PK/PD Modeling of Magnesium in the Mother and Neonate

Completed

• Conditions: Magnesium Sulfate Pharmacokinetics and Pharmacodynamics
• Interventions: Drug: Magnesium sulfate infusion

• Registration Number: NCT01709630
• Lead Sponsor: Stanford University

Brief Summary

Determine significant correlations between maternal serum magnesium levels, and maternal and neonatal outcomes.

Detailed Description

We will construct a pharmacokinetic and pharmacodynamic model of intravenous magnesium sulfate administered antenatally to expectant mothers and exposed fetuses with the aim of optimizing maternal and fetal outcomes while preventing maternal and neonatal overdosing and morbidity associated with current magnesium treatment protocols. Once we have developed a PK/PD model in our own hospital cohort, we will apply this model to a large existing NICHD database to mathematically calculate optimal dosing protocols.

Study Timeline

• Study Start: 2012-09
• Study First Submitted: 2012-10-14
• Study First Submitted QC: 2012-10-16
• Study First Posted: 2012-10-18
• Primary Completion: 2014-10
• Study Completion: 2014-10
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-19
• Last Update Posted: 2014-11-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 151

Inclusion Criteria

• Pregnant women ages 18-45 years
• Magnesium sulfate exposure for preeclampsia, tocolysis, or neuroprotection
• Neonates (male or female) born at 24-42 weeks gestation

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Maternal	Magnesium sulfate infusion	Pregnant women exposed to magnesium sulfate for preeclampsia, tocolysis, or neuroprotection
Neonatal	Magnesium sulfate infusion	Neonates born to pregnant women exposed to magnesium sulfate for preeclampsia, tocolysis, or neuroprotection.

Primary Outcome Measures

Name	Time	Method
Maternal and neonatal blood magnesium levels	24 months	Pregnant women and neonates exposed to magnesium sulfate for preeclampsia, tocolysis, or neuroprotection will have blood samples drawn at set time points around the time of delivery.

Secondary Outcome Measures

Name	Time	Method
Maternal and neonatal side effects	24 months	Maternal drug side effects (flushing, sedation, nausea, vomiting, respiratory rate, oxygen saturations, blood pressure, heart rate, and patella tendon reflex depression) will be assessed prospectively.; Neonatal drug effects: Incidence of cerebral palsy, neonatal mortality, NICU and special care admissions, respiratory distress, intraventricular hemorrhage, necrotizing enterocolitis, hypotonia, feeding difficulties, and diagnosis of hypermagnesemia will be recorded, We will use validated and standardized definitions for diagnoses and all clinical outcome measurements.

Trial Locations

Locations (1)

Lucille Packard Children's Hospital at Stanford University Medical Center; 🇺🇸 Stanford, California, United States