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| Sponsored by: |
Utah HealthCare Institute |
|---|---|
| Information provided by: | Utah HealthCare Institute |
| ClinicalTrials.gov Identifier: | NCT00293735 |
Purpose
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 tissues is a major etiologic factor. Hypertensive encephalopathy from overperfusion, and vascular damage from excessive arterial pressure (cerebral barotrauma) are believed to lead to vasogenic and cytotoxic cerebral edema, with resultant neuronal anomalies, seizure activity and cerebral bleeding if left unchecked. Doppler data have shown that cerebral perfusion pressure (CPP) is abnormally increased in severe preeclampsia and that autoregulation of the middle cerebral artery is affected by this condition leading to increased CPP. Magnesium sulfate (MgSO4) is the most widely accepted eclampsia treatment and prophylactic agent, and it has been used in the USA since the 1950's. Despite widespread use, its mechanism of action is unknown. MgSO4 is given intravenously or intramuscularly and requires specialized nursing training and monitoring to minimize toxicity from respiratory and cardiac depression. Labetalol, a combined alpha and beta blocker, has been used for many years to safely treat hypertension in preeclamptic women, and is now known to reduce CPP in women with preeclampsia. In the United Kingdom labetalol was for many years used as the sole agent in treating preeclampsia, and the rate of seizure was no different to that reported in the USA with MgSO4. Since labetalol can be administered orally, is economical, has low toxicity potential, does not require specialized training to administer or monitor, and decreases CPP, it may be an ideal agent for controlling blood pressure (BP) and decreasing the incidence of eclampsia in women with preeclampsia. The current study is a multicenter, randomized, controlled trial to compare the anti-seizure effect of parenteral MgSO4 versus oral labetalol in hypertensive pregnant women who are eligible for MgSO4 therapy. The primary outcome measure is eclampsia, and the secondary outcome measures include blood pressure control, and relevant antenatal, intrapartum, and postnatal maternal and fetal/neonatal parameters including adverse effects and complications. Inclusion criteria are deliberately broad in order to make the study clinically relevant. Hypertensive pregnant women, in whom the decision for delivery has been made, will be enrolled after written, informed consent. Patients will be randomized to receive MgSO4 therapy as given in their institution, versus oral labetalol (200mg/q6 hours), from enrollment in the study until 24 hours post delivery. There will be 4000 patients in each arm of the study and analysis will be by intention-to-treat. The study is powered to show both therapeutic superiority as well as clinical equivalence. This study has the potential to change the way preeclampsia is managed, and will represent a major advance in terms of the availability and safety of prophylactic therapy, especially in developing nations where MgSO4 is underutilized due to cost constraints.
| Condition | Intervention | Phase |
|---|---|---|
|
Preeclampsia Pregnancy Induced Hypertension Gestational Hypertension Chronic Hypertension Superimposed Preeclampsia |
Drug: labetalol (seizure prevention) Drug: MgSO4 (seizure prevention) |
Phase II Phase III |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Bio-equivalence Study |
| Official Title: | Labetalol Versus MgSO4 for the Prevention of Eclampsia Trial (LAMPET) |
| Estimated Enrollment: | 8000 |
| Study Start Date: | May 2003 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | June 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 1. Labetolol: Active Comparator | Drug: labetalol (seizure prevention) |
| 2. Magnesium Sulfate: Sham Comparator | Drug: MgSO4 (seizure prevention) |
Show Detailed Description
Eligibility| Ages Eligible for Study: | 15 Years to 60 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
We expect these patients to be a minority of the enrollment.
