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.
Study Overview
Status
Conditions
Detailed Description
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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Linus Lee
- Phone Number: 852-25957359
- Email: llt511@ha.org.hk
Study Locations
-
-
-
Hong Kong, Hong Kong
- Pamela Youde Nethersole Eastern Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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.
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: COHORT
- Time Perspectives: PROSPECTIVE
Cohorts and Interventions
Group / Cohort |
|---|
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Sensitivity of First-Trimester Ultrasound for Detecting Velamentous Cord Insertion
Time Frame: Up to 7 months after the baseline assessment, at postnatal placental examination.
|
Sensitivity of first-trimester ultrasound for detection of velamentous cord insertion |
Up to 7 months after the baseline assessment, at postnatal placental examination.
|
|
Specificity of First-Trimester Ultrasound for Detecting Velamentous Cord Insertion
Time Frame: Up to 7 months after the baseline assessment, at postnatal placental examination.
|
Specificity of first-trimester ultrasound for detection of velamentous cord insertion |
Up to 7 months after the baseline assessment, at postnatal placental examination.
|
|
Percentage of Participants with a Definitive Classification Within the Initial 3-Minute Ultrasound Assessment
Time Frame: Baseline
|
Proportion of participants classified as either normal placental cord insertion or velamentous cord insertion within the prespecified 3-minute focused ultrasound assessment. |
Baseline
|
|
Percentage of Participants with a Definitive Classification After Completion of the Assessment Pathway
Time Frame: Up to 1 week after the baseline assessment
|
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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Percentage of Participants with an Indeterminate Initial Placental Cord-Insertion Assessment
Time Frame: Baseline
|
Proportion of participants with an indeterminate initial placental cord-insertion classification and documented reasons for indeterminate assessment, if any |
Baseline
|
|
Neonatal Birth Weight
Time Frame: At delivery
|
Birth weight recorded at delivery, and local gestational age specific centiles where available |
At delivery
|
|
Gestational age at delivery
Time Frame: At delivery
|
Gestational age in completed weeks at delivery |
At delivery
|
|
Mode of delivery
Time Frame: At delivery
|
Mode of delivery recorded from maternity records |
At delivery
|
|
Neonatal Apgar Scores at 1 and 5 Minutes After Birth
Time Frame: At delivery episode, 1 and 5 minutes after birth
|
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
|
|
NICU admission
Time Frame: At delivery episode
|
Admission to a neonatal intensive care unit |
At delivery episode
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Hypertensive disorders of pregnancy
Time Frame: From baseline assessment to delivery, up to 7 months
|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Linus Lee, Hospital Authority
Publications and helpful links
General Publications
- 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.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- CIRB-2026-562-1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.