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NCT00344058 Clinical Trial

Abbreviated MgSO4 Therapy in Post-partum Preeclampsia

Pregnancy Clinical Trial

Official title:
Abbreviated Post-partum Magnesium Sulfate Seizure Prophylaxis in Preeclampsia: A Comparison of 12 and 24 Hour Regimens

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00344058
Other study ID # IRB 01001-OBG-01
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 2001
Est. completion date August 2004

Study information
Verified date August 2005
Source Case Western Reserve University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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

Recruitment information / eligibility
Status Completed
Enrollment 200
Est. completion date August 2004
Est. primary completion date
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• abbreviation of magnesium sulfate therapy (12 hours versus the traditional 24 hours after delivery)

Locations
Country Name City State
United States MetroHealth Medical Center, Labor and Delivery Cleveland Ohio

Sponsors (1)
Lead Sponsor Collaborator
Case Western Reserve University

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Time of magnesium sulfate therapy (minutes)
Primary Blood pressure
Primary Maternal symptoms (headaches, blurred vision, chest pain, shortness of breath)
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