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Umbilical Cord Abnormalities in the Prediction of Adverse Pregnancy Outcomes

NCT05901688 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 5000

Last updated 2024-03-12

No results posted yet for this study

Summary

The objective of our study is to investigate the association of umbilical cord abnormalities with adverse pregnancy outcomes. The umbilical cord parameters that will be investigated as part of this study include the umbilical cord coiling index (UCI), umbilical cord (UC) diameter, umbilical vein (UV) diameter, UV flow velocity and the presence of nuchal cord. The UCI, UC, UV diameter \& flow and presence of nuchal cord will be measured in routine unselected populations at 20-22 weeks and 35-37 weeks gestation during the study period. We will also measure the UC and UV diameter in a nested population of high-risk pregnancies attending our placental disorders clinic which have been deemed to be at risk of having adverse pregnancy outcomes.

Primary objective:

To investigate if prenatal assessment of UCI, UC, UV diameter \& flow and presence of nuchal cord measured routinely in unselected screened populations at 20-22 weeks and 35-37 weeks' can provide an independent prediction of pregnancies that develop adverse pregnancy outcomes.

Secondary objectives:

To assess the correlation of UC and UV diameter measured by ultrasound scan and fetal magnetic resonance imaging in prediction of pregnancy outcome. To examine the association of these umbilical cord measurements and observations in a nested cohort of pregnancies in the high-risk placental disorders clinic.

Conditions

  • Small for Gestational Age at Delivery
  • Hypoxic-Ischemic Encephalopathy
  • Stillbirth
  • Admission to Neonatal Unit

Interventions

OTHER

Umbilical cord measurements & observations

In the screening study of an unselected population at 20-22 weeks' and 35-37 weeks' gestation, women are offered an ultrasound scan as part of standard care and will be invited to take part in the study which will involve taking the following additional ultrasound measurements: 1. Umbilical cord coiling index (UCI) 2. Transverse diameter of umbilical cord (UC) 3. Transverse diameter of umbilical vein (UV) and artery (UA) 4. Umbilical vein (UV) Doppler flow characteristics 5. Presence of nuchal cord

Sponsors & Collaborators

  • Medway NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Ranjit Akolekar, MD MRCOG PhD · Medway NHS Foundation Trust

Eligibility

Min Age
16 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-10-03
Primary Completion
2025-07-03
Completion
2025-12-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05901688 on ClinicalTrials.gov