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PK/PD Modeling of Magnesium in the Mother and Neonate

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01709630
Recruitment Status : Completed
First Posted : October 18, 2012
Last Update Posted : November 20, 2014
Sponsor:
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment
Magnesium Sulfate Pharmacokinetics and Pharmacodynamics Drug: Magnesium sulfate infusion

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 Design

Study Type : Observational
Actual Enrollment : 151 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pharmacokinetics (PK)/Pharmacodynamics (PD) Modeling of Magnesium Sulfate In the Mother and Exposed Neonate
Study Start Date : September 2012
Primary Completion Date : October 2014
Study Completion Date : October 2014

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U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
Neonatal
Neonates born to pregnant women exposed to magnesium sulfate for preeclampsia, tocolysis, or neuroprotection.
Drug: Magnesium sulfate infusion
Participants will be given magnesium sulfate infusion as part of their normal care for either preeclampsia, tocolysis, or neuroprotection.
Maternal
Pregnant women exposed to magnesium sulfate for preeclampsia, tocolysis, or neuroprotection
Drug: Magnesium sulfate infusion
Participants will be given magnesium sulfate infusion as part of their normal care for either preeclampsia, tocolysis, or neuroprotection.


Outcome Measures

Primary Outcome Measures :
  1. Maternal and neonatal blood magnesium levels [ Time Frame: 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 :
  1. Maternal and neonatal side effects [ Time Frame: 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.



Biospecimen Retention:   Samples Without DNA
Blood specimens will be obtained to test magnesium levels in the mother and neonate.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Pregnant women and neonates exposed to magnesium sulfate infusion around the time of delivery for one of three reasons: 1.) preeclampsia 2.) tocolysis 3.) neuroprotection.
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01709630


Locations
United States, California
Lucille Packard Children's Hospital at Stanford University Medical Center
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
More Information

Publications:
Responsible Party: Brendan Carvalho, Associate Professor, Stanford University
ClinicalTrials.gov Identifier: NCT01709630     History of Changes
Other Study ID Numbers: ID-2803
First Posted: October 18, 2012    Key Record Dates
Last Update Posted: November 20, 2014
Last Verified: November 2014

Additional relevant MeSH terms:
Magnesium Sulfate
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics
Central Nervous System Depressants
Anti-Arrhythmia Agents
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Tocolytic Agents
Reproductive Control Agents