Clinical trial NCT04576364: 12-hour Versus 24-hour Postpartum Magnesium Sulphate for Preeclamptic Patients
Official title: 12-hour Versus 24-hour Postpartum Magnesium Sulphate for Preeclamptic Patients :A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Maternal Care Patterns
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2020-10-06
Enrollment: 280
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

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

Primary outcomes:
measure: Need to prolong treatment
timeFrame: up to 12 hour
Secondary outcomes:
measure: Percentage of prevention of eclampsia
timeFrame: up to 24 hour
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assuit University women Health hospital
state: Assuit
city: Assiut
country: Egypt
facility: Mai mahoud
Study officials:
affiliation: Assiut University
name: ِAhmed Fayek, Proffessor
role: STUDY_DIRECTOR
affiliation: Assiut University
name: sherif Badran, Lecturer
role: STUDY_DIRECTOR
References: