Pregnant women diagnosed with pre-eclampsia with severe features will be treated with magnesium sulfate to prevent seizures. Magnesium sulfate will be administered according to My Duc Hospital's protocol for treatment of pre-eclampsia (a loading dose of 4.5g given intravenously in 20 min, followed by a maintenance dose at an infusion rate of 1.5g/h). Serum magnesium concentrations will be measured before the loading dose and 0.5h, 1h, 2h, and every 6 hours thereafter.
This observational, longitudinal, prospective case-series aims to assess serum magnesium concentrations at specific times in pregnant women treated with magnesium sulfate for pre-eclampsia with severe features. Pregnant women aged minimum 18 who are admitted to My Duc Hospital with severe pre-eclampsia, as defined by the American College of Obstetricians and Gynecologists (ACOG) diagnosis criteria, will be indicated for therapy with magnesium sulfate. Only those who give written informed consent will be included in the study. According to the ACOG criteria, pre-eclampsia is considered severe if present with any of the following features : systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥110 mmHg, thrombocytopenia (\<100,000/mm3) abnormal liver function (increase in transaminases to twice the normal value or pain in the upper right quadrant/epigastrium that is unresponsive to medication), abnormal renal function (creatinine \>1.1 mg/dl or twice normal values), acute pulmonary edema and/or new cerebral and/or visual symptoms. Exclusion criteria includes impaired renal function (eGFR \< 60 mL/min/ 1,73 m2 or oliguria ), known hypersensitivity to the drug, severe myasthenia, atrioventricular block or a diminished level of consciousness. All patients will be given the standard loading dose of 4.5 grams of magnesium sulfate administered over 20 minutes, followed by a maintenance dose of magnesium sulfate at an infusion rate of 1.5g/h, in compliance with My Duc Hospital's guidelines. Maternal blood samples will be obtained for serum magnesium and creatinine concentrations at baseline prior to magnesium sulfate administration; at 30 min, 1 hour, 2 hours, 4 hours and every 6 hours until discontinuation of magnesium sulfate therapy. Antihypertensive medications can be given according to My Duc Hospital's guidelines. Patients can choose to withdraw from the study at any point without affect on the course of treatment. Investigators can also offer patients to opt out of the study for medical emergencies. Magnesium sulfate therapy will be discontinued if there is any sign of magnesium toxicity, or the patient has been stable for 24 hours of treatment without any severe hypertensive episode or convulsion. All patients will be followed up until delivery and both mother and neonate are discharged to record obstetric and neonatal outcomes.
Study Type
OBSERVATIONAL
Enrollment
64
My Duc Hospital
Ho Chi Minh City, Vietnam
Serum magnesium concentrations before and during magnesium sulfate infusion
Serum magnesium concentrations are measured immediately before the loading dose of magnesium sulfate and at 30 min, 1 hr, 2 hr, 4 hr, 6 hr and then every 6 hours during magnesium sulfate infusion.
Time frame: From administration of loading dose until termination of magnesium sulfate treatment or occurrence of magnesium toxicity, whichever comes first, approximately up to 36 hours.
Adverse drug reaction
Rates of adverse drug reactions to administration of magnesium sulfate
Time frame: From administration of loading dose until termination of magnesium sulfate treatment or occurrence of magnesium toxicity, whichever comes first, approximately up to 36 hours.
Magnesium toxicity
Rates of patients having signs of magnesium toxicity
Time frame: From administration of loading dose until termination of magnesium sulfate treatment or occurrence of magnesium toxicity, whichever comes first, approximately up to 36 hours.
Mode of delivery
Vaginal delivery, C-section (elective, suspected fetal distress, non-progressive labor)
Time frame: At birth
Gestational age at delivery
Gestational age at delivery
Time frame: At birth
Rate of preterm birth before 28 weeks of gestation
Birth before 28 weeks
Time frame: From date of enrollment until 27 6/7 weeks
Rate of preterm birth before 34 weeks of gestation
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Birth before 34 weeks
Time frame: From date of enrollment until 33 6/7 weeks
Rate of all live births at any gestational age
The birth of at least one newborn, regardless of gestational age, that exhibits any sign of life such as respiration, heartbeat, umbilical pulsation or movement of voluntary muscles
Time frame: At birth
Rate of maternal mortality
Death of the mother
Time frame: From date of enrollment until date of discharge, up to 12 weeks
Rate of eclampsia
Onset of seizures (convulsions) in a patient with pre-eclampsia
Time frame: From date of enrollment until date of discharge, up to 12 weeks
Rate of HELLP syndrome
The clinical presentation of hemolysis, elevated liver enzymes, and low platelet count in a patient with pre-eclampsia
Time frame: From date of enrollment until date of discharge, up to 12 weeks
Rate of placental abruption
Separation of placenta from the inner wall of the uterus before birth
Time frame: From date of enrollment until date of delivery, up to 12 weeks
Rate of postpartum hemorrhage
A cumulative blood loss of greater than or equal to 1,000 mL or blood loss accompanied by signs or symptoms of hypovolemia within 24 hours after the birth process
Time frame: Within 24 hours after delivery
Rate of stroke
Occurrence of stroke in a patient with pre-eclampsia
Time frame: From date of enrollment until date of discharge, up to 12 weeks
Rate of acute kidney injury
A sudden episode of kidney failure or kidney damage that happens within a few hours or a few days in a patient with pre-eclampsia
Time frame: From date of enrollment until date of discharge, up to 12 weeks
Rate of liver capsule hematoma or rupture
Occurrence of hepatic rupture or hematoma in a patient with pre-eclampsia
Time frame: From date of enrollment until date of discharge, up to 12 weeks
Rate of pulmonary edema
Accumulation of excess fluid in the lungs of a patient with pre-eclampsia
Time frame: From date of enrollment until date of discharge, up to 12 weeks
Rate of stillbirth
Infant born with no sign of life at or after 20 weeks' gestation
Time frame: After 20 weeks of gestation until the date of delivery
Birthweight
Weight of infant born
Time frame: At birth
Rate of small-for-gestational-age
Babies born with birthweights below the 10th percentile for babies of the same gestational age.
Time frame: At birth
5-minute Apgar score
Apgar score at 5 minute after birth. 5-minute Apgar score of 7-10 as reassuring, a score of 4-5 as moderately abnormal, and a score of 0-3 as low in the term infant and late-preterm infant.
Time frame: At birth
Rate of admission to the neonatal intensive care unit (NICU)
Admission of infant to the neonatal intensive care unit
Time frame: Up to 28 days of life after the due date
Rate of death before discharge
Death of newborn before discharge from nursery
Time frame: Up to 28 days of life after the due date
Rate of respiratory distress syndrome
Presence of tachypnoea, sternal recession and expiratory grunting, need for supplemental oxygen, and a radiological picture of diffuse reticulogranular shadowing with an air bronchogram
Time frame: Up to 28 days of life after the due date
Rate of proven sepsis
The combination of clinical signs and positive blood cultures
Time frame: Up to 28 days of life after the due date