Pregnant women who experienced financial, emotional or other personal stress in the year before their delivery had an increased chance of having a stillbirth, say researchers who conducted a National Institutes of Health network study.
Stillbirth is the death of a fetus at 20 or more weeks of pregnancy. According to the National Center for Health Statistics, in 2006, there was one stillbirth for every 167 births External Web Site Policy.
The researchers asked more than 2,000 women a series of questions, including whether they had lost a job or had a loved one in the hospital in the year before they gave birth.
Whether or not the pregnancy ended in stillbirth, most women reported having experienced at least one stressful life event in the previous year.
The researchers found that 83 percent of women who had a stillbirth and 75 percent of women who had a live birth reported a stressful life event. Almost 1 in 5 women with stillbirths and 1 in 10 women with livebirths in this study reported recently experiencing 5 or more stressful life events.
This study measured the occurrence of a list of significant life events, and did not include the woman’s assessment of how stressful the event was to her.
Women reporting a greater number of stressful events were more likely to have a stillbirth. Two stressful events increased a woman’s odds of stillbirth by about 40 percent, the researchers’ analysis showed.
A woman experiencing five or more stressful events was nearly 2.5 times more likely to have a stillbirth than a woman who had experienced none.
Women who reported three or four significant life event factors (financial, emotional, traumatic or partner-related) remained at increased risk for stillbirth after accounting for other stillbirth risk factors, such as sociodemographic characteristics and prior pregnancy history.
Non-Hispanic black women were more likely to report experiencing stressful events than were non-Hispanic white women and Hispanic women.
Black women also reported a greater number of stressful events than did their white and Hispanic counterparts.
This finding may partly explain why black women have higher rates of stillbirth than non-Hispanic white or Hispanic women, the researchers said.
“We documented how significant stressors are highly prevalent in pregnant women’s lives,” said study co-author Marian Willinger, Ph.D., acting chief of the Pregnancy and Perinatology Branch of the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), one of two NIH entities funding the research. “This reinforces the need for health care providers to ask expectant mothers about what is going on in their lives, monitor stressful life events and to offer support as part of prenatal care.”
The NIH Office of Research in Women’s Health also funded the study.
“Because 1 in 5 pregnant women has three or more stressful events in the year leading up to delivery, the potential public health impact of effective interventions could be substantial and help increase the delivery of healthy babies,” added lead author Dr. Carol Hogue, Terry Professor of Maternal and Child Health at Emory University’s Rollins School of Public Health, Atlanta.
Dr. Willinger collaborated with colleagues at the NICHD and Emory University; Drexel University School of Medicine, Philadelphia; University of Texas Medical Branch at Galveston; Children’s Healthcare of Atlanta; Brown University School of Medicine, Providence, R.I.; University of Texas Health Science Center at San Antonio; University of Utah School of Medicine and Intermountain Healthcare, Salt Lake City; and RTI International, Research Triangle Park, N.C.
Their findings appear in the American Journal of Epidemiology.
The research was conducted by the NICHD-funded Stillbirth Collaborative Research Network (SCRN). The researchers contacted all women delivering a stillbirth as well as a representative portion of women delivering a live birth in defined counties in Georgia, Massachusetts, Rhode Island, Texas and Utah. The women were enrolled in the study between 2006 and 2008 in 59 community and research hospitals.
Within 24 hours of either a live birth or a stillbirth delivery, the women in the study were asked about events grouped into four categories: emotional, financial, partner-related and traumatic. They answered yes or no to 13 scenarios, including the following:
Some of the stressful events were more strongly associated with stillbirth than were others. For example, the risk of stillbirth was highest:
“At prenatal visits, screening is common for concerns such as intimate partner violence and depression, but the questions in our study were much more detailed,” said co-author Uma Reddy, M.D., M.P.H., also of NICHD. “This is a first step toward cataloguing the effects of stress on the likelihood of stillbirth and, more generally, toward documenting how pregnancy influences a woman’s mental health and how pregnancy is influenced by a woman’s mental health.”
