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Study to Evaluate the Safety and Efficacy of Levetiracetam in Comparison To Magnesium Sulphate in the Management of Severe Pre â?? Eclampsia

A Prospective Study to Evaluate the Safety and Efficacy of Levetiracetam in Comparison To Magnesium Sulphate in the Management of Severe Pre â?? Eclampsia and Imminent Eclampsia. - SELCOMSUPE

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/02/023194
Enrollment
76
Registered
2020-02-07
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: O141- Severe pre-eclampsia

Interventions

Intervention1: Levetiracetam: Loading dose: 1000 mg/day (500 mg twice daily) slowly over 5min intravenously. The proposed regimen is to continue IV drugs for 24 hours then substitute oral levetirace

Sponsors

BLDE Deemed to be University
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. All pregnant women with gestational age above 28 weeks presenting with features of severe pre eclampsia and imminent eclampsia during the period will be recruited into the study 2. Patients giving informed and written consent for investigations

Exclusion criteria

Exclusion criteria: 1. Patients who were diagnosed with other causes of convulsions in pregnancy like cerebral malaria and epilepsy 2. Chronic hypertensive pregnant females 3. Pregnant females with fetal anomalies detected on USG 4. Patients who withdraw the consent for further participation in the study

Design outcomes

Primary

MeasureTime frame
To evaluate the efficacy of Levetiracetam as an alternative to Magnesium sulphate in the prevention of convulsions in severe preeclampsia and imminent eclampsia. To evaluate the neonatal outcomes in babies exposed to levetiracetam and magnesium sulphate Timepoint: 1.Adverse effects st the time of administration 2. Occurence of seizures inspite of giving the drug 3. adverse effects of the drug at 24 hours 4 Adverse effects of drugs between 24 hours to 7 days after the administration 5. advesre effect of the drug at birth on the neonate 6. Adverse effect of the drug between 24 hours to 7 days after administration of the drug on the neonate

Secondary

MeasureTime frame
To study the perinatal outcoe after the exposure to the drugsTimepoint: adverse effect of the drug on the neonate at 1 month after the delivery

Countries

India

Contacts

Public ContactDr Rajasri G Yaliwal

Shri B.M Patil Medical College, Hospital and Research Centre, BLDE(DU) Vijayapura

ryaliwal@yahoo.com9845152240

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026