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

NCT03318211 | Unknown Phase 4 DMC

• 1 other identifier: 14
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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

Conditions

Preeclampsia Severe

Keywords

preeclampsia; Magnisium sulfate

Outcome Measures

Primary Outcomes (1)

• occurrence of convulsions

  occurrence of eclamptic fits postpartum

  48 hours after delivery

Study Arms (2)

MgSO4 discontinuation

ACTIVE COMPARATOR

after delivery , no Extradoses of MgSO4 were given

Drug: Magnesium Sulfate

MgSO4 continuation

ACTIVE COMPARATOR

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

Drug: Magnesium Sulfate

Interventions

Magnesium Sulfate DRUG

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

Also known as: MgSO4

MgSO4 continuation; MgSO4 discontinuation

Eligibility Criteria

• Age: 19 Years - 40 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• \- 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.
• \. 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

Sponsors & Collaborators

• Cairo University: lead

Related Publications (1)

• 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.

  PMID: 37815037 DERIVED

MeSH Terms

Conditions

Pre-Eclampsia

Interventions

Magnesium Sulfate

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds

Study Officials

• Ahmed Maged, MD

  Professor

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmed Maged, MD

CONTACT

+20201005227404; dr_ahmedmaged08@kasralainy.edu.eg

Amira Yehia, MD

CONTACT

+20201005647376; amira_el_sayed_yehia@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: October 19, 2017
• First Posted: October 23, 2017
• Study Start: October 25, 2017
• Primary Completion: February 1, 2018
• Study Completion: March 1, 2018
• Last Updated: October 23, 2017

Record last verified: 2017-10