Health and Human Services (HHS) Secretary Kathleen Sebelius on Wednesday announced that California will partner with the Centers for Medicare & Medicaid Services (CMS) to test a new initiative to improve care for people enrolled in both Medicare and Medi-Cal (California’s Medicaid program).
Under the demonstration, California and CMS will contract with Medicare-Medicaid plans to be accountable for and coordinate delivery of covered services for participating enrollees, and offer them new services.
About 456,000 Medicare-Medicaid enrollees in Alameda, Los Angeles, Orange, Riverside, San Bernardino, San Diego, San Mateo and Santa Clara counties will have an opportunity to receive better, more coordinated care as a result of this new program.
“In California, we have a unique opportunity to forge a new pathway toward a better care experience for the beneficiaries we serve through both Medicare and Medicaid,” said Marilyn Tavenner, acting administrator of CMS. “Today’s announcement marks the beginning of a new effort to provide these Californians with more coordinated care that addresses their unique and individual care needs more effectively.”
The demonstration is designed to offer opportunities for beneficiaries to self-direct services, be involved in care planning, and live independently in the community.
In addition to new dental, vision, and non-emergency transportation services, all beneficiaries in the demonstration will continue to have access to their existing Medicare and Medicaid benefits.
California is one of a handful of states to launch a Financial Alignment Demonstration to coordinate care delivery across primary, acute, behavioral health, prescription drug, and long-term supports and services, to better serve Medicare-Medicaid enrollees.
The demonstration is the culmination of an extensive planning and development process through which Medicare-Medicaid enrollees, caregivers, advocates, and other stakeholders partnered with California and CMS to help shape the design of the new program.
Under the demonstration, Medicare-Medicaid plans will be responsible for working with enrollees and their caregivers to develop person-centered, individualized care plans. The team will be built on the enrollee’s specific preferences and needs.
Services will be delivered with transparency, individualization, respect, and linguistic and cultural competence. The demonstration also includes robust continuity of care requirements so that beneficiaries can continue to see their providers as they enroll in Medicare-Medicaid Plans.
Plans and counties within the state are developing agreements to facilitate integration of In-Home Supportive Services and behavioral health in the demonstration.
CMS will measure quality including the beneficiary’s overall experience of care, level of care coordination, beneficiary care transitions, and the support of community living in California.
CMS also will support a rigorous independent evaluation of both the quality of care received by participants, as well as any impact the demonstration has on Medicare and Medicaid costs.
To learn more about the California-CMS partnership and to see proposals submitted by other states, visit http://www.cms.gov/Medicare-Medicaid-Coordination/Medicare-and-Medicaid-Coordination/Medicare-Medicaid-Coordination-Office/FinancialModelstoSupportStatesEffortsinCareCoordination.html .
Chelation therapy, an unproven alternative medicine in the treatment for heart disease, modestly reduced cardiovascular events for adults aged 50 and older who had suffered a prior heart attack, according to new National Institutes of Health-supported research.
Results from the chelation arm of the Trial to Assess Chelation Therapy (TACT), which will be published in the March 27 issue of the Journal of the American Medical Association, showed that infusions of a form of chelation therapy using disodium ethylene diamine tetra-acetic acid (EDTA) reduced cardiovascular events by 18 percent compared to a placebo treatment.
Investigators stated that more research is needed before considering routine use of chelation therapy for all heart attack patients.
The EDTA-based chelation solution also contained high doses of vitamin C, B-vitamins, and other components.
Between 2002 and 2007, use of chelation therapy to treat heart disease and other diseases grew in the United States by nearly 68 percent to 111,000 people, according to the 2008 National Health Statistics Report.
Chelation therapy removes heavy metals and minerals from the blood, such as lead, iron, copper, and calcium.
