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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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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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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At the Society for Gynecologic Investigation (SGI) Annual Scientific Meeting in San Diego, Calif., in March, the Preeclampsia Foundation, in collaboration with lead authors Dr. Ineke Postma, Dr. Gerda Zeeman, Dr H. Groen of the University Medical Center Groningen, the Netherlands, and Dr. Thomas Easterling of the University of Washington, presented a poster on cognition, quality of life and social functioning after a hypertensive pregnancy. Many formerly preeclamptic women report difficulties with memory or word choice postpartum, but so do many women with normal pregnancy courses. The unanswered question: what is the likelihood that preeclampsia causes brain changes independent of pregnancy itself? If there are preeclampsia-specific changes, can those be separated from the trauma of a medical crisis?

Enrolling more than 1,000 participants in this study, the Preeclampsia Foundation's survey queried women with (cases) and without (controls) a history of hypertension in pregnancy. Participants anonymously completed an online survey assessing their cognitive functions, their quality of life, and their social functioning. The study found that the population of women with a history of preeclampsia scored statistically significantly lower on all three assessments. Although there was significant overlap between the populations, the average score for the populations as a whole was shifted - which suggests that there is actually real change triggered by preeclampsia - and that shift persisted after the populations were adjusted for things that could potentially affect the scores, like current use of blood pressure medication. Seizure was particularly strongly correlated with long-term cognitive difficulty. The study will also be presented in July at the International Society for the Study of Hypertension in Pregnancy (ISSHP) World Congress in Geneva, Switzerland.

"More and more information is emerging suggesting that preeclampsia is a condition with long term implications," explained the lead author on the study, Dr. Ineke Postma. "Preeclampsia can be a very emotional and sometimes traumatizing experience with some women complaining about ongoing memory or attention-deficit problems. In order to provide adequate long term support to preeclampsia survivors, we need to identify the actual scope of the problem. This study is an important step in that direction."

Although this study used subjective neurocognitive testing (that is, the questions and test were not administered by a separate researcher, but self-reported), the study has some potential weaknesses, but it is an important step to investigating this question: does preeclampsia result in some level of permanent damage to your brain?

These kinds of research collaborations are but one way we catalyze research. See our research section for more information about our research initiatives.

 

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Every two years, the International Society for the Study of Hypertension in Pregnancy (ISSHP) World Congress brings together the top researchers and clinicians in the field of hypertension in pregnancy to share innovations and encourage collaborations in research and clinical practice. As in year's past, the Preeclampsia Foundation participated in the 2012 meeting held July 9-12 in Geneva, Switzerland.

Like the current Olympics which inspire us to "Citius, Altius, Fortius" (Latin for "faster, higher, stronger"), the World Congress inspires participants to demonstrate new found knowledge and skills, and to push each other forward. In the enthusiasm of science-swapping and networking at a meeting like ISSHP, sometimes the larger purpose of our endeavors - saving lives and improving health outcomes of mothers and babies worldwide - may be forgotten by those racing from one intriguing lecture to the next.

That's where the Preeclampsia Foundation comes in. It is a testament to the extraordinary outreach of our mission that not only are we widely recognized as a key patient resource by individual health care providers, but are sought out by industry leaders as THE voice to provide a reminder of the patient perspective amongst the plethora of science and research. Our impact can be summarized in that one word: "voice." By joining our members' collective experiences along with the experience of wonderful new friends from European patient advocacy groups, we have become a powerful entity for change. A voice that is not only heard, but valued.

The Foundation's efforts to improve health care practices and catalyze research were also felt at ISSHP. Two investigators presented research findings developed through our collaboration in the Brain Study- and for many of our readers - it was your participation in this study that provided such meaningful data. In one oral presentation, findings suggested an association between history of preeclampsia and post-traumatic stress disorder. In the other, findings suggested an increase in neurocognitive disorders among women with history of preeclampsia. Both studies are being developed for publication and will be promoted via this newsletter when they're published. Both studies were exceedingly well received, with other researchers encouraging us to conduct further studies on long-term patient impact to improve clinical care.

