Comparing Intravenous and Intramuscular Magnesium Sulphate for Preventing Seizure Recurrence in Women With Eclampsia
NCT06997575 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 200
Last updated 2025-12-15
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.
Conditions
- Eclampsia
- Seizures
- Pregnancy
Interventions
- DRUG
-
Magnesium Sulphate infusion
Infusion of 20% MgSO4 solution
- DRUG
-
Magnesium sulphate intramuscular
Intramuscular injections will be instituted in gluteal region.
Sponsors & Collaborators
-
Nishtar Medical University
lead OTHER
Principal Investigators
-
Mehnaz Khakwani Professor, FCPS · Nishtar Medical University & Hospital Multan
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 45 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-05-13
- Primary Completion
- 2025-11-12
- Completion
- 2025-11-12
Countries
- Pakistan
Study Locations
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