Disodium EDTA is not approved by the FDA to treat heart disease, the leading cause of death for both men and women in the United States.
“This study sheds light on a scientific controversy that has previously been untested,” said Gary H. Gibbons, M.D., director of the NIH's National Heart, Lung, and Blood Institute (NHLBI). “We now know more about the safety and efficacy of this therapy than we did before the study. Further research is needed to fully understand these results before this treatment can be applied to the routine clinical care of heart attack patients. We do not yet know whether this therapy can be applied to most people with heart disease, which patients may potentially benefit from it, or how it may work.”
From 2003 to 2010, TACT investigators enrolled 1,708 adults aged 50 and older at 134 sites in the United States and Canada.
Study participants had suffered a heart attack six weeks or more before enrollment (average was about 4.5 years).
They were assigned randomly to receive 40 infusions of either the disodium EDTA chelation solution or a placebo solution.
Patients also were randomly assigned to receive high doses of oral vitamins and minerals or an identical oral placebo.
Most participants also took standard medicines for heart attack survivors, such as aspirin, beta blockers, and statins.
They were followed for a minimum of one year and up to five years, with follow-up ending in October 2011.
“The trial demonstrated that chelation therapy can be safely administered when rigid quality control parameters are in place, and that, under these conditions, therapy has modest benefits,” said Gervasio A. Lamas, M.D., the study’s principal investigator and chairman of Medicine and chief of the Columbia University Division of Cardiology at Mount Sinai Medical Center in Miami Beach, Fla. “Safety remained paramount throughout the course of the trial.”
The study assessed a composite primary endpoint that included death, recurrent heart attack, stroke, hospitalization for angina (chest pains sometimes indicating an impending heart attack), and coronary revascularization (coronary stenting or bypass surgery).
The TACT investigators reported a clinically modest, but statistically significant, benefit of chelation therapy compared with placebo infusions.
Fewer participants in the chelation group (222, or 26 percent) experienced cardiovascular events than did participants in the placebo group (261, or 30 percent). There was no statistically significant effect on mortality.
The study was not designed to have enough patients to detect a difference in mortality.
Some subgroups of study participants, who were predefined at the start of the study, appeared to receive particular benefit from chelation therapy, specifically adults with diabetes, who constituted almost a third of the study population.
Lamas noted that subgroup analyses cannot be considered conclusive, but can guide future research.
TACT was not designed specifically to discover how or why chelation might benefit heart attack patients, which limits the potential application of these results.
Higher mortality rates among Americans younger than 50 are responsible for much of why life expectancy is lower in the United States than most of the world’s most developed nations.
The research, by Jessica Ho, a University of Pennsylvania doctoral candidate in demography and sociology, found that excess mortality among Americans younger than 50 accounted for two-thirds of the gap in life expectancy at birth between American males and their counterparts and two-fifths between females and their counterparts in the comparison countries.
The study, “Mortality Under Age 50 Accounts for Much of the Fact That U.S. Life Expectancy Lags That of Other High-Income Countries,” is published in the March issue of Health Affairs.
Ho used cross-national mortality data from 2006-2008 to identify the key age groups and causes of death responsible for the U.S. life-expectancy shortfall.
Most of the excess mortality of those younger than 50 was caused by noncommunicable diseases, including perinatal conditions, such as pregnancy complications and birth trauma, and homicide and unintentional injuries including drug overdose, a fact that she said constitutes a striking finding of the study.
“These deaths have flown under the radar until recently,” Ho said. “This study shows that they are an important factor in our life expectancy shortfall relative to other countries.”
She said that the majority of the drug overdose deaths stemmed from prescription drug use.
Ho said her study underscores the importance of focusing on policies to prevent the major causes of deaths below age 50 and to reduce the social inequalities that lead to them.
She is a recipient of the National Science Foundation Graduate Research Fellowship and has consulted for the National Academy of Sciences Panel on Understanding International Health Differences in High-Income Countries.