Status:
COMPLETED
First-trimester Placental Ultrasound Study
Lead Sponsor:
Perspectum
Collaborating Sponsors:
University of Oxford
Fetal Medicine Foundation
Conditions:
Fetal Growth Complications
Pregnancy Complications
Eligibility:
FEMALE
18+ years
Brief Summary
An observational cohort study to assess the clinical utility of the OxNNet Toolkit for the prediction of adverse pregnancy outcomes.
Detailed Description
The First PLUS study is a single centre, prospective, observational study recruiting 4000 women from The Harris Birthright Centre, which provides ultrasound scanning for all women who would attend Kin...
Eligibility Criteria
Inclusion
- Pregnant
- 18 years of age, or older
- Presenting for first-trimester combined test screening between 11+0 and 13+6 weeks of pregnancy
- Participant is willing and able to give informed consent for participation in the investigation.
- Able to understand written or verbal English and able to access methods of translation.
- In the opinion of the investigator, the participant is not at risk or under stress or limited in their ability to participate in the study activities.
Exclusion
- Participant with a multiple pregnancy (more than one viable fetus) discovered at the scan
- Participant with a non-viable pregnancy discovered at the scan (no detectable heartbeat)
- Pregnancies with major defects identified during 11+0 to13+6 week scan
- Any pregnancy subsequently found to be chromosomally abnormal as a result of either prenatal or postnatal testing
Key Trial Info
Start Date :
March 15 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 30 2023
Estimated Enrollment :
4000 Patients enrolled
Trial Details
Trial ID
NCT05326191
Start Date
March 15 2022
End Date
May 30 2023
Last Update
December 15 2023
Active Locations (1)
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1
King's College Hospital NHS, Fetal Medicine Foundation
London, United Kingdom, SE5 9RS