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Can Your Stories Really Advance Research?


Eleni Tsigas

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 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 oversees 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 Preeclam
psia Registry?

Approximately 100 "beta users" have 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.


No one's identifiable information will be shared with investigators. 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 at for the 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!


Eleni Tsigas

Executive Director 

Medications in Pregnancy  
Dr. Jason G. Umans 


Editor's Note: Dr. Umans is Scientific Director of the Biomarker, Biochemistry, and Biorepository Core Laboratory at MedStar Health Research Institute, Director of Research Education and Training for the Georgetown-Howard Universities Center for Clinical and Translational Science, and serves as Associate Professor of both Medicine and of Obstetrics and Gynecology at Georgetown University. A more complete biography is associated with the article on our website.    


Safety and Efficacy: These Are the Questions


It's time to resolve the lack of knowledge about optimal use of medications in pregnancy. Despite advances in drug research and policies surrounding clinical trials, we still don't know about the safety of most drugs or the full risks of untreated disease to both the mother and fetus (unborn baby). Indeed, most women and their physicians would be disappointed by how little we really know about the optimal use of medications during pregnancy.

Prior to 1993, pregnant women (or women who might conceive) were specifically not included in drug clinical trials. Thus, most of the safety data for prescribing drugs during pregnancy are either extrapolated from animal data (which can either underestimate or overestimate risk in pregnant women and their unborn babies) or from limited, often uncontrolled reports of "off-label" drug use (use for other purposes than the intended treatment) or adverse outcomes during pregnancy.


The optimal dose of a drug used during pregnancy should maximize therapeutic benefit while minimizing the risk of damage or toxicity to the mother, fetus, and placenta. Obviously, too high a dose could cause toxic effects, out of proportion to therapeutic benefits. Less obviously, too low a dose may deny women any benefits of treatment, while still exposing them to some risk.


Determining the best dose is difficult because a woman's ability to metabolize and excrete drugs, as well as her body's response to drugs, changes dramatically over the course of her pregnancy. A case in point is that most drugs are eliminated from the body either by enzymes in the liver or by excretion into the urine, and the activity of both of these processes can be increased by up to 50% in most pregnant women. This fact is rarely taken into account.


It is a basic principle of pharmacology that, when we weigh potential harms of a drug treatment, we should do so at a dose and dosing interval that maximizes potential benefit. Unfortunately, we lack this sort of dosing information for almost all drugs prescribed to pregnant women.


Most women will require one or more prescription drugs during pregnancy despite the fact that almost no commonly used drugs have been tested specifically for their use in pregnancy. Consequently, while we always have some information about fetal safety (more often in animals than in humans), we know almost nothing about maternal safety, about choosing the right dose for a pregnant woman, or about how effective the drug will be during pregnancy.


My colleagues and I continue to be amazed that in the 21st Century, in most cases, physicians have to use their best judgment to weigh risks and benefits, even though they rarely know the optimal dose of a drug that should be prescribed to their pregnant patient or the full risks of untreated disease.



A Call for Well Designed Research and Clinical Trials


It is the job of clinical trials to determine safety and efficacy, including proper dose response. Men comprise the largest proportion of subjects studied in most drug research. In most cases where there are data, research has shown that different (and, surprisingly, often higher) drug doses are required to achieve the desired drug effects in pregnant women in comparison to non-pregnant women or men. We ask, "Is the choice of not treating a woman during pregnancy better than dealing with the challenges that accompany finding the best treatments?" Surely, "yes" cannot be our answer for this would deny women the potential benefit of newer and, perhaps, safer and more effective drugs than are used currently for underlying maternal illnesses. Furthermore, we need to accelerate the development of sorely needed drugs to prevent or treat disorders unique to pregnancy such as preeclampsia, preterm birth and fetal growth restriction. 



A Call for Overdue Reclassification of Drugs, Based on Accurate Risk and Clinical Considerations


Current medication labeling with respect to pregnancy is dictated by law and regulated by the US Food and Drug Administration (FDA). This labeling typically reports only on fetal safety issues with respect to the use of the medication and provides no information on changes in drug dosing or effectiveness during pregnancy. For decades, the FDA has used a system of letter categories to classify drug risks to the fetus, focusing overwhelmingly on evidence of birth defect risk, without consideration of the risks of untreated or undertreated disease and of appropriately tailored drug use in pregnancy.



US Food and Drug Administration (FDA) Drug Risk
Classifications System for Pregnant Women





Adequate and well-controlled human studies have failed to demonstrate a risk to the fetus in the first trimester of pregnancy (and there is no evidence of risk in later trimesters).


Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women OR Animal studies have shown an adverse effect, but adequate and well-controlled studies in pregnant women have failed to demonstrate a risk to the fetus in any trimester.


Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.


There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.


Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits.



The FDA system differs from grading systems in other countries by depending more heavily on animal data when human data are limited and having fewer, broader, and less specific categories. Most drugs used in pregnant women fall in FDA category C. This is anything but reassuring, as the drugs in category C have not undergone adequate and well-controlled studies in humans and have been correlated with adverse effects on the fetus in animal studies.


Several category D and X drugs are also used in pregnant women. For example, aspirin, a category D drug, is commonly used. There are cases in which category D drugs are apparently safe and crucial to the health of pregnant women and their fetuses, such as drugs used to prevent rejection of transplanted organs, despite these drugs being placed in a category defined by studies indicating risk of fetal abnormalities in humans.


An additional quirk of the FDA classification system is that drugs without proven indications in pregnancy will be classified as category X, by default, even without clear evidence of fetal risk, since they are considered to be "without benefit" and therefore must have an unacceptable risk/benefit ratio. By contrast, the "X" category in either the European or Australian fetal drug risk classification systems is reserved for drugs that have such a high risk of permanent harm to the fetus that they should absolutely not be used. This issue is important for the current classification of all statin drugs (which are classified as D, rather than X by the Australian regulators), as these have not been considered previously to have any indications for their use during pregnancy.


There are several interesting examples how research can change everything. One of the major problems with assessing fetal risk is that birth defects occur in approximately 3% of all healthy pregnancies, so we would still observe birth defects (and might suspect fetal dangers) in 3% of women who take even a perfectly-safe drug during pregnancy. Indeed, a classic example relates to the drug BendectinTM-a combination of pyridoxine and doxylamine, which was widely prescribed for "morning sickness" in the 1960s and 1970s. It was removed from the market after a flood of lawsuits blaming it for causing birth defects (without any controlled studies). It was then subjected to perhaps the largest series of studies of drug safety in pregnancy, proving its safety beyond any doubt, leading to the dismissal of all of the lawsuits, and to its classification in category A. This is why controlled studies are so important. By contrast, ACE inhibitors, a class of antihypertensive agents, were originally classified as FDA category C. The classification was only changed to D years after many reports of toxic effects on the fetal kidneys in the latter part of pregnancy. Finally, perhaps surprisingly, among the best and most thoroughly studied of all drugs in pregnancy are those for the treatment of HIV infection, many of which are now classified in category B, and used to effectively prevent the transmission of HIV from mother to fetus. We are fortunate, in a sense that everyone agreed the stakes were so high that the study of these drugs was necessary in pregnant women, rather than leaving physicians and their patients to guess at safety and the right doses to use during pregnancy.


The FDA has long recognized the current system requires a major overhaul to be more informative and useful to clinicians and patients. Over five years ago, major changes to both the pregnancy and lactation subsections of drug labels were proposed to include a narrative summary of risks, clinical considerations to support patient care decisions and counseling, and a data section with more detailed information. The proposed regulations would eliminate the current pregnancy categories A, B, C, D and X in favor of categories that more accurately and consistently convey risk and benefit. Unfortunately, we are still in limbo between the phase-out of the old letter categories, which appear in all textbooks and review articles, and the new, more informative approach, which is yet to be implemented. 


New National Poll Shows Majority of Americans Would Participate in Clinical Trials if Recommended by Their Doctor


"Most Americans believe in the promise of research and are willing to share their personal health data to advance research; yet for many years now the percentage of people who participate in clinical trials has remained incredibly low," said Mary Woolley, president and CEO of Research!America.


Compared to other ways volunteers contribute to the health of society, clinical trial participation is neither as visible nor as much admired. When asked how much they admire volunteers, nearly 70% say they admire organ donors a great deal, followed by admiration for people who give blood (61%); clinical trial volunteers are admired by only 37%.


In recent meetings with experts from minority health organizations, we have learned that there are cultural differences regarding attitudes toward medical research. For instance, African-Americans are often more distrustful of medical research and Latinas require more family involvement in decision-making.   


