PK/PD Modeling of Magnesium in the Mother and Neonate

Study Overview
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Brief Summary
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Determine significant correlations between maternal serum magnesium levels, and maternal and neonatal outcomes.

Detailed Description
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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.

Official Title
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Pharmacokinetics (PK)/Pharmacodynamics (PD) Modeling of Magnesium Sulfate In the Mother and Exposed Neonate

Conditions
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Magnesium Sulfate Pharmacokinetics and Pharmacodynamics

Intervention / Treatment
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* Drug: Magnesium sulfate infusion


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Neonatal<br>Neonates born to pregnant women exposed to magnesium sulfate for preeclampsia, tocolysis, or neuroprotection. | Drug: Magnesium sulfate infusion<br>* Participants will be given magnesium sulfate infusion as part of their normal care for either preeclampsia, tocolysis, or neuroprotection.<br>|
| Maternal<br>Pregnant women exposed to magnesium sulfate for preeclampsia, tocolysis, or neuroprotection | Drug: Magnesium sulfate infusion<br>* Participants will be given magnesium sulfate infusion as part of their normal care for either preeclampsia, tocolysis, or neuroprotection.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maternal and neonatal blood magnesium levels | 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. | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maternal and neonatal side effects | 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. | 24 months |