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Fetal Growth ComplicationsFirst PLUSNCT05326191

First-trimester Placental Ultrasound Study

An observational study of Fetal Growth Complications and Pregnancy Complications, run by Perspectum at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 years and older, women only
What is being tested?
Ultrasound
How many people
4,000 participants
Where
1 siteUnited Kingdom
Study dates
15 Mar 2022to 30 May 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • Adult, Older adult

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

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • King's College Hospital NHS, Fetal Medicine Foundation

    London, SE5 9RS

Other trials in United Kingdom

About this study

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.

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

Read the 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.

Being tested
Ultrasound
Keywords
Ultrasound, Fetal Growth, Pregnancy
Medical subject headings
Pregnancy Complications

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • UltrasoundDiagnostic test

    All study interventions/procedures will happen during the participants routine clinic visit in which they will receive their routine Ultrasound scan, followed by an additional research scan, which will take approximately 2-3 minutes. A blood sample will also be taken from participants as part of their routine pregnancy care. Residual blood from the same sample will be used to conduct an additional test to quantify Placental Growth Factor (PlGF). Participants will also be asked questions about their relevant medical history and demographic data which is also routinely collected as part of their pregnancy record.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Fetal Growth restriction (FGR)

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

    Measured: 24 months

Secondary outcomes (11)

  1. Small for Gestational Age (GSA)

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

    Measured: 24 months

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

    Defined by the ACOG guidelines for hypertensive disorders of pregnancy:

    • Pre-term pre-eclampsia (delivery <37 weeks)
    • Late onset pre-eclampsia (delivery ≥37 weeks)

    Measured: 24 months

  3. Gestational hypertension (PIH)

    Defined by the ACOG guidelines for hypertensive disorders of pregnancy:

    • Pre-term gestational hypertension (delivery <37 weeks)
    • Late onset gestational hypertension (delivery ≥37 weeks)

    Measured: 24 months

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

    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)

    Measured: 24 months

  5. Eclampsia

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

    • Pre-term eclampsia (delivery <37 weeks)
    • Late onset eclampsia (delivery ≥37 weeks)

    Measured: 24 months

  6. Gestational diabetes

    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.

    Measured: 24 months

  7. Preterm Birth

    Birth ≥24+0 weeks <37+0 weeks

    Measured: 24 months

  8. Miscarriage

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

    Measured: 24 months

  9. Stillbirth

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

    Measured: 24 months

  10. Neonatal death

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

    Measured: 24 months

  11. Neonatal morbidity

    • 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

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Apr 2022
  2. Study start15 Mar 2022
  3. Primary completion14 Nov 2022
  4. Study completion30 May 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
4,000 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05326191
Sponsor's protocol ID
22/WM/0039
Acronym
First PLUS
Status last verified
Dec 2023
First submitted
15 Mar 2022
Last updated
15 Dec 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Salvesen K, Lees C, Abramowicz J, Brezinka C, Ter Haar G, Marsal K; Board of International Society of Ultrasound in Obstetrics and Gynecology (ISUOG). ISUOG statement on the safe use of Doppler in the 11 to 13 +6-week fetal ultrasound examination. Ultrasound Obstet Gynecol. 2011 Jun;37(6):628. doi: 10.1002/uog.9026. No abstract available.

    PubMed 21618313

  • Froen JF, Cacciatore J, McClure EM, Kuti O, Jokhio AH, Islam M, Shiffman J; Lancet's Stillbirths Series steering committee. Stillbirths: why they matter. Lancet. 2011 Apr 16;377(9774):1353-66. doi: 10.1016/S0140-6736(10)62232-5.

    PubMed 21496915

  • Campbell HE, Kurinczuk JJ, Heazell A, Leal J, Rivero-Arias O. Healthcare and wider societal implications of stillbirth: a population-based cost-of-illness study. BJOG. 2018 Jan;125(2):108-117. doi: 10.1111/1471-0528.14972. Epub 2017 Dec 14.

    PubMed 29034559

  • Cousens S, Blencowe H, Stanton C, Chou D, Ahmed S, Steinhardt L, Creanga AA, Tuncalp O, Balsara ZP, Gupta S, Say L, Lawn JE. National, regional, and worldwide estimates of stillbirth rates in 2009 with trends since 1995: a systematic analysis. Lancet. 2011 Apr 16;377(9774):1319-30. doi: 10.1016/S0140-6736(10)62310-0.

