ow-dose aspirin in the prevention of preeclampsia

Phase 3

Completed

• Conditions: Preeclampsia; Pregnancy and Childbirth; Pre-eclampsia

• Registration Number: ISRCTN81414657
• Lead Sponsor: Beacon Pharmaceuticals Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2020-02-28
• Study Start: 2022-05-19
• Last Update Posted: 9 January 2023

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 200

Inclusion Criteria

Current inclusion criteria as of 26/05/2022:
1. Maternal age =18 years
2. Live foetus at gestational age 12–19 weeks
3. Any one of the following criteria:
3.1. BMI =30 kg/m2
3.2. Pregnancy interval >10 years
3.3. Multiple pregnancy
3.4. Pregnancy assisted by ovulation-inducing drugs/in vitro fertilization
3.5. Pregnant women with medical disorders, e.g. chronic hypertension, hyperglycaemia in pregnancy, autoimmune disease (e.g. antiphospholipid syndrome [APS], systemic lupus erythematosus [SLE])
3.6. Previous history of gestational hypertension, pre-eclampsia or eclampsia
3.7. Previous history of intrauterine growth restriction (IUGR), intrauterine death or stillbirth
3.8. Family history (mother and/or sister) of hypertension, gestational hypertension or pre-eclampsia

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Previous inclusion criteria:
1. Nulliparous
2. Maternal age =16 years and =35 years
3. BMI =30 kg/m²
4. Live foetus at gestational age 12 weeks – 19 weeks
5. Pregnancy interval >10 years
6. Multiple pregnancy
7. Pregnancy assisted by ovulation-inducing drugs/in vitro fertilization
8. Pregnant women with medical disorders: chronic HTN, hyperglycaemia in pregnancy, thyroid disorder, autoimmune disease - antiphospholipid syndrome (APS), systemic lupus erythematosus (SLE)
9. Previous history of gestational HTN, preeclampsia (PE), eclampsia
10. Previous history of intrauterine growth restriction (IUGR), IUD, stillbirth
11. Family history of HTN, gestational HTN, PE (mother and/or sister)

Exclusion Criteria

Current exclusion criteria as of 26/05/2022:
1. Allergic to aspirin
2. Peptic ulcer disease
3. Mental disease
4. Treatment with antifolate drugs (antiepileptics, methotrexate)
5. Patient will not give consent to participate
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Previous exclusion criteria:
1. Allergic to aspirin
2. Peptic ulcer disease
3. Pregnant women who are at risk of developing PE but who have renal failure, hepatic failure, cardiac failure and hematological disorder
4. Mental disease
5. Treatment with antifolate drugs (antiepileptics, methotrexate)
6. Patient will not give consent to participate

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Occurrence of preeclampsia measured by measuring blood pressure (following standard procedures) and proteinuria (by dipstick test) at the time of delivery