Abbreviated MgSO4 Therapy in Post-Partum Preeclampsia

This study has been completed.
Sponsor:
Information provided by:
Case Western Reserve University
ClinicalTrials.gov Identifier:
NCT00344058
First received: June 23, 2006
Last updated: NA
Last verified: August 2005
History: No changes posted

June 23, 2006
June 23, 2006
January 2001
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  • Time of magnesium sulfate therapy (minutes)
  • Blood pressure
  • Maternal symptoms (headaches, blurred vision, chest pain, shortness of breath)
Same as current
No Changes Posted
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Abbreviated MgSO4 Therapy in Post-Partum Preeclampsia
Abbreviated Post-Partum Magnesium Sulfate Seizure Prophylaxis in Preeclampsia: A Comparison of 12 and 24 Hour Regimens

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.

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

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Pregnancy
  • Preeclampsia
Drug: abbreviation of magnesium sulfate therapy (12 hours versus the traditional 24 hours after delivery)
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.
 
Completed
200
August 2004
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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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00344058
IRB 01001-OBG-01
Not Provided
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Case Western Reserve University
Not Provided
Principal Investigator: Hugh M Ehrenberg, MD MetroHealth Medical Center at Case Western Reserve School of Medicine
Case Western Reserve University
August 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP