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CompletedNCT04576364

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

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
280 (actual)
Sponsor
Assiut University · Academic / Other
Sex
Female
Age
18 Years – 45 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
DRUGMagnesium sulfate for 12 hourdrug used to prevent convulsions in patients having preeclampsia with severe features
DRUGMagnesium sulfate for 24 hourdrug used to prevent convulsions in patients having preeclampsia with severe features

Timeline

Start date
2020-11-01
Primary completion
2022-11-20
Completion
2022-11-30
First posted
2020-10-06
Last updated
2023-09-01

Locations

2 sites across 1 country: Egypt

Source: ClinicalTrials.gov record NCT04576364. Inclusion in this directory is not an endorsement.