Status:
WITHDRAWN
Labetalol Versus Magnesium Sulfate (MgSO4) for the Prevention of Eclampsia Trial
Lead Sponsor:
Baylor College of Medicine
Conditions:
Preeclampsia
Pregnancy Induced Hypertension
Eligibility:
FEMALE
15-60 years
Phase:
PHASE2
PHASE3
Brief Summary
Eclampsia is a major cause of perinatal morbidity and mortality. The pathophysiology is not known but magnetic resonance imaging (MRI) and Doppler data suggest that overperfusion of the cerebral tissu...
Detailed Description
Research Design and Methods: The study will be a multicenter, randomized, controlled, clinical trial comparing the anti-seizure effect of parenteral and/or oral labetalol (n = 4000) versus parenteral...
Eligibility Criteria
Inclusion
- Any patient with preeclampsia (BP \> 140 systolic and/or \> 90 mmHg diastolic with 1+ or more proteinuria \[or a 24 hour specimen with \> 300 mg/day\]), chronic hypertension (or superimposed preeclampsia), or gestational hypertension deemed to be at risk for eclamptic convulsions and who would routinely be treated in the participating institution with some form of anti-seizure prophylaxis during labor and delivery.
Exclusion
- Any patient for whom informed consent cannot be obtained.
- Any patient who has received an antihypertensive medication within 6 hours prior to enrollment will not be eligible but those who have received antihypertensive medications other than beta-blockers or magnesium sulfate may still be enrolled as long as they have not been given a dose within the 6 hours prior to enrollment. If a patient has received MgSO4 or a short acting beta-blocker or calcium channel blocker more than 12 hours prior to enrollment or if they have received a long acting beta-blocker more than 24 hours before enrollment she may still be considered eligible. This stipulation will allow increased recruitment of patients especially those with chronic hypertension and those transferred from outlying institutions. We expect these patients to be a minority of the enrollment.
- A history of bronchial asthma, emphysema, heart block, angina, cardiomyopathy or myocardial infarction.
- Any history or signs of congestive cardiac failure, or arrhythmia with a ventricular rate of less than 60 bpm.
- Patients with severe mental or physical disorders which, in the opinion of the investigators, might affect responsiveness to therapy or any other aspect of the study.
- Patients who are allergic to drugs with a chemical structure similar to labetalol or magnesium sulfate.
- Patients given magnesium sulfate, labetalol or short acting beta blockers or calcium channel blockers less than 12 hours prior to enrollment in the study.
- Evidence of fetal distress or fetal anomalies.
- Inability to secure intravenous access.
- Patient's primary physician declines to enroll patient in study.
Key Trial Info
Start Date :
June 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2017
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00293735
Start Date
June 1 2015
End Date
January 1 2017
Last Update
January 13 2017
Active Locations (2)
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1
Baylor College of Medicine
Houston, Texas, United States, 77030
2
Institute of Maternal and Child Health Medicine
Kerala, India, 673008