Pregnancy and Childbirth
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: i Presence of one high risk factor for preeclampsia: Previous history of hypertensive disorders of pregnancy, autoimmune diseases (SLE and APS), chronic hypertension, diabetes mellitus. ii Presence of two or more moderate risk factors for preeclampsia: =35 years, first pregnancy, nulliparity, BMI =30kg/m2, pregnancy interval >10 years, family history of preeclampsia, personal history (low birth weight or small for gestational age, and previous adverse pregnancy outcome). iii Willingness to be followed up until 37 weeks or occurrence of outcome.
Exclusion criteria
Exclusion criteria: i Hypersensitivity to aspirin ii Long-term use of non-steroidal anti-inflammatory drugs (NSAID) iii Asthmatic patients iv Chronic liver or kidney disease v Bleeding disorders including peptic ulcer disease vi Cigarette smoking, alcohol consumption or illicit drug use vii Multifetal gestation viii Fetal congenital anomalies
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1 -Preeclampsia, defined as systolic blood pressure at =140 mm Hg and/or diastolic blood pressure at =90 mm Hg on at least two occasions measured 4 hours apart in previously normotensive women and new onset proteinuria (i.e., =2+ on dipstick) at or after 20 weeks of gestation. 2 -Preeclampsia-associated fetal growth restriction, defined as abdominal circumference <3rd centile at <32 weeks’ gestation (early-onset) and =32 weeks’ gestation (late-onset) respectively. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1 - Any of the other features of severity in preeclampsia including: acute kidney injury (creatinine =90 µmol/L; 1mg/dL); liver involvement (elevated transaminases, e.g. alanine aminotransferase or aspartate aminotransferase >40 IU/L) with or without right upper quadrant or epigastric abdominal pain; haematological complications (thrombocytopenia–platelet count <150,000/µL, disseminated intravascular coagulation, haemolysis); neurological complications (e.g. severe headaches, persistent visual scotomata, eclampsia, altered mental status, blindness, stroke, clonus); or uteroplacental dysfunction (stillbirth). 2 - Possible adverse effects of aspirin among participants such as upper abdominal (epigastric) pain, upper gastrointestinal bleeding e.g., haematochezia or haematemesis, antepartum haemorrhage (APH). | — |
Countries
Nigeria
Contacts
Chief Consultant;Visiting ProfessorNational Hospital Abuja