Serum Concentration of Magnesium Attained in Magnesium Sulfate Therapy in Pregnant Women With Severe Preeclampsia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Serum magnesium concentrations before and during magnesium sulfate infusion
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Serum magnesium concentrations before and during magnesium sulfate infusion
时间窗: From administration of loading dose until termination of magnesium sulfate treatment or occurrence of magnesium toxicity, whichever comes first, approximately up to 36 hours.
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.
次要结局
- Mode of delivery(At birth)
- Rate of all live births at any gestational age(At birth)
- Rate of preterm birth before 28 weeks of gestation(From date of enrollment until 27 6/7 weeks)
- Rate of preterm birth before 34 weeks of gestation(From date of enrollment until 33 6/7 weeks)
- 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.)
- Gestational age at delivery(At birth)
- Rate of maternal mortality(From date of enrollment until date of discharge, up to 12 weeks)
- Rate of HELLP syndrome(From date of enrollment until date of discharge, up to 12 weeks)
- 5-minute Apgar score(At birth)
- Rate of acute kidney injury(From date of enrollment until date of discharge, up to 12 weeks)
- Rate of liver capsule hematoma or rupture(From date of enrollment until date of discharge, up to 12 weeks)
- Birthweight(At birth)
- Rate of small-for-gestational-age(At birth)
- Rate of admission to the neonatal intensive care unit (NICU)(Up to 28 days of life after the due date)
- Rate of respiratory distress syndrome(Up to 28 days of life after the due date)
- Adverse drug reaction(From administration of loading dose until termination of magnesium sulfate treatment or occurrence of magnesium toxicity, whichever comes first, approximately up to 36 hours.)
- Rate of eclampsia(From date of enrollment until date of discharge, up to 12 weeks)
- Rate of stillbirth(After 20 weeks of gestation until the date of delivery)
- Rate of stroke(From date of enrollment until date of discharge, up to 12 weeks)
- Rate of pulmonary edema(From date of enrollment until date of discharge, up to 12 weeks)
- Rate of proven sepsis(Up to 28 days of life after the due date)
- Rate of placental abruption(From date of enrollment until date of delivery, up to 12 weeks)
- Rate of postpartum hemorrhage(Within 24 hours after delivery)
- Rate of death before discharge(Up to 28 days of life after the due date)