search
Back to results

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

Primary Purpose

Severe Preeclampsia

Status
Completed
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Magnesium Sulfate
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Severe Preeclampsia

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Assiut University, woman health hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

One gram magnesium sulfate

Two grams magnesium sulfate

Arm Description

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

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

Outcomes

Primary Outcome Measures

The rate of convulsions in each group.
the number of participants who have convulsion
The percentage of women reaching the Mg therapeutic level of 4,8 mg/dl
Follow up by Serum Magnesium level
The rate of adverse events in each group
the number of participants who have adverse events

Secondary Outcome Measures

Full Information

First Posted
May 17, 2017
Last Updated
April 22, 2020
Sponsor
Assiut University
search

1. Study Identification

Unique Protocol Identification Number
NCT03164304
Brief Title
Efficacy and Safety of 1 g Vs 2 g Per Hour Intravenous Maintenance Dose of MgSO4 in Women With Severe Pre-eclampsia
Official Title
Efficacy and Safety of One Gram Versus Two Grams Intravenous Maintenance Dose of Magnesium Sulfate in Women With Severe Pre-eclampsia: a Randomized Clinical Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
May 30, 2017 (Actual)
Primary Completion Date
January 30, 2020 (Actual)
Study Completion Date
January 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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)
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Severe Preeclampsia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
222 (Actual)

8. Arms, Groups, and Interventions

Arm Title
One gram magnesium sulfate
Arm Type
Active Comparator
Arm Description
Pregnant women with a diagnosis of severe pre-eclampsia will receive 1 g of mgso4 to prevent and control of convulsions
Arm Title
Two grams magnesium sulfate
Arm Type
Experimental
Arm Description
Pregnant women with a diagnosis of severe pre-eclampsia will receive 2 g of mgso4 to prevent and control of convulsions
Intervention Type
Drug
Intervention Name(s)
Magnesium Sulfate
Intervention Description
intravenous
Primary Outcome Measure Information:
Title
The rate of convulsions in each group.
Description
the number of participants who have convulsion
Time Frame
24 hour
Title
The percentage of women reaching the Mg therapeutic level of 4,8 mg/dl
Description
Follow up by Serum Magnesium level
Time Frame
24 hour
Title
The rate of adverse events in each group
Description
the number of participants who have adverse events
Time Frame
24 hour

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Assiut University, woman health hospital
City
Assiut
Country
Egypt

12. IPD Sharing Statement

Citations:
PubMed Identifier
12057549
Citation
Altman D, Carroli G, Duley L, Farrell B, Moodley J, Neilson J, Smith D; Magpie Trial Collaboration Group. Do women with pre-eclampsia, and their babies, benefit from magnesium sulphate? The Magpie Trial: a randomised placebo-controlled trial. Lancet. 2002 Jun 1;359(9321):1877-90. doi: 10.1016/s0140-6736(02)08778-0.
Results Reference
background
PubMed Identifier
26048352
Citation
Zakiyah N, Postma MJ, Baker PN, van Asselt AD; IMPROvED Consortium. Pre-eclampsia Diagnosis and Treatment Options: A Review of Published Economic Assessments. Pharmacoeconomics. 2015 Oct;33(10):1069-82. doi: 10.1007/s40273-015-0291-x.
Results Reference
background
PubMed Identifier
24150027
Citation
Hypertension in pregnancy. Report of the American College of Obstetricians and Gynecologists' Task Force on Hypertension in Pregnancy. Obstet Gynecol. 2013 Nov;122(5):1122-1131. doi: 10.1097/01.AOG.0000437382.03963.88. No abstract available.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs