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| Sponsored by: |
Case Western Reserve University |
|---|---|
| Information provided by: | Case Western Reserve University |
| ClinicalTrials.gov Identifier: | NCT00344058 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Pregnancy Preeclampsia |
Drug: abbreviation of magnesium sulfate therapy (12 hours versus the traditional 24 hours after delivery) |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment |
| Official Title: | Abbreviated Post-Partum Magnesium Sulfate Seizure Prophylaxis in Preeclampsia: A Comparison of 12 and 24 Hour Regimens |
| Estimated Enrollment: | 200 |
| Study Start Date: | January 2001 |
| Estimated Study Completion Date: | August 2004 |
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
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Ohio | |
| MetroHealth Medical Center, Labor and Delivery | |
| Cleveland, Ohio, United States, 44109 | |
| Principal Investigator: | Hugh M Ehrenberg, MD | MetroHealth Medical Center at Case Western Reserve School of Medicine |
More Information
| Study ID Numbers: | IRB 01001-OBG-01 |
| Study First Received: | June 23, 2006 |
| Last Updated: | June 23, 2006 |
| ClinicalTrials.gov Identifier: | NCT00344058 |
| Health Authority: | United States: Institutional Review Board |
|
pregnancy preeclampsia treatment |
|
Calcium, Dietary Hypertension, Pregnancy-Induced Pregnancy Complications Eclampsia Magnesium Sulfate |
Seizures Pregnancy toxemia /hypertension Pre-Eclampsia Preeclampsia Hypertension |
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Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Anesthetics Central Nervous System Depressants Calcium Channel Blockers Reproductive Control Agents Cardiovascular Agents Pharmacologic Actions Membrane Transport Modulators |
Tocolytic Agents Sensory System Agents Therapeutic Uses Analgesics Peripheral Nervous System Agents Anti-Arrhythmia Agents Central Nervous System Agents Anticonvulsants |
