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

Maternal Care Patterns Clinical Trial

— Mgso4  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04576364
• Other study ID #: Postpartum Mgso4
• Status: Completed
• Phase: N/A
• Start date: November 1, 2020
• Est. completion date: November 30, 2022

Study information

• Verified date: August 2023
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 280
• Est. completion date: November 30, 2022
• Est. primary completion date: November 20, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Maternal Care Patterns

Intervention

Drug:
• Magnesium sulfate for 12 hour
drug used to prevent convulsions in patients having preeclampsia with severe features
• Magnesium sulfate for 24 hour
drug used to prevent convulsions in patients having preeclampsia with severe features

Locations

Country	Name	City	State
Egypt	Assuit University women Health hospital	Assiut	Assuit
Egypt	Mai mahoud	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Percentage of prevention of eclampsia	Number of patients who develop eclampsia in each group.	up to 24 hour