About this trial
Preeclampsia in pregnancy is a dreaded complication which has both fetal and maternal adverse outcomes. Studies and WHO have advocated that this complication can be prevented by Aspirin. However which dose is more effective in preventing preeclampsia, whether 75mg or 150mg, will be known from this study.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
• All pregnant women with Gestosis score of 3 or more who consents for the study and aged 18 years and above.
Disqualifiers
• Known hypersensitivity to aspirin, uncontrolled asthma with NSAID sensitivity
Bleeding disorders, platelet dysfunction, thrombocytopenia, anticoagulant use, active peptic ulcer, history of GI bleed, severe hepatic/ renal disease
Trial design
Parallel
Treatments tested in this trial
Aspirin
DrugThis interventional study is being doe in pregnant women after calculationg their Gestosis score and if Gestosis score of 3 or more, they will be randomised into aspirin 75mg and aspirin 150mg in the ratio 1:1. After their delivery, the result will be recorded as to whether preeclampsia had been prevented.
Treatment groups
Trial outcomes
Primary outcomes
Incidence of Preeclampsia
Preeclampsia will be assessed during routine antenatal visits and at delivery by trained obstetric clinicians. Blood pressure will be measured using a calibrated sphygmomanometer with the participant in a seated position after adequate rest. Hypertension will be defined as systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg recorded on two occasions at least 4 hours apart after 20 weeks of gestation. Proteinuria will be assessed using urine dipstick testing (≥1+) or 24-hour urine protein estimation (≥300 mg). In the absence of proteinuria, preeclampsia will be diagnosed based on hypertension with evidence of maternal end-organ dysfunction. The incidence of preeclampsia will be recorded after the the time of randomization until delivery .
Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Dr. Sunita Pun
Lead sponsor
Tribhuvan University, Nepal
Sponsor institution
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