PK/PD Modeling of Magnesium in the Mother and Neonate

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2012 by Stanford University
Sponsor:
Information provided by (Responsible Party):
Brendan Carvalho, Stanford University
ClinicalTrials.gov Identifier:
NCT01709630
First received: October 14, 2012
Last updated: October 16, 2012
Last verified: October 2012
  Purpose

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


Condition Intervention
Magnesium Sulfate Pharmacokinetics and Pharmacodynamics
Drug: Magnesium sulfate infusion

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pharmacokinetics (PK)/Pharmacodynamics (PD) Modeling of Magnesium Sulfate In the Mother and Exposed Neonate

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Maternal and neonatal blood magnesium levels [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    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:
  • Maternal and neonatal side effects [ Time Frame: 24 months ] [ Designated as safety issue: No ]

    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.


Estimated Enrollment: 140
Study Start Date: September 2012
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01709630

Locations
United States, California
Lucille Packard Children's Hospital at Stanford University Medical Center Recruiting
Stanford, California, United States, 94305
Contact: Brendan Carvalho, M.D.    650-861-8607    bcarvalho@stanford.edu   
Contact: Kathleen Brookfield, M.D.    305.785.1386    kbrook@stanford.edu   
Principal Investigator: Brendan Carvalho, M.D.         
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
Study First Received: October 14, 2012
Last Updated: October 16, 2012
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on July 29, 2014