- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01709630
PK/PD Modeling of Magnesium in the Mother and Neonate
Pharmacokinetics (PK)/Pharmacodynamics (PD) Modeling of Magnesium Sulfate In the Mother and Exposed Neonate
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
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California
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Stanford, California, United States, 94305
- Lucille Packard Children's Hospital at Stanford University Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Neonatal
Neonates born to pregnant women exposed to magnesium sulfate for preeclampsia, tocolysis, or neuroprotection.
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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
|
Participants will be given magnesium sulfate infusion as part of their normal care for either preeclampsia, tocolysis, or neuroprotection.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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24 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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. |
24 months
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anesthetics
- Membrane Transport Modulators
- Anticonvulsants
- Calcium-Regulating Hormones and Agents
- Reproductive Control Agents
- Calcium Channel Blockers
- Tocolytic Agents
- Magnesium Sulfate
Other Study ID Numbers
- ID-2803
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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