Frequency of Recurrence of Seizures With Intravenous Versus Intramuscular Magnesium Sulphate in Women With Eclampsia

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 45
Healthy Volunteers: f
View:

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

Locations
Other Locations
Pakistan
Nishtar Medical University & Hospital
RECRUITING
Multan
Contact Information
Primary
Laraib Irshad Principal Investigator, MBBS
laraibirshad1002@gmail.com
+92 03179984660
Time Frame
Start Date: 2025-05-13
Estimated Completion Date: 2025-11-12
Participants
Target number of participants: 200
Treatments
Active_comparator: Group A
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.
Experimental: Group B
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.
Related Therapeutic Areas
Sponsors
Leads: Nishtar Medical University

This content was sourced from clinicaltrials.gov