Magnesium Sulfate Pharmacokinetics and Pharmacodynamics
Conditions
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.
Interventions
Participants will be given magnesium sulfate infusion as part of their normal care for either preeclampsia, tocolysis, or neuroprotection.
Sponsors
Stanford University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed