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

Assiut University

Status: Completed

Conditions: Maternal Care Patterns

Treatments: Drug: Magnesium sulfate for 12 hour; Drug: Magnesium sulfate for 24 hour

Study type: Interventional

Funder types: Other

Identifiers

NCT04576364

Postpartum Mgso4

Details and patient eligibility

About

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.

Full 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

Enrollment: 280 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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280 participants in 2 patient groups

12-hour postpartum Mgso4

Active Comparator group

Description:

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

Treatment:

Drug: Magnesium sulfate for 12 hour

24-hour postpartum Mgso4

Active Comparator group

Description:

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

Treatment:

Drug: Magnesium sulfate for 24 hour