TEST – An Open-Label Randomized-Controlled Trial of Low dose Aspirin with an Early Screening Test For Pre-eclampsia and Growth restriction.
Principal Investigator- Fionnuala Mc Auliffe (National Maternity Hospital)
Pre-eclampsia is a condition that affects 2-8% of pregnancies. It causes increased blood pressure in pregnancy (hypertension) and protein in the urine (proteinuria), which can cause eclampsia (seizures). Internationally it is a major cause of poor outcome in pregnancy for both mother and baby.
Previous studies have shown that low dose of Aspirin (LDA) can reduce the chance of developing pre-eclampsia in women with known risk factors. However, there is a lack of information regarding low risk populations.
The study was designed to assess the effectiveness of routine prescription of LDA to low risk women in their first pregnancy versus women who were prescribed aspirin on the basis of a positive early pregnancy screening test for pre-eclampsia and fetal growth restriction.
The effectiveness was measured by the following outcomes:
- The number of eligible women who agree to participate in the study.
- How well the protocol for the study is followed
- The number of women in whom it was possible to get first trimester abdominal uterine artery Doppler examination (ultrasound test of blood flow to the uterus)
- The number of women with a completed screening test who are issued the screening result on time
- The acceptability of undergoing a screening test and or of taking aspirin to women in their first pregnancy
In this study, 500 first time mothers with low risk pregnancies were recruited and randomised to a group. Group 1 received 75mg of aspirin, group 2 did not receive aspirin and group 3 received aspirin until 36 weeks if they had positive early screening.