Overview
Comparison of Doses of Acetylsalicylic Acid in Women With Previous History of Preeclampsia
Status:
Completed
Completed
Trial end date:
2015-03-01
2015-03-01
Target enrollment:
0
0
Participant gender:
Female
Female
Summary
Placental insufficiency is the source of preeclampsia (PE) and intrauterine growth retardation (IUGR). Current data demonstrate a significant beneficial effect of prophylactic use of aspirin on the recurrence of placental insufficiency and its complications, mainly preeclampsia, when started early in pregnancy. However, there is a significant heterogeneity in medical practice in Canada and around the world in terms of the dose of aspirin used. The objectives of this study are: 1) Evaluate whether a dose of 160 mg of aspirin is associated with greater improvement in placental function assessed by biochemistry (sFlt-1 and endoglin) and ultrasound (uterine artery Doppler) than a dose of 80 mg in women with a history of PE, 2) Assess whether the change is dependent on platelet aggregation measured by a test used in several Canadian centers (PFA-100).Phase:
Phase 4Accepts Healthy Volunteers?
Accepts Healthy VolunteersDetails
Lead Sponsor:
Centre Hospitalier Universitaire de Québec, CHU de Québec
CHU de Quebec-Universite LavalTreatments:
Aspirin
Criteria
Inclusion Criteria:- Gestational age between 10 0 / 7 and 13 6 / 7 weeks
- History of preeclampsia (as defined by The Society of Obstetricians and Gynaecologists
of Canada) confirmed by medical records
Exclusion Criteria:
- Negative Fetal Heart
- Multiple pregnancy
- Anaphylactic allergy to lactose
- Kown coagulopathy (antithrombin III deficiency, factor V Leiden, antiphospholipid
syndrome, the prothrombin mutation, deficiency of protein S or protein C)
- Use of heparin or other anticoagulants.
- Contraindications to aspirin
- Severe fetal abnormality (cystic hygroma, nuchal translucency> 95th percentile,
anencephaly, etc.)
- History or active peptic ulcer