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Difficulty recruiting, only one participant in 18 months, rarity of event
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This is a double blinded, placebo-controlled trial to determine if IV dexamethasone more quickly than placebo assists resolution of Posterior Reversible Encephalopathy Syndrome (PRES) encountered in eclamptic patients. All patients regardless of assignment to placebo or steroid will receive standard therapy to include magnesium sulfate, blood pressure medications and diuretics. We hypothesize that the addition of dexamethasone to standard therapy will accelerate CNS recovery more quickly than standard management without dexamethasone.
30 eclamptic patients who do not require steroids for fetal lung maturation purposes will be randomized to placebo or steroid. This includes patients with eclampsia encountered antepartum prior to 23 weeks gestation, postpartum eclampsia, undelivered patients encountered after 33 weeks gestation who would not be candidates for fetal lung maturation steroids, or patients not eligible for repeat steroid administration in the 23-34 week gestational window. Planned enrollment in this pilot study is up to 30 patients with at least 12 in each group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dexamethasone | Active Comparator | Dexamethasone 12 mg, 2 doses, 12 hours apart. |
|
| Placebo | Placebo Comparator | Placebo, 2 doses, 12 hours apart |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexamethasone | Drug | Intravenous Dexamethasone 12 mg, 2 doses, 12 hours apart |
|
| Measure | Description | Time Frame |
|---|---|---|
| Eclampsia and Posterior Reversible Encephalopathy Syndrome (PRES): Arandomized Clinical Trial Evaluating Corticosteroid Efficacy to Augment Standard Therapy and Shorten Recovery | To learn if giving IV dexamethasone to eclamptic women with PRES will accelerate normalization of CNS function. | 36 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| James Martin, MD | University of Mississippi Medican Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Mississippi Medical Center | Jackson | Mississippi | 39216 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Dexamethasone | Dexamethasone 12 mg, 2 doses, 12 hours apart. Dexamethasone: Intravenous Dexamethasone 12 mg, 2 doses, 12 hours apart |
| FG001 | Placebo | Placebo, 2 doses, 12 hours apart |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Dexamethasone | Dexamethasone 12 mg, 2 doses, 12 hours apart. Dexamethasone: Intravenous Dexamethasone 12 mg, 2 doses, 12 hours apart |
| BG001 | Placebo | Placebo, 2 doses, 12 hours apart |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Number |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Eclampsia and Posterior Reversible Encephalopathy Syndrome (PRES): Arandomized Clinical Trial Evaluating Corticosteroid Efficacy to Augment Standard Therapy and Shorten Recovery | To learn if giving IV dexamethasone to eclamptic women with PRES will accelerate normalization of CNS function. | Logistic hurdles caused to stop the study after the first participant and not proceed further. No analysis was undertaken. | Posted | 36 months |
|
No AE.
No AE
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Dexamethasone | Dexamethasone 12 mg, 2 doses, 12 hours apart. Dexamethasone: Intravenous Dexamethasone 12 mg, 2 doses, 12 hours apart |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| James N. Martin, Jr. | University of Mississippi Medical Center | 601-984-5358 | jnmartin@umc.edu |
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| ID | Term |
|---|---|
| D004461 | Eclampsia |
| ID | Term |
|---|---|
| D046110 | Hypertension, Pregnancy-Induced |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D003907 | Dexamethasone |
| D013256 | Steroids |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D000072473 | Fused-Ring Compounds |
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| BG002 | Total | Total of all reporting groups |
| participants |
|
| Gender | Number | participants |
|
| Region of Enrollment | Number | participants |
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Placebo | Placebo, 2 doses, 12 hours apart | 0 | 0 | 0 | 0 |
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| D011083 |
| Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |