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

NCT ID: NCT03318211

Last Updated: 2017-10-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-25

Study Completion Date

2018-03-31

Brief Summary

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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

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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

Conditions

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Preeclampsia Severe

Keywords

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preeclampsia Magnisium sulfate

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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MgSO4 discontinuation

after delivery , no Extradoses of MgSO4 were given

Group Type ACTIVE_COMPARATOR

Magnesium Sulfate

Intervention Type DRUG

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

MgSO4 continuation

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

Group Type ACTIVE_COMPARATOR

Magnesium Sulfate

Intervention Type DRUG

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

Interventions

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Magnesium Sulfate

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

Intervention Type DRUG

Other Intervention Names

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MgSO4

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Ahmed Maged

professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ahmed Maged, MD

Role: PRINCIPAL_INVESTIGATOR

Professor

Central Contacts

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Ahmed Maged, MD

Role: CONTACT

Phone: +20201005227404

Email: [email protected]

Amira Yehia, MD

Role: CONTACT

Phone: +20201005647376

Email: [email protected]

References

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Diaz V, Long Q, Oladapo OT. Alternative magnesium sulphate regimens for women with pre-eclampsia and eclampsia. Cochrane Database Syst Rev. 2023 Oct 10;10(10):CD007388. doi: 10.1002/14651858.CD007388.pub3.

Reference Type DERIVED
PMID: 37815037 (View on PubMed)

Other Identifiers

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14

Identifier Type: -

Identifier Source: org_study_id