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Different Regimens of Magnesium Sulphate in Patients With Severe Preeclampsia

Comparison of Different Regimens of Magnesium Sulphate in Patients With Severe Preeclampsia in Ain Shams University Maternity Hospital (Retrospective Cohort)

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06791668
Enrollment
400
Registered
2025-01-24
Start date
2024-12-03
Completion date
2026-03-31
Last updated
2025-01-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Preeclampsia (PE)

Keywords

eclampsia, magnesium sulphate, intensive care unit, pulmonary edema

Brief summary

The goal of this observational study is to learn about the effects of the different drug regimens of magnesium sulphate in treatment of (severe pre-eclampsia). This condition affects some pregnant women and raises their blood pressure. It may also cause seizures (fits). The medication (magnesium sulphate) helps to prevent seizures. The main question this study aims to answer is: What are the different regimens of magnesium sulphate that are used to prevent seizures in pregnant women with severe pre-eclampsia? Participants already have taken the magnesium sulphate as part of their regular medical care for severe pre-eclampsia. Researchers will look into the records of the participants in the past 5 years to collect the data.

Detailed description

This will be a retrospective study describing the different regimens of MgSO4 used in patients diagnosed with SPE in Ain Shams University Maternity Hospital (ASUMH), and the occurrence of eclamptic fits and any other complications with each of them. Methodology: 1. Protocol approval will be sought from ethical committee and hospital administration. 2. Screening of all hospital records over the past 5 years to identify eligible records. 3. Eligible records will be reviewed to extract the following data: Age, Parity, Gestational age, BMI, Prior medical disorders, previous surgeries - including cesarean section (CS). Data upon admission: (Blood pressure, albuminuria) Available labs (CBC, AST, ALT, serum creatinine, PTT, INR) Timing (since admission) and route of delivery. Regimen of MgSO4 used (loading and maintenance doses, the route, and total time of therapy - antepartum and postpartum); any changes in dosage, and the reason for change. Any DOCUMENTED patient-reported MgSO4 side effects (nausea, vomiting, muscle weakness, palpitations, hypotension dizziness). Any DOCUMENTED signs of magnesium toxicity (clinical: defined as a presence of respiratory depression with less than 16 respirations per minute or loss of deep tendon reflexes necessitating cessation of MgSO4 or administration of calcium gluconate and / or biochemical: serum magnesium level \>8.4mg/dl) Occurrence of eclamptic fits despite MgSO4 therapy, and timing, duration, how it was managed. Maternal admission to intensive care unit (ICU). Other complications (pulmonary edema, postpartum hemorrhage) Neonatal ICU (NICU) admission. All files with SPE will be examined. The number of files excluded from analysis will be noted as well as a table for the different causes of exclusion . Files showing serum magnesium level will be also analyzed in more detailed tables together with the reasons behind checking the serum level. 4. Data will be recorded in a case report form (appendix 1) 5. Statistical analysis will be done accordingly. Ethical Consideration: * The study design will be approved by the Local Ethics committee, Faculty of Medicine, Ain Shams University. * Confidentiality will be respected in all levels of the study.

Interventions

None listed

Sponsors

Ain Shams Maternity Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* All hospital records of patients diagnosed as preeclampsia with severe features planned to receive magnesium sulphate.

Exclusion criteria

* Records with missing data about the regimen of magnesium sulphate used

Design outcomes

Primary

MeasureTime frameDescription
Occurrence of eclamptic fitswithin 24 hours before or after deliveryDevelopment of generalized tonic clonic convulsions in pregnant women with preeclampsia

Secondary

MeasureTime frameDescription
ICU admissionwithin 48 hours before or after deliveryadmission to the intensive care unit
magnesium sulphate toxicitywithin 48 hours before or after deliveryclinical: defined as a presence of respiratory depression with less than 16 respirations per minute or loss of deep tendon reflexes necessitating cessation of MgSO4 or administration of calcium gluconate and / or biochemical: serum magnesium level \>8.4mg/dl
primary postpartum hemorrhagewithin 24 hours after deliveryoccurrence of complications as primary postpartum hemorrhage (the loss of 500 ml or more of blood from the genital tract within 24 hours of the birth of a baby)

Countries

Egypt

Contacts

Primary ContactRania HM Ahmed, MD
raneyah@med.asu.edu.eg20201200522444
Backup ContactSherif Ashoush, MD
sherifashoush@med.asu.edu.eg

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026