On November 20-22, 2007, a meeting was held in Vancouver, British Columbia to discuss The Preeclampsia Integrated Estimate of Risk Study (PIERS) which was lead by Dr. Peter von Dadelszen. Besides being the lead investigator for the study, Dr. von Dadelszen is also a member of the Preeclampsia Foundation’s prestigious Medical Advisory Board, President of the North American Society for the Study of Hypertension in Pregnancy (NASSHP), and the President of ERIPED (Equipede Recherché Interdisciplinaire sur la Pre-Eclamspie et ses Determinants), Canada’s preeclampsia research alliance.

The goal of the 41-month PIERS study was to create a rigorous standard care protocol for the diagnosis and intervention of preeclampsia and the purpose of the meeting was to move to the next level of the PIERS study. After prospective gathering of data for seven years, and publishing the findings, the next step was to strategize about what had been learned and figure out how to get hospital administrators to adopt the findings as the standard protocol for care.

Representing the Preeclampsia Foundation in non-scientific roles during the two-day PIERS meeting were Executive Director J. Thomas Viall and Fiona Morrow, Forum Administrator and preeclampsia survivor. Morrow was involved in the PIERS study and presented the human component behind the graphs and charts by sharing her story and answering questions. Viall could tell by the eagerness of the interaction that she really got the audience’s attention and described her speech as “emotive and clear.” He said their entire presentation, “…was very powerful. Many of the scientists and medical professionals had tears in their eyes.” They were “just stricken.” Viall credits von Dadelszen with presenting and keeping the human component “front and center” to keep the researchers focused on the importance of the study. “There are moms losing babies, and husbands losing wives,” said Mr. Viall.

The researchers looked at past practice and records of how 400 women were evaluated for, and diagnosed with preeclampsia, as well as the recommendations that were made for intervention. The researchers compiled a snapshot of how, in these 400 cases, monitoring was done; what diagnostic protocols were used, and what interventions were taken. They matched those data to the outcomes of each of the women and found that five percent of the women had negative outcomes (loss of life, stroke, seizures, organ failure, etc). The next step was to develop a standard protocol for all possible cases of preeclampsia, because one cannot predict the outcomes.

Approximately 300 women participated in this phase of the initiative. When the standard protocol of care, which was very stringent, was used for these women, it produced a significant decrease in negative outcomes; which dropped from five percent to approximately seven-tenths of one percent. Viall pointed out, that unfortunately, there was no shift in neonatal outcomes with the standard care protocol. Viall thought this study might present a major opportunity for the Preeclampsia Foundation, in that the Foundation could seek grants to do similar studies in the U.S., based on the PIERS findings. The goal would be to change diagnostic and intervention protocols in the States, though Viall acknowledged that differences in the Canadian and U.S. health care systems might present certain challenges. At a minimum, he said, “the Preeclampsia Foundation could be a clarion voice for the patient by promoting its view of best practices.” We must continue to be the honest broker with no agenda other than minimizing negative outcomes…that will help to save lives.”

Acknowledging that preeclampsia is an even bigger problem in the developing world, the meeting also focused on the development of condensed recommendations for diagnosis and intervention in less developed countries. ”I had the opportunity to meet and speak to the Coordinator of Maternal and Perinatal Health activities within the Reproductive Health Division of the World Health Organization. He was quite impressed with our work and I do believe we will stay in touch and consider ways in which we can collaborate in the future,” said Viall. While delving into the underdeveloped world is “not necessarily a front line mission-issue for the Preeclampsia Foundation, the Board of Directors has begun to look at ways we might begin developing materials and guidelines to have an impact beyond North America,” said Viall.

 

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Say “matrix” and visions of a kick-boxing, black-clad Keanu Reeves may come to mind. No, this is not a movie review.

Every day, a small army of Harvard Medical School researchers reports to The Life Sci­ences Building in Boston’s Longwood Medi­cal Area. It’s new, ultra high-tech. It towers over its neighboring hospitals and research facilities and, with its clean lines, giant glass panels and sweeping marble stairway, would be a set designer’s dream for another sequel to “The Matrix”. The men and women who spend so much of their lives in this futuristic workplace are pulmonologists, oncologists, nephrologists, neurologists; they are natives of France, Norway, Sweden, Finland, India, China, Japan, Turkey, and the U.S. They study and work under the leadership of Dr. Raghu Kalluri, Chief of the Division of Matrix Biology at Beth Israel Deaconess Medical Center.

Composed of proteins and found through­out the body, the matrix serves as a platform for cells. Kalluri says just ten years ago, scien­tists believed that a cell contained all the in­formation it needed to function. Researchers have since discovered that the extracellular matrix actually tells the cells how to behave. After countless division, cells become liver cells, kidney cells, brain cells.all kinds of cells. Kalluri says the matrix supporting kidney cells, for example, tells those cells to “behave like a kidney”. Transfer them to a matrix in the brain and they’re no longer act­ing like kidney cells, but rather assuming the function of brain cells. Kalluri says as many as 50 different human diseases can be traced to defects in proteins outside the cell, which would explain in part, why the matrix has become a field of study in itself. And matrix biology has served as a powerful attraction for these graduate students and medical professionals from a range of disciplines.

New Jersey native, Scott Potenta, whose research paper had just been accepted the day we spoke, says he’s always been inter­ested in matrix proteins and their effect on cell behavior. He is studying the way blood vessels react in diseases such as cancer. Valerie LeBleu, a native of France and the first Har­vard graduate student to work at the Matrix Biology Lab, is trying to find alternatives to dialysis for treatment of Alport Syndrome, a genetic kidney disease that affects 1 in 5,000 people. LeBleu and Potenta say they appreci­ate the richness of the laboratory, which is obvious in the diversity of the workforce and the wide representation of specialties, all of which foster the sharing of knowledge and experience. Formal discussions at stations in the main laboratory, as well as informal con­versation over coffee in the break room can and do give way to new ideas, and more than a few “aha!” moments. Both of these young researchers and their colleagues made it clear to this reporter, it’s a privilege to work in this cutting-edge environment.

Their days are spent comparing graphs on a split computer screen or peering into micro­scopes deciphering cells on a slide, manipu­lating organic solutions, each with their own requirements for survival: simple refrigera­tion or having to be gingerly lowered into giant cylinders, filled with dry ice.

