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An open-label randomized-controlled trial of low dose aspirin with an early screening test for pre-eclampsia and
Fionnuala Mone1, Cecilia Mulcahy2, Peter McParland2
1UCD Obstetrics and Gynaecology, School of Medicine and Medical Science, University College Dublin, National Maternity Hospital, Holles St, Dublin, Ireland; Department of Fetal Medicine, National Maternity Hospital, Holles St, Dublin, Ireland.
Insights
This study compares routine low-dose aspirin (LDA) to no aspirin or test-indicated LDA for preventing pre-eclampsia in low-risk women. It assesses efficacy and acceptability to optimize maternal and perinatal health outcomes.
Area of Science:
- Obstetrics and Gynecology
- Maternal-Fetal Medicine
- Pharmacology
Background:
- Pre-eclampsia is a significant global cause of maternal and perinatal mortality.
- Low-dose aspirin (LDA) is proven to reduce pre-eclampsia in high-risk pregnancies.
- First-trimester screening tests can identify placental disease risk, including pre-eclampsia.
Purpose of the Study:
- To evaluate the efficacy and acceptability of routine LDA versus test-indicated LDA in nulliparous, low-risk women.
- To compare routine LDA, no aspirin, and screening-indicated LDA for pre-eclampsia prevention.
- To determine the most beneficial approach for low-risk pregnancies regarding placental disease prevention.
Main Methods:
- A three-arm, multi-center, open-label randomized controlled trial.
- Interventions: routine LDA, no aspirin, or LDA based on positive first-trimester screening.
- Primary outcomes: participant acceptability, protocol compliance, feasibility of Doppler examination, and timely screening result delivery.
Main Results:
- This section is not available in the provided abstract.
Conclusions:
- This trial is the first to assess routine versus screening-indicated LDA in low-risk women for placental disease prevention.
- The study aims to establish the most effective and acceptable strategy for pre-eclampsia prevention in this population.
Objective:
Pre-eclampsia remains a worldwide cause of maternal and perinatal morbidity and mortality. Low dose aspirin (LDA) can reduce the occurrence of pre-eclampsia in women with identifiable risk factors. Emerging screening tests can determine the maternal risk of developing placental disease, such as pre-eclampsia from the first trimester of pregnancy. The aim of this study is to determine if it is more beneficial in terms of efficacy and acceptability to routinely prescribe LDA to nulliparous low-risk women compared to test indicated LDA on the basis of a positive screening test for placental disease.
Methods:
We propose a three armed multi-center open-labeled randomized control trial of; (i) routine LDA, (ii) no aspirin, and (iii) LDA on the basis of a positive first trimester pre-eclampsia screening test. LDA (75mg once daily) shall be given from the first trimester until 36-week gestation. The primary outcome measures include; (i) the proportion of eligible women that agree to participate (acceptability), (ii) compliance with study protocol (acceptability and feasibility), (iii) the proportion of women in whom it is possible to obtain first trimester trans-abdominal uterine artery Doppler examination (feasibility) and (iv) the proportion of women with a completed screening test that are issued the screening result within one week of having the test performed (feasibility).
Conclusion:
This will be the first clinical trial to determine the efficacy and acceptability in low-risk women of taking routine LDA versus no aspirin versus LDA based on a positive first trimester screening test for the prevention of placental disease.
