abetalol vs Magnesium Sulfate for Prevention of Eclampsia Trial ( LAMPET TRIAL )
- Conditions
- Health Condition 1: null- Females with Severe preclampsia
- Registration Number
- CTRI/2010/091/001285
- Lead Sponsor
- Govt Medical College Kozhikode
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 120
Inclusion criteria
Adult females aged between 15-60 years of age with a diagnosis of severe preeclampsia who are deemed to be at sufficient risk to warrant seizure prophylaxis with MgSO4.
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 Criteria:
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Occurrence of eclamptic seizure(s) after enrollment in the study. <br/ ><br>Timepoint: [ Time Frame: 24 Hours Postpartum ] [ Designated as safety issue: Yes ]
- Secondary Outcome Measures
Name Time Method Maternal: Blood pressure pulse pressure and heart rate. <br/ ><br>Need for additional antihypertensive medication <br/ ><br>Incidence of complications like HELLP syndrome,renal failure,cerebral hemorrhage and death <br/ ><br>Incidence of uterine atony and PPH <br/ ><br>Perinatal morbidity and mortality <br/ ><br>Difference between two drugs in terms of anaesthesia <br/ ><br>Acceptability ,ease and cost of treatmentTimepoint: [ Time Frame: discharge from hospital ] [ Designated as safety issue: Yes ] <br/ ><br>