First-Trimester Ultrasound Assessment of Velamentous Cord Insertion (1T-VCI)
Prospective Study of First-Trimester Ultrasound Direct Visualisation of Velamentous Cord Insertion
The goal of this observational study is to learn whether a short ultrasound assessment during the routine first-trimester pregnancy scan can identify velamentous cord insertion, an abnormal location where the umbilical cord joins the placenta. The study will include pregnant participants aged 18 years or older with a singleton pregnancy who attend first-trimester combined screening between 11+0 and 13+6 weeks of pregnancy.
The main questions it aims to answer are:
- How often can the placental cord-insertion site be successfully classified within a 3-minute assessment?
- How accurately does first-trimester ultrasound identify velamentous cord insertion compared with examination of the placenta after delivery?
Participants will:
- Attend their usual first-trimester ultrasound examination.
- Have an additional transabdominal ultrasound assessment of the placental cord-insertion site after the routine scan, taking no more than 3 minutes.
- Allow the study team to review relevant pregnancy and birth records.
- If they deliver at the study hospital, allow examination of the placenta after delivery as part of the study reference standard.
Przegląd badań
Status
Warunki
Szczegółowy opis
Participants with singleton pregnancies attending first-trimester combined screening between 11+0 and 13+6 weeks will be invited to participate. The research-specific placental cord-insertion assessment will be performed after completion of routine clinical care and will not replace or alter standard ultrasound assessment. The insertion will be initially classified as normal, VCI, or undetermined.
VCI or undetermined examinations will undergo repeat ultrasound assessment in the same setting or within 1 week by maternal-fetal-medicine team, transvaginal ultrasound may be considered to facilitate visualization. If an abnormal insertion is confirmed, subsequent care, including repeat assessment and transvaginal ultrasound for vasa previa where clinically indicated, will follow existing practice.
For participants who deliver at the study hospital, available placentas will undergo blinded structured postnatal gross examination and standardized photographic documentation. The final postnatal placental classification, reviewed by an assessor blinded to antenatal ultrasound classifications and neonatal outcome, will serve as the reference standard for the primary diagnostic-accuracy analysis.
Typ studiów
Zapisy (Szacowany)
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Linus Lee
- Numer telefonu: 852-25957359
- E-mail: llt511@ha.org.hk
Lokalizacje studiów
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Hong Kong, Hongkong
- Pamela Youde Nethersole Eastern Hospital
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Metoda próbkowania
Badana populacja
The study population comprises pregnant participants aged 18 years or older with singleton pregnancies who attend routine first-trimester combined screening at Pamela Youde Nethersole Eastern Hospital Hong Kong between 11+0 and 13+6 weeks of gestation. Participants must have capacity to provide written informed consent. Individuals with multiple pregnancies and those who decline or withdraw consent will not be included. All enrolled participants will undergo the same focused, research-specific transabdominal ultrasound assessment of the placental cord-insertion site after completion of their routine clinical screening examination.
Opis
Inclusion Criteria:
- Pregnant participants aged 18 years or older with a singleton pregnancy
- Attendance for first-trimester combined screening at 11+0 to 13+6 weeks
- Capacity to provide written informed consent
Exclusion Criteria:
- Multiple pregnancy
- Declined or withdrawn consent
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Modele obserwacyjne: COHORT
- Perspektywy czasowe: PROSPECTIVE
Kohorty i interwencje
Grupa / Kohorta |
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Singleton pregnancies undergoing first-trimester placental cord-insertion assessment
Consenting pregnant participants aged 18 years or older with singleton pregnancies attending first-trimester combined screening at Pamela Youde Nethersole Eastern Hospital Hong Kong at 11+0 to 13+6 weeks gestation. Following routine screening, participants undergo a focused transabdominal placental cord-insertion assessment of up to 3 additional minutes, with review or repeat assessment according to the prespecified pathway where needed. |
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Sensitivity of First-Trimester Ultrasound for Detecting Velamentous Cord Insertion
Ramy czasowe: Up to 7 months after the baseline assessment, at postnatal placental examination.
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Sensitivity of first-trimester ultrasound for detection of velamentous cord insertion |
Up to 7 months after the baseline assessment, at postnatal placental examination.
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Specificity of First-Trimester Ultrasound for Detecting Velamentous Cord Insertion
Ramy czasowe: Up to 7 months after the baseline assessment, at postnatal placental examination.
