Archive for the ‘Research & Studies’ Category

May 16, 2013

Truth in Medicine: Vast Majority of Assisted Reproductive Technologies Fail

by Miriam Zoll

In an essay recently published in the Wall Street Journal, Sarah Elizabeth Richards, author of the new book “Motherhood Rescheduled,” encourages women to ward off age-related infertility by simply freezing their eggs — like she did.

Between the ages of 36 and 38, Richards spent $50,000 to freeze 70 eggs that she plans to thaw, fertilize, and insert into her uterus when she is 44 or 46.

“Egg freezing,” she said, “stopped the sadness that I was feeling at losing my chance to have the child I had dreamed about my entire life.” Still looking for a mate at almost 40, Richards says she now goes onto Match.com and has the confidence to tell men that she can “have kids whenever I want.”

While Richards’ decision appears to have provided her with a sense of hope and temporary emotional equilibrium, it may prove to be illusory. Sadly, as millions of women, including me, can attest, the vast majority of assisted reproductive technologies fail.

In 2012, of the 1.5 million treatments performed globally, 1.1 million failed: a 77 percent failure rate. In the United States, the overall failure rate was 68 percent. Once optimistic and hopeful about the promise of reproductive science, I endured four failed in vitro fertilization (IVF) cycles, one miscarriage, and two donor egg attempts in which both donors were diagnosed as being infertile.

But it is no wonder that Richards believes she will be able to bear children with her frozen eggs whenever she wants to. A $4 billion industry is driving the public discourse about often unproven discoveries through a lens that focuses attention on the minority of successes rather than the whole messy, complicated story.


Related: What’s Wrong With Fertility Clinics and Online Advertising



Growing up in a culture that reveres science, she has been bombarded with overly optimistic and one-sided media stories touting the miracles of creating babies in laboratories. The truth is, many women signing up for treatments do not realize until later the extent to which they are participating in a vast experiment, where evidence-based medicine has yet to establish a reasonable foothold.

The only current independent effort to track the health of all women going through treatments remains largely invisible to patients who might sign up to have their health — and that of their offspring — tracked over time.

The voluntary Infertility Family Research Registry is based at the Dartmouth Hitchcock Medical Center and is funded in part by the American Society for Reproductive Medicine (ASRM). To date, the vast majority of large fertility centers in the United States are not displaying the registry’s placard in their waiting rooms, greatly reducing the potential benefits such a long-term study would provide. [Ed note: Our Bodies Ourselves is actively encouraging infertility clinics and centers across the country to promote awareness of the Infertility Family Research Registry.]

Richards’ desire to protect her ability to bear a biological child is heartfelt, and her willingness to undergo egg freezing procedures that were considered experimental at the time speaks to her commitment — and her panic — to try anything to preserve that opportunity. But her statement that this decision was “the best investment” she ever made is premature, to say the least.

The general public knows virtually nothing about the failure and success rates of vitrification — a new flash-freezing technique that has been used to preserve the eggs of women younger than 30 who are facing life-threatening illnesses. While an estimated 1,000 babies have been born from this technology worldwide, there is virtually no data that tells us if these live births were the result of 3,000 or 10,000 trials.

We have no idea how many miscarriages or still births may have ensued, and there are few, if any, long-term infant health studies evaluating how flash freezing half of a child’s DNA might affect that child later in life. The one study Richards cites found that 900 babies exhibited no more risk of birth defects than babies conceived naturally by young mothers, but is one study really enough?

Apparently the ASRM believed it was proof enough for them to lift the “experimental” label from the still young procedure last fall. The ASRM Practice Committee said it was not yet ready to endorse widespread use of egg freezing for elective use. However, while randomized controlled studies were rare, the committee did find sufficient evidence to “demonstrate acceptable success rates in young, highly selected populations.”

Citing a lack of data on safety, efficacy, cost-effectiveness, and potential emotional risks, their report states, “Marketing this technology for the purpose of deferring childbearing may give women false hope and encourage them to delay childbearing. Patients who wish to pursue this technology should be carefully counseled.”

As would be expected, once the ASRM decision became public, their caution about women’s age and infant health was obscured and eventually obliterated by the dust kicked up by a stampede of panicked but hopeful 30- and 40-something women running to the nearest fertility clinic to have their eggs harvested for future use — for anywhere between $10,000 and $15,000 per harvest, or more.

One must wonder why the ASRM felt so compelled to provide a stamp of approval for a procedure still lacking in reliable safety and efficacy data. As legal scholars Debora Spar and Naomi Cahn have written in their books, “The Baby Business” and “Test Tube Babies,” respectively, in the context of an unregulated industry in the United States, it is virtually impossible to separate the medical and market forces at play when new techniques and procedures are advertised to potential clients.

The blurred boundaries between fertility clinics wanting to provide patients with safe, evidence-based procedures while also needing to generate business to meet their bottom lines puts that much more pressure on consumers to know what they are signing up for. But when evidence and information is scarce, biased, or non-existent, well-heeled consumers like Richards feel they have no choice but to close their eyes, write a check, and jump off that technological cliff called “hope.”

For Richards’ sake, I hope she succeeds. If not, she may well join the ranks of millions of men and women who, since the first IVF baby was born in Britain 35 years ago, have experienced involuntary biological childlessness as a result of delaying parenthood and relying on science for last-minute miracles.

Miriam Zoll is an award-winning writer and an international health and human rights advocate and educator. She is the author of “Cracked Open: Liberty, Fertility and the Pursuit of High Tech Babies” and is on the board of Our Bodies Ourselves. This article was originally published at RH Reality Check, and is reprinted with permission.


April 25, 2013

How Can We Help Teen Mothers Avoid and Cope With Postpartum Depression?

Although there is a fair amount of information and research available on postpartum depression in general, very little of it seems to focus specifically on the needs or care of teen mothers.

A pilot study published in the American Journal of Obstetrics and Gynecology in March attempts to fill in this gap — and it shows some promising results.

First, the authors explain why the risks of PPD in teens are important:

PPD puts adolescent mothers and their children at risk during an already challenging time in their lives, and this hardship may be a major determinant of poor outcomes for these young mothers and their children. Untreated, depression is associated with school dropout, suicide, and substance use. Among adolescent mothers, evidence suggests that depression may prevent them from engaging in health-promoting behaviors for their infants and themselves.

The study is based on a randomized controlled trial of the REACH program (Relax, Encourage, Appreciate, Communicate, Help), which is designed to help expectant mothers develop stress management and other skills. The program was offered as structured therapy during pregnancy, followed by a postpartum “booster” session.

Participants in the therapy group used interpersonal therapy to work on effective communication skills, conflict management, improving their social support systems and building healthy relationships, and goal setting. They, as well as the control group, received a handbook of typical pregnancy and postpartum/newborn health information. A total of 106 teens age 17 or younger and without pre-existing mental health issues were randomized to the therapy or control groups.

The researchers looked for major depressive episodes within the six months after birth. Although only 12.5 percent of the REACH teens developed postpartum depression, compared with 25 percent of the control teens, the results were not statistically significant, as the study was fairly small and very few teens (19) overall developed postpartum depression. A larger study may be needed to better determine the utility of the program.

Despite a lack of clear effect, the study highlights a need for further investigation into the postpartum mental health needs of teens. As the authors explain:

Although validated treatments for adolescent depression exist and include interpersonal therapy, cognitive behavioral therapy, and antidepressant medication, teen mothers with mental health problems are mostly under treated. To date, only one published report of 2 small open-trial pilot studies addressed treatment for depression in pregnant adolescents. Despite the potentially high burden of depression to young women and their families, studies on the prevention of PPD in pregnant adolescents are virtually nonexistent.

Another lesson learned in this study was that teens preferred individual therapy sessions over the planned group sessions, so sessions were adjusted to be one-on-one. The researchers also took care to specifically design the REACH program to be culturally appropriate for a diverse group of racial and ethnic backgrounds.


April 23, 2013

Study: IUDs Offer Safe Contraception Option for Teens But Rarely Prescribed

Intrauterine devices (IUDs) are a fairly safe, long-acting form of contraception, but many myths about the devices persist. For example, it’s somewhat common to hear that women who haven’t already had a baby, and especially teenagers, are not good candidates for IUDs; neither of these is true.

For a new study published in the journal Obstetrics & Gynecology, researchers reviewed data from health insurance records of more than 90,000 women who had IUDs inserted (including both hormonal and copper IUDs). They looked specifically at how many records indicated a IUD-related complication, discontinuation, or pregnancy.

When the researchers looked at the data by age group, they found that women ages 15-19 did not discontinue using IUDs any more frequently than older women. Teens were slightly more likely than older women to experience dysmenorrhea (menstrual cramps) or absence of menstruation within one year of insertion, or failure of the IUD to prevent a normal pregnancy, but rates for both of these were very low. Only 1.8 percent of teens using a levonestrogel-releasing IUD experienced a pregnancy (3.6 percent for copper), and 2.4 percent experienced cramping (6.2 percent for copper).

Pelvic inflammatory disease occurred in less than half a percent of teens. Women of all ages using a copper IUD were much more likely to stop using it than women using the hormone-releasing IUD, and this was most true for teens, although it’s not completely clear why. Rates of removal within 30 days for any complication were estimated to be very low for teens (2.9 percent for hormone IUD, 5.2 percent for copper) as well as older women.

The researchers conclude:

Overall, these data indicate that the IUD is an appropriate contraceptive for younger women and is not likely to cause serious side effects among teenagers. Physician recommendations play an important role in their patients’ decision-making, and their recommendation of the IUD could increase the use of this cost-effective and safe method of birth control among teenagers. Thus, physicians should include information about this highly effective method when they counsel young patients on their contraceptive options to help reduce the unintended pregnancy rate among teenagers in the United States.

The authors cite evidence that teens may indeed face clinician education barriers when seeking an IUD. One survey found that “only 19% of obstetrician–gynecologists surveyed in a 2010 study stated that they would offer an IUD to an unmarried 17 year old who had never been pregnant.”

With more evidence like the current study on hand, we hope it will become easier for teens to access this long-acting, effective form of contraception.

Related: Revisiting the IUD for Contraception – Pros and Cons for Women looks at the rise in IUD use and the safety record.


April 10, 2013

Eating Disorders in Adolescence Can Have a Long Term Effect on Women’s Health

Despite the prevalence of eating disorders in adolescent girls, it’s difficult to find information about longer term health consequences in adults, as little follow-up has been done. A new article in the journal Maturitas on the long-term health consequences of the female athlete triad, a syndrome that may include eating disorders, is an important contribution to the research.

First defined in the early 1990s, female athlete triad used to be defined as the combination of an eating disorder, amenorrhea (lack of a menstrual period), and osteoporosis.

The definition was adjusted in 2007 to focus more on a spectrum of health and now includes low energy (with or without an eating disorder), menstrual function, and bone mineral density. These are interrelated; it is thought that the lack of energy due to excessive exercise or disordered eating leads to changes in menstrual cycles and loss of bone mineral density.

While it’s not original research, the new review by Jill Thein-Nissenbaum of the University of Wisconsin-Madison’s physical therapy program points out some important health issues for women beyond the teen years.

Of major concern, based on a review of the literature, are the long-term effects of decreased bone mineral density associated with the triad. Women who restricted their energy intake may have missed crucial bone mass building time, and this bone density may not be made up even with eating disorder recovery.

Thus, as women age, they are losing additional bone mass from an already depleted system. Thein-Nissenbaum notes that women with the triad may also be at greater risk of musculoskeletal injury, and these injuries may have negative effects throughout life.

Thein-Nissenbaum suggests that women who currently have or have recovered from female athlete triad discuss with their healthcare provider their history of eating behaviors and menstrual history, dating back to adolescence, and review details from previous bone scans.

She also cites the need for bone mineral density assessment in women who have had a history of disordered eating behaviors, menstrual irregularity, or more than one stress fracture.

The National Eating Disorders Association provides a toolkit for coaches and athletic trainers that includes a section on the female athlete triad, including causes, treatment, and behaviors to look out for. The guide also has information on other types of eating disorders and the role of coaches and trainers in prevention and early intervention.

Plus: Eating disorders are most commonly associated with adolescents, but adults are also susceptible to anorexiabulimia, binge eating and other disorders, and they face a unique set of challenges, says Cynthia M. Bulik, author of the new book ”Midlife Eating Disorders.” Women’s eNews recently published an excerpt.

“If we look at the numbers,” writes Bulik, “the most common profile of someone with an eating disorder is a woman in her 30s or 40s who struggles with weight control and suffers from binge eating disorder. But countless women and men in midlife and beyond — from all racial, ethnic and socioeconomic backgrounds — wake up each morning to an ongoing battle with eating and body image, with many suffering from anorexia nervosa, bulimia nervosa, purging disorder, binge eating disorder and night eating syndrome.”


April 9, 2013

The Saga of Michael Klein: A Poem in Praise of a Pristine Perineum

by Allison Saran

Some of the world’s greatest medical discoveries never receive the attention they deserve. For Canadian physician Michael Klein, the attention came late, but it’s been growing ever since.

And thanks to one very humorous and talented fan, Klein’s work is immortalized in rhyme.

Dr. Jerry Kruse, the newly named executive associate dean of the School of Medicine at Southern Illinois University School of Medicine, where he had been chair of the department of Family and Community Medicine, has a flair for writing poetry and limericks – often under the pseudonym of Dr. Kreuss, which, yes, rhymes with “Seuss.”

Kruse’s talents were on full display last December at the annual meeting of the North American Primary Care Research Group. In the video above, he pays tribute to Klein, who is widely known for his landmark randomized control trial that showed routine episiotomies during childbirth (an incision on the perineum and the posterior vaginal wall during second stage of labor) cause an increase in the very complications they aim to prevent.

Klein believed that women given routine episiotomies experienced deeper perineal tears than women who were not given episiotomies. Though his study confirmed this, it was initially met with resistance within the medical community. In 1992, eight years after the original request for publication in an accredited journal, Klein’s findings were finally published.

Once released, the study caused a medical, and thus cultural, shift. Routine episiotomy was slowly abandoned by medical caregivers (“scissors were thrown to the floor with disdain,” notes Kruse in his poem) and with that, severe perineal injuries declined.

The results of Klein’s trial helped to decrease episiotomies not only in Canada, but throughout the world. In his opening remarks, Kruse credits Klein with “improving the lives of millions of women.”

In “The Saga of Michael Klein,” billed as the story of Klein’s “search for truth regarding episiotomy,” Kruse begins with a description of Klein’s holistic obstetric practice. Klein had advocated that women in labor should not be treated as if they have a disease, and that the first intervention during labor often leads to a cascade of other interventions, disrupting a natural process.

Here’s an excerpt:

Michael knew in his heart, way deep down inside
That obstetrical knowledge was not well applied.
“Technology’s great, for those who are ill,
But for those who are healthy it’s really no thrill
To be strapped down and poked, and scared stiff as a board.
This just isn’t right!” his fervent voice roared.

One thing more than others, did gnaw at his heart,
Made his blood boil, and stung like a dart.
He just couldn’t stand it, to see a long slice,
A cut, an epis – what a terrible vice,
Disruption of skin for no reason at all,
A snip with the scissors that starts very small
But rips and extends as the baby comes through
Tears into the sphincter and up the wazoo.
A third, then a fourth, oh my what a mess
“They must like to sew,” was his only guess.

So Michael rose up, and he raised his right hand
And opened his mouth, and took a firm stand:
“I’ll study this problem,” he said with a shout,
“And when I am finished there won’t be a doubt
That these cuts are no good—the whole world will see—
This idea’s a good one, they’ll have to agree.
I’ll start up a randomized, single-blind study
And I’ll work with Michel who’s my very good buddy
And we’ll put ole’ McGill right here on the map.
This study of perineal trauma’s a snap.

“The Saga of Michael Klein” concludes with a clear message: Never give up on your cause if the research is true and good can come of it.

Klein’s quest is one of many that healthcare providers and birth advocates have completed to make birth healthier and safer for all women. No matter if you are a doctor, midwife, nurse, pregnant woman, or just someone who cares about childbirth, “The Saga of Michael Klein” encourages you to laugh – and to carry the hope of bettering birth.

Ed. note: You can view the full poem in Family Medicine journal (October 2012), along with a complete bibliography.

—————————–

Allison Saran is a senior at Brandeis University, majoring in anthropology and public health. She is a keen advocate for evidence-based birth and is excited to continue her studies at the Yale School of Nursing (CNM speciality). 


April 5, 2013

Study: Expand Abortion Access by Expanding the Types of Professionals Who Can Provide Care

In the United States, 87 percent of counties have no abortion provider, forcing some women to travel potentially long distances for reproductive health services, while others delay making a decision until later in the pregnancy, when an abortion is more costly and restrictions are more severe.

One way to increase access is to increase the range of providers who are permitted to do abortions, such as nurse practitioners, nurse midwives, and physician assistants.

Currently, non-physician clinicians can perform surgical (aspiration) abortions legally only in Montana, Oregon, New Hampshire and Vermont. In some states, these providers can oversee medication abortions, though that, too, has become a contentious issue as more legislatures seek to restrict women’s access to abortion.

Are laws requiring physicians to perform surgical abortions necessary, from a patient-safety perspective? Not according to a recently published study.

Tracy Weitz, director of Advancing New Standards in Reproductive Health, a collaborative research group and think tank at University of California, San Francisco, and Diana Taylor, ANSIRH’s director of research and evaluation, primary care initiative, set out to answer the question of healthcare outcomes and applied for a waiver of California legal statutes that limit surgical abortion to physicians. They note:

In 2008, 1.21 million abortions took place in the United States, with more 200,000 (18%) in the State of California. Nationally, 92% of abortions take place in the first trimester, but Black, uninsured, and low-income women have less access to this care. In California, only 87% of women using state Medicaid insurance obtain abortions in the first trimester. Because the average cost of a second-trimester abortion is substantially higher than that of a first-trimester procedure, shifting the population distribution of abortions to earlier gestations would result in safer, less costly care. Increasing the types of health care professionals involved in abortion care is one way to reduce this health care disparity.

For the purpose of the study, 40 certified nurse midwives, nurse practitioners and physician assistants in ANSIRH’s Health Workforce Pilot Project, who already had experience with medication abortions, were trained to perform surgical abortions. (ANSIRH’s Early Abortion Training Workbook, which is used in medical schools around the world, is also available online.)

