12-hour Versus 24-hour Magnesium Sulfate Regimen for the Management of Severe Preeclampsia
- Conditions
- Pregnancy and Childbirth
- Registration Number
- PACTR202304555642144
- Lead Sponsor
- Samah Mohammed Ahmed Hussein
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Female
- Target Recruitment
- 320
Pregnant women with a viable fetus.
Age from 18 to 44 years old.
Admitted to the hospital's obstetrics unit for inpatient care.
Diagnosed with severe preeclampsia.
Severe preeclampsia is defined as blood pressure equal to or greater than 160/110 mm Hg at a single reading with proteinuria of 2+ on dipstick or 24-hour urinary protein of more than 5g, oliguria urine output of less than less than 30 mL/hour, cerebral or visual disturbances, renal failure as persistent oliguria despite of using of intravenous fluid and furosemide challenge with deranged serum electrolytes, rising creatinine greater than 1.5 mg/L, and urea greater than 45 mg/ dL”, pulmonary edema or cyanosis, epigastric or right upper quadrant pain, impaired liver function, thrombocytopenia, or fetal growth restriction.
Women with any condition considered as a contraindication for MgSo4 therapy, like:
Drug hypersensitivity
Myasthenia gravis
Anuria
Oliguria
Prior intake of any other anticonvulsant
History of epilepsy
Women with diabetes mellitus.
Women with HELP syndrome (hemolysis, elevated liver enzymes, and low platelets).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary outcome will be a comparison of the effectiveness and safety of the 24-hour versus 12-hour maintenance doses of MgSO4 therapy on pregnant women with severe preeclampsia, which will be assessed by the occurrence of convulsions after receiving the magnesium sulfate therapy. Safety assessment will be assessed by the associated maternal adverse effects including reduced urination, respiratory difficulties/depression such as the onset of shortness of breath with a respiratory rate less than 12/minute, weakness, dizziness, hot flushes, and reduced or absent patella reflexes.
- Secondary Outcome Measures
Name Time Method The secondary outcome will be to estimate maternal and neonatal morbidity and mortality associated with the magnesium sulfate therapy, which includes mode of delivery, maximum BP during admission (diastolic and systolic), duration of admission, duration of urethral catheterization, maternal complications (pulmonary edema, renal insufficiency, hemodialysis, ICU admission, maternal death), gestational age at delivery, baby status at delivery, birth weight, Apgar score at 5 minutes, NICU admission and duration of it. <br><br>