndrome. Am J Obstet Gynecol. 2013 Jan;208(1):3-18. doi: 10.1016/j.ajog.2012.10.880. Epub 2012 Nov 27.
Bamberg C, Hecher K. Update on twin-to-twin transfusion syndrome. Best Pract Res Clin Obstet Gynaecol. 2019 Jul;58:55-65. doi: 10.1016/j.bpobgyn.2018.12.011. Epub 2019 Jan 5.
Mikaye S. Anatomy of the placenta. LinkedIn. Published May 2025. Accessed March 11, 2026. https://www.linkedin.com/posts/dr-s-0-mikaye-12a369a3_anatomy-of-the-placenta-the-placenta-is-activity-7427704464637149185-VeCK
Borse V, Shanks AL. Twin-to-Twin Transfusion Syndrome. [Updated 2022 Oct 10]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK563133/
Wang Y, Zhao S. Vascular Biology of the Placenta. San Rafael, CA: Morgan & Claypool Life Sciences; 2010. Chapter 2, Placental Blood Circulation. In: NCBI Bookshelf. National Center for Biotechnology Information, U.S. National Library of Medicine. https://www.ncbi.nlm.nih.gov/books/NBK53254/. Accessed February 17, 2026.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
July 1, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
June 25, 2026
Record last verified: 2026-06
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Source: ClinicalTrials.gov.
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