The authors compared the outcomes of abortions performed by those medical professionals to outcomes of abortions performed by 96 physicians. Patients were not randomized to a provider type; they were asked if they would agree to have the non-MD provider on duty perform their first trimester abortion.

Complications were rare in general, with only 1.3 percent of the 11,487 abortions resulting in any type of complication. While the newly trained CNM/NP/PA group had slightly more complications than the group with abortions performed by more clinically experienced MDs, the difference was not considered significant.

The authors conclude that “only 1 additional complication would occur for every 120 procedures as a consequence of having an NP, CNM, or PA as the abortion provider,” and these would largely be minor complications, such as a low-level infection or bleeding that could be treated at home or at an out-patient clinic.

The study was published in the American Journal of Public Health. Based on the findings, the authors argue in favor of expanding the types of providers who can perform abortions:

The benefits of expanding access to abortion for California’s women outweigh the small initial difference in risk, particularly because it would likely move many second-trimester abortions into the first trimester, significantly decreasing the overall risk of complications, which increases with gestational age. Expanded access is also likely to afford more women the opportunity to obtain care without the additional indirect costs associated with traveling to a geographically distant abortion provider.

We would hope, after reading this study, that more state legislatures would consider removing restrictions on non-physician clinicians, but we know such a move would require great amounts of political will, as the trend in recent years has been to restrict rather than increase access.


March 29, 2013

Access to Contraception Increases Social and Economic Benefits for Women And Society

The Guttmacher Institute recently published a report examining how access to and the use of effective birth control affects women’s lives.

The Social and Economic Benefits of Women’s Ability to Determine Whether and When To Have Children“ reviews more than 66 studies over the past 30 years. According to researchers, access to contraception and avoidance of unplanned pregnancy have led to:

  • increases in young women obtaining at least some college education
  • increases in college-educated women pursuing advanced professional degrees
  • increased participation in the workforce by women
  • increases in women’s earning power and decreases in the gender gap in pay

The researchers identify several gaps in the literature as well as areas where additional research is needed, such as how contraception benefits older women and women with low incomes, of racial and ethnic minorities, single mothers, and women with other sociodemographic factors that might prevent them from getting the full benefits of contraception.

The authors conclude with an important call for ongoing efforts to enhance access to contraception:

Clearly, access to reproductive health care and the recognition of reproductive rights cannot be addressed in isolation from the rest of an individual’s life, or from the rest of society’s inequities. Rather, policies and programs that advance contraceptive access and those that affect whether a woman is still able to achieve her life goals if and when she becomes a mother should be considered as part of a greater whole.

By helping women and couples, regardless of background or income, determine and exercise their own reproductive choices, government and organizational policies can help advance broader economic equality and social justice for individual women, families and society.

The report is available online as a PDF; a summary with links to more information is also provided. Also check out OBOS’s Brief History of Birth Control and discussion of Global Access to Birth Control.


March 27, 2013

What Explains Variation in Cesarean Rates Between Hospitals?

While cesarean rates (which reached an all-time high in 2007) are known to vary widely by state, they also vary quite a bit by hospital. One common explanation for this has been that different hospitals have different c-section rates because they see different types of patients – patients who are sicker or healthier, or more likely to have complications requiring cesarean.

In an article published in PLOS ONE, researchers report findings from a study designed to look at other factors that influence cesarean rates. The authors looked at birth certificate and hospital discharge data in Massachusetts to determine which factors were linked to cesarean rates at each hospital.

The researchers focused on first births of single, non-breech births in Massachusetts hospitals from the beginning of 2004 through the end of 2006. They report that at the hospital level, the percent of cesarean deliveries varied between 14.0 percent and 38.3 percent (average of 26.4 percent). Then they adjusted for health and sociodemographic factors, like labor induction and maternal age, that are linked to higher rates of cesarean.

They found, predictably, that individual risk for cesarean varied by demographic, socioeconomic, pregnancy, and preexisting medical conditions. After they adjusted for these factors, though, there was still significant variation in rates between hospitals that could not be explained by those medical and personal risk factors.

While the authors did not set out to explain why this variation occurred, they note that it has been observed in other studies (such as in Arizona, and in military hospitals), and that contributing factors may include liability- and insurance-related factors, whether a woman delivers at a teaching hospital, the provider’s approach to delivery, hospital practices related to labor induction and augmentation, and others. They conclude that additional research is needed on hospital characteristics to figure out what is driving variability between hospitals and reduce the influence of non-clinical factors on women’s risk of cesarean delivery.

Finding out the rate of cesarean sections at any given hospital can be difficult, as is understanding why the rates are high in any given situation. At her  website, CesareanRates.com, consumer advocate Jill Arnolds attempts to bring together the available statistics, allowing users to compare cesarean rates by state and by individual hospital.

If you’re interested in finding out more about what you can do increase your chances of having a vaginal birth, see this tip sheet from Childbirth Connection.


March 21, 2013

Are Right-to-Know Breast Density Laws Good for Women’s Health?

There’s been much discussion lately about routine mammogram screening for breast cancer, including, according a new study, the very real psychological harm connected to false positive readings.

Complicating this information further is the issue of breast density. Dense breasts have less fat and more glandular and connective tissue. While some women’s breasts become less dense and more fatty as they age, other women’s breasts remain relatively dense.

Why does this matter? Having dense breast tissue makes it harder to obtain an accurate reading of mammograms. It also increases a woman’s risk of developing breast cancer.

However, questions remain about what women should do with that information. In fact, recent research suggests that actual risk of death from breast cancer is not increased for women with denser breast tissue.

Despite a lack of certainty about how dense breast tissue affects health outcomes, a handful of states have mandated that providers discuss breast density with women. On April 1, California will become the fifth state with a breast density notification law in place. Similar bills have been introduced in other states.

At the federal level, the Breast Density and Mammography Reporting Act was introduced in Congress in 2011, but never made it out of committee. It, too, would require that women be told about breast density, the correlation with cancer, and that they might benefit from supplemental screening tests.

It’s not clear, however, if additional tests would even help.

The authors of a recent commentary in the medical journal Radiology note that while explaining the increased risk of cancer to women with dense breasts “seems ethical, reasonable, and appropriate,” there is little known about what additional follow-up might help those women.

They conclude that “the advocacy push to legislate mandatory reporting of breast density and possible adjunct screening for all women with heterogeneously or extremely dense breasts is far outpacing the reporting of evidence that supplemental screening may provide better outcomes for these patients.”

They also raise concerns about invasive procedures: “Because some cancers detected at screening may not go on to cause symptoms or death, additional interventions performed on these excess cancers would only increase morbidity for these patients.”

These concerns are similar to those raised about routine mammography in younger women — that more testing may increase harm to women from extra procedures, while not actually increasing survival rates.

Breast Cancer Action addressed mandatory notification laws in late 2012, coming down against such legislation:

Unfortunately, the importance of breast density is still not well understood and as a result there is no clear action for women who receive this information. Breast Cancer Action believes that medical practitioners should discuss all aspects of a woman’s health with her and we do not believe legislation is the appropriate way to address the issue of breast density. We believe resources and energy are better spent on working for better medical care and understanding the ways to prevent breast cancer in the first place.

Laura Newman, a medical journalist, has also looked at this issue. Her Patient POV blog has a couple of clear, useful posts, including “Are Dense-Breast, Right-to-Know Laws Helpful?” and “Is the Bar High Enough for Screening Breast Ultrasounds for Dense Breasts?

Where does this leave women, especially those who may be told they have dense breast tissue as a result of one of these new laws? Unfortunately, there is no clear answer right now.


February 25, 2013

CDC Releases Data on Intimate Partner Violence and Sexual Violence by Sexual Orientation

The Centers for Disease Control and Prevention (CDC) recently released the first-ever set of national data focused on intimate partner violence, sexual violence, and stalking victimization by sexual orientation.

According to the findings, lesbians and gay men experience higher rates of partner and sexual violence than do heterosexuals, and bisexual women have significantly higher lifetime prevalence rates of rape and sexual violence committed by any perpetrator (that could include an intimate partner, family member, acquaintance or stranger.)

The data, gathered from the National Intimate Partner and Sexual Violence Survey, includes responses from almost 10,000 women; here’s a FAQ about the findings and methodology.

“We know that violence affects everyone, regardless of sexual orientation. This report suggests that lesbians, gay men and bisexuals in this country suffer a heavy toll of sexual violence and stalking committed by an intimate partner,” CDC Director Tom Frieden said in a release. “While intervening and providing services are important, prevention is equally critical.”

Among the findings:

  • 43.8% of lesbian women, 61.1% of bisexual women, and 35.0% of heterosexual women had experienced rape, physical violence, and/or stalking by an intimate partner.
  • Approximately 1 in 8 lesbians (13.1%), nearly half of bisexual women (46.1%), and 1 in 6 heterosexual women (17.4%) have been raped in their lifetime (translating to about 214,000 lesbians, 1.5 million bisexual women, and 19 million heterosexual women).
  • 1 in 3 bisexual women and 1 in 6 heterosexual women (15.5%) have experienced stalking victimization at some point during their lifetime. (Numbers were too small to be reliable for lesbian women.)
  • More than one-third of lesbians (36.3%), over half of bisexual women (55.1%), and more than one-quarter of heterosexual women (29.8%) have been slapped, pushed, or shoved by an intimate partner at some point in their lifetime.
  • 23.6% of heterosexual women, 29.4% of lesbian women, and 49.3% of bisexual women had experienced severe physical violence by an intimate partner (e.g., hit with fist or something hard, slammed against something, or beaten).
  • The majority of women who reported experiencing sexual violence, regardless of their sexual orientation, reported that they were victimized by male perpetrators. Most bisexual and heterosexual women (89.5% and 98.7%, respectively) reported having only male perpetrators of intimate partner violence.

Neither the full report nor the sexual orientation report provide information about intimate partner violence related to gender identity, although transgender women and men may be more likely to experience severe partner violence. The CDC notes that the Department of Health and Human Services is working on “developing standardized measures of sexual orientation and gender identity” to include in national surveys like this one in order to collect better data.

The National Coalition of Anti-Violence Programs provides some related information in its report, “Lesbian, Gay, Bisexual, Transgender, Queer, and HIV-Affected Intimate Partner Violence, 2011,” using data collected from member and affiliate programs — this limits the data, though, to LGBTQH-identified people who actually sought help from one of the programs.

It’s fairly clear, as the CDC explains, that “more research as well as ongoing data collection is needed,” and that violence against non-heterosexual, non-cisgender populations remains a major concern.

Meanwhile, House Republicans last week introduced their own version of the Violence Against Women Act without provisions for LGBT, Native American, and immigrant populations. We’re still waiting for Congress to do the right thing and pass an inclusive version.

Related: No Country for All Women: Holding Up Violence Against Women Act


February 7, 2013

New Study Shows Excellent Outcomes in Birth Centers

More than 9 out of 10 women (94%) who entered labor planning a birth center birth achieved a vaginal birth

According to the CDC, in 2009, 98.9 percent of all U.S. births were in hospitals, while only 1.1 percent took place elsewhere.

Many women, however, wish to give birth in an environment that is more homelike, or want to reduce their likelihood of experiencing many of the interventions that have become very common in hospitals, such as continuous electronic fetal monitoring, induction of labor, and cesarean section.

Of the non-hospital births documented in 2009, 27.6 percent (just over 12,000 births) took place in freestanding birth centers – an option for women interested in giving birth with trained professionals outside of hospital obstetrics units. At birth centers, midwives generally provided prenatal, birth and postpartum care.

Now, there’s a large new study showing that birth centers are a safe option for both mothers and babies, reaffirming safety findings from previous research.

The study, published in the Journal of Midwifery & Women’s Health, looked at data from U.S. birth centers to assess outcomes for women and babies, including the need for a hospital transfer, mode of birth, complications, and deaths from 2007 through 2010.

The study is referred to as the National Birth Study II (NBSII); the research is an update of the National Birth Center Study conducted by Judith Rooks and colleagues and published in 1989.

The study gathered data from member organizations of the American Association of Birth Centers; 79 birth centers took part, with 59 of those sending data for the complete study period. The analysis included 15,574 women who planned and were eligible for a birth center birth at the onset of labor.

What does “eligible” mean in this context? Pregnancies considered medically low-risk: single-baby deliveries; pregnancies that went to full-term; and no breeches or medical/obstetric risk factors that required cesarean, continuous electronic fetal monitory, or labor induction.

