Labetalol Versus Magnesium Sulfate (MgSO4) for the Prevention of Eclampsia Trial (LAMPET)
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ClinicalTrials.gov Identifier: NCT00293735 |
Recruitment Status :
Withdrawn
(Lack of funding)
First Posted : February 17, 2006
Last Update Posted : January 13, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Preeclampsia Pregnancy Induced Hypertension Gestational Hypertension Chronic Hypertension Superimposed Preeclampsia | Drug: labetalol (seizure prevention) Drug: MgSO4 (seizure prevention) | Phase 2 Phase 3 |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 0 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Official Title: | Labetalol Versus MgSO4 for the Prevention of Eclampsia Trial (LAMPET) |
Study Start Date : | June 2015 |
Actual Primary Completion Date : | January 2017 |
Actual Study Completion Date : | January 2017 |

Arm | Intervention/treatment |
---|---|
Active Comparator: 1. Labetolol |
Drug: labetalol (seizure prevention)
20mg IV (can be increased to an escalating dose of maximum of 80 mg (20mg, 40 mg, 80 mg q 20min) Cumulative max of 240 mg. 20mg labetalol PO every 6 hours |
Active Comparator: 2. Magnesium Sulfate |
Drug: MgSO4 (seizure prevention)
4-6g bolus over 20 minutes; 1-2 grams/hr Discontinued 24 hours after delivery. |
- Occurrence of eclamptic seizure(s) after enrollment in the study. [ Time Frame: 24 Hours Postpartum ]
- Maternal: Blood pressure, pulse pressure and heart rate changes [ Time Frame: 24 hours postpartum ]
- Need for additional antihypertensive medication (defined by need to control BP > 160 mmHg systolic and/or 110 mmHg) [ Time Frame: 24 hours postpartum ]
- Subjective assessment of side effects by the patient [ Time Frame: 24 hours postpartum ]
- Objective assessment of new onset complications and/or side effects by the treating clinicians [ Time Frame: 24 hours postpartum ]
- Labor and delivery parameters including; induction to delivery interval, rate of cervical dilatation, oxytocin dosages, length of labor, delivery route, blood loss at delivery, and postpartum course; and [ Time Frame: 24 hours postpartum ]
- Type of anesthesia administered (none, local infiltration for delivery only, epidural for labor, epidural for delivery, spinal for delivery, combined/spinal epidural for labor and delivery, general anesthesia for delivery). [ Time Frame: 24 hours postpartum ]
- Fetal and Neonatal: Occurrence of newly diagnosed fetal distress during labor necessitating emergent delivery [ Time Frame: 24 hour postpartum ]
- Umbilical cord gases at delivery (if available in institution) [ Time Frame: 30 minutes after delivery ]
- Apgar scores; and [ Time Frame: 1min and 5 minutes after delivery ]
- Neonatal outcome as defined by NICU admission, hospital survival to discharge, length of hospital survival, days in NICU, need for blood transfusion, need for pressor agents, need for mechanical ventilation, neonatal cardiac dysrhythmias, [ Time Frame: Discharge from hospital ]
- neonatal cardiac failure, necrotizing enterocolitis, sudden infant death, neonatal sepsis, neonatal hypoglycemia, and there will be an other block for recording any other identified complications not mentioned. [ Time Frame: discharge from hospital ]

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Ages Eligible for Study: | 15 Years to 60 Years (Child, Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00293735
United States, Texas | |
Baylor College of Medicine | |
Houston, Texas, United States, 77030 | |
India | |
Institute of Maternal and Child Health Medicine | |
Kerala, India, 673008 |
Principal Investigator: | Michael A Belfort, MD, PhD | Baylor College of Medicine |
Publications:
Responsible Party: | Michael Belfort, Chairman and Professor, Baylor College of Medicine |
ClinicalTrials.gov Identifier: | NCT00293735 History of Changes |
Other Study ID Numbers: |
H-28505 |
First Posted: | February 17, 2006 Key Record Dates |
Last Update Posted: | January 13, 2017 |
Last Verified: | January 2017 |
Preeclampsia Pregnancy Hypertension Eclampsia |
HELLP Syndrome Seizures Prevention |
Pre-Eclampsia Eclampsia Hypertension, Pregnancy-Induced Hypertension Vascular Diseases Cardiovascular Diseases Pregnancy Complications Magnesium Sulfate Labetalol Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anesthetics Central Nervous System Depressants |
Anti-Arrhythmia Agents Anticonvulsants Calcium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Calcium-Regulating Hormones and Agents Tocolytic Agents Reproductive Control Agents Adrenergic beta-Antagonists Adrenergic Antagonists Adrenergic Agents Neurotransmitter Agents Antihypertensive Agents Sympathomimetics Autonomic Agents |