Blood, placenta tissue and other specimens will be saved.

A Seattle Children’s project to reduce premature births and still births opens a new facility today to store tissue from pregnant women that researchers from around the world can use to study both normal and abnormal pregnancies.

The biorepository will be run by the medical center’s Global Alliance to Prevent Prematurity and Stillbrith (GAPPS).

Specimens stored at the facility will include maternal blood and urine, cervical vaginal swabs, placenta tissue, and cord blood.

Samples will are collected from the first trimester through the postpartum period.

The specimens will be linked with information about the mothers’ preconception history, course of her current pregnancy, environmental exposures, medical and reproductive history, mental health, nutritional intake, and behaviors.

Participation is voluntary, and the identity of participating mothers is kept confidential with the specimens being identified only by number.

“While pregnancy specimen biobanks have been developed before, this is the first time that specimens paired with information about mothers and their pregnancies have been made widely accessible,” said Dr. Craig Rubens, executive director of GAPPS.

The repository currently has more than 8,000 individual specimens available to scientists, with 800-900 specimens being added each month.

The collection includes contributions from women representing a wide range of racial, ethnic, regional, and socioeconomic backgrounds.

Among the goasl of the GAPPS Repository project are to:

• Help researchers discover biomarkers and create screening tools to identify women and babies at risk for preterm birth and stillbirth

• Use those findings to develop diagnostic tests, treatments, and prevention strategies

• And to support research to identify the causes of poor birth outcomes and the fetal origin of adult diseases in the hope of developing cures.

“Many adult health problems can be traced to fetal development,” Dr. Rubens said. “With these specimens, researchers can begin to understand what causes adverse pregnancy outcomes, and develop novel interventions to prevent them.”

To learn more:

• Visit the GAPPS website: www.gapps.org.

• Go to the GAPPS Flickr page to see more photos of the repository.

The guidelines, which were published online this week by the  American Journal of Obstetrics & Gynecology, were written to help health-care providers counsel mothers-to-be on how to avoid such toxins as lead, mercury, and a class of chemicals called “endocrine disrupters” that resemble hormones and have been linked to a number health problems including reproductive tract and neurodevelopment abnormalities.

Although the guidelines were written for health-care providers, the guidelines contain helpful information for patients, too, says Dr. Sathyanarayana.

“There are simple ways to reduce exposures to lead, mercury, pesticides and endocrine-disrupting chemicals . . .  by following the guidelines we have outlined,” Dr. Sathyanarayana said.

“Women and their partners should be aware that pregnancy is an important time for development, that environmental chemicals can cause harm to a developing fetus, and that this topic is important to discuss with health care providers,” said Dr. Sathyanarayana.

A summary of the guidelines provided by Seattle Children’s Research Institute is below:

Environmental Exposures:  

Tips for Reproductive Health Care Providers, Preconception and Prenatal Women

Mercury

• Risk factors: Exposure can come from eating fish, contact with quicksilver, and use of skin-lightening creams.  Exposure during pregnancy can lead to adverse neurodevelopmental outcomes that include lower IQ, poor language and motor development
• Reducing exposure to mercury:  Pregnant, preconception and breastfeeding women should follow U.S. Environmental Protection Agencyand state-specific fish consumption guidelines.  Avoid shark, swordfish, king mackerel, tile fish and large tuna.
• Resources:  Fish Chart and mercury guide.

Lead

• Risk factors: Risk factors for exposure include recent immigration to the U.S., occupational exposure, imported cosmetics, and renovating or remodeling a home built before 1970.  Lead is neurotoxic to a developing fetus.
• Reducing exposure:  Never eat nonfood items (clay, soil, pottery or paint chips); avoid jobs or hobbies that may involve lead exposure; stay away from repair, repainting, renovation and remodeling work conducted in homes built before 1978; eat a balanced diet with adequate intakes of iron and calcium; avoid cosmetics, food additives and medicines imported from overseas; and remove shoes at the door to prevent tracking in lead and other pollutants.
• Resources: Lead in Pregnancy/CDC and Poison Center Locator.

Pesticides

• Risk factors: Exposure can come from eating some produce and from using pesticides in your home or on your pets.  Exposure to pesticides in pregnancy has been shown to increase risk of intrauterine growth retardation, congenital anomalies, leukemia and poor performance on neurodevelopmental testing.
• Reducing exposure:  Do not use chemical tick and flea collars or dips; avoid application of pesticides indoors and outdoors; consider buying organic produce when possible; wash all fruits and vegetables before eating; and remove shoes at the door.
• Resources:  http://www.ewg.org/foodnews (focus on the “Dirty Dozen,” a list of the 12 most contaminated products published by the Environmental Working Group.