A recent article of the Society for Women's Health Research (SWHR) makes the point that historically, biomedical scientists and researchers have preferred studying male subjects for a variety of reasons including:

  • The desire both to protect a woman's potential fetus (regardless of whether she is pregnant, uses contraceptives, or intends to conceive) and to avoid legal liability from prenatal exposure.
  • The potentially confounding effects of women's hormonal changes.

SWHR broke down these rationales and sought to have it understood by the scientific community that:

  • The logic that the exclusion of women protects them (or their potential fetuses) is problematic in that protecting women from exposure during research means that women's exposure to a drug being tested is merely delayed until the drug is released and on the market.
  • The fact that a woman's physiology does change throughout her hormonal cycle makes the study of the impacts of these changes crucial.
Read about barriers to participation of women in clinical trials and SWHR proposed solutions by clicking here.

Could a Drug for Heart Disease Treat Preeclampsia? 



Dr. Jason G. Umans

Here is an update on studies underway.  


Pravastatin, a "statin" drug (known scientifically as an HMG-CoA reductase inhibitor) inhibits a key early step required for cholesterol synthesis in the liver and is used widely for prevention of coronary artery disease. Somewhat surprisingly, it is now the subject of two clinical studies (one in the US and one in the UK) to find out whether it might be safe and useful to prevent or treat severe or early-onset preeclampsia.


Animal studies in different rat and mouse animal models, which mimic many of the key characteristics of preeclampsia, have shown that pravastatin improves several of the biochemical measures associated with severe preeclampsia in women. It also seems to improve blood pressure and fetal growth. It is impossible to predict whether these exciting results in mice and rats will translate to either prevention or treatment of preeclampsia in women without well-designed and carefully conducted clinical studies in pregnant women.


Research is now underway that seeks to answer questions on two parallel tracks. The first addresses the question of whether pravastatin improves the health of women who already have severe disease and thus may allow their pregnancies to continue. The second will determine the proper dose to use in a study which will evaluate whether pravastatin can prevent preeclampsia from occurring in the first place.


More specifically, the first study, underway in the UK, aims to determine whether pravastatin improves biochemical markers of preeclampsia (the same ones which are improved in the animal studies) in women who already have early-onset severe disease. The British study is titled "StAmP [Statins to ameliorate early-onset preeclampsia]" ( ISRCTN23410175).


The US study, to determine the proper dose of pravastatin in order to design a subsequent preeclampsia prevention study, is titled "Pravastatin for prevention of preeclampsia" ( NCT01717586).


To read the rest of the article, including references, click here





Editor's Note: The Preeclampsia Foundation is one of the 30 organizations that built the following consensus, and we are part of a few of the subcommittees that are still developing the tools and protocols addressed. 

Every birthing facility in the United States should have specific practices and equipment to optimize maternal safety in pregnancy, according to a recent consensus meeting of national medical organizations.These include so-called "safety bundles," or safety initiatives, of protocols and equipment for preventing and managing obstetric hemorrhage, venous thromboembolism, and severe hypertension, as well as for supporting patients, families, and staff. Specific early-warning criteria should trigger a maternal evaluation, and facilities should regularly review severe maternal morbidity from a systems perspective.


"Motivated by climbing maternal mortality rates in the United States in recent decades, the recommendations build on preliminary success from California efforts to improve maternal safety," said Dr. Elliott K. Main, who co-chaired the "National Maternal Health Initiative: Strategies to Improve Maternal Health and Safety" consensus meeting in New Orleans in May 2013.


"Maternal mortality rates declined in California since 1970, but started increasing again around 2000, so that by 2005, the rate of 17 maternal deaths/100,000 live births was similar to rates in the early 1970s. Nationally, U.S. maternal mortality rates increased from 1980 to 2008, in contrast with decreases in many other developed countries," he said at a meeting on antepartum and intrapartum management sponsored by the University of California, San Francisco.


"Debate continues about the definition of severe preeclampsia, and ACOG should be issuing a presidential task force statement later this year on the topic," Dr. Main said.


"Meanwhile, key elements of a 'safety bundle' for hypertension in pregnancy include having unit-standard protocols and policies for the treatment of severe hypertension and eclampsia, safe use of magnesium therapy, and managing magnesium overdose," he said. "The birthing unit also should have an agreed-upon definition of severe preeclampsia, early warning tools employing vital signs and symptoms, and regular review of all hypertension cases with severe morbidity to look for systems issues. The California Maternal Quality Care Collaborative (CMQCC) is expected soon to publish a California Preeclampsia QI Toolkit for quality improvement, which will be tested in 26 hospitals," he added. 


