Clinical trial NCT05283473: Serum Magnesium Concentration in Magnesium Sulfate Therapy for Severe Preeclampsia
Official title: Serum Concentration of Magnesium Attained in Magnesium Sulfate Therapy in Pregnant Women With Severe Preeclampsia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Severe Pre-Eclampsia
Keywords: Pre-eclampsia
Magnesium sulfate
Eclampsia
magnesium concentration
Lead sponsor: Mỹ Đức Hospital
Sponsor class: OTHER
First posted: 2022-03-17
Enrollment: 64
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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, and indicated for therapy with magnesium sulfate will be included.

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Serum magnesium concentrations before and during magnesium sulfate infusion
timeFrame: 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 outcomes:
measure: Adverse drug reaction
timeFrame: From administration of loading dose until termination of magnesium sulfate treatment or occurrence of magnesium toxicity, whichever comes first, approximately up to 36 hours.
measure: Magnesium toxicity
timeFrame: From administration of loading dose until termination of magnesium sulfate treatment or occurrence of magnesium toxicity, whichever comes first, approximately up to 36 hours.
measure: Mode of delivery
timeFrame: At birth
measure: Gestational age at delivery
timeFrame: At birth
measure: Rate of preterm birth before 28 weeks of gestation
timeFrame: From date of enrollment until 27 6/7 weeks
measure: Rate of preterm birth before 34 weeks of gestation
timeFrame: From date of enrollment until 33 6/7 weeks
measure: Rate of all live births at any gestational age
timeFrame: At birth
measure: Rate of maternal mortality
timeFrame: From date of enrollment until date of discharge, up to 12 weeks
measure: Rate of eclampsia
timeFrame: From date of enrollment until date of discharge, up to 12 weeks
measure: Rate of HELLP syndrome
timeFrame: From date of enrollment until date of discharge, up to 12 weeks
measure: Rate of placental abruption
timeFrame: From date of enrollment until date of delivery, up to 12 weeks
measure: Rate of postpartum hemorrhage
timeFrame: Within 24 hours after delivery
measure: Rate of stroke
timeFrame: From date of enrollment until date of discharge, up to 12 weeks
measure: Rate of acute kidney injury
timeFrame: From date of enrollment until date of discharge, up to 12 weeks
measure: Rate of liver capsule hematoma or rupture
timeFrame: From date of enrollment until date of discharge, up to 12 weeks
measure: Rate of pulmonary edema
timeFrame: From date of enrollment until date of discharge, up to 12 weeks
measure: Rate of stillbirth
timeFrame: After 20 weeks of gestation until the date of delivery
measure: Birthweight
timeFrame: At birth
measure: Rate of small-for-gestational-age
timeFrame: At birth
measure: 5-minute Apgar score
timeFrame: At birth
measure: Rate of admission to the neonatal intensive care unit (NICU)
timeFrame: Up to 28 days of life after the due date
measure: Rate of death before discharge
timeFrame: Up to 28 days of life after the due date
measure: Rate of respiratory distress syndrome
timeFrame: Up to 28 days of life after the due date
measure: Rate of proven sepsis
timeFrame: Up to 28 days of life after the due date
Other outcomes:
Locations:
city: Ho Chi Minh City
country: Vietnam
facility: My Duc Hospital
Study officials:
affiliation: University of Medicine and Pharmacy at Ho Chi Minh City
name: Lan N Vuong, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: