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First PLUS: First-trimester Placental Ultrasound Study

Sponsor
Perspectum (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05326191
Collaborator
University of Oxford (Other), Fetal Medicine Foundation (Other)
4,000
Enrollment
1
Location
13.5
Anticipated Duration (Months)
295.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Ultrasound

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 Design

Study Type:
Observational
Anticipated Enrollment :
4000 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
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.
Actual Study Start Date :
Mar 15, 2022
Anticipated Primary Completion Date :
Sep 1, 2022
Anticipated Study Completion Date :
May 1, 2023

Outcome Measures

Primary Outcome Measures

  1. Fetal Growth restriction (FGR) [24 months]

    Fetal Growth restriction (FGR) defined according to the ISUOG Delphi consensus guidelines for diagnosis of FGR, at the time of delivery.

Secondary Outcome Measures

  1. Small for Gestational Age (GSA) [24 months]

    Defined if <10 centile on population-based centiles or <10th centile on customised centiles, at the time of delivery.

  2. Pre-eclampsia (with, and without, severe features) [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)

  3. Gestational hypertension (PIH) [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)

  4. Haemolysis, elevated liver enzymes and low platelets (HELLP) syndrome [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)

  5. Eclampsia [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)

  6. Gestational diabetes [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.

  7. Preterm Birth [24 months]

    Birth ≥24+0 weeks <37+0 weeks

  8. Miscarriage [24 months]

    Live fetus at the first-trimester ultrasound scan but subsequent in utero fetal death or delivery <24+0 weeks

  9. Stillbirth [24 months]

    Baby born with no signs of life at ≥24+0 weeks' gestation

  10. Neonatal death [24 months]

    Baby born alive but dies within the first 28 days of life

  11. Neonatal morbidity [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 King's College Hospital NHS, Fetal Medicine Foundation London United Kingdom SE5 9RS

Sponsors and Collaborators

  • Perspectum
  • University of Oxford
  • Fetal Medicine Foundation

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Perspectum
ClinicalTrials.gov Identifier:
NCT05326191
Other Study ID Numbers:
  • 22/WM/0039
First Posted:
Apr 13, 2022
Last Update Posted:
Apr 13, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Perspectum
Ultrasound
Fetal Growth
Pregnancy
Additional relevant MeSH terms:
Pregnancy Complications

Study Results

No Results Posted as of Apr 13, 2022