Different Regimens of Magnesium Sulphate in Patients With Severe Preeclampsia

NCT ID: NCT06791668

Last Updated: 2025-01-24

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 400 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-12-03
• Study Completion Date: 2026-03-31

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.

Conditions

Preeclampsia (PE)

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

pregnant women with severe preeclampsia

Preeclampsia with severe hypertension that does not respond to treatment or is associated with ongoing or recurring severe headaches, visual scotomata, nausea or vomiting, epigastric pain, oliguria, and severe hypertension, as well as progressive deterioration in laboratory blood tests such as rising creatinine or liver transaminases or falling platelet count, or failure of fetal growth or abnormal doppler findings.

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams Maternity Hospital

OTHER

Sponsor Role: lead

Responsible Party

Rania Hassan Mostafa

Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ain Shams University Maternity Hospital

Cairo, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Rania HM Ahmed, MD

Role: CONTACT

raneyah@med.asu.edu.eg

20201200522444

Sherif Ashoush, MD

Role: CONTACT

sherifashoush@med.asu.edu.eg

Facility Contacts

Sherif Ashoush, MD

Role: primary

sherifashoush@med.asu.edu.eg

20201222660266

Other Identifiers

FMASU MS 619/2024

Identifier Type: -

Identifier Source: org_study_id