PK/PD Modeling of Magnesium in the Mother and Neonate

NCT01709630 | Completed

• 1 other identifier: ID-2803
• Study Type: observational
• Target: 151
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Magnesium Sulfate Pharmacokinetics and Pharmacodynamics

Outcome Measures

Primary Outcomes (1)

• Maternal and neonatal blood magnesium levels

  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.

  24 months

Secondary Outcomes (1)

• Maternal and neonatal side effects

  24 months

Study Arms (2)

Neonatal

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

Drug: Magnesium sulfate infusion

Maternal

Pregnant women exposed to magnesium sulfate for preeclampsia, tocolysis, or neuroprotection

Drug: Magnesium sulfate infusion

Interventions

Magnesium sulfate infusion DRUG

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

Maternal; Neonatal

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• Pregnant women ages 18-45 years
• Magnesium sulfate exposure for preeclampsia, tocolysis, or neuroprotection
• Neonates (male or female) born at 24-42 weeks gestation

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Lucille Packard Children's Hospital at Stanford University Medical Center

Stanford, California, 94305, United States

Location

Related Publications (3)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood specimens will be obtained to test magnesium levels in the mother and neonate.

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 14, 2012
• First Posted: October 18, 2012
• Study Start: September 1, 2012
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: November 20, 2014

Record last verified: 2014-11

Locations

US (1)