Among the findings:

  • Of the women admitted to the birth center in labor, 87.6 percent did give birth there. The rest (12.4 percent) were transferred to the hospital. Most of the transfers were considered non-emergencies and occurred because of prolonged labor or arrest of labor. Just 1.9 percent of women or newborns required emergency transfer. Women who had never given birth before accounted for most (81.6 percent) of the transfers.
  • A few women (4.5 percent) planned to give birth at a center but were not able to, for issues such as breech, premature membrane rupture, or the woman’s choice.
  • Most of the births (92.3 percent) for all women who planned a birth center birth were head-first, spontaneous vaginal births. The mode of birth data includes women who transferred to a hospital as well — 1.2 percent ended up with an assisted vacuum or forceps birth, and 6.1 percent ended up having a cesarean birth.
  • There were no maternal deaths.
  • Women can mostly expect care from Certified Nurse-Midwives at AABC birth centers. Most of the care providers in the study were CNMs (80 percent, in 63 of the birth centers); Certified Professional Midwives or Licensed Midwives provided care in 11 of the centers (14 percent). In five of the centers, care was delivered by mixed teams of these providers.

There are some things the study can’t tell us, such as the outcomes at non-AABC birth centers and at AABC centers that don’t report their data to the AABC registry, and outcomes for women attempting vaginal birth after a prior cesarean (because most birth centers do not support it).

The NBSII study found a rate of 6.1 percent for cesareans. The authors looked at the cost savings related to reducing cesareans, and conclude, “Had this same group of 15,574 low-risk women been cared for in a hospital, an additional 2,934 cesarean births could be expected.”

They base this comparison on national rates of cesareans in low-risk women, currently reported at 26.5 percent (derived from data reported on birth certificates).

“Given the increased payments for facility services for cesarean birth compared with vaginal birth in the hospital,” the researchers wrote, “the lower cesarean birth rate potentially saved an additional $4,487,524. In total, one could expect a potential savings in costs for facility services of more than $30 million for these 15,574 births.”

I had some questions about whether the 26.5 percent figure was the best comparison group (versus older data with a lower rate), so I emailed the study authors, who responded: “It is not a perfect comparison, because this pool of low-risk women from birth certificate data may not be as stringently selected as women screened for birth center eligibility. But it is the best estimate we have for low-risk women being cared for in hospitals.” [We can discuss this issue in more detail in the comments if anyone is interested.]

Without a perfect comparison, we can still safely assume that the rate of cesarean is pretty low for women who qualify for AABC birth center births. It’s also fair to assume that very few women at AABC birth centers require emergency transfer to a hospital, and that the vast majority (almost 80 percent) of women who qualify for birth center care do end up giving birth there and being discharged to home.

There were no maternal deaths recorded in the study, and low fetal/neonatal death rates — the researchers found an intrapartum fetal mortality rate for women who were admitted to the birth center in labor of 0.47/1,000, and a neonatal mortality rate excluding lethal anomalies of 0.40/1,000. From this, we can conclude that AABC birth centers are a reasonably safe choice for low-risk women.

On Feb. 13, the American Association of Birth Centers and the American College of Nurse-Midwives are holding a Congressional briefing focused on the role of midwives and birth centers in potentially affecting health care costs and outcomes (such as cesarean rates). More information and registration are available here.

For more information, here a Q&A about the study. Visit Science & Sensibility for an interview with one of the study’s authors.

Plus: “It took more than two decades of labor,” writes Julie Deardorff in the Chicago Tribune, “but Illinois is finally poised to permit its first free-standing birth center, an alternative model of care for low-risk pregnant women who want to deliver in a homey environment with a reduced chance of medical interventions.”

Read about the pilot program and steps supporters took, along with the Illinois Department of Public Health, to negotiate with hospitals and doctors.


January 30, 2013

Evidence-Based Health Information: Resources from Cochrane Collaboration and CUE

If you spend any time reading about evidence-based medicine, eventually you are going to hear someone mention a “Cochrane” review. These reviews take a systematic look at the research on a health topic, and try to provide answers to questions about best practices.

The Cochrane Collaboration is the international non-profit organization that produces these reviews and works to spread the findings to health care providers and patients. There’s a helpful newcomers’ guide to introduce people to Cochrane, and the video below provides some history and context for the organization.

The United States Cochrane Center, one of 14 centers around the world, is based at Johns Hopkins Bloomberg School of Public Health in Maryland. In addition to performing evidence reviews, the USCC also runs Consumers United for Evidence-based Health Care (CUE), a coalition of advocacy groups working to provide consumers with access to evidence-based information about health. Our Bodies Ourselves is a member organization.

CUE offers an online course on understanding evidence-based healthcare topics, such as research design, statistics, and other topics.

The video below offers more explanation, and features Zobeida Bonilla, who works on OBOS’s Latina Health Initiative.

Related: 
Meeting Dispatch: Resources from the CUE/Cochrane/Campbell Colloquium - Links to sources of evidence-based information, critiques of health journalism, info on pharmaceutical company payments to doctors, and more, collected from the 2010 joint meeting of CUE and the Cochrane and Campbell Collaborations.


January 18, 2013

Fixing Persistent Liability Concerns in Maternity Care: We Can Do It!

by Carol Sakala, Director of Programs, Childbirth Connection

One of most commonly cited barriers to improving maternity care is the risk of providers and hospitals being held liable for bad outcomes. Whether it is reining in overuse of tests and procedures, honoring women’s preferences, or increasing interdisciplinary collaboration, good ideas often cannot move forward once the issue of liability is raised.

If we cannot make progress toward more evidence-based, woman-centered care because of liability concerns, then the liability system is functioning poorly. But what are the aims of a high-functioning liability system? Is it just to avoid lawsuits and hold liability insurance premiums down?

In our new report, Maternity Care and Liability, we hold 25 possible liability reforms up to a framework that addresses the needs and interests of all of the system stakeholders: those who deliver care, those who pay for care, and most importantly, the women and newborns who receive care.

