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

No results posted yet for this study

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

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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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06997575 on ClinicalTrials.gov