In the next row of lab stations, is Dr Keizo Kanasaki, a Japanese native and research fel­low in medicine. Kanasaki collaborated with Kalluri on a paper reported in the May 11, 2008 online “Nature”. They theorize that preeclampsia is actually linked to an absence of 2-ME, and that administering that pro­tein to women with the disease would be a viable treatment. Because this is a women’s disease, you might think that Kanasaki is an obstetrician. He is a nephrologist; he studies the kidney. Which brings us back to the common ground for all of these dedicated researchers…the matrix. Discoveries within that mass of protein, the scaffolding for cells throughout the human body, could yield the keys to unlocking the mystery of pre-eclampsia and, hopefully, lead to prevention.

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Blood pressure cuffs, urine dipsticks, and the scale: for decades, these simple tools have aided health care providers in the detection of preeclampsia. As a woman's pregnancy progresses, her prenatal visits come closer together, so that her weight gain, urine, and blood pressure readings can be monitored for signs of the disorder. However, this system isn't perfect. While preeclampsia most frequently occurs at term, it can sometimes strike much earlier. The disorder can sometimes progress rapidly between appointments, or the warning signs can be too subtle to trigger alarm.

But soon, clinicians may have another method for detecting preeclampsia: a reliable screening test that can spot changes in the bloodstream relatively early in pregnancy, warning healthcare providers when preeclampsia may occur before term.

In the past eight years, a substantial amount of preeclampsia research has focused on proteins found in blood known as soluble factors. The chain of events that will eventually lead to preeclampsia seems to begin quite early in pregnancy -- in fact, during the implantation of the placenta. Something disrupts the implantation process. As pregnancy progresses, the placenta intermittently runs short of oxygen, and the levels of many of these soluble factors start to vary from normal.

One of these proteins raises maternal blood pressure and inhibits Placental Growth Factor, or PlGF. Another protein, called soluble endoglin (sEng), also affects blood vessel function and is particularly elevated in HELLP syndrome. The hope is that by measuring levels of PlGF and sEng, the ratio between them, and the rate at which they are changing, clinicians can detect preeclampsia much sooner, well before symptoms appear. At that point, monitoring and management of that pregnancy would become more aggressive, in expectation that she will develop the symptoms of the disease as pregnancy continues.

Several companies in the United States and abroad have invested in these and other biomarkers to develop diagnostic or screening tests.

Miraculins Inc., a company that develops diagnostic tests from academic research and further adapts them for clinical use, first acquired the rights to an ensemble of 35 soluble factors, including endoglin, from Mount Sinai hospital. On January 7, they announced a new partnership with Inverness Medical Innovations Inc., a company that manufactures and markets such tests worldwide. "It was just a natural fit for us," said Ferran Prat, Vice President of Oncology and Women's Health for Inverness. "We're [already] launching a PlGF test in Europe, where the regulatory environment is different."


Christopher Moreau, President and CEO of Miraculins, plans to launch the first US ELIZA-based test through a few labs within the year, under a FDA exemption called an ASR, to build data while progressing towards full FDA approval. One way to apply the test would be to take a blood draw around the 24th week of pregnancy and compare it with first trimester bloodwork. This could detect changes that warn that a woman is likely to develop early preeclampsia, before 35 weeks gestation. The test could likely also be used as an instant diagnostic confirmation that a woman less than 35 weeks pregnant is suffering from preeclampsia and needs immediate treatment. The test itself only requires basic infrastructure and when the costs of the phlebotomist and shipping, if needed, are factored in, the total price will likely be $100- $200.

Preliminary serum and plasma studies indicate that the test will have very high sensitivity and specificity, which means it will capture essentially all of the women who will go on to develop early preeclampsia, plus a small number of women who will be monitored more closely but won't go on to develop the disease before 35 weeks gestation.

And there's hope for a first trimester screening test within a few years. "We're delighted to be able to move forward with developing this test," said Moreau. "Maternal and child health has been terribly neglected, and the opportunity to do something positive for women in this position, and save lives, is just tremendous."

 

 

 

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Vitamin D and Microchimerisms:

Could the sun really have something to do with preeclampsia?
"Maternal vitamin D deficiency may be an independent risk factor for preeclampsia. Vitamin D supplementation in early pregnancy should be explored for preventing preeclampsia and promoting neonatal well-being," reads a paper published in the Journal of Clinical Endocrinology & Metabolism in 2007. Although some of us who had our babies in, say, Portland, Oregon, where the sun rarely shines, would love to claim Vitamin D deficiency, other preeclampsia survivors sweltered under the Arizona or California sun. If you think this might be a possible therapy to explore, talk to your health care professional and check out the discussions in our Community Forum on this topic.

Micro-what?
Researchers have found that women with preeclampsia, which causes high blood pressure in late pregnancy and can kill both mother and child, had five times the microchimerism of healthy women. Fetal cells, it turned out, are complex characters. A chimera is an organism with DNA from different sources, which of course is what fetal cells are, since their DNA derives from both mother and father. Read the article, The Yin-Yang Factor, published in Stanford Medicine Magazine, if you weren't already convinced that preeclampsia is a really complex disease.

Patent issued for preeclampsia diagnostic test
A press release from Miraculins announced that the United States Patent and Trademark Office has issued US Patent 7,754,495 entitled "Methods for Early Diagnosing of an Increased Risk of Preeclampsia." Previous issues of Expectations discussed this company's development of a diagnostic marker for preeclampsia.

 

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Last month, a team from the University of Alberta reported in the journal Hypertension on a method to determine that a woman is at high risk of developing preeclampsia. While this method may or may not be developed into a screening test in the future, it confirmed that changes in the metabolism and the vasculature of women who go on to develop preeclampsia can be detected at 15 weeks gestation.

Two Preeclampsia Foundation members were involved in media coverage on the topic and we are very grateful to them for bringing a human face to the stories about preeclampsia. Because of the press conference and media efforts of the University, a lot of lay press picked up the story and we are fortunate that the Foundation was mentioned in several of those stories. The research findings while seemingly exciting to a lay public are far from commercial realization and would need more validation for most governmental oversight bodies (e.g., FDA). Our message of "cautious optimism" is a responsible middle ground at this early juncture. Read more here.

