A study to compare the effects and safety of of Injection Levetiracetam and Injection Magnesium Sulphate in the prevention of fits in pregnant women with high blood pressure

A randomised control study to evaluate the safety and efficacy of Levetiracetam in comparison to Magnesium Sulphate in the management of severe pre-eclampsia

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/04/064992

Enrollment

102

Registered

2024-04-01

Start date

Unknown

Completion date

Unknown

Last updated

2026-01-12

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

Eligibility

Inclusion criteria

Inclusion criteria: 1. Pregnant women with gestational age of more than or equal to 28 weeks presenting with features of severe pre-eclampsia and/ or imminent eclampsia, needing immediate delivery as per treating clinician’s decision 2. No contraindication to either of the study drugs 3. Patients giving written informed consent for investigations and the proposed intervention

Exclusion criteria

Exclusion criteria: 1. Patients diagnosed with other causes of convulsions in pregnancy like cerebral malaria and epilepsy 2. Pregnant women with chronic hypertension without super-imposed pre-eclampsia 3. Pregnant females with fetal anomalies detected on USG 4. Pregnant women who already have deranged renal parameters

Design outcomes

Primary

Measure	Time frame
To study the effeciacy and safety of Levetiracetam in prevention of seizures in PreeeclampsiaTimepoint: WIthin 30 min of administeting the drug. At 24 hours of administering the drug. At delivery of the baby	—

Secondary

Measure	Time frame
To observe the adverse effects of Levetiracetam and Magnesium sulphateTimepoint: For 5 days	—

Countries

India

Contacts

Public ContactDr Rajasri G Yaliwal

BLDE(DU) Shri BM Patil Medical COllege, Hopsiyal and Research Center

ryaliwal@bldedu.ac.in9845152240

Outcome results

None listed

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