PK/PD Modeling of Magnesium in the Mother and Neonate

Stanford University

Status: Completed

Conditions: Magnesium Sulfate Pharmacokinetics and Pharmacodynamics

Treatments: Drug: Magnesium sulfate infusion

Study type: Observational

Funder types: Other

Identifiers

NCT01709630

ID-2803

Details and patient eligibility

About

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

Full 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.

Enrollment: 151 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

151 participants in 2 patient groups

Neonatal

Description:

Neonates born to pregnant women exposed to magnesium sulfate for preeclampsia, tocolysis, or neuroprotection.

Treatment:

Drug: Magnesium sulfate infusion

Maternal

Description:

Pregnant women exposed to magnesium sulfate for preeclampsia, tocolysis, or neuroprotection

Treatment:

Drug: Magnesium sulfate infusion