Also, a new study into changes in maternal weight between pregnancies was published in the journal Obstetrics and Gynecology by a team from the University of St. Louis Medical Center. It confirmed that women who lose weight after a preeclamptic pregnancy have a lower risk of preeclampsia in later pregnancies than women who maintain their weight or who gain weight. Losing weight may change the uterine environment and help encourage normal placental development. A link to the abstract and discussion among forum participants may be found here.

The National Institutes of Health announced that research shows taking vitamin C and E supplements early in pregnancy does not reduce the risk for hypertensive disorders and other complications during pregnancy.

An Irish study to be published in an upcoming issue of Hypertension shows that metabolites found in women's blood early in pregnancy may be able to serve as accurate predictors of preeclampsia. This is a significant breakthrough, as biomarkers for preeclampsia have not previously been very precise. Further studies on the topic are planned.

 

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On October 18, the Iowa Section of the Association of Women's Health, Obstetric and Neonatal Nurses hosted Preeclampsia: A Team Approach to help provide healthcare providers with a greater understanding of the disease. More than 70 participants enjoyed the viewing of the 2009 Chairman's Hope Award for Outstanding Service video highlighting John and Brenda Warner, opening comments by Sue Gehlsen , Executive Director of Women's Services at Iowa Health, presentations by Joseph Hwang, MD, FACOG and George Lederhaas, MD on hypertension in pregnancy and anesthesia issues in preeclampsia and HELLP syndrome, and dinner discussion with Christine Streets, Mrs. Iowa United States, who shared her own HELLP syndrome story.

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Several major disorders that occur during pregnancy result from failure of the placenta to implant correctly into the uterus or womb. During early pregnancy cells from the placenta, known as trophoblast cells, invade into the uterus and tap into the mother’s blood supply to sustain the growing baby. Failure of this process can lead to insufficient supply of blood to the placenta resulting in preeclampsia, as well as low birth weight babies, stillbirth or recurrent miscarriage.

The invading placental trophoblast cells intermingle with maternal immune cells in the uterine lining. Trophoblast express not only maternal but also paternal genes and these will be different or “foreign” to the mother. Maternal immune cells can recognize these “foreign” fetal molecules and are thought to regulate the implantation process, allowing sufficient but not excessive invasion of the placenta. In the preeclamptic pregnancy this interactive process goes wrong and there is inadequate modification of the blood vessels which can lead to “starvation” of the placenta and subsequently triggering of the preeclamptic syndrome later in gestation in the mother.

The important molecules displayed by the trophoblast that are recognized by maternal immune cells are members of the HLA (Human Leucocyte Antigen) family known as HLA-C. The maternal receptors that recognize and interact with HLA-C are the KIR family (Killer Immunoglobulin-like Receptors). These two gene families (HLA and KIR) are very variable or polymorphic meaning that each mother will inherit a particular set of KIR genes and the fetus an HLA-C gene from both mother and father. This means maternal KIR will bind to fetal HLA-C can vary from one pregnancy to another. The interaction should lead to successful implantation but sometimes the combination of these genes from mother and baby results in inadequate invasion and leads to complications in the pregnancy.

Last month, in the Journal of Clinical Investigation, a team from the University of Cambridge reported new findings on the genetics underlying preeclampsia and other placental diseases. Women with a particular set of KIR genes – the KIR-AA genotype – who were carrying a fetus with a HLA-C2 gene were at higher risk of developing preeclampsia than those carrying other KIR/HLA-C gene combinations. This was especially so if the fetus had inherited the HLA-C2 gene from the father.

These genetic findings do not translate directly into therapeutic interventions in preeclampsia although it may be useful eventually in choosing a compatible sperm donor in IVF. The results tell us more about why placental implantation goes wrong sometimes. They might explain the old idea of the “dangerous male”, where pregnancy with particular men often results in preeclampsia. The report does emphasize the common underlying processes that would explain why a history of miscarriage or infertility is associated with a heightened risk of preeclampsia in subsequent pregnancies. Furthermore this risk cannot be affected by lifestyle, which helps those of us who “did everything right” to explain what went wrong.

Also this month, a team from the University of British Columbia, Vancouver, followed up on the connection between blood levels of vitamin D and preeclampsia in the British Journal of Obstetrics and Gynecology. It makes sense to think that the levels of vitamin D in the maternal bloodstream might have something to do with the later development of preeclampsia, because the vitamin is already known to affect some immune responses and because early small observational studies have shown an increased level of preeclampsia in the group of women with low vitamin D levels.

To check this, researchers measured serum levels of vitamin D in a population of women at high risk for preeclampsia, and then recorded their pregnancy outcomes. While the majority of the women had low levels (over three-quarters of the test population had lower levels than normal, and half were technically deficient), there was no connection between the severity of their pregnancy outcomes and the level of deficiency. In other words, some women with normal vitamin D levels still had severe preeclampsia, and some women who were deficient according to current guidelines did not go on to develop preeclampsia at all. This finding suggests that supplementing vitamin D may not have an effect on preeclampsia, although it is still interesting that women who develop the condition also tend to have low levels. There may be some connection between "having the sorts of genes or environment that lead you to develop low levels of vitamin D" and "having the sorts of genes or environment that lead you to develop preeclampsia."

 

A special thanks to Dr. Ashley Moffett, University of Cambridge, and Dr. Timothy Green, University of British Columbia for their expertise and technical input.

 

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Currently there's no way to know for certain whether preeclampsia will develop during any given pregnancy. This leaves pregnant women and their care providers with little choice but to wait for symptoms to appear... dangerous symptoms that mean the disease has progressed to the point where mother and baby are critically ill and will need intensive monitoring and carefully timed delivery to protect their health and lives. The only screening method to date is to measure those symptoms when they appear.

