EclampsiaPhase 4NCT06997575
Comparing Intravenous and Intramuscular Magnesium Sulphate for Preventing Seizure Recurrence in Women With Eclampsia
A Phase 4 study testing Magnesium Sulphate infusion and Magnesium sulphate intramuscular in people with Eclampsia and Seizures, run by Nishtar Medical University at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- What is being tested?
- Magnesium Sulphate infusion and Magnesium sulphate intramuscular
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 sitePakistan
- Study dates
- 13 May 2025to 12 Nov 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Admitted in labor room due to eclampsia (new onset of grand mal seizure activity and/or unexplained coma during pregnancy)
Who cannot join
- Patients with intracranial bleeding (on CT-scan)
- Already received MgSO4, phenytoin and diazepam before attending the hospital
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Nishtar Medical University & Hospital
Multan, Punjab Province, 60000
About this study
Official title: Frequency of Recurrence of Seizures With Intravenous Versus Intramuscular Magnesium Sulphate 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:
Read more
- 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:
- Be women aged 18-45 years diagnosed with eclampsia in the labour room.
- Have their basic health information (age, gestation, parity, body mass index) recorded
- 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).
- Continue treatment for 24 hours after their last seizure or delivery, whichever is later.
- Be monitored in hospital for seizure recurrence.
- Have any repeat seizure treated immediately with an extra IV dose of magnesium sulphate.
- Being tested
- Magnesium Sulphate infusion, Magnesium sulphate intramuscular
- Keywords
- Magnesium sulphate, eclampsia, Seizures, intramuscular, intravenous
- Medical subject headings
- Eclampsia, Seizures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnesium Sulphate infusionDrug
Also called magnesium sulphate intravenous
Infusion of 20% MgSO4 solution
Magnesium sulphate intramuscularDrug
Also called MgSO4 intramuscular
Intramuscular injections will be instituted in gluteal region.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Magnesium Sulphate infusion; Drug: Magnesium sulphate intramuscular |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seizure
Seizure recurrence
Measured: Within 48 hours after the last dose of MgSO4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2025
- Study start13 May 2025
- Primary completion12 Nov 2025
- Study completion12 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for EclampsiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nishtar Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Laraib Irshad, Nishtar Medical University
- Investigators
- Mehnaz Khakwani Professor, FCPS, Study chair, Nishtar Medical University & Hospital Multan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06997575
- Sponsor's protocol ID
- U1111-1323-1123
- Status last verified
- Dec 2025
- First submitted
- 21 May 2025
- Last updated
- 15 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28714170
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Frequency of Recurrence of Seizures With Intravenous Versus Intramuscular Magnesium Sulphate in Women With Eclampsia
- ClinicalTrials.gov ID
- NCT06997575
- Acronym / sponsor ID
- U1111-1323-1123
- Keywords
- Magnesium sulphate, eclampsia, Seizures, intramuscular, intravenous
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Nishtar Medical UniversityUniversity, hospital or other
- Study start
- 13 May 2025 (actual)
- Primary completion
- 12 Nov 2025 (actual)
- Study completion
- 12 Nov 2025 (actual)
- First posted
- 30 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- Be women aged 18-45 years diagnosed with eclampsia in the labour room.
- Have their basic health information (age, gestation, parity, body mass index) recorded
- 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).
- Continue treatment for 24 hours after their last seizure or delivery, whichever is later.
- Be monitored in hospital for seizure recurrence.
- Have any repeat seizure treated immediately with an extra IV dose of magnesium sulphate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Drug: Magnesium Sulphate infusionPatients 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. |
| Group B | Experimental | Drug: Magnesium Sulphate infusion, Drug: Magnesium sulphate intramuscularPatients 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Admitted in labor room due to eclampsia (new onset of grand mal seizure activity and/or unexplained coma during pregnancy)
Key exclusion criteria (2 listed)
- Patients with intracranial bleeding (on CT-scan)
- Already received MgSO4, phenytoin and diazepam before attending the hospital
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnesium Sulphate infusionAlso: magnesium sulphate intravenousInfusion of 20% MgSO4 solution | Drug | Group A, Group B |
| Magnesium sulphate intramuscularAlso: MgSO4 intramuscularIntramuscular injections will be instituted in gluteal region. | Drug | Group B |
Primary outcome
Seizure
Time frame: Within 48 hours after the last dose of MgSO4
Seizure recurrence
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2025.
- Background: PubMed 28714170Saha 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mehnaz Khakwani Professor, FCPS study chair
Nishtar Medical University & Hospital Multan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Magnesium Sulphate infusion and Magnesium sulphate intramuscular in people with Eclampsia and Seizures, run by Nishtar Medical University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Seizure (time frame: Within 48 hours after the last dose of MgSO4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06997575, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2025.