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Specificity of first-trimester ultrasound for detection of velamentous cord insertion |
Up to 7 months after the baseline assessment, at postnatal placental examination.
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Percentage of Participants with a Definitive Classification Within the Initial 3-Minute Ultrasound Assessment
Ramy czasowe: Baseline
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Proportion of participants classified as either normal placental cord insertion or velamentous cord insertion within the prespecified 3-minute focused ultrasound assessment. |
Baseline
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Percentage of Participants with a Definitive Classification After Completion of the Assessment Pathway
Ramy czasowe: Up to 1 week after the baseline assessment
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Proportion of participants with a final classification of either normal placental cord insertion or velamentous cord insertion after maternal-fetal-medicine review and/or repeat ultrasound assessment, where required. |
Up to 1 week after the baseline assessment
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Percentage of Participants with an Indeterminate Initial Placental Cord-Insertion Assessment
Ramy czasowe: Baseline
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Proportion of participants with an indeterminate initial placental cord-insertion classification and documented reasons for indeterminate assessment, if any |
Baseline
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Neonatal Birth Weight
Ramy czasowe: At delivery
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Birth weight recorded at delivery, and local gestational age specific centiles where available |
At delivery
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Gestational age at delivery
Ramy czasowe: At delivery
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Gestational age in completed weeks at delivery |
At delivery
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Mode of delivery
Ramy czasowe: At delivery
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Mode of delivery recorded from maternity records |
At delivery
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Neonatal Apgar Scores at 1 and 5 Minutes After Birth
Ramy czasowe: At delivery episode, 1 and 5 minutes after birth
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Apgar scores assessed at 1 and 5 minutes after birth. Scores range from 0 to 10, with higher scores indicating better neonatal condition. |
At delivery episode, 1 and 5 minutes after birth
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NICU admission
Ramy czasowe: At delivery episode
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Admission to a neonatal intensive care unit |
At delivery episode
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Inne miary wyników
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Hypertensive disorders of pregnancy
Ramy czasowe: From baseline assessment to delivery, up to 7 months
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Incidence of gestational hypertension, pre-eclampsia, or chronic hypertension with superimposed pre-eclampsia, summarized descriptively according to antenatal and postnatal placental cord-insertion status |
From baseline assessment to delivery, up to 7 months
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Współpracownicy i badacze
Sponsor
Śledczy
- Główny śledczy: Linus Lee, Hospital Authority
Publikacje i pomocne linki
Publikacje ogólne
- Padula F, Lagana AS, Vitale SG, Mangiafico L, D'Emidio L, Cignini P, Giorlandino M, Gulino FA, Capriglione S, Giorlandino C. Ultrasonographic evaluation of placental cord insertion at different gestational ages in low-risk singleton pregnancies: a predictive algorithm. Facts Views Vis Obgyn. 2016 Mar 28;8(1):3-7.
- Siargkas A, Tsakiridis I, Pachi C, Mamopoulos A, Athanasiadis A, Dagklis T. Impact of velamentous cord insertion on perinatal outcomes: a systematic review and meta-analysis. Am J Obstet Gynecol MFM. 2023 Feb;5(2):100812. doi: 10.1016/j.ajogmf.2022.100812. Epub 2022 Nov 12.
- Derisbourg S, Boulay A, Lamy C, Barlow P, Van Rysselberge M, Thomas D, Rozenberg S, Daelemans C. First trimester ultrasound prediction of velamentous cord insertions: a prospective study. J Matern Fetal Neonatal Med. 2021 Aug;34(16):2642-2648. doi: 10.1080/14767058.2019.1670797. Epub 2019 Sep 26.
- Sepulveda W, Rojas I, Robert JA, Schnapp C, Alcalde JL. Prenatal detection of velamentous insertion of the umbilical cord: a prospective color Doppler ultrasound study. Ultrasound Obstet Gynecol. 2003 Jun;21(6):564-9. doi: 10.1002/uog.132.
- Sepulveda W. Velamentous insertion of the umbilical cord: a first-trimester sonographic screening study. J Ultrasound Med. 2006 Aug;25(8):963-8; quiz 970. doi: 10.7863/jum.2006.25.8.963.
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Inne numery identyfikacyjne badania
- CIRB-2026-562-1
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
Individual participant data will not be shared outside the study team because the study involves potentially identifiable pregnancy, ultrasound, placental, and perinatal clinical data held under institutional data-governance and privacy requirements. De-identified aggregate data may be available in publications or on reasonable request, subject to applicable approval and requirements.
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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