Plain English Summary
Background and study aims
Abnormal development of the placenta (afterbirth) can cause serious pregnancy complications such as abruption, preeclampsia, and small for gestational age (SGA) (complications also known as Placenta Mediated Disease [PMD]). PMD can lead to devastating pregnancy outcomes such as the mother and baby’s death as well as affect the mother’s and baby’s health later in life. Thus prediction and prevention of PMD remains a high priority for researchers and clinicians worldwide. Currently, all women deemed to be at increased risk for PMD are offered a low dose of aspirin as a preventative measure. Unfortunately humans process aspirin differently so the effectiveness of this preventative treatment varies. A simple ultrasound assessment of the blood flow in the womb arteries performed at the time of 20 weeks scan has been shown to be a good predictor of poor pregnancy outcome. However, the clinical importance of such assessment in women receiving aspirin therapy is unclear. This study will explore the change (worsening or improvement) in the blood flow through the womb arteries from the start of aspirin treatment to the mid-point of pregnancy in those who respond to the treatment and those who do not. Women’s response to aspirin will be checked by a blood test.
Who can participate?
Women at risk of preeclampsia
What does the study involve?
Participants are asked to provide information about their health at the first study visit. Then the blood flow to the uterus (womb) is measured using ultrasound. This examination is painless and takes only a few minutes to perform. During the participant’s second visit at the time of a routine 20 weeks scan, the ultrasound measurement is repeated, and participants are asked to provide a urine sample and about 10 ml of blood (about two teaspoons). The blood and urine are tested in the hospital laboratory to see if the participants have responded to aspirin. This is done at a later date as it is not a routine test. The results will therefore not be available to participants.
What are the possible benefits and risks of participating?
There are no direct benefits to participants from the study. It is anticipated that the information gained from participation in this study will help to improve the care of women with a high risk of developing placenta-mediated disease in the future. The results of this study may allow a better understanding of aspirin’s role in preventing PMD and also may allow clinicians to detect non-responders who are more likely to develop PMD and in whom alternative treatment could be offered. The researchers do not anticipate that any harm will come to participants by taking part in this study as the only additional element is collecting blood and urine samples. This will be carried out by an experienced member of the research team.
Where is the study run from?
Newcastle upon Tyne NHS Hospitals Foundation Trust (UK)
When is the study starting and how long is it expected to run for?
May 2017 to October 2019
Who is funding the study?
College of Radiographers Industry Partnership Scheme Research Grants
Who is the main contact?
Raya Vinogradov
raya.vinogradov@ncl.ac.uk
Trial website
Contact information
Type
Public
Primary contact
Mrs Raya Vinogradov
ORCID ID
http://orcid.org/0000-0001-9375-7915
Contact details
The Reproductive Research Team
Level 6
Leazes Wing
The Royal Victoria Infirmary
Queen Victoria Road
Newcastle upon Tyne
NE1 4LP
United Kingdom
+44 (0)191 2820540
raya.vinogradov@ncl.ac.uk
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
V7 (03.10.2018)
Study information
Scientific title
Sequential analysis of uterine artery Doppler waveforms in high-risk population for placenta-mediated disease undergoing prophylactic aspirin therapy controlled by levels of serum thromboxane
Acronym
Wave 1
Study hypothesis
Is the change in uterine artery pulsatility index between first and second trimester influenced by response to aspirin therapy (as determined by serum Tbx inhibition) in women at high risk of placenta-mediated disease?
Ethics approval
Approved 17/03/2017, East of Scotland Research Ethics Service, (Tayside Academic Health Sciences Centre, Residency Block Level 3, George Pirie Way, Ninewells Hospital & Medical School, Dundee, DD1 9SY, UK; Tel: +44 (0)1382 383871; Email: eosres.tayside@nhs.net), ref: 17/ES/0018
Study design
Observational study
Primary study design
Observational
Secondary study design
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format. Please call +44 (0)1912820540 to request a participant information sheet
Condition
Preeclampsia
Intervention
1. Change in the blood flow calculated from routine uterine artery Doppler examination at 12 and 20 weeks gestation
2. Urine and blood test at 20 weeks gestation looking at the levels of Thromboxane
Intervention type
Other
Phase
Drug names
Primary outcome measure
Level of serum Thromboxane B2 measured in blood at 20 weeks gestation
Secondary outcome measures
Pregnancy outcome (i.e. preeclampsia) at delivery of the baby
Overall trial start date
08/05/2017
Overall trial end date
21/10/2019
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Women at risk of preeclampsia according to NICE criteria
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
294
Participant exclusion criteria
Unable to give informed consent
Recruitment start date
01/06/2017
Recruitment end date
25/03/2019
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Newcastle upon Tyne NHS Hospitals Foundation Trust
The Reproductive Research Team
Level 6, Leazes Wing
The Royal Victoria Infirmary
Queen Victoria Road
Newcastle upon Tyne
NE1 4LP
United Kingdom
Sponsor information
Organisation
Newcastle upon Tyne Hospitals NHS Foundation Trust
Sponsor details
Newcastle Joint Research Office
Level 1 Regent Point
Regent Farm Road
Gosforth
Newcastle upon Tyne
NE3 3HD
United Kingdom
+44 (0)191 282 5959
trust.r&d@nuth.nhs.uk
Sponsor type
Hospital/treatment centre
Website
http://www.newcastle-hospitals.org.uk/about-us/staff-information_research-development.aspx
Funders
Funder type
Other
Funder name
College of Radiographers Industry Partnership Scheme Research Grants
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
1. Summary of the study protocol is available at: https://www.sor.org/system/files/article/201609/write_up_131.pdf
2. Peer reviewed journals and through relative charities (APEC)
IPD sharing statement
The datasets generated during and/or analysed during the current study are/will be available upon request from Raya Vinogradov (Raya.vinogradov@ncl.ac.uk) or Marc Davies (Marc.Davies@nuth.nhs.uk). The dataset is fully anonymised by assigning a study ID number to all participants. Only the clinical/research team is able to link the study ID to participant information. Data will be stored in line with the sponsor’s requirements by the local trial coordinator upon completion of data collection, data query and analysis. Fully anonymised data will be analysed by a PI with support from a statistician from Newcastle University.
Intention to publish date
01/10/2020
Participant level data
Available on request
Basic results (scientific)
Publication list