    PubMed 21496917

  • Pillay T, Modi N, Rivero-Arias O, Manktelow B, Seaton SE, Armstrong N, Draper ES, Dawson K, Paton A, Ismail AQT, Yang M, Boyle EM. Optimising neonatal service provision for preterm babies born between 27 and 31 weeks gestation in England (OPTI-PREM), using national data, qualitative research and economic analysis: a study protocol. BMJ Open. 2019 Aug 22;9(8):e029421. doi: 10.1136/bmjopen-2019-029421.

    PubMed 31444186

  • Monier I, Blondel B, Ego A, Kaminiski M, Goffinet F, Zeitlin J. Poor effectiveness of antenatal detection of fetal growth restriction and consequences for obstetric management and neonatal outcomes: a French national study. BJOG. 2015 Mar;122(4):518-27. doi: 10.1111/1471-0528.13148. Epub 2014 Oct 27.

    PubMed 25346493

  • Looney P, Stevenson GN, Nicolaides KH, Plasencia W, Molloholli M, Natsis S, Collins SL. Fully automated, real-time 3D ultrasound segmentation to estimate first trimester placental volume using deep learning. JCI Insight. 2018 Jun 7;3(11):e120178. doi: 10.1172/jci.insight.120178. eCollection 2018 Jun 7.

    PubMed 29875312

  • Looney P, Yin Y, Collins SL, Nicolaides KH, Plasencia W, Molloholli M, Natsis S, Stevenson GN. Fully Automated 3-D Ultrasound Segmentation of the Placenta, Amniotic Fluid, and Fetus for Early Pregnancy Assessment. IEEE Trans Ultrason Ferroelectr Freq Control. 2021 Jun;68(6):2038-2047. doi: 10.1109/TUFFC.2021.3052143. Epub 2021 May 25.

    PubMed 33460372

  • Yin Y, Looney P, Collins SL. Standardization of blood flow measurements by automated vascular analysis from power Doppler ultrasound scan. Proc SPIE Int Soc Opt Eng. 2020 Feb;11314:113144C. doi: 10.1117/12.2549349. Epub 2020 Mar 16. No abstract available.

    PubMed 33132475

  • Welsh AW, Fowlkes JB, Pinter SZ, Ives KA, Owens GE, Rubin JM, Kripfgans OD, Looney P, Collins SL, Stevenson GN. Three-dimensional US Fractional Moving Blood Volume: Validation of Renal Perfusion Quantification. Radiology. 2019 Nov;293(2):460-468. doi: 10.1148/radiol.2019190248. Epub 2019 Oct 1.

    PubMed 31573404

  • Barker DJ, Thornburg KL. Placental programming of chronic diseases, cancer and lifespan: a review. Placenta. 2013 Oct;34(10):841-5. doi: 10.1016/j.placenta.2013.07.063. Epub 2013 Aug 2.

    PubMed 23916422

  • Barker DJP. Fetal origins of cardiovascular disease. Ann Med. 1999;31(sup1):3-6. doi: 10.1080/07853890.1999.11904392.

    PubMed 28850284

  • Barker DJ. Adult consequences of fetal growth restriction. Clin Obstet Gynecol. 2006 Jun;49(2):270-83. doi: 10.1097/00003081-200606000-00009.

    PubMed 16721106

  • Rolnik DL, Wright D, Poon LC, O'Gorman N, Syngelaki A, de Paco Matallana C, Akolekar R, Cicero S, Janga D, Singh M, Molina FS, Persico N, Jani JC, Plasencia W, Papaioannou G, Tenenbaum-Gavish K, Meiri H, Gizurarson S, Maclagan K, Nicolaides KH. Aspirin versus Placebo in Pregnancies at High Risk for Preterm Preeclampsia. N Engl J Med. 2017 Aug 17;377(7):613-622. doi: 10.1056/NEJMoa1704559. Epub 2017 Jun 28.

    PubMed 28657417

  • Mosimann B, Pfiffner C, Amylidi-Mohr S, Risch L, Surbek D, Raio L. First trimester combined screening for preeclampsia and small for gestational age - a single centre experience and validation of the FMF screening algorithm. Swiss Med Wkly. 2017 Aug 25;147:w14498. doi: 10.4414/smw.2017.14498. eCollection 2017.

    PubMed 28871576

Questions about this trial

What is this clinical trial studying?

An observational study of Fetal Growth Complications and Pregnancy Complications, run by Perspectum at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Fetal Growth restriction (FGR) (time frame: 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05326191, which also lists 44 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2023.

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