A poll of the audience found that 31% have a comprehensive, standardized protocol for severe pregnancy hypertension in their hospital, 22% have one that could be improved, 35% don't have one, and 11% had not a clue. (The percentages added up to 99% rather than 100% when the survey results were displayed at the meeting.)


To read the full article by Sherry Boschert, click here

You may be eligible for this study if you have experienced preeclampsia and delivery at or before 34 weeks in either of your 2 most recent pregnancies, and you are currently pregnant. This is a study of a medication that may be useful in preventing recurrence of preeclampsia in women at high risk for recurrence. This is an FDA-approved medication for the treatment of high cholesterol, as well as for decreasing the risk of heart attack and stroke. In this study, the medication is experimental because it has not been approved for the prevention of preeclampsia in pregnant women. This study will evaluate the effects of this medication on chemicals in the blood that are associated with preeclampsia, the safety of the medication, and how the body handles and responds to the medication.

Participation in this study will involve collecting information from you and your medical records, physical exams, blood and urine collections, monitoring for side effects, and taking the study medication. For more information about participation, please contact the University of Washington Medical Center study coordinator Navi Gill, at 206-616-9902 or by e-mail at

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Your Support Equals Advancements

Science has gotten us closer, but there is still no known cause, definitive diagnosis, or treatment for preeclampsia. Your support funds the Preeclampsia Foundation's programs in research, education, advocacy and patient services.
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Upcoming Activities

2013 International Federation of Placenta Associations Conference
Whistler, British Columbia, Canada
September 11-14, 2013

NASSHP 2013 Scientific Meeting
Montreal, Quebec, Canada
September 13-15, 2013

North American Society of Obstetric Medicine Annual Meeting
Providence, RI
September 20-21, 2013

Advances in Prenatal Molecular Diagnostics
Boston, MA
September 23-24, 2013

Preeclampsia Foundation Google+ Hangout with Pregnancy Magazine
September 25, 2013

International Society for the Study of Hypertension in Pregnancy (ISSHP)
First International Conference
Surabaya, Indonesia
September 30 - October 1, 2013

Preeclampsia Foundation Twitter Chat with AWHONN
October 3, 2013

Preeclampsia in 2013 (CME)
Cedars-Sinai Medical Center
Los Angeles, CA
October 8, 2013

University of Iowa Women's Health Conference: Controversies in the Care of Women with Preeclampsia
Iowa City, IA
October 18, 2013

Saving Grace - A Night of Hope
Iowa City, IA
October 18, 2013

Mission Moment  
Thank you for your quick and well thought out answer, and thank you for being such a wonderful resource! I called my friend with swollen feet, asked her several questions and pushed her to call her health care provider ASAP. Keep up the marvelous work you do!

~Mary Magennis, Facebook Comment

Karin Morgan, Program Coordinator for Hospital City; Sonya Parashar, Research Assistant; and Dr. Ashley Simmons, Medical Director of the Adelaide C. Ward Women's Heart Health Center at the University of Kansas Hospital shared with us this news: 


"The Preeclampsia Foundation's brochures have been fundamental in our quest to better serve our patients at the Adelaide C. Ward Women's Heart Health Center at the University of Kansas Hospital. Recently, we have started a preeclampsia and heart disease service that seeks to better educate preeclampsia patients about their increased risk of developing heart disease and stroke. Using the Foundation's preeclampsia and heart disease brochures, we are able to not only reach out to many women during their hospital stay but also to send them home with a reminder. Additionally, we are making a concentrated effort to screen Spanish-speaking women using translated materials.


"Ultimately, our goal is to not only educate women about their risk but also help them make positive lifestyle changes. Our clinic offers a 90-minute personalized heart health risk assessment, which evaluates each patient's risk. During the assessment, our cardiac nurse practitioner uses each patient's results to make customized recommendations to help lower her risk in the future. Using the Preeclampsia Foundation brochures, our clinic has been able to seek out a higher risk population, educate them, and potentially help them reduce their risk in the future. These brochures have been a great tool and asset to us, and more importantly, to our patients."
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Newsletter Contributors
Alina Brewer
Deborah Bush
Angela Little 
Laney Poye
Eleni Tsigas
Jason G. Umans, MD, PhD  

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