We developed this framework based on maternity care and liability studies and with the input of clinicians, legal scholars, consumer advocates, policy makers, and others. For each possible reform, we asked whether it does or would likely:

  • promote safe, high-quality maternity care that is consistent with best evidence and minimizes avoidable harm
  • minimize maternity professionals’ liability-associated fear and unhappiness
  • avoid incentives for defensive maternity practice
  • foster access to high-value liability insurance policies for all maternity caregivers without restriction or surcharge for care supported by best evidence
  • implement effective measures to address immediate concerns when women and newborns sustain injury, and provide rapid, fair, efficient compensation
  • assist families with responsibility for costly care of infants or women with long-term disabilities in a timely manner and with minimal legal expense
  • minimize the costs associated with the liability system

The proposed framework has the potential to move discourse and policy forward. When options for reform are held up to criteria in the framework, many that have been widely implemented do not appear to meet any of the criteria. Most notably, the best available evidence shows that tort reforms fare poorly against these aims, despite the fact that they are the most widely advocated and enacted liability reforms.

On the other hand, various reforms have the potential to be win-win-win solutions for women and newborns, providers, and payers. Strategies are needed both to prevent harm and ensure that it is rare and to respond appropriately to harm or claims of harm when they occur. For preventing negligent injury and related lawsuits, these reforms include rigorous quality improvement programs and shared decision making initiatives.

A series of recent reports clarifies the “business case” for quality improvement initiatives: successful programs with strong leadership are achieving better care, better health outcomes, and rapid substantial declines in liability claims, payouts, and premiums. Among redress approaches, disclosure and apology programs were the most promising, but have not yet been evaluated in maternity care.

The report includes summary tables with the full list of more promising and less promising strategies assessed and their demonstrated or plausible impact on the various areas addressed in the framework.

To achieve the high-performing maternity care system that stakeholders need, we cannot allow longstanding liability concerns to continue to rankle. By seeking guidance from the best available evidence about the nature of liability problems in maternity care and the effectiveness of possible solutions, we can move constructively beyond belief and entrenched positions.

It is time to pilot and evaluate the most promising strategies and scale up those that are effective, beginning with routine maternity care quality improvement initiatives. They have the potential to transform the quality and value of maternity care, and to ensure that maternity care work offers the joy and honor that draws talented, passionate individuals to the profession and keeps them caring for women, babies, and families.

For the full report, a set of 10 fact sheets, links to three related open-access Women’s Health Issues articles and an invited commentary from legal scholars Sara Rosenbaum and William Sage, and other resources, please visit http://transform.childbirthconnection.org/reports/liability.

This entry was originally posted at Transforming Maternity Care and is republished with permission.

Carol Sakala, director of programs at Childbirth Connection, is a long-time contributor to “Our Bodies, Ourselves.” She has worked on maternity care issues as an advocate, educator, researcher, author, and policy analyst for more than 25 years, with a continuous focus on meeting the needs of childbearing women and their families.


January 16, 2013

When Pregnancy is a Crime: Arrests, Forced Interventions in the Name of Public Health

Although this January marks the 40th anniversary of the landmark Supreme Court decision legalizing abortion, we know that there is still much work to be done to ensure reproductive justice for all women.

The Guttmacher Institute reports that 2012 saw the second highest number of abortion restrictions enacted in a single year; the Center for Reproductive Justice addresses each state in this report.

Among the provisions ultimately defeated were “fetal personhood” bills in Mississippi and Oklahoma. But the notion that fetuses should be protected from the women carrying them has resulted in the restriction and punishment of women across America.

Lynn Paltrow, executive director of National Advocates for Pregnant Women, and Jeanne Flavin, a professor of sociology at Fordham University and chair of NAPW’s board, have put together an extremely interesting and important study: “Arrests of and Forced Interventions on Pregnant Women in the United States, 1973–2005: Implications for Women’s Legal Status and Public Health.”

Paltrow and Flavin (who is also the author of the 2008 book “Our Bodies, Our Crimes: The Policing of Women’s Reproduction in America“) tried to identify and examine U.S. cases from 1973, the year of Roe v. Wade, through 2005, in which a medical or government authority tried or succeeded in stripping a woman’s autonomy because of pregnancy. The study appears in the Journal of Health Politics, Policy and Law.

These cases could have involved threat of or actual arrest, incarceration, or increased prison/jail time; detention in a hospital, treatment program, or mental institution; or forced medical intervention. Descriptive detail of several cases is provided, along with summary statistics on the findings.

Looking at legal, medical and other sources, Paltrow and Flavin analyzed 413 cases, which they speculate are “a substantial undercount,” because cases were difficult to identify and some sources referred to additional cases.

The data reveals substantial racial, income and geographic disparities. While almost every state had multiple cases, the regions with the most were the south (56 percent) and midwest (22 percent). These cases disproportionately targeted black women (52 percent of cases overall, and 72 percent of cases in the south), and 71 percent involved low-income women (enough so that they qualified for indigent defense).

Most women who faced criminal charges were charged with felonies; a greater percentage of black women (85 percent) were charged with felonies than white women (71 percent).

The authors explore how these disparities are interlinked with disparities in drug laws, disproportionate application of criminal laws, and outdated stereotypes about cocaine use (such as the “crack baby” myth).

The vast majority of the cases — 84 percent — involved allegations of illegal drug use. In the remaining cases, “women were deprived of their liberty based on claims that they had not obtained prenatal care, had mental illness, or had gestational diabetes, or because they had suffered a pregnancy loss.”

Although concern for the health of the fetus/infant is typically offered as a reason for increased scrutiny or detainment of pregnant women, in 64 percent of the cases there was no reported health issue cited in the allegation.

Chillingly, most cases were reported by people in so-called “helping professions”: health care providers (41 percent), social workers (12 percent), and hospital, child protective services, or police personnel (17 percent). Health care providers reported black women at a higher rate (48 percent) than white women (27 percent).

As the authors point out:

Due in part, no doubt, to the strong public health opposition to such measures, no state legislature has ever passed a law making it a crime for a woman to go to term in spite of a drug problem, nor has any state passed a law that would make women liable for the outcome of their pregnancies. Similarly, no state legislature has amended its criminal laws to make its child abuse laws applicable to pregnant women in relationship to the eggs, embryos, or fetuses that women carry, nurture, and sustain. No state has rewritten its drug delivery or distribution laws to apply to the transfer of drugs through the umbilical cord. To date no state has adopted a personhood measure, and no law exists at the state or federal level that generally exempts pregnant women from the full protection afforded by federal and state constitutions.

