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

Sponsor

Assiut University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04576364

Collaborator

(none)

280

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Maternal Care Patterns	Drug: Magnesium sulfate for 12 hour Drug: Magnesium sulfate for 24 hour	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

280 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Anticipated Study Start Date :

Nov 1, 2020

Anticipated Primary Completion Date :

Dec 30, 2021

Anticipated Study Completion Date :

Jan 1, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Need to prolong treatment [up to 12 hour]
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.

Secondary Outcome Measures

Percentage of prevention of eclampsia [up to 24 hour]
Number of patients who develop eclampsia in each group.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Assiut University

Investigators

Study Director: ِAhmed Fayek, Proffessor, Assiut University
Study Director: sherif Badran, Lecturer, Assiut University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mai Mahmoud Mohamed, Principal Investigator, Assiut University

ClinicalTrials.gov Identifier:

NCT04576364

Other Study ID Numbers:

Postpartum Mgso4

First Posted:

Oct 6, 2020

Last Update Posted:

Oct 6, 2020

Last Verified:

Oct 1, 2020

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Magnesium Sulfate

Study Results

No Results Posted as of Oct 6, 2020