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

NCT ID: NCT04576364

Last Updated: 2023-09-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 280 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-01
• Study Completion Date: 2022-11-30

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.

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

Conditions

Maternal Care Patterns

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

12-hour postpartum Mgso4

Patients having preeclampsia with severe features will receive 12-hour postpartum Mgso4

Group Type: ACTIVE_COMPARATOR

Magnesium sulfate for 12 hour

Intervention Type: DRUG

drug used to prevent convulsions in patients having preeclampsia with severe features

24-hour postpartum Mgso4

Patients having preeclampsia with severe features will receive 24-hour postpartum Mgso4

Group Type: ACTIVE_COMPARATOR

Magnesium sulfate for 24 hour

Intervention Type: DRUG

drug used to prevent convulsions in patients having preeclampsia with severe features

Interventions

Magnesium sulfate for 12 hour

drug used to prevent convulsions in patients having preeclampsia with severe features

Intervention Type: DRUG

Magnesium sulfate for 24 hour

drug used to prevent convulsions in patients having preeclampsia with severe features

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Mai Mahmoud Mohamed

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

ِAhmed Fayek, Proffessor

Role: STUDY_DIRECTOR

Assiut University

sherif Badran, Lecturer

Role: STUDY_DIRECTOR

Assiut University

Locations

Assuit University women Health hospital

Asyut, Assuit, Egypt

Mai mahoud

Asyut, , Egypt

Countries

Egypt

Other Identifiers

Postpartum Mgso4

Identifier Type: -

Identifier Source: org_study_id