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PK/PD Modeling of Magnesium in the Mother and Neonate

NCT ID: NCT01709630

Last Updated: 2014-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

151 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-09-30

Study Completion Date

2014-10-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Magnesium Sulfate Pharmacokinetics and Pharmacodynamics

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Neonatal

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

Magnesium sulfate infusion

Intervention Type DRUG

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

Magnesium sulfate infusion

Intervention Type DRUG

Participants will be given magnesium sulfate infusion as part of their normal care for either preeclampsia, tocolysis, or neuroprotection.

Interventions

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Magnesium sulfate infusion

Participants will be given magnesium sulfate infusion as part of their normal care for either preeclampsia, tocolysis, or neuroprotection.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Brendan Carvalho

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Lucille Packard Children's Hospital at Stanford University Medical Center

Stanford, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 18753646 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19701048 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22836873 (View on PubMed)

Other Identifiers

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ID-2803

Identifier Type: -

Identifier Source: org_study_id