12-hour Versus 24-hour Postpartum Magnesium Sulphate for Preeclamptic Patients (Mgso4)

12-hour Versus 24-hour Postpartum Magnesium Sulphate for Preeclamptic Patients :A Randomized Controlled Trial

To compare the use of magnesium sulfate for 12 hours versus 24 hours in postpartum women with pre-eclampsia with severe features , to ensure maximum efficacy of anticonvulsant action that can be achieved with least exposure to Mgso4 side effects.

Study Overview

• Status: Completed
• Conditions: Maternal Care Patterns
• Intervention / Treatment: Drug: Magnesium sulfate for 12 hour; Drug: Magnesium sulfate for 24 hour

Detailed Description

Hypertensive disorders of pregnancy constitute one of the leading causes of maternal and perinatal mortality worldwide. It has been estimated that preeclampsia complicates 2-8% of pregnancies globally.

Preeclampsia is a disorder of pregnancy associated with new-onset hypertension, which occurs most often after 20 weeks of gestation and frequently near term. Although often accompanied by new-onset proteinuria, hypertension and other signs or symptoms of preeclampsia may present in some women in the absence of proteinuria. Recently preeclampsia is divided into preeclampsia with severe features, preeclampsia without severe, features. One of serious complication of preeclampsia is occurrence of eclampsia. Eclampsia refers to the occurrence of new-onset, generalized, tonic-clonic seizures or coma in a woman with preeclampsia. Eclampsia can be prevented with magnesium sulphate, which decreases the risk of seizures by 50%, paralleled by a reduction in maternal mortality. It is considered as the gold standard of management of eclampsia Although magnesium sulphate administration is recommended for all women with severe preeclampsia, consensus has not yet to be reached on the ideal duration of prophylactic postpartum anticonvulsant therapy. The use of magnesium sulphate has been recommended for 24 hours following delivery, the period of greatest risk for the occurrence of eclampsia. There are other regimen 12-hour, 6-hour Use of magnesium sulphate therapy is not without complications, consequently longer duration therapy possesses the risk of magnesium toxicity such as respiratory depression, renal and neuromuscular dysfunction. Risks of these complications require regular supervision; hence it is particularly important to assess the minimum effective duration of treatment

• Study Type: Interventional
• Enrollment (Actual): 280
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mai Mahmoud, MBBCh; Phone Number: 01097930365; Email: zahramahmoud219@gmail.com

Study Locations

• Egypt
  • Assiut, Egypt, 71511
    • Mai mahoud
  • Assuit
    • Assiut, Assuit, Egypt, 71511
      • Assuit University women Health hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 43 years (Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients who have pre-eclampsia with severe features as defined by American College of Obstetricians and Gynecologists guidelines 2019(defined in methodology)
• Singleton pregnancy.
• who accept to participate the study.

Exclusion Criteria:

• Patients with eclampsia
• Epilepsy
• Central Nervous System disorder
• Chronic kidney disease
• Seizures due to metabolic disturbances, space occupying lesions or intra cerebral infections
• Cardiac patients
• Hypersensitivity to Mgso4

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 12-hour postpartum Mgso4; Patients having preeclampsia with severe features will receive 12-hour postpartum Mgso4	Drug: Magnesium sulfate for 12 hour; drug used to prevent convulsions in patients having preeclampsia with severe features
Active Comparator: 24-hour postpartum Mgso4; Patients having preeclampsia with severe features will receive 24-hour postpartum Mgso4	Drug: Magnesium sulfate for 24 hour; drug used to prevent convulsions in patients having preeclampsia with severe features

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Need to prolong treatment	Compare efficacy of 12-hour vs 24 hour postpartum Mgso4 in the term of Percentage of patients who will Need to prolong treatment in each group.	up to 12 hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of prevention of eclampsia	Number of patients who develop eclampsia in each group.	up to 24 hour

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Study Director: ِAhmed Fayek, Proffessor, Assiut University; Study Director: sherif Badran, Lecturer, Assiut University

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2020
• Primary Completion (Actual): November 20, 2022
• Study Completion (Actual): November 30, 2022

Study Registration Dates

• First Submitted: September 28, 2020
• First Submitted That Met QC Criteria: October 1, 2020
• First Posted (Actual): October 6, 2020

Study Record Updates

• Last Update Posted (Actual): September 1, 2023
• Last Update Submitted That Met QC Criteria: August 31, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anticonvulsants; Calcium-Regulating Hormones and Agents; Reproductive Control Agents; Calcium Channel Blockers; Tocolytic Agents; Magnesium Sulfate
• Other Study ID Numbers: Postpartum Mgso4

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No