Understanding the relationship between uterine artery Doppler measurements (blood flow to the placenta) and aspirin response

ISRCTN ISRCTN41944844
DOI https://doi.org/10.1186/ISRCTN41944844
Secondary identifying numbers V7 (03.10.2018)
Submission date
16/04/2019
Registration date
23/04/2019
Last edited
10/05/2024
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Pregnancy and Childbirth
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

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

Contact information

Mrs Raya Vinogradov
Public

The Reproductive Research Team
Level 6, Leazes Wing
The Royal Victoria Infirmary
Queen Victoria Road
Newcastle upon Tyne
NE1 4LP
United Kingdom

ORCiD logoORCID ID 0000-0001-9375-7915
Phone +44 (0)191 2820540
Email raya.vinogradov@ncl.ac.uk

Study information

Study designObservational study
Primary study designObservational
Secondary study design
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format. Please call +44 (0)1912820540 to request a participant information sheet
Scientific titleSequential analysis of uterine artery Doppler waveforms in high-risk population for placenta-mediated disease undergoing prophylactic aspirin therapy controlled by levels of serum thromboxane
Study acronymWave 1
Study objectivesIs 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(s)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
Health condition(s) or problem(s) studiedPreeclampsia
Intervention1. 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 typeOther
Primary outcome measureLevel of serum Thromboxane B2 measured in blood at 20 weeks gestation
Secondary outcome measuresPregnancy outcome (i.e. preeclampsia) at delivery of the baby
Overall study start date08/05/2017
Completion date21/10/2019

Eligibility

Participant type(s)Patient
Age groupAdult
SexFemale
Target number of participants294
Total final enrolment345
Key inclusion criteriaWomen at risk of preeclampsia according to NICE criteria
Key exclusion criteriaUnable to give informed consent
Date of first enrolment01/06/2017
Date of final enrolment25/03/2019

Locations

Countries of recruitment

  • England
  • United Kingdom

Study 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

Newcastle upon Tyne Hospitals NHS Foundation Trust
Hospital/treatment centre

Newcastle Joint Research Office
Level 1 Regent Point
Regent Farm Road
Gosforth
Newcastle upon Tyne
NE3 3HD
England
United Kingdom

Phone +44 (0)191 282 5959
Email trust.r&d@nuth.nhs.uk
Website http://www.newcastle-hospitals.org.uk/about-us/staff-information_research-development.aspx
ROR logo "ROR" https://ror.org/05p40t847

Funders

Funder type

Other

College of Radiographers Industry Partnership Scheme Research Grants

No information available

Results and Publications

Intention to publish date01/05/2021
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination plan1. 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 planThe 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.

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol file version 7 03/10/2018 11/08/2022 No No
HRA research summary 28/06/2023 No No
Other publications Aspirin non-adherence in pregnant women at risk of preeclampsia (ANA): a qualitative study 06/08/2021 10/05/2024 Yes No

Additional files

ISRCTN41944844_PROTOCOL_V7_03Oct18.pdf

Editorial Notes

10/05/2024: Publication reference added.
17/08/2022: Total final enrolment added.
11/08/2022: Protocol file uploaded.
03/11/2020: The intention to publish date was changed from 01/10/2020 to 01/05/2021.
26/04/2019: Internal review.
17/04/2019: Trial's existence confirmed by East of Scotland Research Ethics Service.