Abbreviated MgSO4 Therapy in Post-Partum Preeclampsia
| Tracking Information | |||||
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| First Received Date ICMJE | June 23, 2006 | ||||
| Last Updated Date | June 23, 2006 | ||||
| Start Date ICMJE | January 2001 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Abbreviated MgSO4 Therapy in Post-Partum Preeclampsia | ||||
| Official Title ICMJE | Abbreviated Post-Partum Magnesium Sulfate Seizure Prophylaxis in Preeclampsia: A Comparison of 12 and 24 Hour Regimens | ||||
| Brief Summary | Magnesium sulfate is used for seizure prophylaxis in pregnancies complicated by preeclampsia. There is debate as to how long to continue this therapy after delivery of the pregnancy. Different schemes have been offered to shorten the exposure to magnesium sulfate after delivery, with little data. We seek to investigate the effect of shortened magnesium sulfate therapy on the post-partum recovery phase of mild preeclampsia. Our hypothesis was that shortened therapy (12 hours versus the traditional 24 hours post-partum) has no effect on disease course, and will result in significantly shorter exposure to magnesium sulfate. |
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| Detailed Description | The study has been completed at this time. Consenting women with suspected mild preeclampsia (new onset/exacerbated hypertension with proteinuria) were randomly assigned 12 (12-hour) or 24-hours (24-hour) of postpartum MgSO4. Treatment was continued beyond the initially assigned time period for new findings of severe preeclampsia. Clinical and laboratory data were collected. Analysis was by intent to treat, utilizing Fisher’s exact, chi-square, and Student’s t-tests where appropriate |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE | Drug: abbreviation of magnesium sulfate therapy (12 hours versus the traditional 24 hours after delivery) | ||||
| Study Arm (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 200 | ||||
| Completion Date | August 2004 | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00344058 | ||||
| Other Study ID Numbers ICMJE | IRB 01001-OBG-01 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Not Provided | ||||
| Study Sponsor ICMJE | Case Western Reserve University | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Case Western Reserve University | ||||
| Verification Date | August 2005 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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