A comparison of 150mg and 75mg aspirin for preventing preterm preeclampsia and associated fetal growth restriction amongst women at risk in Abuja: a randomised controlled study
- Conditions
- Pregnancy and Childbirth
- Registration Number
- PACTR202312795734215
- Lead Sponsor
- Dr. Suraiya Auwal Suleiman
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Female
- Target Recruitment
- 95
iPresence of one high risk factor for preeclampsia: Previous history of hypertensive disorders of pregnancy, autoimmune diseases (SLE and APS), chronic hypertension, diabetes mellitus.
iiPresence 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).
iiiWillingness to be followed up until 37 weeks or occurrence of outcome.
iHypersensitivity to aspirin
iiLong-term use of non-steroidal anti-inflammatory drugs (NSAID)
iiiAsthmatic patients
ivChronic liver or kidney disease
vBleeding disorders including peptic ulcer disease
viCigarette smoking, alcohol consumption or illicit drug use
viiMultifetal gestation
viiiFetal congenital anomalies
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.<br>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.<br>
- Secondary Outcome Measures
Name Time Method <br>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).<br>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).<br>