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In Las Vegas for the Society for Maternal-Fetal Medicine’s 37th Annual Pregnancy Meeting™ – attended by more than 2,700 high-risk specialists – Preeclampsia Foundation staff learned more about the state of preeclampsia research, presented at several meetings, and announced the Foundation’s 2017 Vision Grant program.
Findings from a highly anticipated clinical study that would allow women with preeclampsia to extend their pregnancies safely – the PRESERVE-1 study – were presented. Unfortunately, the study results were negative, deflating many in the community who were optimistic that use of a recombinant antithrombin in pregnant women with preeclampsia could delay delivery, thus increasing the gestational age of those babies. Findings from this randomized double-blind study, the largest randomized trial in preeclampsia to date for any intervention, showed that the intervention did no better than placebo in preterm preeclampsia patients.
Dr. Michael Paidas, Yale University professor and physician, member of the Foundation’s Medical Advisory Board, and principal investigator of the study, said, “While the trial was negative, we learned a lot about preeclampsia. First, no matter how good preliminary results are from small studies, this trial underscores the need to conduct larger rigorous clinical trials, to prove whether a promising therapy works. Second, we also learned that the diagnosis of preeclampsia could be challenging. Preeclampsia is not just one disease. It manifests in different ways. In this regard, I hope biomarkers can truly help to identify women who are at high risk for requiring delivery or unlikely to benefit from postponing delivery when preeclampsia is diagnosed remote from term. Third, we learned that we could successfully complete a large clinical trial in a high-risk group of women. I am very appreciative of the patients with preeclampsia who participated in the trial. Without patient participation, we would not be able to find a cure or the best treatment.”
At a private dinner for the Foundation’s board and advisors, Paidas went on to affirm the need for biochemical markers to help determine which women would be helped by specific therapies. The precision medicine movement promises “the right medicine for the right patient at the right time.” The results of this trial underscore the quandary that many research studies for screening and diagnostic tests, as well as therapeutic interventions, have – we would generate better results by looking at subgroups of affected patients. “Preeclampsia is a mystery disease. We need to tease it apart and figure out which patients will benefit from prevention and treatment strategies,” said Paidas.
In scientific meetings, research such as the following, is presented as a way to have it questioned and sharpened by colleagues before overcoming the even more challenging hurdle of publication in a peer-reviewed medical journal.
The study set out to evaluate the impact of a pregnancy medical home model on the utilization of emergency services and hospital days in a low-income population in Houston, TX. Researchers compared this care model that included comprehensive health services in one facility with traditional obstetric care and found that women, as well as their newborns, receiving care at the medical home were significantly less likely to utilize the emergency department and also spent significantly fewer days in the hospital.
Why this is important: In an era of skyrocketing medical costs and scrutiny on ways to save money and improve the health of US citizens, finding new ways to deliver effective prenatal care that results in better outcomes for mom and baby is needed in health services research. These results offer one apparently successful model that may work in low-income settings.
Tens of thousands of births in the US, with various outcomes, between 2003-2013 were analyzed for day and month of delivery. The findings demonstrated a dramatic increase in US maternal mortality rate on weekends, despite higher admissions and deliveries on weekdays. A similar phenomenon was seen for stillbirths, although this association may have been impacted by a delay between death and delivery. No “July phenomenon” – that is, a potential increase in medical errors during the month when US medical schools release their graduates into their first-year residencies – was found for either maternal or fetal mortality.
Why this is important: This data suggests that the US system of obstetric care delivery itself plays a significant role in known maternal and possibly fetal outcomes disparities between the US and other high-income countries. Protocols, checklists, and bundles should note this concerning finding.
In this randomized clinical trial – MOMFIT – the behaviorally adapted, nutrient-dense, energy-balanced diet and lifestyle intervention resulted in better adherence to Institute of Medicine guidelines for weight gain during pregnancy, but improvements in pregnancy outcomes were not observed. Specifically, MOMFIT did not result in fewer diagnoses of gestational diabetes, preeclampsia or gestational hypertension, or birth weight >4 kg. A higher rate of cesarean birth was observed in the intervention group.
Why this is important: Although the study is relatively small, it suggests that trying to get fit and healthy once you are pregnant may be too late to reduce the risk of poor pregnancy outcomes such as preeclampsia or gestational hypertension. It is more important to go into that pregnancy at a healthy weight with a healthy lifestyle already established, as demonstrated by numerous other studies.
Researchers found that women who have two or more pregnancies complicated by hypertensive disease of pregnancy have a higher risk for early mortality from diabetes, ischemic heart disease, and stroke compared to women who only have one affected pregnancy.
Why this is important: This is not new information, but it is probably the largest US-based study that found this correlation between a history of preeclampsia, particularly repeated occurrences, and cardiovascular disease.
Researchers at a major delivery hospital in Houston reviewed over 17,000 deliveries during the study period to see if rates of recurrent preeclampsia went down after implementation of the USPSTF guidelines to provide low dose aspirin to all pregnant women at high risk for developing preeclampsia. Women with a history of preeclampsia were the cohort of interest due to the highest risk for recurrence. 441 women were identified as high risk for preeclampsia based on a history of preeclampsia. Recurrent preeclampsia occurred in 33% of women with a history of preeclampsia before compared to 17% of women after. This is a 50% reduction in rates of recurrent preeclampsia.
Why this is important: Numerous guidelines now recommend low dose aspirin for all women at high risk of developing preeclampsia as a means of preventing or at least lessening the severity of preeclampsia. Women at high risk for developing preeclampsia should take this evidence to their healthcare providers to discuss if this intervention is right for them.
State and national guidelines have been proposed to increase the efficiency of treating the patients with critically high blood pressure with antihypertensive medication, magnesium sulfate infusions, and providing timely postpartum follow-up. The purpose of this study was to determine if improvements in those objectives would result in a reduction in the rate of eclampsia. Data was collected from 23 hospitals in 2015 and 2016. This study had three important findings: 1) Compliance with national treatment guidelines is low without monitoring; 2) high levels of compliance can be achieved in a relatively short period of time with monitoring; 3) early intervention with blood pressure medication and magnesium sulfate for sustained critical blood pressures results in a significant reduction in the rate of eclampsia.
Why this is important: Across the US, guidelines and protocols for improved diagnosis and management of preeclampsia are being developed and used, with improved outcomes. Evidence like this study should stimulate a commitment from all hospitals to measure and implement these best practices.
This study’s objective was to determine whether daily enoxaparin begun in the first trimester would improve outcomes. Most often known under its brand name Lovenox (but also other brands), enoxaparin was evaluated in 156 patients across five sites in three countries and not found not to reduce preeclampsia or intrauterine growth restriction in women with a prior history of preeclampsia. The intervention also included a prescription of daily low dose aspirin and calcium.
Why this is important: Although animal studies have not shown enoxaparin to have any risk to the fetus, there have not been any good studies to demonstrate its usefulness for pregnant women. That said, some healthcare providers believe it to be a beneficial aid to women with thrombophilia (clotting disorders). Women who may have these underlying disorders may want to discuss the details of this study with their providers.
On the first day of The Pregnancy Meeting™, Putting the “M” back in Maternal-Fetal Medicine, an initiative to improve focus on the maternal health side of the pregnancy equation, held its five-year review, looking retrospectively at what has been accomplished since the initiative’s launch in 2012. The Foundation’s Executive Director Eleni Tsigas was invited to give an update on legislative activity that the Foundation is spearheading and will be introduced into the 115th Congress in a few weeks. Dr. Haywood Brown, the President-Elect of the American College of Obstetricians and Gynecologists, applauded the effort and encouraged the audience to support the forthcoming legislation, stating that this was a much-needed follow-up in the years since the Safe Motherhood legislation was introduced in 2002.
As for lowlights, we continue to be astounded that animal studies with a long road ahead before anything really “promising” can be reported (see news above about the PRESERVE-1 clinical human study that made it all the way to the finish line and then failed). Case in point, no less than a dozen news stories on how heartburn medicine is going to cure preeclampsia were published in the last couple of weeks. These were all driven by some early basic science studies conducted in mice. This is irresponsible reporting, or at the very least poor headline writing. We are, of course, encouraged to see creative preeclampsia research underway.
Patience with the process, as well as urgency for more funding and investigator engagement, continue to fuel us at the Preeclampsia Foundation.
Finally, the Foundation announced its call for Vision Grant applications at two preeclampsia-specific research symposia held at The Pregnancy Meeting. Early career investigators are encouraged to submit their novel proposals to be competitively reviewed and recommended for one of three Vision Grants. Funding is intended to support small pilot studies for new ideas. Applications and more information can be found online. This successful program continues to be one of the most catalytic research initiatives that Foundation donors are driving.