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Contemp Clin Trials. 2016 Jul;49:143-8. doi: 10.1016/j.cct.2016.07.003. Epub 2016 Jul 6.

An open-label randomized-controlled trial of low dose aspirin with an early screening test for pre-eclampsia and growth restriction (TEST): Trial protocol.

Author information

1
UCD 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.
2
Department of Fetal Medicine, National Maternity Hospital, Holles St, Dublin, Ireland.
3
Molecular and Cellular Therapeutics, Royal College of Surgeons in Ireland, St. Stephen's Green, Dublin, Ireland.
4
Department of Pathology and Laboratory Science, National Maternity Hospital, Holles St, Dublin, Ireland.
5
Department of Pharmacy, National Maternity Hospital, Holles St, Dublin, Ireland.
6
Royal College of Surgeons in Ireland, Rotunda Hospital, Parnell Square, Dublin, Ireland.
7
UCD 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. Electronic address: Fionnuala.mcauliffe@ucd.ie.

Abstract

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.

KEYWORDS:

Aspirin; First trimester; Low-risk; Placental disease; Pre-eclampsia; Screening

PMID:
27394381
DOI:
10.1016/j.cct.2016.07.003
[Indexed for MEDLINE]

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