Contacts and Locations| Contact: Michael A Belfort, MD, PhD | 801 743-4700 | michael.belfort@HCAhealthcare.com |
| Contact: Shalece Shalece, RN, MPH | 801-743-4709 | shalece.kofford@hcahealthcare.com |
| United States, Arizona | |
| St. Joseph's Regional Medical Center | Recruiting |
| Phoenix, Arizona, United States, 85013 | |
| Principal Investigator: James Balducci, MD | |
| United States, California | |
| Loma Linda Medical Center | Recruiting |
| Loma Linda, California, United States, 92354 | |
| Principal Investigator: Bryan T. Oshiro, MD | |
| United States, Kansas | |
| Overland Park Regional Medical Center | Recruiting |
| Overland Park, Kansas, United States, 66215 | |
| Principal Investigator: Tracey Cowles, MD | |
| Wesley Medical Center | Recruiting |
| Wichita, Kansas, United States, 67214 | |
| Principal Investigator: Margaret O'Hara, MD | |
| United States, Louisiana | |
| Women's and Children's Hospital | Active, not recruiting |
| Lafayette, Louisiana, United States, 70508 | |
| United States, Ohio | |
| The Toledo Hospital | Active, not recruiting |
| Toledo, Ohio, United States, 43606 | |
| United States, Tennessee | |
| University of Tennessee | Recruiting |
| Chattanooga, Tennessee, United States, 37403 | |
| Principal Investigator: David C. Adair, MD | |
| University of Tennessee - Knoxville | Recruiting |
| Knoxville, Tennessee, United States, 37996 | |
| Principal Investigator: David C. Adair, MD | |
| United States, Texas | |
| Medical City Hospital | Recruiting |
| Dallas, Texas, United States, 75230 | |
| Principal Investigator: Victor Vines, MD | |
| Woman's Hospital of Texas | Not yet recruiting |
| Houston, Texas, United States, 77054 | |
| Principal Investigator: Joanie Hare-Morris, MD | |
| United States, Utah | |
| St. Mark's Hospital | Recruiting |
| Salt Lake City, Utah, United States, 84124 | |
| Principal Investigator: Michael A Belfort, MD, PhD | |
| University of Utah Medical Center | Recruiting |
| Salt Lake City, Utah, United States, 84132 | |
| Principal Investigator: Robert Silver, MD | |
| University of Utah Medical Center | Recruiting |
| Salt Lake City, Utah, United States, 84132 | |
| Contact: Jennifer Warren, MD 801-581-8425 jennifer.warren@hsc.utah.edu | |
| Principal Investigator: Robert Silver, MD | |
| United States, Virginia | |
| Henrico Doctor's Hospital | Recruiting |
| Richmond, Virginia, United States, 23294 | |
| Principal Investigator: J.T. Christmas, MD | |
| Germany | |
| Landstuhl Regional Medical Center | Recruiting |
| Landstuhl, Germany | |
| Principal Investigator: Mark Sewell, MD | |
| Principal Investigator: | Michael A Belfort, MD, PhD | St. Mark's Hospital |
More Information
| Responsible Party: | HCAPS ( Michael Belfort ) |
| Study ID Numbers: | IND 63,966 |
| Study First Received: | February 16, 2006 |
| Last Updated: | February 17, 2009 |
| ClinicalTrials.gov Identifier: | NCT00293735 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Preeclampsia Pregnancy Hypertension Eclampsia |
HELLP Syndrome Seizures Prevention |
|
Neurotransmitter Agents Pregnancy Complications Eclampsia Adrenergic Agents Seizures Vascular Diseases Pre-Eclampsia Adrenergic alpha-Antagonists Cardiovascular Agents |
Antihypertensive Agents Preeclampsia Labetalol HELLP Syndrome Hypertension, Pregnancy-Induced Adrenergic beta-Antagonists Adrenergic Antagonists Peripheral Nervous System Agents Hypertension |
|
Sympatholytics Neurotransmitter Agents Pregnancy Complications Eclampsia Adrenergic Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Vascular Diseases Pre-Eclampsia Adrenergic alpha-Antagonists Cardiovascular Agents |
Antihypertensive Agents Pharmacologic Actions Labetalol Hypertension, Pregnancy-Induced Autonomic Agents Therapeutic Uses Adrenergic beta-Antagonists Cardiovascular Diseases Adrenergic Antagonists Peripheral Nervous System Agents Hypertension |