Comparing Intravenous and Intramuscular Magnesium Sulphate for Preventing Seizure Recurrence in Women With Eclampsia

Phase 4

Recruiting

• Conditions: Eclampsia; Seizures; Pregnancy
• Interventions: Drug: Magnesium Sulphate infusion; Drug: Magnesium sulphate intramuscular

• Registration Number: NCT06997575
• Lead Sponsor: Nishtar Medical University

Brief Summary

The goal of this clinical study is to learn whether the way we give magnesium sulphate-into a vein (intravenous, IV) versus into a muscle (intramuscular, IM)-affects how often women with eclampsia have repeat seizures.

The main question it aims to answer is:

1. Do women who receive IV magnesium sulphate have fewer recurrent seizures than those who receive IM magnesium sulphate?

Researchers will compare two groups of women with eclampsia: one group will receive a bolus and a continuous IV infusion of magnesium sulphate, and the other will receive a combined IV-plus-IM dosing regimen.

Participants will:

1. Be women aged 18-45 years diagnosed with eclampsia in the labour room.

2. Have their basic health information (age, gestation, parity, body mass index) recorded

3. Be randomly assigned (by sealed envelope) to receive either the IV regimen (4 g loading dose then 1 g/hour infusion) or the IM regimen (10 g loading dose with 4 g IV plus 6 g IM, then 2.5 g IM every 4 hours).

4. Continue treatment for 24 hours after their last seizure or delivery, whichever is later.

5. Be monitored in hospital for seizure recurrence.

6. Have any repeat seizure treated immediately with an extra IV dose of magnesium sulphate.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-05
• Study Start: 2025-05-13
• Study First Submitted: 2025-05-21
• Study First Submitted QC: 2025-05-21
• Last Update Submitted: 2025-05-21
• Study First Posted: 2025-05-30
• Last Update Posted: 2025-05-30
• Primary Completion: 2025-11-12
• Study Completion: 2025-11-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 200

Inclusion Criteria

• Admitted in labor room due to eclampsia (new onset of grand mal seizure activity and/or unexplained coma during pregnancy)

Exclusion Criteria

• Patients with intracranial bleeding (on CT-scan)
• Already received MgSO4, phenytoin and diazepam before attending the hospital

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	Magnesium Sulphate infusion	Patients will receive 4 g of Intravenous MgSO4 as 20% solution followed by 1 g Intravenous per hour as continuous IV infusion. MgSo4 will be continued for 24 h after the last seizure or 24 h after delivery, whichever will occur last.
Group B	Magnesium Sulphate infusion	Patients initially will receive a 10 g loading dose of MgSO4: 4 g will be given Intravenous as 20% solution, 6 g IM 50% solution divided equally 3 g in each buttock with 1% of 1 ml of lidocaine) followed by 2.5 g IM every 4 h as maintenance therapy. MgSo4 will be continued for 24 h after the last seizure or 24 h after delivery, whichever will occur last.
Group B	Magnesium sulphate intramuscular	Patients initially will receive a 10 g loading dose of MgSO4: 4 g will be given Intravenous as 20% solution, 6 g IM 50% solution divided equally 3 g in each buttock with 1% of 1 ml of lidocaine) followed by 2.5 g IM every 4 h as maintenance therapy. MgSo4 will be continued for 24 h after the last seizure or 24 h after delivery, whichever will occur last.

Primary Outcome Measures

Name	Time	Method
Seizure	Within 48 hours after the last dose of MgSO4	Seizure recurrence

Trial Locations

Locations (1)

Nishtar Medical University & Hospital; 🇵🇰 Multan, Punjab, Pakistan