ASPRE Follow Up
Research type
Research Study
Full title
Combined multi-marker screening and randomised patient treatment with aspirin for evidence-based pre-eclampsia prevention: Follow up study
IRAS ID
258742
Contact name
Kypros Nicolaides
Contact email
Sponsor organisation
King's College Hospital NHS Foundation Trust
Duration of Study in the UK
3 years, 0 months, 0 days
Research summary
Preeclampsia (PE) is a pregnancy specific disorder affecting 2-5% of pregnancies. It is a leading cause of maternal death worldwide and can cause significant health problems for the mother, her unborn child and infant. The exact cause of PE is unknown, but abnormal placental development is thought to be a primary cause. Previous research has shown that the effects of PE are not only detrimental to maternal health in the short term, but can extend into later life, leading to lifelong problems such as heart disease, stroke and high blood pressure.
The environment of the unborn baby is pivotal in influencing it’s development after birth. Mothers with PE release toxins into their blood which affect this delicate environment, causing changes in the genetic programming of the fetus. Long term studies have shown impaired neurological development, higher blood pressures and increased risk of stroke in offspring born to mothers with PE.
Recent evidence has demonstrated that effective screening for preterm (<37 weeks) PE is achievable by a combined test performed in the first trimester of pregnancy. Through a recent randomized control trial (Aspirin for Evidence-Based Preeclampsia Prevention: ASPRE), the rate of preterm PE was shown to be reduced by greater than 60% with the use of 150mg aspirin every night, given to high-risk women from 11-14 weeks’ until 36 weeks’ gestation. Preterm PE occurred in 1.6% of participants in the aspirin group and in 4.3% of the placebo group, showing a significant benefit of aspirin prophylaxis versus placebo.
The aim of the current study is follow up the patients in the ASPRE trial, to investigate whether aspirin prophylaxis leads to improvements in (i) risk of stroke or heart disease in mothers (ii) survival, risk of heart disease and neurodevelopmental outcome in children born to mothers at high-risk of PE.
REC name
London - London Bridge Research Ethics Committee
REC reference
19/LO/0647
Date of REC Opinion
6 Aug 2019
REC opinion
Further Information Favourable Opinion