What happens to low doses of aspirin (75 and 150 mg) and how it affects certain blood particles in pregnant women at risk of pre-eclampsia?

A randomised crossover design study comparing the pharmacokinetics and pharmacodynamics of two single Doses of ORal Aspirin (75 mg v 150 mg) in pregnant women at risk of pre-eclampsia (DORA)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN14693054

Enrollment

Registered

2021-03-09

Start date

2021-07-01

Completion date

Unknown

Last updated

2024-11-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pre-eclampsia Pregnancy and Childbirth Pre-eclampsia

Interventions

Online non-blinded envelope randomisation will be performed. The lab will be blinded to the randomisation. Participants will be randomised to either a sequence of a single dose of 75 mg aspirin follow

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. Pregnant women at risk of pre-eclampsia according to NICE criteria

Exclusion criteria

Exclusion criteria: 1. Hypersensitivity to aspirin, salicylic acid compounds, or prostaglandin synthase inhibitors (e.g. certain asthma patients who may suffer an attack or faint) 2. Active, or history of, recurrent peptic ulcer and/or gastric/intestinal haemorrhage, or other kinds of bleeding such as cerebrovascular haemorrhage 3. Haemorrhagic diathesis or coagulation disorders such as hemophilia and thrombocytopenia 4. Severe hepatic or renal impairment 5. Gout 6. Taken aspirin over the preceding 4 weeks 7. Current anticoagulant therapy 8. Unable to give informed consent 9. Multiple pregnancy 10. Known fetal anomaly 11. Vegetarian/vegan diet

Design outcomes

Primary

Measure	Time frame
1. Pharmacokinetics and pharmacodynamics measured using serum salicylic acid concentration and serum thromboxane B2 concentration from blood samples taken at baseline, 1, and 8 days	—

Secondary

Measure	Time frame
1. Time to the detection limit of salicylic acid in plasma measured from blood samples taken at baseline, 1, and 8 days	—

Countries

England, United Kingdom

Contacts

Public ContactRaya Vinogradov

raya.vinogradov@ncl.ac.uk+44 (0)191 2820540

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026