Randomized Controlled Study to Compare Efficacy of Aspirin 75mg and 150mg In the Prevention of Preeclampsia In High Risk Pregnant Women

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age18+
SponsorDr. Sunita Pun

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 volunteers

Qualifiers

• 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

Design model

Parallel

Treatments tested in this trial

  • Aspirin

    Drug

    This 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

86 Participants
are divided into 2 treatment groups
Group A: 75mg Aspirin ArmExperimental treatment 1 intervention
Group B: 150mg Aspirin ArmActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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 .

Time frame
1 year (After the time of randomization till delivery)

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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Dr. Sunita Pun

Lead sponsor

Tribhuvan University, Nepal

Sponsor institution

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