Ain Shams University Maternity Hospital
Cairo, Egypt
Location status: Recruiting
NCT Number: NCT06791668
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.
Interested in participating?
Request Info18 year and older
Female
Observational
Cairo, Egypt
Location status: Recruiting
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:
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.
Ethical Consideration:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: within 24 hours before or after delivery
Development of generalized tonic clonic convulsions in pregnant women with preeclampsia
Time frame: within 48 hours before or after delivery
admission to the intensive care unit
Time frame: within 48 hours before or after delivery
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
Time frame: within 24 hours after delivery
occurrence 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)
Contact information is provided by the study sponsor or research team.
Rania HM Ahmed, MD
CONTACT
Sherif Ashoush, MD
CONTACT
Ain Shams Maternity Hospital
Other
Comparison of Different Regimens of Magnesium Sulphate in Patients With Severe Preeclampsia in Ain Shams University Maternity Hospital (Retrospective Cohort)
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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