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NCT Number: NCT05283473

Serum Magnesium Concentration in Magnesium Sulfate Therapy for Severe Preeclampsia

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.

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Key information

Conditions

Severe Pre-eclampsia Eclampsia Female Urogenital Diseases and Pregnancy Complications Hypertension, Pregnancy-Induced Pre-Eclampsia Pregnancy Complications Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

My Duc Hospital

Ho Chi Minh City, Vietnam

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Serum magnesium concentrations before and 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.

    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.

Secondary outcomes

  1. Adverse drug reaction

    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.

    Rates of adverse drug reactions to administration of magnesium sulfate

  2. 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.

    Rates of patients having signs of magnesium toxicity

  3. Mode of delivery

    Time frame: At birth

    Vaginal delivery, C-section (elective, suspected fetal distress, non-progressive labor)

  4. Gestational age at delivery

    Time frame: At birth

    Gestational age at delivery

  5. Rate of preterm birth before 28 weeks of gestation

    Time frame: From date of enrollment until 27 6/7 weeks

    Birth before 28 weeks

  6. Rate of preterm birth before 34 weeks of gestation

    Time frame: From date of enrollment until 33 6/7 weeks

    Birth before 34 weeks

  7. Rate of all live births at any gestational age

    Time frame: At birth

    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

  8. Rate of maternal mortality

    Time frame: From date of enrollment until date of discharge, up to 12 weeks

    Death of the mother

  9. Rate of eclampsia

    Time frame: From date of enrollment until date of discharge, up to 12 weeks

    Onset of seizures (convulsions) in a patient with pre-eclampsia

  10. Rate of HELLP syndrome

    Time frame: From date of enrollment until date of discharge, up to 12 weeks

    The clinical presentation of hemolysis, elevated liver enzymes, and low platelet count in a patient with pre-eclampsia

  11. Rate of placental abruption

    Time frame: From date of enrollment until date of delivery, up to 12 weeks

    Separation of placenta from the inner wall of the uterus before birth

  12. Rate of postpartum hemorrhage

    Time frame: Within 24 hours after delivery

    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

  13. Rate of stroke

    Time frame: From date of enrollment until date of discharge, up to 12 weeks

    Occurrence of stroke in a patient with pre-eclampsia

  14. Rate of acute kidney injury

    Time frame: From date of enrollment until date of discharge, up to 12 weeks

    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

  15. Rate of liver capsule hematoma or rupture

    Time frame: From date of enrollment until date of discharge, up to 12 weeks

    Occurrence of hepatic rupture or hematoma in a patient with pre-eclampsia

  16. Rate of pulmonary edema

    Time frame: From date of enrollment until date of discharge, up to 12 weeks

    Accumulation of excess fluid in the lungs of a patient with pre-eclampsia

  17. Rate of stillbirth

    Time frame: After 20 weeks of gestation until the date of delivery

    Infant born with no sign of life at or after 20 weeks' gestation

  18. Birthweight

    Time frame: At birth

    Weight of infant born

  19. Rate of small-for-gestational-age

    Time frame: At birth

    Babies born with birthweights below the 10th percentile for babies of the same gestational age.

  20. 5-minute Apgar score

    Time frame: At birth

    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.

  21. Rate of admission to the neonatal intensive care unit (NICU)

    Time frame: Up to 28 days of life after the due date

    Admission of infant to the neonatal intensive care unit

  22. Rate of death before discharge

    Time frame: Up to 28 days of life after the due date

    Death of newborn before discharge from nursery

  23. Rate of respiratory distress syndrome

    Time frame: Up to 28 days of life after the due date

    Presence of tachypnoea, sternal recession and expiratory grunting, need for supplemental oxygen, and a radiological picture of diffuse reticulogranular shadowing with an air bronchogram

  24. Rate of proven sepsis

    Time frame: Up to 28 days of life after the due date

    The combination of clinical signs and positive blood cultures

Sponsors and collaborators

Lead sponsor

Mỹ Đức Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Mar 17, 2022
Registry last updated
Jan 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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