Early detection wouldn't be a treatment. But what if a screening test could let us know, weeks or even months in advance, that we'd probably be getting ill? Knowing might change the way we seek care - possibly choosing specialist care providers with the education and experience to manage medically complicated pregnancies. Women in parts of the world (like Wyoming in the winter) where such care is in short supply might be moved to bigger cities where NICUs and maternal-fetal medicine (MFM) specialists are more accessible. Neonatal specialists could be brought into the consulting team, and steroid shots to accelerate fetal lung development could be planned. All of these interventions together have the potential to lower the rates of fetal and maternal death and severe complications dramatically. (By the way, you may agree or disagree with this assessment; either way, we'd really like to hear your perspective in this important survey we recently launched.)

 

Since many experts consider such a test preferable to our current screening methods, recent research has tried to find a workable test with high levels of both specificity and sensitivity. An ideal test would be one that picked up *all* cases of preeclampsia - it would be sensitive - and *only* cases of preeclampsia, with no false positives - it would be specific. In practice this is all but impossible to achieve, but it's quite possible to find tests with very high levels of sensitivity and specificity, with one measure performing slightly better than the other.

 

So for researchers this creates a choice between creating tests that would produce false positives, and tests that would miss some cases. The worst-case scenario of a false positive is likely to be unnecessary close monitoring; it would not be an indication for immediate delivery. It would provide a reason to follow the pregnancy more closely for symptoms that do indicate that the acute phase of the illness has developed. Since the worst-case scenario of a false negative is a missed case of preeclampsia leading to death of mother and/or baby, public health researchers would prefer to develop tests that will overdetect cases of preeclampsia, but with a low rate of false positives.

 

At a meeting of the American Society of Nephrology (ASN) in November, Dr. Vesna Garovic (Mayo Clinic) reported on a study into the use of urinary podocytes as a screening test for preeclampsia, a test that may turn out to have both high sensitivity and specificity for preeclampsia. Podocytes are cells which line the blood vessels in the kidneys and act as filters which keep protein in the bloodstream. Their loss allows protein to spill into the urine, one of the primary signs of preeclampsia.

 

Garovic's research team used a population of 267 women and collected their urine between 25-28 weeks gestation. The samples were examined for podocytes. The 15 women who went on to develop preeclampsia all had podocytes in their urine at that gestational age. The 15 women who developed gestational hypertension did not. The control group of women who had normal pregnancies also did not.

 

Previous research from the same group has indicated that podocytes are present in the urine when preeclampsia symptoms first appear. When they shed into the urine, they cause disruptions in the filtration barrier in the kidney, resulting in proteinuria. The "classic lesion" of preeclampsia - glomerular endotheliosis - may include the loss of these podocytes from the glomeruli in the kidneys.

 

To confirm that this test works well, it will need to be repeated in multiple centers serving broader populations of pregnant women, and to make it available for general use, it will need to be turned into a commercially available testing product. That said, these are very hopeful results - unlike the soluble factors researchers are also pursuing, podocytes appear to only be elevated in women who go on to develop preeclampsia. The soluble factors are elevated in all pregnant women, and just unusually elevated in preeclamptics, which makes it very difficult to develop a screening test with high sensitivity and specificity.

 

Interestingly, it's likely that the podocytes are damaged because of the increased level of sFlt-1, which binds VEGF, which impairs repair of the podocytes and increases the rate at which they die off. It seems likely, given this new research, that it will be easier to detect the damage to the podocytes themselves than it will be to detect an increase of the soluble factors above the point where damage is likely.

 

If it's possible to develop a test similar to a standard pregnancy test, this might be a very effective method which wouldn't require laboratory work, and would make screening much easier and more rapid. Pregnant women who will likely go on to develop preeclampsia could be moved to the care teams that manage complications before they are critically ill, allowing both them and their babies to receive appropriate medical care that would probably reduce poor outcomes substantially.

 

 

A special thanks to Dr. Vesna Garovic at Mayo Clinic, for her expertise and technical input.

 

 

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Perinatal Outreach Educator Networks (POENs) are generally funded by individual states to provide perinatal (the care offered to a mother and child just before and just after birth) medical education to health care providers in the region, enhancing the quality of care for mothers and infants and reducing morbidity and mortality. Specialists share their experience and knowledge with other physicians and community hospitals across regions by offering or facilitating programs such as physician and nurse consultation services, continuing education for health care professionals, emergency medical transport for referring hospitals within the region, consultation and technical assistance on emerging perinatal issues, and sometimes even lending libraries.

For example, in Illinois, there are 10 perinatal centers designated by the state. Rush Hospital in Chicago is home to the the largest network, involving 18 hospitals delivering more than 30,000 infants. The Rush Perinatal Center maintains a 24-hour hotline to facilitate the transfer of high-risk mothers and infants. Through the perinatal center, Rush offers an extensive series of classes for physicians, nurses and other health professionals. Other centers are housed out of the Other centers are housed out of the University of Chicago Perinatal Center; John H. Stroeger, Jr. Hospital of Cook County Perinatal Center; Northwestern/Childrens/Evanston Perinatal Center; University of Illinois /Christ Perinatal Center; Loyola University Perinatal Center; Northwest Illinois Perinatal Center - Rockford Memorial Hospital; North Central Perinatal Center - St. Francis Hospital; South Central Illinois Perinatal Center - St. John’s Hospital; Southern Illinois Perinatal Network - SSM Cardinal Glennon Children's Medical Center and SSM St. Mary’s Health Center.

These regional networks have been widely credited as one of the principle reasons for the rapid decline in neonatal mortality rates in the last several decades. Although, the other principal reason is the introduction in the late 1980s of surfactant replacement therapy, which reduced the incidence of lung disease in newborns.

In Illinois, especially the Chicago area, Preeclampsia Foundation volunteers have been making presentations about the Foundation to various perinatal networks. These volunteers share their stories and information about resources available through the Foundation. They also ask for input on what additional materials would be helpful. From these discussions came the development of a unique HELLP syndrome seminar involving a point-counterpoint type of presentation contrasting the input of Dr. Judith Hibbard of the University of Illinois-Chicago against that of HELLP survivors' real world experiences. As a result of these presentations, orders for the Foundation's patient education materials have increased tremendously. These interactions have also provided good opportunities for raising awareness about upcoming Promise Walks for Preeclampsia™.

Debbie Schy from Advocate Lutheran General Hospital is one of the current co-chairs of the Perinatal Outreach Educators of Illinois and has attended presentations from Foundation volunteers. "We're so appreciative of the volunteers from the Foundation," said Schy. "They are a phenomenal group and we are lucky to have you here."

