Magnesium Sulfate for Pre-eclampsia

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Overseen ByAlexander M Harrison, MD
Age: 18 - 65
Sex: Female
Trial Phase: Phase 4
Sponsor: Alexander Harrison
Must be taking: Magnesium sulfate
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests how different durations of magnesium sulfate treatment affect recovery in individuals with preeclampsia with severe features, a pregnancy condition that causes high blood pressure and organ issues. Participants will receive magnesium sulfate for either 12 or 24 hours after delivery to assess recovery speed. Blood samples will be collected at various intervals to monitor changes. This trial may suit those diagnosed with severe preeclampsia during pregnancy who are about to deliver. As a Phase 4 trial, the research aims to understand how an already FDA-approved and effective treatment can benefit more patients.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It seems that the focus is on administering magnesium sulfate after delivery, so your usual medications might not be affected, but it's best to discuss this with the trial coordinators.

What is the safety track record for magnesium sulfate?

Research has shown that magnesium sulfate, a treatment for severe pre-eclampsia, is generally safe to use after childbirth. Studies have found that a 12-hour magnesium sulfate treatment can effectively prevent seizures associated with pre-eclampsia. This shorter treatment also tends to cause fewer side effects, such as drowsiness or breastfeeding difficulties, compared to a longer 24-hour treatment.

One study found that while the 12-hour treatment might slightly increase the number of eclampsia cases, it remains a safe option for managing pre-eclampsia after delivery. Overall, magnesium sulfate is well-tolerated and has been widely used successfully, reducing the risk of serious complications.12345

Why are researchers enthusiastic about this study treatment?

Researchers are excited about the trial of magnesium sulfate for pre-eclampsia because it explores a potentially more efficient treatment protocol. Unlike the standard 24-hour postpartum magnesium sulfate administration, this study examines the effects of a shorter, 12-hour administration. The hope is that this new approach could offer the same benefits—like reducing the risk of seizures in new mothers—while minimizing side effects and improving patient comfort. If successful, this could streamline treatment, reduce hospital stays, and enhance overall patient care in pre-eclampsia cases.

What is the effectiveness track record for magnesium sulfate in treating preeclampsia with severe features?

Research has shown that magnesium sulfate effectively prevents and treats seizures in women with preeclampsia. One study found that magnesium sulfate reduced the risk of eclampsia by more than half. In this trial, one group will receive a 12-hour treatment of magnesium sulfate, while another group will receive the standard 24-hour treatment. The 12-hour treatment resulted in slightly more cases of eclampsia compared to the 24-hour treatment, with 86 more cases in a large theoretical group. However, magnesium sulfate remains superior to other treatments in reducing seizures and has been shown to protect the brain and reduce swelling. Overall, magnesium sulfate is a proven treatment for managing symptoms in preeclampsia.12678

Who Is on the Research Team?

JO

John O'Brien, MD

Principal Investigator

University of Kentucky

Are You a Good Fit for This Trial?

This trial is for pregnant people aged 18-45 who have just delivered and were diagnosed with severe preeclampsia based on symptoms, lab results, or high blood pressure. People with HELLP syndrome, kidney problems, eclampsia, certain medical conditions like Myasthenia Gravis, multiple pregnancies (twins/triplets), or those unable to consent in English cannot join.

Inclusion Criteria

I am 18-45, pregnant, and delivering with severe preeclampsia.
I have been diagnosed with severe preeclampsia based on symptoms, labs, or high blood pressure.

Exclusion Criteria

I do not have HELLP syndrome, kidney injury, eclampsia, or issues with magnesium treatment.
Multiple gestations (twins, triplets, etc)
I am not able to give consent in English.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

During hospital admission

Treatment

Participants receive magnesium sulfate administration post-partum for either 12 or 24 hours, with blood samples collected at specified intervals

Up to 4 days
Continuous monitoring during hospital stay

Follow-up

Participants are monitored for safety and effectiveness after treatment, including chart review until 6 weeks post-partum

6 weeks
Standard postpartum outpatient follow-up

What Are the Treatments Tested in This Trial?

Interventions

  • Magnesium Sulfate

Trial Overview

The study compares two groups of postpartum patients with severe preeclampsia: one receives magnesium sulfate for 12 hours after delivery and the other for 24 hours. The goal is to see if a shorter treatment works as well and is safe by monitoring lab values and recovery speed. Participants are randomly assigned to each group.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: 12 hour administration groupExperimental Treatment1 Intervention
Group II: Standard of CareActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Alexander Harrison

Lead Sponsor

Citations

Efficacy and safety of 12-hour versus 24-hour magnesium ...

Although strong evidence indicates magnesium sulfate's effectiveness in both the prophylaxis and treatment of seizures in pre-eclampsia and ...

12 versus 24 hours of postpartum magnesium sulfate for ...

A 12-hour regimen in this theoretical cohort of 45,800 postpartum patients compared with a 24-hour regimen resulted in 86 more cases of eclampsia (398 vs 312) ...

The Management of Preeclampsia: A Comprehensive Review ...

Magnesium sulfate also protects the blood-brain barrier and reduces the formation of cerebral edema [14]. Furthermore, it also acts as a ...

Comparison of outcomes following intravenous magnesium...

Intravenous labetalol provides proper reduction of blood pressure in Han Chinese women with preeclampsia but has the risk of undesirable maternal and neonatal ...

Magnesium sulfate in preeclampsia: Broad indications, not ...

The medication proved to be superior to other anticonvulsants to reduce the incidence of recurrent convulsions among women with eclampsia. Additionally, ...

A Comparative Study of Short Versus Twenty-Four Hours ...

Effective seizure prophylaxis is central to managing this condition, and magnesium sulfate (MgSO₄) has emerged as the gold standard, ...

A 12-hour postpartum magnesium sulfate regimen was ...

RESULTS: A 12-hour regimen in this theoretical cohort of 45,800 postpartum patients compared with a 24-hour regimen resulted in 86 more cases of ...

Medline ® Abstracts for References 51-54 of 'Preeclampsia

CONCLUSIONS Our findings do not support clear associations between antenatal magnesium sulphate for beneficial indications and adverse neonatal outcomes.