MoDi Twin Placental Imaging

NCT07667647 | Not Yet Recruiting FDA Device

• 1 other identifier: IRB-26-2309
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Monochorionic Diamniotic Placenta; Monochorial Monoamniotic Placenta; Monochorionic Twins; Ultrasound Doppler; Ultrasound; Pregnancy; Twin Pregnancy, Monochorionic; Twin Twin Transfusion Syndrome

Keywords

Carilion Clinic; Maternal Fetal Medicine; Obstetrics; OB; OBGYN; Pregnancy; Twin Pregnancy; Whitham; Monochorionic; Monochorionic Diamniotic; MoDi; MoMo; Monochorionic Monoamniotic; Twin; TTTS; Twin-Twin Transfusion Syndrome; Twin Twin Transfusion Syndrome; uPDI; ultrafast power Doppler Imagine; Quantitative Ultrasound; QUS; Fetoscopic laser photocoagulation; FLP; Verasonic; Ultrasound; Doppler; Doppler Imaging; Prenatal Care

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• 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

  24 months

• Ability of the Verasonics Vantage 256 Ultrasound System to Distinguish Individual Twin Placental Vasculature

  24 months

Study Arms (1)

Healthy Monochorionic Twin Pregnancy

EXPERIMENTAL

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).

Device: Verasonics Vantage 256 Ultrasound

Interventions

Verasonics Vantage 256 Ultrasound DEVICE

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.

Healthy Monochorionic Twin Pregnancy

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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
• 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

Sponsors & Collaborators

• Carilion Clinic: lead
• Virginia Polytechnic Institute and State University: collaborator

Study Sites (1)

Carilion Clinic, Community Medical Office Building

Roanoke, Virginia, 24013, United States

Location

Related Publications (13)

• 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.

  PMID: 39029545 BACKGROUND

• Leung KY, Wan YL. Update on Color Flow Imaging in Obstetrics. Life (Basel). 2022 Jan 31;12(2):226. doi: 10.3390/life12020226.

  PMID: 35207514 BACKGROUND

• Li, Y. L. et al. in 2020 IEEE International Ultrasonics Symposium (IUS). 1-4.

  BACKGROUND

• 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.

  PMID: 30685076 BACKGROUND

• 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.

  PMID: 32013792 BACKGROUND

• 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.

  PMID: 32928602 BACKGROUND

• 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.

  PMID: 28833701 BACKGROUND

• 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.

  PMID: 18504775 BACKGROUND

• 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.

  PMID: 23200164 BACKGROUND

• 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.

  PMID: 30850326 BACKGROUND

• 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

  BACKGROUND

• 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/

  BACKGROUND

• 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.

  BACKGROUND

Related Links

• Verasonics Vantage Ultrasound System Manufacturer Webpage

MeSH Terms

Conditions

Fetofetal Transfusion

Condition Hierarchy (Ancestors)

Anemia, Neonatal; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Megan D Whitham, MD

  Carilion Clinic

  PRINCIPAL INVESTIGATOR

• Aiguo Han, PhD

  Virginia Polytechnic Institute and State University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Megan D Whitham, MD

CONTACT

540-985-9985; MDWhitham@carilionclinic.org

Nicholas C Joseph, CCRC

CONTACT

540-985-9985; ncjoseph@carilionclinic.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2026
• First Posted: June 25, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2029
• Last Updated: June 25, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)