Serum Magnesium Concentration in Magnesium Sulfate Therapy for Severe Preeclampsia

NCT05283473 | Completed

• 1 other identifier: 01/22/DD-BVMD
• Study Type: observational
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Severe Pre-Eclampsia

Keywords

Pre-eclampsia; Magnesium sulfate; Eclampsia; magnesium concentration

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (24)

• 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.

• 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

  At birth

• Gestational age at delivery

  At birth

• Rate of preterm birth before 28 weeks of gestation

  From date of enrollment until 27 6/7 weeks

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mỹ Đức Hospital: lead

Study Sites (1)

My Duc Hospital

Ho Chi Minh City, Vietnam

Location

MeSH Terms

Conditions

Pre-Eclampsia; Eclampsia

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Lan N Vuong, MD, PhD

  University of Medicine and Pharmacy at Ho Chi Minh City

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2022
• First Posted: March 17, 2022
• Study Start: March 15, 2022
• Primary Completion: February 21, 2024
• Study Completion: March 30, 2024
• Last Updated: January 7, 2025

Record last verified: 2024-03

Locations

VN (1)