Condition category
Pregnancy and Childbirth
Date applied
16/04/2019
Date assigned
23/04/2019
Last edited
26/04/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

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

Publication citations

Additional files

Editorial Notes

26/04/2019: Internal review. 17/04/2019: Trial's existence confirmed by East of Scotland Research Ethics Service.