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

NCT06997575 | Completed Phase 4

• 1 other identifier: U1111-1323-1123
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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. 1.Be women aged 18-45 years diagnosed with eclampsia in the labour room.
2. 2.Have their basic health information (age, gestation, parity, body mass index) recorded
3. 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. 4.Continue treatment for 24 hours after their last seizure or delivery, whichever is later.
5. 5.Be monitored in hospital for seizure recurrence.
6. 6.Have any repeat seizure treated immediately with an extra IV dose of magnesium sulphate.

Conditions

Eclampsia; Seizures; Pregnancy

Keywords

Magnesium sulphate; eclampsia; Seizures; intramuscular; intravenous

Outcome Measures

Primary Outcomes (1)

• Seizure

  Seizure recurrence

  Within 48 hours after the last dose of MgSO4

Study Arms (2)

Group A

ACTIVE COMPARATOR

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.

Drug: Magnesium Sulphate infusion

Group B

EXPERIMENTAL

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.

Drug: Magnesium Sulphate infusion; Drug: Magnesium sulphate intramuscular

Interventions

Magnesium sulphate intramuscular DRUG

Intramuscular injections will be instituted in gluteal region.

Also known as: MgSO4 intramuscular

Group B

Magnesium Sulphate infusion DRUG

Infusion of 20% MgSO4 solution

Also known as: magnesium sulphate intravenous

Group A; Group B

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Pregnant women with eclampsia
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Patients with intracranial bleeding (on CT-scan)
• Already received MgSO4, phenytoin and diazepam before attending the hospital

Sponsors & Collaborators

• Nishtar Medical University: lead

Study Sites (1)

Nishtar Medical University & Hospital

Multan, Punjab Province, 60000, Pakistan

Location

Related Publications (1)

• Saha PK, Kaur J, Goel P, Kataria S, Tandon R, Saha L. Safety and efficacy of low dose intramuscular magnesium sulphate (MgSO4) compared to intravenous regimen for treatment of eclampsia. J Obstet Gynaecol Res. 2017 Oct;43(10):1543-1549. doi: 10.1111/jog.13424. Epub 2017 Jul 16.

  PMID: 28714170 BACKGROUND

MeSH Terms

Conditions

Eclampsia; Seizures

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Mehnaz Khakwani Professor, FCPS

  Nishtar Medical University & Hospital Multan

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 21, 2025
• First Posted: May 30, 2025
• Study Start: May 13, 2025
• Primary Completion: November 12, 2025
• Study Completion: November 12, 2025
• Last Updated: December 15, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)