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OpenTrials
Completed

NCT Number: NCT06997575

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

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.

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Nishtar Medical University & Hospital

Multan, Punjab Province, 60000, Pakistan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Magnesium sulphate infusion

Drug

Infusion of 20% MgSO4 solution

Other names: magnesium sulphate intravenous

Magnesium sulphate intramuscular

Drug

Intramuscular injections will be instituted in gluteal region.

Other names: MgSO4 intramuscular

Primary outcomes

  1. Seizure

    Time frame: Within 48 hours after the last dose of MgSO4

    Seizure recurrence

Sponsors and collaborators

Lead sponsor

Nishtar Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
May 30, 2025
Registry last updated
Dec 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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