Efficacy and Safety of 1 g Vs 2 g Per Hour Intravenous Maintenance Dose of MgSO4 in Women With Severe Pre-eclampsia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

222 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-30

Study Completion Date

2020-01-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Preeclampsia is commonly viewed as one of the hypertensive pregnancy disorders, which cover a spectrum of clinical presentations from chronic hypertension ( hypertension occurring prior to 20 weeks of gestation) and gestational hypertension (hypertension occurring after 20 weeks of gestation) To more severe forms, including preeclampsia, eclampsia (its convulsive form), and HELLP syndrome (hemolysis, elevated liver enzyme S, and low platelets)

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

12-hour Versus 24-hour Postpartum Magnesium Sulphate for Preeclamptic Patients

NCT04576364

Maternal Care Patterns

COMPLETED NA

Different Regimens of Magnesium Sulphate in Patients With Severe Preeclampsia

NCT06791668

Preeclampsia (PE)

RECRUITING

Discontinuation of Magnesium Sulfate After Delivery in Women With Severe Preeclampsia. A Randomized Controlled Trial

NCT03318211

Preeclampsia Severe

UNKNOWN PHASE4

New Magnesium Sulphate Protocol for Pre-eclampsia

NCT01846156

Pre-eclampsia

COMPLETED PHASE3

Abbreviated MgSO4 Therapy in Post-partum Preeclampsia

NCT00344058

Pregnancy Preeclampsia

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Treatment for patients who have developed preeclampsia or eclampsia mainly consists of control of hypertension, magnesium sulphate for prevention of eclampsia and convulsions, and planning for delivery.

Magnesium sulfate has been used to prevent eclamptic convulsion since 1925, its efficacy was confirmed by a large randomized controlled trial in 2002. Eclampsia could be prevented in more than 50% after magnesium sulfate administration . The World Health Organization recommended magnesium sulfate as the most effective, safe, and low-cost drug for the prevention of seizure in severe preeclampsia and eclampsia . The recommended dose of magnesium sulfate is 4 to 6 gram intravenous loading dose, followed by maintenance intravenous drip at the rate of 1 to 2 gram per hour .

Although different magnesium sulfate regimens have been tested, two dosing regimens are internationally recommended and widely used. The Pritchard regimen is a predominantly intramuscular regimen given as a loading dose of 4 g intravenously , and 5 g Intramuscular into each buttock followed by a maintenance dose of 5 g Intramuscular every 4 hours. This regimen is popular in resource-limited settings where intravenously administration of magnesium sulfate may not be feasible. However, it is associated with pain and a higher risk of infection at the injection site.

The Zuspan regimen is given as a 4 gram intravenously loading dose followed by continuous intravenously infusion of 1 gram per hour.

Either 1 gram or 2 gram maintenance dose of Magnesium Sulphate has been reported to reduce the development of eclampsia. Randomized controlled trials offering direct comparison between these 2 doses are lacking.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Severe Preeclampsia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

One gram magnesium sulfate

Pregnant women with a diagnosis of severe pre-eclampsia will receive 1 g of mgso4 to prevent and control of convulsions

Group Type ACTIVE_COMPARATOR

Magnesium Sulfate

Intervention Type DRUG

intravenous

Two grams magnesium sulfate

Pregnant women with a diagnosis of severe pre-eclampsia will receive 2 g of mgso4 to prevent and control of convulsions

Group Type EXPERIMENTAL

Magnesium Sulfate

Intervention Type DRUG

intravenous

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Magnesium Sulfate

intravenous

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Pregnant women admitted to Women health hospital with a diagnosis of severe pre-eclampsia

Exclusion Criteria

* 1- Women with Non-proteinuric hypertension, 2- severe renal impairment 3- Myasthenia gravis 4- High amount of magnesium in blood 5- Low or high amount of calcium in blood 6- Myocardial damage, diabetic coma, heart block

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No