The Foundation is working with local volunteers to take the success we've enjoyed in Illinois to other major markets across the nation.

 

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Is there a nutritional connection to preeclampsia? That idea seems plausible at first, as when the blood samples of women have been analyzed, some researchers have found altered levels of various vitamins and minerals. Furthermore, preeclamptic women have altered patterns of weight gain during pregnancy; and obese women are more likely to develop preeclampsia.

 

Such considerations may lead one to speculate that certain diets may prevent or reverse the disease, in which case the appropriate diet becomes a therapeutic intervention. However the best research to date suggests this just isn't so.

 

Reviews of all the trials we could locate show that the major and well-designed trials mainly show no benefit. The very large trials show either no benefit to the generalized population (i.e. Calcium supplementation), or even potential harm (i.e. Vitamins C and E). Likewise, attempts to alter rate of maternal weight gain during pregnancy towards normal levels does not alter preeclampsia rates either.


In some instances, preeclampsia itself might be causing the alterations in nutritional status. The placenta, because it is shallowly implanted, needs to use other strategies to improve its ability to ferry nutrients to the fetus, strategies that include altering the maternal metabolism. In addition, obese women may be more likely to carry genes that both make them more likely to develop obesity in a modern environment and to develop preeclampsia in pregnancy.


The example of Vitamin D shows how one such supplementation research line has developed and been disproved. Sure, vitamin D levels are lower in early-onset preeclamptic women, but this happens once the symptoms of the disease have already appeared. And if we check women at the end of the first trimester, the women who will go on to develop preeclampsia cannot be picked out of the rest of the population. Some reviewers wonder if the researchers analyzed the correct form or metabolyte of Vitamin D when deciding if the woman is "deficient." Supplementing vitamin D doesn't seem to do much beyond raising vitamin D levels in blood work

 

That said, there is an important role for nutrition in pregnancy and it behooves everyone to check with a qualified health care provider to assess the appropriateness of their diet as soon as they learn they are pregnant.

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On May 24, 2012, the U.S. Senate passed the Food and Drug Safety and Innovation Act, which reauthorizes funding for activities related to the drug and device approval process at the U.S. Food and Drug Administration (FDA). The legislation also includes requirements and provisions for faster review of new and innovative therapies in order to allow patients to be able to access these therapies more quickly. The next step is for the U.S. House of Representatives to pass the bill, and then a final bill will go to the President for signature.

During debate on the Senate bill, Senator Mark Warner (D-VA) spoke on the necessity of finding ways to strengthen and improve the FDA’s review process of new and innovative diagnostic tests, including biomarkers. While biomarkers are not specifically addressed by the legislation, during his remarks, Senator Warner specifically cited preeclampsia as an example of why the country needs to move biomarkers forward and develop a better process for the FDA to work with industry. The following is a copy of the Senator’s remarks as recorded in the Congressional Record:

“Preeclampsia is a disorder that affects hundreds of thousands of pregnant women every year, which undiagnosed, can put a woman at risk for death and the fetus at risk of still-birth.

Doctors currently use a mix of imprecise signs and symptoms to diagnose it but often times such signs and symptoms are wrong. However, researchers have found a biomarker—a particular biological process or sign—that can accurately identify women with preeclampsia that are at risk for pregnancy complications.

Unfortunately, tests for novel biomarkers are taking five or more years to get approved by the FDA, delaying patients from receiving the benefits of more accurate diagnoses and treatments.

I was pleased that a recent commitment letter between the FDA and industry specifically mentions the FDA’s commitment to work together with industry to create a transitional IVD, or “T IVD” process for the development of tests for novel biomarkers.

I look forward to seeing how this T IVD process develops in discussions between FDA and industry and am interested in progress towards its implementation, which supports advances in the sciences and promotes access to these emerging diagnostics.

If reducing healthcare costs is a national priority, we need to act today. I encourage my colleagues to pass S. 3187 and allow the FDA to work more closely with the medical industry to safely bring new technologies to the marketplace.”

The Preeclampsia Foundation is engaging with industry and the federal government to ensure biomarkers for preeclampsia can be carefully considered and the barriers to movement can be understood and addressed. The Foundation is pleased to have Congressional attention focused on this issue.

 

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Last week, the Supreme Court upheld the constitutionality of The Patient Protection and Affordable Care Act, otherwise known as the "health reform law." This means that implementation of this landmark legislation can continue to move forward. However, the law continues to be the subject of debate through this year's presidential and congressional election cycle, and depending on the election results could be altered by Congress and the White House in the future. As it currently stands, the law directly benefits childbearing women and newborns by:

  • prohibiting the use of pregnancy as a preexisting condition by health insurance providers;
  • widening access to certified nurse-midwives by eliminating inequities in how they are reimbursed under Medicare;
  • paying for home visits by nurses for at-risk families during or after pregnancy;
  • expanding access to primary maternity care by improving Medicaid coverage of freestanding birth centers;
  • expanding access to Medicaid and affordable private health insurance for women of childbearing age who are now uninsured or under-insured;
  • requiring maternal health coverage as an essential health benefit to be provided by individual and small health plans offered within state health care exchanges.*

As the election nears, we will continue to keep you updated on issues related to maternal health that are affected by the health reform law.

*Some information above provided by Childbirth Connection

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By Dr. Anne Wallis ~ Who remembers the first season ER episode "Love's Labours Lost"? The answer: pretty much anyone who ever watched ER! In the episode, a pregnant woman presents to the emergency room with a complaint of bladder problems, has a seizure and later dies. This was my first exposure to the hypertensive disorders of pregnancy. Eclampsia is, thankfully, rare, but it carries a high case fatality rate for the mother and/or the infant. Gestational hypertension and preeclampsia are far more common, affecting between 5% and 8% of all pregnancies in the US. Moreover, these conditions are on the rise and globally, these conditions are a leading cause of maternal and infant illness and death.

Obstetric providers are acutely aware of the dangers of preeclampsia because of its potential severity and rapidity of onset and progression, making high-quality prenatal care and patient education essential.

