Wave 1
Research type
Research Study
Full title
Sequential analysis of uterine artery Doppler waveforms in pregnant women at high risk of placenta mediated disease receiving prophylactic aspirin therapy.
IRAS ID
222077
Contact name
Stephen Robson
Contact email
Sponsor organisation
Newcastle Upon Tyne NHS Foundation Trust
Clinicaltrials.gov Identifier
131, College of Radiographers Industry Partnership Scheme
Duration of Study in the UK
1 years, 2 months, 1 days
Research summary
Abnormal development of the placenta (afterbirth) can cause serious pregnancy complications such as preeclampsia and low birth weight. These complications are also known as Placenta Mediated Disease (PMD) and can lead to devastating pregnancy outcomes such as maternal and baby death as well as affecting both 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 because aspirin availability varies dramatically across individuals, the effectiveness of this preventative treatment varies with many women still developing PMD.
A simple ultrasound assessment of the blood flow in the uterine (womb) arteries performed at the time of 20 weeks scan has been shown to be a good predictor of PMD and poor pregnancy outcome. However the clinical significance of these assessments in women receiving aspirin therapy is less clear.
This study will explore the change in the blood flow in the uterine arteries from the start of aspirin therapy to the mid-point of pregnancy (20 weeks) in women who show evidence of responding to aspirin and those who do not. Women’s response to aspirin will be determined by measurement of thromboxane in the blood (women who have responded to aspirin have very low levels of thromboxane). Ultimately it is hoped that the study will show whether ultrasound can detect women who have not responded to aspirin (and are at greater chance of developing PMD) allowing clinicians to consider alternate treatment.REC name
East of Scotland Research Ethics Service REC 1
REC reference
17/ES/0018
Date of REC Opinion
17 Mar 2017
REC opinion
Further Information Favourable Opinion