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
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
Public
The Reproductive Research Team
Level 6, Leazes Wing
The Royal Victoria Infirmary
Queen Victoria Road
Newcastle upon Tyne
NE1 4LP
United Kingdom
 ORCID ID |
0000-0001-9375-7915 |
|---|---|
| Phone | +44 (0)191 2820540 |
| raya.vinogradov@ncl.ac.uk |
Study information
| Study design | Observational study |
|---|---|
| Primary study design | Observational |
| Secondary study design | |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format. Please call +44 (0)1912820540 to request a participant information sheet |
| 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 |
| Study acronym | Wave 1 |
| Study objectives | 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(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) studied | 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 |
| 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 study start date | 08/05/2017 |
| Completion date | 21/10/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 294 |
| Total final enrolment | 345 |
| Key inclusion criteria | Women at risk of preeclampsia according to NICE criteria |
| Key exclusion criteria | Unable to give informed consent |
| Date of first enrolment | 01/06/2017 |
| Date of final enrolment | 25/03/2019 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Level 6, Leazes Wing
The Royal Victoria Infirmary
Queen Victoria Road
Newcastle upon Tyne
NE1 4LP
United Kingdom
Sponsor information
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 |
|---|---|
| trust.r&d@nuth.nhs.uk | |
| Website | http://www.newcastle-hospitals.org.uk/about-us/staff-information_research-development.aspx |
"ROR" |
https://ror.org/05p40t847 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 01/05/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| 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 plan | 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. |
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
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.
