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

Nishtar Medical University

Status and phase: Completed; Phase 4

Conditions: Seizures; Eclampsia; Pregnancy

Treatments: Drug: Magnesium sulphate intramuscular; Drug: Magnesium Sulphate infusion

Study type: Interventional

Funder types: Other

Identifiers

NCT06997575

U1111-1323-1123

Details and patient eligibility

About

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.

Enrollment: 200 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Group A

Active Comparator group

Description:

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.

Treatment:

Drug: Magnesium Sulphate infusion

Group B

Experimental group

Description:

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.

Treatment:

Drug: Magnesium Sulphate infusion

Drug: Magnesium sulphate intramuscular