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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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
PACTR
Registry ID
PACTR202312795734215
Enrollment
95
Registered
2023-12-22
Start date
2023-12-01
Completion date
Unknown
Last updated
2026-09-14

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

Conditions

Pregnancy and Childbirth

Interventions

Tab Aspirin 75mg
Tab Aspirin 150mg

Sponsors

Dr. Suraiya Auwal Suleiman
Lead Sponsor

Eligibility

Sex/Gender
Female

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

MeasureTime 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

MeasureTime 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

Public ContactKorede;Ibrahim Durojaiye Wasiri;Yakasai

Chief Consultant;Visiting ProfessorNational Hospital Abuja

drkorededurojaiye@yahoo.com;ibrahimyakasai57@hotmail.com+2348023733643;+2348032349387

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026