<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01709630</url>
  </required_header>
  <id_info>
    <org_study_id>ID-2803</org_study_id>
    <nct_id>NCT01709630</nct_id>
  </id_info>
  <brief_title>PK/PD Modeling of Magnesium in the Mother and Neonate</brief_title>
  <official_title>Pharmacokinetics (PK)/Pharmacodynamics (PD) Modeling of Magnesium Sulfate In the Mother and Exposed Neonate</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Stanford University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Stanford University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Determine significant correlations between maternal serum magnesium levels, and maternal and&#xD;
      neonatal outcomes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      We will construct a pharmacokinetic and pharmacodynamic model of intravenous magnesium&#xD;
      sulfate administered antenatally to expectant mothers and exposed fetuses with the aim of&#xD;
      optimizing maternal and fetal outcomes while preventing maternal and neonatal overdosing and&#xD;
      morbidity associated with current magnesium treatment protocols. Once we have developed a&#xD;
      PK/PD model in our own hospital cohort, we will apply this model to a large existing NICHD&#xD;
      database to mathematically calculate optimal dosing protocols.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">October 2014</completion_date>
  <primary_completion_date type="Actual">October 2014</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Maternal and neonatal blood magnesium levels</measure>
    <time_frame>24 months</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Maternal and neonatal side effects</measure>
    <time_frame>24 months</time_frame>
    <description>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.&#xD;
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.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">151</enrollment>
  <condition>Magnesium Sulfate Pharmacokinetics and Pharmacodynamics</condition>
  <arm_group>
    <arm_group_label>Neonatal</arm_group_label>
    <description>Neonates born to pregnant women exposed to magnesium sulfate for preeclampsia, tocolysis, or neuroprotection.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Maternal</arm_group_label>
    <description>Pregnant women exposed to magnesium sulfate for preeclampsia, tocolysis, or neuroprotection</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Magnesium sulfate infusion</intervention_name>
    <description>Participants will be given magnesium sulfate infusion as part of their normal care for either preeclampsia, tocolysis, or neuroprotection.</description>
    <arm_group_label>Maternal</arm_group_label>
    <arm_group_label>Neonatal</arm_group_label>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Blood specimens will be obtained to test magnesium levels in the mother and neonate.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Pregnant women and neonates exposed to magnesium sulfate infusion around the time of&#xD;
        delivery for one of three reasons: 1.) preeclampsia 2.) tocolysis 3.) neuroprotection.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Pregnant women ages 18-45 years&#xD;
&#xD;
          -  Magnesium sulfate exposure for preeclampsia, tocolysis, or neuroprotection&#xD;
&#xD;
          -  Neonates (male or female) born at 24-42 weeks gestation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Lucille Packard Children's Hospital at Stanford University Medical Center</name>
      <address>
        <city>Stanford</city>
        <state>California</state>
        <zip>94305</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Rouse DJ, Hirtz DG, Thom E, Varner MW, Spong CY, Mercer BM, Iams JD, Wapner RJ, Sorokin Y, Alexander JM, Harper M, Thorp JM Jr, Ramin SM, Malone FD, Carpenter M, Miodovnik M, Moawad A, O'Sullivan MJ, Peaceman AM, Hankins GD, Langer O, Caritis SN, Roberts JM; Eunice Kennedy Shriver NICHD Maternal-Fetal Medicine Units Network. A randomized, controlled trial of magnesium sulfate for the prevention of cerebral palsy. N Engl J Med. 2008 Aug 28;359(9):895-905. doi: 10.1056/NEJMoa0801187.</citation>
    <PMID>18753646</PMID>
  </reference>
  <reference>
    <citation>Pryde PG, Mittendorf R. Contemporary usage of obstetric magnesium sulfate: indication, contraindication, and relevance of dose. Obstet Gynecol. 2009 Sep;114(3):669-673. doi: 10.1097/AOG.0b013e3181b43b0e.</citation>
    <PMID>19701048</PMID>
  </reference>
  <reference>
    <citation>Greenberg MB, Penn AA, Whitaker KR, Kogut EA, El-Sayed YY, Caughey AB, Lyell DJ. Effect of magnesium sulfate exposure on term neonates. J Perinatol. 2013 Mar;33(3):188-93. doi: 10.1038/jp.2012.95. Epub 2012 Jul 26.</citation>
    <PMID>22836873</PMID>
  </reference>
  <verification_date>November 2014</verification_date>
  <study_first_submitted>October 14, 2012</study_first_submitted>
  <study_first_submitted_qc>October 16, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 18, 2012</study_first_posted>
  <last_update_submitted>November 19, 2014</last_update_submitted>
  <last_update_submitted_qc>November 19, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 20, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Stanford University</investigator_affiliation>
    <investigator_full_name>Brendan Carvalho</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Magnesium Sulfate</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01709630
org study id: ID-2803
nct id: NCT01709630
lead sponsor: 
has dmc: No
Determine significant correlations between maternal serum magnesium levels, and maternal and
      neonatal outcomes.
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.
observational model: Cohort
time perspective: Prospective
measure: Maternal and neonatal blood magnesium levels
time frame: 24 months
description: 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.
measure: Maternal and neonatal side effects
time frame: 24 months
description: 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.
arm group label: Neonatal
description: Neonates born to pregnant women exposed to magnesium sulfate for preeclampsia, tocolysis, or neuroprotection.
arm group label: Maternal
description: Pregnant women exposed to magnesium sulfate for preeclampsia, tocolysis, or neuroprotection
intervention type: Drug
intervention name: Magnesium sulfate infusion
description: Participants will be given magnesium sulfate infusion as part of their normal care for either preeclampsia, tocolysis, or neuroprotection.
arm group label: Maternal
arm group label: Neonatal
Blood specimens will be obtained to test magnesium levels in the mother and neonate.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: No
facility: 
country: United States
citation: Rouse DJ, Hirtz DG, Thom E, Varner MW, Spong CY, Mercer BM, Iams JD, Wapner RJ, Sorokin Y, Alexander JM, Harper M, Thorp JM Jr, Ramin SM, Malone FD, Carpenter M, Miodovnik M, Moawad A, O'Sullivan MJ, Peaceman AM, Hankins GD, Langer O, Caritis SN, Roberts JM; Eunice Kennedy Shriver NICHD Maternal-Fetal Medicine Units Network. A randomized, controlled trial of magnesium sulfate for the prevention of cerebral palsy. N Engl J Med. 2008 Aug 28;359(9):895-905. doi: 10.1056/NEJMoa0801187.
PMID: 18753646
citation: Pryde PG, Mittendorf R. Contemporary usage of obstetric magnesium sulfate: indication, contraindication, and relevance of dose. Obstet Gynecol. 2009 Sep;114(3):669-673. doi: 10.1097/AOG.0b013e3181b43b0e.
PMID: 19701048
citation: Greenberg MB, Penn AA, Whitaker KR, Kogut EA, El-Sayed YY, Caughey AB, Lyell DJ. Effect of magnesium sulfate exposure on term neonates. J Perinatol. 2013 Mar;33(3):188-93. doi: 10.1038/jp.2012.95. Epub 2012 Jul 26.
PMID: 22836873
responsible party type: Principal Investigator
investigator affiliation: Stanford University
investigator full name: Brendan Carvalho
investigator title: Associate Professor
mesh term: Magnesium Sulfate