Unfortunately for patients, preeclampsia education is not a required component of prenatal care visits, though the Preeclampsia Foundation is working hard to change this. Perinatal practice guidelines currently published by the American Academy of Pediatrics (AAP) and the American College of Obstetricians and Gynecologists (ACOG) provide no guidance to providers regarding patient education to help women recognize early signs and symptoms of preeclampsia, which could guide them to early diagnosis and improved clinical management.

Little is known about how many prenatal care providers discuss preeclampsia with their patients or if women understand what is communicated to them when such discussions occur. In response to this fundamental gap in knowledge, the Preeclampsia Foundation conducted an internet-based survey in March and April of 2008 to determine what women learned about preeclampsia in the context of prenatal care during their first pregnancy (2000-2008). The study is currently being submitted for publication, but the results were surprising and could help health care providers make informed decisions about patient education.

Only 40% of the women indicated that their prenatal care provider "definitely" described preeclampsia; 35% said they were "definitely not" given information about preeclampsia, and the remaining 16% did not remember. Of those who definitely had preeclampsia described to them, slightly more than half said they "fully understood the explanation," 37% "understood most of the explanation," while 15% either "understood some of the explanation," or did not remember.

Here is the really interesting bit: a full 75% of women who said they "definitely" received information on the signs and symptoms of preeclampsia and understood "fully" or "most" of the explanation, indicated that because of this information, they took one or more of the following actions:

Reported symptoms to their provider,
Went to the hospital,
Monitored their own blood pressure,
Complied with an order of bedrest,
Responded in some other way (e.g., made dietary changes, did their own research on preeclampsia).

However, of those who did not understand the explanations provided, only 6% took any action based on the presence of symptoms.

Survey participants tended to be well-educated and middle class, making the importance of what we learned from this online survey clear: even among well-educated, middle-to-high income women, a substantial proportion were not told about preeclampsia or did not fully understand their providers' explanations about the signs and symptoms of preeclampsia. Our findings likewise suggest that when women know how to recognize the signs and symptoms of preeclampsia and they understand the explanation offered, they are likely to act on that information and contact their provider or go to an emergency department.

It follows logically that women with fewer resources and less education, who may also be at higher risk for preeclampsia, may receive and retain even less information; and due to disparities in health care access, they may not have adequate resources to report symptoms to a provider.

Education about preeclampsia and related hypertensive disorders must continue into the post-partum period so that women can recognize prodromal symptoms of post-partum and late post-partum eclampsia. Most cases of eclampsia that develop after the first 48 postpartum hours are first seen in an emergency department. A woman with legitimate complaints who presents at an emergency department may leave untreated if the staff are emergency or trauma providers, not OB/GYN specialists. Thus, women not only need basic education in preeclampsia, but they require repeated education to ensure they understand the risks and can be empowered with knowledge that will allow them to advocate strongly for their own care.

We offer several recommendations based on our observations:

More research is needed to fully assess the health literacy, knowledge, attitudes, and behavior of pregnant women and to examine the practices of prenatal care providers;
ACOG/AAP guidelines for prenatal care should include more deliberate and detailed explanations of the hypertensive conditions of pregnancy;
At all prenatal visits, providers should clearly explain warning signs and symptoms with directions about what their patients should do if they experience or recognize any of the signs or symptoms.
All women should be hearing a strong public health message that they can and should be advocates for their own care.

Guest columnist Dr. Anne B Wallis, University of Iowa, also wrote on this topic in her blog, [bloga epidimiologica]. It's worth reading the longer version, especially if you like the science-y stuff.

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That was my goal with the once-in-a-lifetime opportunity I was given to present one of three President's Program lectures at the American College of Obstetricians & Gynecologists' Annual Clinical Meeting.

"Patient Perspectives on Preeclampsia" - or as I joked, "lessons from this side of the stirrups" - was well-received by the standing-room-only crowd in the main auditorium of the San Diego Convention Center. More importantly, the many comments I received after the lecture satisfied me that I achieved my objective - to reach their hearts with compelling, real-life stories illustrating the impact preeclampsia has on mothers, fathers, and babies; and to reach their minds by inspiring clinical practice behaviors that include educating each and every expectant mother with non-alarmist, but sound information about the signs and symptoms of preeclampsia, as well as addressing the psychological and long-term physical impact of the disease. (Presentation available for purchase)

If you have ever shared your experience with us, know that you, and the stories of 10,000+ other women, were with me in spirit on May 7. The ACM News wrote about my presentation and the other two preeclampsia lectures (delivered engagingly by renown preeclampsia researcher Dr. James Roberts and clinician Dr. John Barton).

The awareness and education theme was echoed in a Foundation news announcement at the San Diego Promise Walk. With co-authors Dr. Doug Woelkers and Ms. Jennifer Carney, we announced our official list of the Top 10 Pregnancy Guidebooks. This report was created using five criteria designed to ascertain how well the books treated the topic of preeclampsia in a way that would be useful to the one in 12 pregnant women whose pregnancies become complicated by it. Several of the top guidebook authors have already contacted us, thankful that their diligence has been recognized, even while women's real-life feedback has reinforced our findings that the bestsellers aren't always the best books.

And although I'm no Twitter expert, it was fun to join College staff and two Ob/Gyn physicians on a Twitter Chat on preeclampsia that resulted in tens of thousands impressions, and to shoot a quick interview that was aired onsite for the 5,000+ people in attendance.

By all accounts, the entire experience left us all exhausted, but exhilarated. We frequently tout the importance of a patient-provider relationship and it was abundantly evident that the country's leading Ob/Gyn organization shares this goal. We are very grateful.

 

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May and Mother's Day are so intertwined that it's hard to think about one without the other, especially here at the Preeclampsia Foundation, where we've built a nationwide campaign at www.promisewalk.org/campaign to get the word out about preeclampsia - the "thing" that for many survivors turned our entrance into motherhood into a nightmare.


I believe celebrating mothers is a commemoration of extremes. Not just because preeclampsia is an extreme condition, but because the mothers I am privileged to know represent the extremes that make up all mothers: soft and tough, nurturing and driven, catalytic and comforting, impatient and optimistic.


