Abbreviated MgSO4 Therapy in Post-Partum Preeclampsia
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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: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Abbreviated Post-Partum Magnesium Sulfate Seizure Prophylaxis in Preeclampsia: A Comparison of 12 and 24 Hour Regimens |
- Time of magnesium sulfate therapy (minutes)
- Blood pressure
- Maternal symptoms (headaches, blurred vision, chest pain, shortness of breath)
| 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:
- Women with suspected mild preeclampsia diagnosed antepartum, intrapartum, or post-partum were eligible for inclusion after delivery at term (≥ 34 weeks’ gestational age).
Exclusion Criteria:
- Inability to give informed consent, preterm delivery, severe preeclampsia
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
No publications provided
| ClinicalTrials.gov Identifier: | NCT00344058 History of Changes |
| Other Study ID Numbers: | IRB 01001-OBG-01 |
| Study First Received: | June 23, 2006 |
| Last Updated: | June 23, 2006 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Case Western Reserve University:
|
pregnancy preeclampsia treatment |
Additional relevant MeSH terms:
|
Pre-Eclampsia Hypertension, Pregnancy-Induced Pregnancy Complications Magnesium Sulfate Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses |
Anesthetics Central Nervous System Depressants Anti-Arrhythmia Agents Cardiovascular Agents Anticonvulsants Calcium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Tocolytic Agents Reproductive Control Agents |
ClinicalTrials.gov processed this record on May 16, 2013