In other words, nothing about existing law should make women subject to such persecution. They also note that public health groups have observed that targeting pregnant women may lead to women avoiding medical care or having unwanted abortions to avoid increased and punitive scrutiny.

Paltrow and Flavin also highlight these cases in the context of proposed personhood laws, which would give fetuses individual rights and potentially could lead to increased prosecutions of women. They authors note that they have identified “more than two hundred cases initiated against pregnant women since 2005 that also overwhelmingly rest on the claim of separate rights for fertilized eggs, embryos, and fetuses.”

Opponents to personhood laws have cautioned that such measures could lead to forced medical interventions on pregnant women along with possible punishment for miscarriages and stillbirths. While personhood proponents often dismiss these warnings as scare tactics, the research shows there is good reason to be concerned.

Paltrow and Flavin conclude with a call for change:

In light of these continued efforts and our findings, we challenge health care providers, law enforcement and child welfare officials, social workers, judges, and policy makers to examine the role they play in the arrests and detentions of and forced interventions on pregnant women. We call on these same people to develop and support only those policies that are grounded in empirical evidence, that in practice will actually advance the health, rights, and dignity of pregnant women and their children, and that will not perpetuate or exacerbate America’s long and continuing history of institutionalized racism.

Finally, our study provides compelling reasons for people who value pregnant women, whether they support or oppose abortion, to work together against personhood and related measures so women can be assured that on becoming pregnant they will retain their civil and human rights.

The whole article is well worth a read if you can get a copy. The abstract is freely available online.


December 19, 2012

Some Doctors Use Risky Drug, Aiming to Shape Girls’ Genitals and Behaviors

by Alice Dreger

Dr. Mark Sloan, a pediatrician based in northern California, has written a very helpful overview of a controversial fetal engineering intervention: prenatal dexamethasone for pregnant women considered at risk of giving birth to a daughter with congenital adrenal hyperplasia (CAH). The article has been posted on the Our Bodies Ourselves website .

Although CAH is relatively rare, the use of this prenatal intervention should interest and concern all women’s health advocates for two reasons:

  • This fetal intervention has been pushed through the use of highly problematic sexist and heterosexist stereotypes.
  • The unscientific and unethical ways in which the intervention has been deployed send up all sorts of red flags with regard to patient safety and patients’ rights to informed consent.

CAH is a serious inborn endocrine disease; newborns are screened for it, and people who have it usually require lifelong hormonal management. One “side effect” of CAH is atypical (different from average) sex development in some females.

In an effort to prevent that atypical sex development, some doctors have offered prenatal dexamethasone, a synthetic steroid, to pregnant women identified through genetic analysis as being at risk of having a child with CAH. Giving a pregnant woman dexamethasone cannot prevent CAH or cure her offspring of CAH. The intervention is offered only in an attempt to ensure typical sex development in the offspring who are genetic females.

A genetic female fetus with CAH may develop differently from average females because CAH can result in high levels of masculinizing hormones. The process is called virilization, because it leaves a female skewed more toward the middle or even the male end of the genital development spectrum. (For an animated primer on genital development, click here.)

A female with CAH may be born with a large clitoris, even one that looks something like a penis; her labia may be joined like a scrotum; and her vagina and urethra in some cases will form joined together, which can put her at increased risk for infection and, at sexual maturity, difficulties with intercourse and giving birth.

Although in theory ensuring typical genital development may sound reasonable, in practice, this off-label use of dexamethasone has been a high-risk game. For the drug to work, doctors must give it starting by about week 7 of fetal life, before the genitals sexually differentiate. At this early stage, doctors cannot know if the woman is carrying a male or female fetus or whether the fetus even has CAH.

Only about 10 percent of the fetuses exposed will actually turn out to be females with CAH, meaning about 90 percent of those exposed will bear all the risk of fetal biochemical engineering with no chance to benefit.

As Dr. Sloan explains, the CAH-affected population of girls and women also shows signs of having their brains “virilized” during development. They are more likely than non-CAH girls to be tomboyish, and more likely to grow up to be lesbian, bisexual, or to identify as male in terms of their gender. (This population contributes to the idea that gender identity and sexual orientation have a biological component.)

I find it disturbing that the chief clinical-researcher proponent of the intervention has indicated that she’s interested in seeing if the intervention can “successfully” prevent this “behavioral masculinization” — in other words, she’s interested in seeing whether the fetal intervention can lower the rates of tomboyism, lesbianism, and bisexuality in this population.

As University of Michigan pediatric psychologist David Sandberg told Time magazine, “Maybe this gives clinicians the idea that the treatment goal is normalizing behavior. To say you want a girl to be less masculine is not a reasonable goal of clinical care.” (I agree.)

Most troublingly, as Dr. Sloan notes in his article, there has been shockingly little study of what this intervention does to the exposed children’s health.

After nearly 30 years of use, we have stunningly little data on efficacy and safety on this off-label use. It appears that, in many cases, women have been offered this drug without the protections of being enrolled in formal studies, after being lured into the intervention with claims that it “has been found safe for mother and child.”

Dr. Sloan discusses a paper I recently authored on this matter with my colleagues Ellen Feder, PhD, of American University, and Anne Tamar-Mattis, JD, of Advocates for Informed Choice. I encourage you to read Dr. Sloan’s article, and then, if you want to learn more about how this history unfolded, read our article, which is available for free download.

I also encourage you to read the “Dex Diaries” series I have mounted at fetaldex.org. There you’ll find a series of short essays unpacking this story from a personal point of view.

Kiira Triea (who recently died of cancer) wrote there about her own experience of having been changed in the womb; Fran Howell has relayed about how hard it is to watch this after herself being exposed to DES in the womb; Ellen Feder has expressed sympathy for the poorly informed mothers; Aron Sousa has analyzed the game that has apparently been played here with regard to federal funding; and Anne Tamar-Mattis has reported on the real silent majority of doctors who are troubled by how this population has historically been treated.

Finally, I encourage you to watch the videos at The Interface Project, where real people born with uncommon forms of sex development explain why no body is shameful.

Alice Dreger is Professor of Clinical Medical Humanities and Bioethics at Northwestern University’s Feinberg School of Medicine. Her personal website is alicedreger.com, and you can follow her on Twitter @AliceDreger.