Next Monday, I'll be representing you to 5,000 Ob/Gyns at their Annual Clinical Meeting in San Diego. You've heard us espouse the importance of the patient-provider relationship; now we need "the docs" to embrace their half of the partnership. Who better than an "extreme" mother to tell 'em so?

And, starting next weekend, that same message about the power of knowledge - along with a clarion cry for more research to solve this puzzling problem - will be spread across this country, via The Promise Walk for Preeclampsia. Which Promise Walk are you supporting? We use the walks to force ourselves into the consciousness of our communities and to say "Do not take for granted this thing we call birth." It is can be the most beautiful thing and the most tragic thing to happen to us. Help us end the tragedy.

"Before you were conceived, I wanted you. Before you were born, I loved you. Before you were here an hour, I would die for you. This is the miracle of Mother's Love." ~ Maureen Hawkins


"Well behaved women seldom make history" ~ Laurel Ulrich

Two quotes representing who we are at the extremes. The first one, obvious. The second one, despite its Mae West undertones, I like to think of as the reason "bold" and "influential" are two of our organization's core values. We're here to be effective and sometimes that means making some noise, ruffling some feathers. I guess that brings me back to my lecture to 5,000 physicians. I hope they're ready!

There are lots of ways you can be a mother at the extremes this month.

  • Join us for one of our Twitter Chats with the March of Dimes (Thursday, May 17 at 1 PM) and with HealthyWomen.org (Thursday, May 24 at 12 noon).
  • Click to make your Facebook profile picture our Preeclampsia Awareness Month image throughout the month of May.
  • Share your story in your local community, using any of the resources available on the Awareness Month Campaign page.

We're honored to have you in our tribe. Happy Mother's Day!

 
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The October 2011 issue of Expectations (featuring patient-centered care month) highlighted two powerful, silver-screen accounts of parents confronted with the unthinkable: a child's health crisis with no known cure leading doctors to tell them "there is nothing more we can do." Those simple words - and the prospect that there was no hope - prompted these every-day parents to take on the most important "projects" of their lives: saving the lives of their children.

These extreme examples of patient advocacy provide a humbling reminder of how important our own voices - and understanding of our conditions - are in our individual health care (during pregnancy and otherwise).

In thinking about patient advocacy in relation to my own pregnancy, I am ashamed I didn't ask more questions when I was ordered to take my first (and then second!) 24-hour urine test. I didn't know that a 24-hour urine test wasn't routine, and my doctor was certainly not offering up any unsolicited explanation. I was too shell-shocked to ask any intelligent questions when she took my blood pressure a few days after I returned my second urine sample and simply told me I had "earned a vacation in the hospital." In my recollection - and that of my entire family, who shared in all the details of my pregnancy and have since been grilled on this subject - there was no mention of the word preeclampsia or HELLP syndrome until much later.

Those were the opportunities I missed. It wasn't until weeks later when I had come out of a coma and begun recovering from multiple organ failure that I saw a glimmer of my ability to advocate for myself. Growing tired of the feeding tube that was giving me sustenance (and a very obvious indication and reminder of my less-than-hopeful situation), I became committed to getting it out. I lobbied my doctors for a follow-up swallow test in the hopes that this would be the one that I would pass. I did, the feeding tube was removed, and it wasn't much longer until I was home, caring for my baby daughter, and back to a "normal life." Ultimately it was an important milestone representing the first step I could take toward setting my own recovery process.

CNN medical reporter and author Elizabeth Cohen advocates for making sure we get our business "DUN" when at the doctor's office: find out our diagnosis, understand the plan to make us better, and learn the next steps toward feeling better. She recommends the following simple questions to get the ball rolling and to gain clarity on our personal health status:

  • What's my diagnosis?
  • Which drugs should I take, if any?
  • Are there any other treatments or instructions?
  • Do I need a specialist? If so, do you have a specific recommendation?
  • How long should I wait for this treatment to work?
  • If my problem doesn't get better in that time, what should I do?
  • Am I awaiting any test results? If so, when are they due back in your office?


And, during pregnancy, the following questions may be important to ask:

  • What was my blood pressure?
  • How much protein was in my urine today?
  • Does my weight gain over the last few weeks seem okay?
  • What other symptoms should I be looking out for?

I asked none of these questions and didn't appreciate enough how the age of managed care, rushed doctor's visits, and healthcare reform might be affecting my pregnancy. It wasn't until much later when I needed hope that I began advocating for myself. Now more than ever, though, we all need to prepare to work with our doctors to get the best care we can - and to have hope that there can be a positive outcome.

 
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Nadine Brunk, a Certified Nurse-Midwife, started a program called Midwives for Haiti (MFH). We’ve been talking to Nadine about how we can extend our work in patient and community education to prenatal care settings like those found in Haiti. I feel like we have much to learn from Nadine, as one minute with her blog will show you. Recently, she shared this amazing story with us.

It was February 5th. The pink Jeep took four midwives to do the monthly prenatal clinic at Saltadere [a town in rural Haiti]. On the way, they stopped at the Birth Center at Thomassique to drop off two nurse-midwives who were going to conduct continuing education with the birth center staff on the difference between chronic hypertension and preeclampsia and the treatment protocols for both.

Thomassique is an hour's ride from Hinche and the road is very rough. Saltadere is another hour east of Thomassique and there is no birth center there. When the midwives arrived, they set up their stations and proceeded to see 26 pregnant women and one who had a negative pregnancy test. One woman was treated with Aldomet for chronic hypertension at 20 weeks gestation. Her blood pressure came down to normal one hour after taking her medication so she went home with a month's supply.

But there were five women who were very sick. They had very high blood pressures related to preeclampsia - the major killer of pregnant women in Haiti. (In 3 of the charts I saw records of 194/120, 208/128 and 154/100.) Two of them were in labor and vomiting. Three were term pregnancies and two were preterm.

So when the Jeep stopped in Thomassique at the end of the day to pick up our midwives, Diane and Marion, they told the driver to "Prese, prese" (hurry, hurry) because they had five high-risk pregnant women to take to the hospital. Two were in labor.

It was a harrowing ride. One of the risks of moving women with high blood pressures is that they will have seizures. Quiet, still, and lying on the left side would be the safest way to transport them. But there was no room in the Jeep for them to lie down and that Jeep ride over that bumpy road is anything but quiet and still.

