An Open-Label Randomized-Controlled Trial of Low dose Aspirin with an Early Screening Test For Pre-eclampsia and Growth restriction : A Pilot Study : TEST Study
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 can reduce the chance of developing pre-eclampsia in women with known risk factors but we know little for low risk populations. Investigations performed early in pregnancy can aid the identification of women who are at risk of developing pre-eclampsia. These investigations include ultrasound (Uterine Artery Doppler), blood pressure measurement, blood tests (PAPP-A and PLGF) and mother’s previous medical history as advocated by the Fetal Medicine Foundation®.1
Through identifying women that are risk of pre-eclampsia and starting them on a low dose of Aspirin before 16-weeks of pregnancy, the risk of pre-eclampsia is more than halved, as well as reducing the risks of early delivery (pre-term birth) and limited growth of the baby (fetal growth restriction).2 Evidence has demonstrated that low dose Aspirin is safe for use in pregnancy3 and it is already routinely used in ‘at-risk’ populations.
The hypothesis of this study is to assess if it is beneficial in terms of effectiveness and acceptability to to routinely prescribe Low dose aspirin to low risk women in their first pregnancy compared with test indicated aspirin on the basis of a positive early pregnancy screening test for pre-eclampsia and fetal growth restriction.
The specific aims of this study are to determine:
1. The number of eligible women who agree to participate in the study.
2. How well the protocol for the study is followed
3. 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)
4. The number of women with a completed screening test who are issued the screening result on time
5. The acceptability of undergoing a screening test and or of taking aspirin to women in their first pregnancy
Who can participate?
Women who are expecting their first baby, less than 14 weeks pregnant at their first visit, not on aspirin, with enough English to understand the purpose of the study.
What does the study involve?
500 first time mothers with low-risk pregnancies will be randomly allocated to one of three groups from early pregnancy:
Group 1 will receive 75mg of aspirin until 36 weeks
Group 2 will not receive aspirin
Group 3 will receive 75mg of aspirin until 36 weeks only if they screen positive using the Fetal Medicine Foundation (FMF) early pregnancy screening test for pre-eclampsia and fetal growth restriction prediction. If this screening test is negative, group 3 will not receive aspirin.
All participants will undergo these first trimester screening tests but the results will only be given for group 3.
What are the possible benefits and risks of participating?
Benefits include detailed scans performed of the baby in the first and second trimester of pregnancy as well as monitoring of blood pressure. Mothers involved in the study will be contributing to a study which has the potential to significantly reduce the occurrence of pregnancy complications such as pre-eclampsia and fetal growth restriction which risks the lives of mothers and babies worldwide. Studies have shown that low dose aspirin appear to be safe for mother and baby, it is a medication frequently used by mothers who are at high risk of developing pre-eclampsia.
Where is the study run from?
The study will run from the National Maternity Hospital, Rotunda Maternity Hospital and Coombe Women’s Hospital, Dublin, Ireland.
When is the study starting and how long is it expected to run for?
The trial is starting in February 2014 and is expected to run for two years.
Who is funding the study?
Perinatal Ireland Consortium (Ireland)
How to I get in contact?
Contact firstname.lastname@example.org or contact the research team on 0879416845
1. Akolekar R, Syngelaki A, Poon L, et al. Competing risks model in early screening for preeclampsia by biophysical and biochemical markers. Fetal Diagnosis and Therapy 2013; 33(1): 8-15
2. Bujold E, Roberge, Lacasse Y, et al. Prevention of Pre-eclampsia and intrauterine growth restriction with aspirin started in early pregnancy: a meta-analysis. Obstet Gynecol 116: 402-14
3. Coomarasamy A, Braunholtz D, Song F, et al. Individualizing use of aspirin to prevent pre-eclampsia: a framework for clinical decision-making. BJOG 2003;110: 882-888
4. CLASP (Collaborative Low-dose Aspirin Study in Pregnancy) Collaborative Group: CLASP - a randomised trial of low-dose aspirin for the prevention and treatment of pre-eclampsia among 9364 pregnant women. CLASP 1994;343(8898): 619-29.