Discontinuation of Magnesium Sulfate After Delivery in Women With Severe Preeclampsia. A Randomized Controlled Trial

Phase 4

• Conditions: Preeclampsia Severe
• Interventions: Drug: Magnesium Sulfate

• Registration Number: NCT03318211
• Lead Sponsor: Cairo University

Brief Summary

All women with severe preeclmapsia were given a loading dose of 4 g magnesium sulfate IV followed by the maintenance dose of 1 g/h infusion till the delivery. After delivery, women who received magnesium sulfate for 8 hours or more were randomly divided into two groups:

Group I ( 50 cases) No magnesium sulfate received postpartum and Group II ( 50 cases)-magnesium sulfate infusion is given for conventional 24 h postpartum at a rate of 1 gm per hour

Detailed Description

All women with severe preeclmapsia were given a loading dose of 4 g magnesium sulfate IV followed by the maintenance dose of 1 g/h infusion till the delivery. After delivery, women who received magnesium sulfate for 8 hours or more were randomly divided into two equal groups:

Group I is the study group: No post partum magnesium sulfate doses were given. Group II is the control group where magnesium sulfate infusion is given for conventional 24 h postpartum at a rate of 1 gm per hour

Study Timeline

• Status Verified: 2017-10
• Study First Submitted: 2017-10-19
• Study First Submitted QC: 2017-10-19
• Last Update Submitted: 2017-10-19
• Study First Posted: 2017-10-23
• Last Update Posted: 2017-10-23
• Study Start: 2017-10-25
• Primary Completion: 2018-02
• Study Completion: 2018-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

• women with severe preeclampsia
• Severe features of preeclampsia include any of the following findings: systolic blood pressure of 160 mmHg or higher, or diastolic blood pressure of 110 mmHg or higher on two occasions at least 4 hours apart while the patient is on bed rest (unless antihypertensive therapy is initiated before that time),thrombocytopenia, impaired liver function, progressive renal insufficiency, pulmonary edema or new onset cerebral or visual disturbances

Exclusion Criteria

• severe preeclampsia with serum creatinine[1.2 mg/dl 2. previous history of eclampsia 3. Associated maternal medical diseases: pre-existing diabetes mellitus, epilepsy, renal disease.

4. Renal insufficiency. 5. anuric or oliguric urinary out-put under 25 mL/hour. 6. contraindication to the use of magnesium sulfate such as known hypersensitivity to the drug 7. Those with evident hemolysis, elevated liver enzymes, and low platelet count (HELLP) syndrome

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MgSO4 continuation	Magnesium Sulfate	After delivery , Mg Sop4 was given at a rate of 1 gram /hour for 24 hours after delivery
MgSO4 discontinuation	Magnesium Sulfate	after delivery , no Extradoses of MgSO4 were given

Primary Outcome Measures

Name	Time	Method
occurrence of convulsions	48 hours after delivery	occurrence of eclamptic fits postpartum