Serum Magnesium Concentration in Magnesium Sulfate Therapy for Severe Preeclampsia

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Serum Concentration of Magnesium Attained in Magnesium Sulfate Therapy in Pregnant Women With Severe Preeclampsia

Conditions
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Severe Pre-Eclampsia

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pregnant women Aged ≥ 18 Diagnosed with pre-eclampsia with severe features, with or without chronic hypertension, as defined by the American College of Obstetricians and Gynecologists (ACOG) diagnosis criteria. Provision of written informed consent to participate as shown by a signature on the patient consent form. Exclusion Criteria: Impaired renal function (eGFR < 60 mL/min/ 1,73 m2 or oliguria ) Occurrence of eclampsia before magnesium sulfate administration Known hypersensitivity to the drug, Severe myasthenia, atrioventricular block A diminished level of consciousness.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | From administration of loading dose until termination of magnesium sulfate treatment or occurrence of magnesium toxicity, whichever comes first, approximately up to 36 hours. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse drug reaction | Rates of adverse drug reactions to administration of magnesium sulfate | 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 | 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) | At birth | 
| Gestational age at delivery | Gestational age at delivery | At birth | 
| Rate of preterm birth before 28 weeks of gestation | Birth before 28 weeks | From date of enrollment until 27 6/7 weeks | 
| Rate of preterm birth before 34 weeks of gestation | Birth before 34 weeks | 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 | At birth | 
| Rate of maternal mortality | Death of the mother | 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 | 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 | 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 | 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 | Within 24 hours after delivery | 
| Rate of stroke | Occurrence of stroke in a patient with pre-eclampsia | 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 | 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 | 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 | 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 | After 20 weeks of gestation until the date of delivery | 
| Birthweight | Weight of infant born | At birth | 
| Rate of small-for-gestational-age | Babies born with birthweights below the 10th percentile for babies of the same gestational age. | 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. | At birth | 
| Rate of admission to the neonatal intensive care unit (NICU) | Admission of infant to the neonatal intensive care unit | Up to 28 days of life after the due date | 
| Rate of death before discharge | Death of newborn before discharge from nursery | 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 | Up to 28 days of life after the due date | 
| Rate of proven sepsis | The combination of clinical signs and positive blood cultures | Up to 28 days of life after the due date | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pre-eclampsia, Magnesium sulfate, Eclampsia, magnesium concentration