A study aspirin pharmacokinetics in women at high risk of preeclampsia
Research type
Research Study
Full title
A study of aspirin pharmacokinetics in pregnant women at high risk of placental-mediated disease
IRAS ID
241212
Contact name
Stephen Robson
Contact email
Sponsor organisation
Joint Research Office
Duration of Study in the UK
0 years, 4 months, 31 days
Research summary
Background: All women at high risk of preeclampsia (PE) are recommended to take 75 mg aspirin (ASA. Recent studies identified that ~30% of women taking 75 mg ASA have no evidence of platelet response (determined by plasma thromboxane A2). A pilot study failed to identify salicylic acid [the predominant ASA metabolite] in these samples – inferring failed compliance, inadequate dosing or enhanced metabolism.
The purpose of this study is to understand ASA kinetics in pregnant women prescribed ASA to reduce the risk of PE.
Design: Twenty high risk women due to start ASA for clinical indications will be recruited from the Antenatal Clinic at Newcastle upon Tyne Hospitals NHS Foundation Trust (NuTH). All women will give informed written consent.
Each recruit will be given 75 mg or 150 mg oral ASA (determined at random) between 0900-1000. Blood and urine samples will be collected at baseline, 20 min, 40 min, 1 h, 2 h, 4 h and 24 h for measurement of serum thromboxane A2 and urinary ASA metabolites. The studies will be conducted in the Clinical Research Facility, NuTH and supported by the Reproductive Health & Childbirth Research Group.REC name
North East - Newcastle & North Tyneside 2 Research Ethics Committee
REC reference
18/NE/0095
Date of REC Opinion
28 Mar 2018
REC opinion
Unfavourable Opinion