We also presented two research travel grants, which helped promising young investigators attend this important meeting, interact with seasoned researchers, and become committed members of the hypertension in pregnancy community.

Every day, our website and social media platforms receive thousands of visitors from more than 200 countries around the world, so it was particularly wonderful to meet global health care providers who interact with those patients and who themselves use our website regularly. Unfortunately, we are sometimes the only source for additional patient support and education. So though no one received any laurel wreaths or gold medals during the Foundation's international journey, the patients are the real victors through the furthering of global preeclampsia research.

 

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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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Margaret Meade once said, "Never doubt what a small committed group of citizens can do to change the world. Indeed, it is the only thing that has."

At the Preeclampsia Foundation, we like to say, "Never doubt what a large cohort of preeclampsia survivors can do to catalyze research. Indeed, it is the only thing that will."

Welcome to our Special Research Edition of Expectations.

I've heard thousands of stories with poor outcomes that started with "If only I had known" or "If only I had known and pushed harder to be taken seriously." What women wanted to know were the signs and symptoms of preeclampsia. With that information, they would have immediately responded to that unrelenting headache or the searing pain running up over the shoulder. They would have known to push back, if their complaints weren't taken seriously, with a request to be have their blood pressure checked, be seen by an expert, or have blood drawn for analysis.

After so many stories, we initiated research to quantify what we already knew anecdotally regarding the need for patient education. Our own 2008 "Lack of Preeclampsia Awareness Study" and studies performed by Dr. Whitney You and published in 2011 in the American Journal of the Obstetrics & Gynecology, confirmed our suspicion that not enough women are informed about preeclampsia, and even if they are informed, comprehension is poor.

Thus began an active part of our mission: patient education. Those outcomes are now being realized as the professional organization that board certifies the majority of our nation's obstetricians will be formally recommending patient education as a regular part of prenatal and postpartum care. Our Illustrated Preeclampsia Symptoms Tear Pad has been included in a California state-wide collaborative, CMQCC, that is intended to reduce maternal deaths.

Improving patient education tools and methods is just one way that women affected by preeclampsia -- our "cohort" -- identified a problem and then worked to change it. (Our work in patient education is definitely not done, but enormous progress has been realized.)

But can preeclampsia survivors advance medical research? Can we push scientists more quickly to a prevention, a cure, or an intervention (other than delivering the baby)?

Before the summer is out, we will be launching The Preeclampsia Registry, a living data source of patients and family members, to accelerate research.

There is plenty of precedent that citizen scientists, armed with their own "stories" and DNA, have successfully isolated genes responsible for their disease, or identified useful therapies. We, too, can catalyze research, equip researchers with novel hypotheses and a cohort -- a cohort not just willing, but impatient to see progress and to use their own cases as the enabling data.

What's ahead for The Preeclampsia Registry?

Approximately 100 "beta users" have already enrolled in the registry to help us test the technology. We have already secured approval from our Institutional Review Board. Before the summer is over, the registry will be open for public enrollment, including international registrants. Participants will include those directly affected and their female relatives who will enter self-reported information, upload medical records, and, in Phase 2 (planned for next year), biological samples such as DNA.

Researchers will be able to do studies over long periods of time, across geographical boundaries, and within various demographic groups.

How can you participate?

1. Check back often at www.PreeclampsiaRegistry.org for the upcoming announcement about the Registry's public launch.

2. Participate in our soon to be announced Patient Advisory Council, a diverse group of affected individuals who will influence research questions.

3. Give a gift to the Preeclampsia Foundation and, if you wish, earmark it for The Preeclampsia Registry.

I'm looking forward to joining Registry participants as we add our collective experiences to the scientific body of knowledge that will make a difference for future mothers and their babies!

Warmest regards,

Eleni Tsigas
Executive Director

 

 

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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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