Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neonatal | Neonates born to pregnant women exposed to magnesium sulfate for preeclampsia, tocolysis, or neuroprotection. |
| |
| Maternal | Pregnant women exposed to magnesium sulfate for preeclampsia, tocolysis, or neuroprotection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Magnesium sulfate infusion | Drug | Participants will be given magnesium sulfate infusion as part of their normal care for either preeclampsia, tocolysis, or neuroprotection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Maternal and neonatal side effects | 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. |
Not provided
Inclusion Criteria:
Not provided
Not provided
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.
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lucille Packard Children's Hospital at Stanford University Medical Center | Stanford | California | 94305 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18753646 | Background | 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. | |
| 19701048 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Blood specimens will be obtained to test magnesium levels in the mother and neonate.
| 24 months |
| 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. |
| 22836873 | 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. |