First-trimester Placental Ultrasound Study (First PLUS)

December 14, 2023 updated by: Perspectum

First-trimester Placental Ultrasound Study (First PLUS): an Observational Cohort Study to Assess the Clinical Utility of the OxNNet Toolkit for the Prediction of Adverse Pregnancy Outcomes.

An observational cohort study to assess the clinical utility of the OxNNet Toolkit for the prediction of adverse pregnancy outcomes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 King's College Hospital NHS Foundation Trust for their pregnancy care.

This study aims to develop a tool to provide reliable measurements of placental size and estimate the blood flow within the placenta during the first trimester of pregnancy. These metrics hope to develop a screening tool for fetal growth restriction (FGR), which is a condition in which a baby fails to grow to its full potential and can cause adverse pregnancy outcomes and is the single most common cause of stillbirth. This devastating outcome could potentially be reduced by stratifying pregnancies into high risk, allowing women to undergo additional monitoring and limiting clinician resource to those in need of it most. Stillbirth is also a serious adverse pregnancy outcome that NHS England is looking to reduce the rate of as part of their long-term plan.

Women 18 years of age or older, attending their first trimester scan during 11-14 weeks of pregnancy, who has a viable pregnancy with no more than one baby with no major defects identified during the scan will be eligible to take part.

The study will take place over 24 months and participants will undergo a single study visit in which their demographics and routine medical history will be recorded, an additional research ultrasound scan will be conducted alongside their routine scan, and blood from a sample taken as part of routine care will be used to assess the level of Placental Growth Factor (PlGF). Participants will then be followed up until the completion of their pregnancy via their pregnancy records (remote follow up) and the outcome of their pregnancy will be recorded.

Study Type

Observational

Enrollment (Actual)

4000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom, SE5 9RS
        • King's College Hospital NHS, Fetal Medicine Foundation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Pregnant women attending the Fetal Medicine Foundation for their first-trimester screening scan

Description

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fetal Growth restriction (FGR)
Time Frame: 24 months
Fetal Growth restriction (FGR) defined according to the ISUOG Delphi consensus guidelines for diagnosis of FGR, at the time of delivery.
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Small for Gestational Age (GSA)
Time Frame: 24 months
Defined if <10 centile on population-based centiles or <10th centile on customised centiles, at the time of delivery.
24 months
Pre-eclampsia (with, and without, severe features)
Time Frame: 24 months

Defined by the ACOG guidelines for hypertensive disorders of pregnancy:

  • Pre-term pre-eclampsia (delivery <37 weeks)
  • Late onset pre-eclampsia (delivery ≥37 weeks)
24 months
Gestational hypertension (PIH)
Time Frame: 24 months

Defined by the ACOG guidelines for hypertensive disorders of pregnancy:

  • Pre-term gestational hypertension (delivery <37 weeks)
  • Late onset gestational hypertension (delivery ≥37 weeks)
24 months
Haemolysis, elevated liver enzymes and low platelets (HELLP) syndrome
Time Frame: 24 months

Defined by the ACOG guidelines for hypertensive disorders of pregnancy:

  • Pre-term HELLP (delivery <37 weeks)
  • Late onset HELLP (delivery ≥37 weeks) Pre-term pre-eclampsia (delivery <37 weeks)
24 months
Eclampsia
Time Frame: 24 months

Defined by the ACOG guidelines for hypertensive disorders of pregnancy(22)

  • Pre-term eclampsia (delivery <37 weeks)
  • Late onset eclampsia (delivery ≥37 weeks)
24 months
Gestational diabetes
Time Frame: 24 months
Defined as fasting plasma glucose level ≥5.6 mmol/L and/or 2-h plasma glucose level ≥7.8 mmol/L after ingestion of 75g oral glucose.
24 months
Preterm Birth
Time Frame: 24 months
Birth ≥24+0 weeks <37+0 weeks
24 months
Miscarriage
Time Frame: 24 months
Live fetus at the first-trimester ultrasound scan but subsequent in utero fetal death or delivery <24+0 weeks
24 months
Stillbirth
Time Frame: 24 months
Baby born with no signs of life at ≥24+0 weeks' gestation
24 months
Neonatal death
Time Frame: 24 months
Baby born alive but dies within the first 28 days of life
24 months
Neonatal morbidity
Time Frame: 24 months
  • Neonatal intensive care unit admission and length of stay
  • Neonatal ventilation - defined as need of positive pressure (CPAP, NCPAP or intubation)
  • Respiratory distress syndrome - defined as need of ventilation with or without surfactant
  • Intraventricular haemorrhage (IVH) grade II or above - defined as bleeding into the ventricles
  • Neonatal sepsis confirmed bacteraemia in cultures
  • Anaemia - defined as low haemoglobin and / or haematocrit requiring blood transfusion
  • Necrotizing enterocolitis requiring surgical intervention
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Perspectum

Collaborators

University of Oxford
Fetal Medicine Foundation

Investigators

  • Principal Investigator: Kypros Nicolaides, BSc, MMBS, Fetal Medicine Foundation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 15, 2022

Primary Completion (Actual)

November 14, 2022

Study Completion (Actual)

May 30, 2023

Study Registration Dates

First Submitted

March 15, 2022

First Submitted That Met QC Criteria

April 12, 2022

First Posted (Actual)

April 13, 2022

Study Record Updates

Last Update Posted (Estimated)

December 15, 2023

Last Update Submitted That Met QC Criteria

December 14, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22/WM/0039

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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.

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