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

Primary Purpose

Preeclampsia Severe

Status

Unknown status

Phase

Phase 4

Locations

Study Type

Interventional

Intervention

Magnesium Sulfate

About this trial

This is an interventional treatment trial for Preeclampsia Severe focused on measuring preeclampsia, Magnisium sulfate

Eligibility Criteria

19 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

MgSO4 discontinuation

MgSO4 continuation

Arm Description

after delivery , no Extradoses of MgSO4 were given

After delivery , Mg Sop4 was given at a rate of 1 gram /hour for 24 hours after delivery

Outcomes

Primary Outcome Measures

occurrence of convulsions

occurrence of eclamptic fits postpartum

Secondary Outcome Measures

Full Information

NCT ID

NCT03318211

First Posted

October 19, 2017

Last Updated

October 19, 2017

Sponsor

Cairo University

1. Study Identification

Unique Protocol Identification Number

NCT03318211

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2017

Overall Recruitment Status

Unknown status

Study Start Date

October 25, 2017 (Anticipated)

Primary Completion Date

February 2018 (Anticipated)

Study Completion Date

March 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Preeclampsia Severe

Keywords

preeclampsia, Magnisium sulfate

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

MgSO4 discontinuation

Arm Type

Active Comparator

Arm Description

after delivery , no Extradoses of MgSO4 were given

Arm Title

MgSO4 continuation

Arm Type

Active Comparator

Arm Description

After delivery , Mg Sop4 was given at a rate of 1 gram /hour for 24 hours after delivery

Intervention Type

Drug

Intervention Name(s)

Magnesium Sulfate

Other Intervention Name(s)

MgSO4

Intervention Description

Intravenous ampules of MgSo4 was given to only to control group after delivery

Primary Outcome Measure Information:

Title

occurrence of convulsions

Description

occurrence of eclamptic fits postpartum

Time Frame

48 hours after delivery

10. Eligibility

Sex

Female

Gender Based

Yes

Minimum Age & Unit of Time

19 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ahmed Maged, MD

Phone

+20201005227404

dr_ahmedmaged08@kasralainy.edu.eg

First Name & Middle Initial & Last Name or Official Title & Degree

Amira Yehia, MD

Phone

+20201005647376

amira_el_sayed_yehia@hotmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ahmed Maged, MD

Organizational Affiliation

Professor

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

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

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