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

Preeclampsia Severe Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03318211
• Other study ID #: 14
• Status: Not yet recruiting
• Phase: Phase 4
• First received: October 19, 2017
• Last updated: October 19, 2017
• Start date: October 25, 2017
• Est. completion date: March 2018

Study information

• Verified date: October 2017
• Source: Cairo University
• Contact: Ahmed Maged, MD
• Phone: +20201005227404
• Email: dr_ahmedmaged08[@]kasralainy.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: March 2018
• Est. primary completion date: February 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 19 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Pre-Eclampsia
• Preeclampsia Severe

Intervention

Drug:
• Magnesium Sulfate
Intravenous ampules of MgSo4 was given to only to control group after delivery

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	occurrence of convulsions	occurrence of eclamptic fits postpartum	48 hours after delivery