Study indicates Mississippi Protocol effective in treating preeclamptic women
By Jack Mazurak
A recently released University of Mississippi Medical Center study of 190 pregnant women with HELLP Syndrome, a severe form of preeclampsia, further underscores the effectiveness of a locally formulated treatment called the Mississippi Protocol.
Co-authors on a study of UMMC patients with HELLP Syndrome are, from left,
"What this paper shows is that by identifying mothers who are moving toward HELLP and starting the protocol early o - starting steroids and controlling systolic blood pressure - helps to speed the mother's recovery. It slows and can stop the disease progression," said Dr. Jim Martin, professor of obstetrics-gynecology and the study's principal investigator.
HELLP Syndrome is an acronym for the symptoms defining it - hemolysis, or the breaking down of red blood cells, elevated liver enzymes and low blood platelet count. While it causes few maternal deaths in developed countries, it can disrupt renal function, cause liver hematomas or hemorrhages, strokes and cardiovascular problems.
Of the 190 women studied from 2000-07, Martin and his team saw no maternal deaths, strokes or hemorrhages develop. Only two women suffered cardiovascular complications.
Of 163 patients who were below class 1 status in HELLP Syndrome when doctors began the protocol, only 39 women - 24 percent - progressed to class 1. Only 18.2 percent of class 1 and 2.4 percent of the less-acute class 2 patients subsequently developed major maternal morbidity.
The journal "Hypertension in Pregnancy" released an online abstract of the study in January. Print publication is expected this spring.
"This is the first study to show that using such a protocol, if initiated early enough in the disease process, can slow down disease and minimize excess morbidity," said Martin, director of maternal-fetal medicine. "The protocol doesn't change the fact that the patient came in with HELLP. It won't reverse it, but it will slow or stop it."
Traditionally doctors give preeclamptic mothers corticosteroids, such as Decadron, on the baby's behalf. Steroids speed fetal lung development and allow an earlier delivery. Once delivered, preeclampsia usually subsides.
Martin and his team developed the Mississippi Protocol throughout the 1990s. When they realized the effect of steroids on the mother - slowing and sometimes stopping the advance of HELLP - they made it a key aspect of their protocol.
The Mississippi Protocol is still considered experimental, not the standard of care but certainly within it, Martin said.
"Not everybody in the profession uses it because there's been no large, randomized controlled study that proves it effective," he said. "Still, we've been down this treatment road so long now, with such good results, I wouldn't want to expose those moms to anything but."
The National Heart, Lung and Blood Institute decided against funding such a study that Martin and his team proposed in the late 1990s.
"A large randomized study would be a tremendous undertaking and quite expensive," Martin said. "We had 26 centers across the country involved and an independent data-monitoring center and a proposed 1,500 patients."
The somewhat rare nature of HELLP and that it's often misdiagnosed further complicates prospects for a nationwide study. UMMC sees 30-45 HELLP patients annually, more than average for hospitals because Mississippi's population is the nation's unhealthiest. And with UMMC's expertise in preeclampsia and its standing as the state's only academic health science center, many preeclamptic mothers get referred to the Medical Center from elsewhere in the state.
The completed study of 190 women was funded by Department of Obstetrics and Gynecology revenue. Co-authors include Dr. Michelle Owens, Dr. Sharon Keiser, Dr. Marc Parrish, Dr. Kiran Tam Tam and Dr. Justin Brewer. Co-authors Julie Cushman and Pam Blake, clinical research coordinator, along with Warren May, professor in the Center of Biostatistics and Bioinformatics, assisted with gathering and managing the study's data.
The next step, Martin said, and one which Owens is already working on, is figuring out just why the steroids work for the mothers.
Dr. James Martin and his team developed the Mississippi Protocol, a treatment course for HELLP Syndrome, throughout the 1990s. Its precepts are:
- Early identification of preeclamptic women who may be developing HELLP Syndrome;
- Administer corticosteroids quickly if there's epigastric pain, eclampsia or rapid HELLP progression;
- If not, monitor platelet counts and lactic dehydrogenase (LDH) and aspartate aminotransferase (AST) levels;
- Monitor systolic blood pressure, treat with antihypertensive drugs if above 160; and
- Administer corticosteroids with decreases in platelet count and LDH or increases in AST.