Low dose aspirin with an early screening test for pre-eclampsia and fetal growth restriction

Update Il y a 4 ans
Reference: ISRCTN15191778

Woman Man

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Extract

Background and study aims Pre-eclampsia is a condition that affects 2-8% of pregnancies. Previous studies have shown that aspirin can reduce the occurrence of pre-eclampsia in women with known risk factors but we know little for low risk populations. This study aims to assess if it is beneficial in terms of effectiveness and patient acceptability to routinely prescribe low dose aspirin to low risk women on the basis of a positive early pregnancy screening test for pre-eclampsia and fetal growth restriction. The specific aims of this study are: 1. Number of eligible women who agree to participate in the study. 2. Adherence to the study methodology 3. Number of women in whom it was possible to get first trimester abdominal uterine artery Doppler examination 4. Number of women with completed screening test who are issued the screening result on time 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, Coombe Maternity Hospital and Rotunda Maternity 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) Who is the main contact? Professor Fionnuala McAuliffe PI [email protected]


Inclusion criteria

  • Pregnancy / pre-eclampsia/ fetal growth restriction/ randomsied-controlled trial

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