Diane and Marion found bags for the 2 vomiting women and tried to make others comfortable sitting on the floor with their heads in the midwives' laps. By the time the ride was over everyone on the Jeep was nauseated. The midwives had started IV's on all the pregnant women so that they would be well-hydrated for whatever needed to be done at the hospital. It was the best they could do. They feared the two in labor would deliver on the way and that the others would have seizures from the bumpy ride.

All eventually safely arrived at the hospital and were turned over to the midwives (all MFH graduates) at the maternity unit. Before the night was over 4 had delivered and were still on MgSO4 for severe preeclampsia and two preemie babies were transported to Cange. The next morning the 5th was being induced for being 2 weeks postdate and delivered later that day, still on MgSO4.

The good news is that, although we do not know the outcomes for the babies who went to Cange, we know that the other three babies and all the mothers did well and were eventually discharged. The following morning, two of the women, who were still in the same clothing from the day before, had no family to take them home to Saltadere and no clothing for their babies so Marion paid for their moto-taxi rides home and gave them cloth diapers, onesies, and receiving blankets from the MFH supply closet.

I know this is only one day and one story from Saltadere where the mobile prenatal clinic's monthly trip to Saltadere saved the lives of mothers and babies.

Nadine wants our help: “A graphic-based educational tool to use in rural Haiti about signs and symptoms of preeclampsia would be great. We teach matrones who cannot read and write, and deliver skilled prenatal care to about 500 women per month in the Central Plateau. Haitians respond well to visual learning.”


One of the benefits of the Illustrated Symptoms Tear Pad is its application in a multitude of settings and languages. With some minor language translation and a check on cultural sensitivity, we are eager to equip health care providers in low resource settings with this important patient and community education tool.

 
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By Dr. Linda Burke-Galloway ~ October is Patient Centric Care Month, a term you will likely see more of as our healthcare system moves further into the 21st century. What does 21st century healthcare look like? It means that all of your records will be computerized and not on paper. It means that you will receive your "chart" on a flash drive so that when if you leave your physician's office and go to a hospital, your health records remain with you. Gone will be the days when your labs will have to be repeated because no one can locate your prenatal chart. Repeating labs is not only annoying, it's costly.

"Patient Centric Care" means that the emphasis will no longer center on your physician. Or a hospital. Or an ambulatory care center. It will be centered on you, the patient. Why? Because at the end of the day, if you're not well, if the outcome was less than expected, then the system has failed. The $2.3 trillion dollars spent each year on healthcare has not provided a "return" for its investment.

Traditionally, the physician or healthcare provider was looked upon as an authority, but you, the patient, have now taken center stage. Under patient-centric care, healthcare providers will function more like coaches and you, as the patient, will be expected to become more involved in your care. For a pregnant mom, this is critical. Gone will be the days of physicians "rushing through patients," barely listening to the fetal heartbeats and missing important clues that could compromise your care. Why? Because of the use of electronic medical records and the new system of "pay for performance." The electronic medical records have safety measures programmed into its system making it difficult for doctors to miss important red flags. Physicians will not be paid based on their number of office visits but by the outcome of the patient. Did the care provided by the physician improve the patient's health? That is the basis by which they will be paid.

One of the main reasons for missing a diagnosis of preeclampsia is that someone is not paying attention. Somewhere during the course of your care, someone drops the ball. The blood pressure that has been creeping up for the past 2 visits is not addressed. The protein in the urine ignored. The 5-pound weight gain in one week overlooked. The new complaint of a headache not heard. Unfortunately preeclampsia does not always present in textbook-fashion in the manner that we were taught in medical school. It has many disguises and there must be a high index of suspicion for those disguises to be recognized.

In business, there is something called a "butterfly effect" where one "small" missed detail can cause big problems. The same principle can be applied to medicine. When a "small" risk factor of a patient is overlooked, it places her in harm's way. Women who are pregnant for the first time, especially those who are under 18 and over 35, are at risk for preeclampsia. All African American women are at risk. Women who have a history of hypertension are at risk. All of these patients should be duly informed at their first prenatal visit of the potential for developing preeclampsia. The purpose is not to alarm but to inform.

Patient-Centric-Care Month is a time for celebration. The patient has finally returned to center stage. Although long overdue, better late than never.

Linda Burke-Galloway, MD, MS, FACOG, is the author of The Smart Mother's Guide to a Better Pregnancy, one of the Top 3 books in our Report on Pregnancy Guidebooks. She is also an Ob-Gyn Patient Safety and Risk Management Expert.

 
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Professors Chris Redman and Isabel Walker, co-authors of Pre-eclampsia: The Facts (Oxford University Press 1992) and co-founders of Action on Pre-eclampsia (APEC) in the UK, are seeking input from members of the Preeclampsia Foundation for their latest book, The Pre-eclampsia Survival Guide.

The new book, also co-authored by Joyce Cowan, a midwife who is Director of New Zealand APEC (NZAPEC), will be a comprehensive guide to pre-eclampsia for women and midwives. It will cover everything from historical theories to current treatments; from causation to detection; from prevention to management. It will be rooted very firmly in the real experiences of women who have suffered pre-eclampsia - and that's where you come in.

The authors are keen to illustrate their key points with real life case histories gathered from several different parts of the world. You could be part of this process by contributing to an online survey. Your input will only be used for the book, not any other research studies.

The Pre-eclampsia Survival Guide is expected to be published in the spring/summer of 2013. We will be reviewing the book in draft form to ensure that North American management practices are represented, since the intended audience includes all English speakers worldwide and, of course, we will have the finished product available in our Marketplace.

Despite conflicts over the hyphen in "pre-eclampsia", our universal understanding and management of the hypertensive disorders of pregnancy is mostly aligned in high resource countries. As with most medical issues, there will always be a variety of opinions, especially in a disorder with the moniker "the disease of theories", but we expect this will be a very sought after and trusted reference book for patients and providers alike.

 

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The Preeclampsia Registry

    The Preeclampsia Registry is a "Living Database" bringing together those affected, their family members, and researchers to advance knowledge and discover preventions and treatments for preeclampsia, HELLP syndrome, and related hypertensive disorders of pregnancy.

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