An observational study in Preeclampsia (PE), sponsored by Ain Shams Maternity Hospital. Recruiting at 1 site in Egypt. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-01-24.
Sponsored by Ain Shams Maternity Hospital · Observational
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.
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:
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.
Ethical Consideration:
Hospital records will be reviewed for pregnant women presented to Ain Shams University Maternity Hospital (ASUMH) diagnosed as a case of preeclampsia with criteria of severity:
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.
Exclusion Criteria:
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.
Occurrence of eclamptic fits
Development of generalized tonic clonic convulsions in pregnant women with preeclampsia
Time frame: within 24 hours before or after delivery
ICU admission
admission to the intensive care unit
Time frame: within 48 hours before or after delivery
magnesium sulphate 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
Time frame: within 48 hours before or after delivery
primary postpartum hemorrhage
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)
Time frame: within 24 hours after delivery
Plan to share: Yes — We plan to share the dataset generated and analyzed in this study after publication of the results.
Supporting information: Study protocol, Analytic code
No publications or documents are linked to this record.
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Ain Shams Maternity Hospital