Endocrine-disrupting chemicals

• Risk factors: Human prenatal phthalate exposure is associated with changes in male reproductive anatomy and behavioral changes primarily in young girls. Animal studies suggest prenatal exposure to BPA is associated with obesity, reproductive abnormalities and neurodevelopmental abnormalities in offspring. Endocrine-disrupting chemicals mimic or antagonize the effects of hormones in the endocrine system and can cause adverse health effects that can be passed on to future generations.
• Reducing exposure:  Decrease consumption of processed foods; increase fresh and/or frozen foods; reduce consumption of canned foods;  avoid use of plastics with recycled codes #3, #6 and #7; be careful when removing old carpet because padding may contain chemicals; and use a vacuum machine fitted with a HEPA filter to get rid of dust that may contain chemicals.
• Resources:  BPA, CDC, and EPA.

Photo Dan Shirley

By Julie Appleby
KHN Staff Writer

While controversy over one aspect of the Obama administration’s contraception rule – whether and when religiously affiliated employers must comply – has dominated recent headlines, that debate has obscured other questions about how the rules will actually be implemented.

Under the health law, insured women will qualify for contraceptives without a copaymentas part of a range of preventive medical services. But insurers and advocates are frustrated by the lack of details. They’re asking, for example, whether surgical procedures must also be covered at no additional cost to patients.

“The unknown answers to the myriad of questions remain very worrisome,” says Judith Lichtman, senior advisor to the National Partnership for Women and Families, an advocacy group in Washington D.C.

America’s Health Insurance Plans (AHIP), the industry lobbying group, sent a list of questions to the Department of Health and Human Services (HSS) in September, asking for clarification on what types of contraceptives must be covered and how insurers should structure their policies. A spokesman for AHIP says the group is still awaiting answers to some questions.

Contraceptives are part of a package of women’s preventive health care services under the Affordable Care Act — including screening for diabetes, counseling about sexually transmitted diseases and breast feeding support — that must be provided without deductibles or co-pays in all new policies beginning Aug. 1. The package was drawn up after recommendations from the Institutes of Medicine (IOM). Other parts of the health law also provide no-cost-sharing preventive services for children and all adults, such as certain cancer screenings and immunizations.

Here are some questions, and answers when we could determine them, about the rules:

1) Are male-based contraceptive methods, such as vasectomies or condoms, covered by the rule?

An HHS official said on Friday that women’s preventive services guidelines apply to women only.

Guidelines issued by the Health Resources and Services Administration, part of HHS, require coverage without cost sharing for “all Food and Drug Administration-approved contraceptive methods, sterilization procedures and patient education and counseling for all women with reproductive capacity” as prescribed by a provider, according to the Federal Register.

The insurers’ letter from September says they interpreted the rule to include only female-based contraception and that the requirement to waive co-payments “does not apply to methods and procedures intended for males.”

But Adam Sonfield, senior public policy associate at the Guttmacher Institute, a reproductive health research group, says the language is unclear, and it would be foolish to exclude vasectomies. For one thing, he says, they are less expensive and pose a lower risk of complications than female surgical sterilization methods. Plus, he says, waiving co-payments for services for one sex but not the other raises issues of discrimination.

“I can’t see how it would be in anyone’s interest to treat them differently,” says Sonfield.

2) Are over-the-counter products like female condoms, spermicides, sponges covered by the rules and, if so, will they require a prescription and how will insurers reimburse policyholders for purchases at retail stores?

Products that must be covered without cost-sharing include over-the- counter contraceptives when they are prescribed by doctors, the HHS official said Friday. But getting a prescription for such items raises other issues, say advocates and insurers.

Insurers wrote HHS in September that “it is unclear what specific over-the-counter products are to be included.”

In addition, the letter warned that requiring a prescription for such items “would increase the burden on an already over-burdened primary care system and drive up administrative costs.”

Insurers wrote the industry has no simple way to track and reimburse policyholders who purchase those items at retail stores. Setting up such systems, “could cost tens of millions” and exceed the cost of the products themselves.

Requiring a prescription should definitely not be required, says Lichtman, who said such a move would make using contraception more difficult and expensive for women.

3) If a hospital stay is required for surgical procedures, such as when a women gets her tubes tied, would the procedure be covered without cost sharing?

Insurers say it is not clear if hospitalization or complications that might occur from surgery would be covered without the patient paying a co-payment or a deductible because they are not considered preventive.

Sonfield at Guttmacher argues they would be covered.

“It’s like saying you have to cover blood transfusions, but not the hospital stay,” he says. “That doesn’t make sense. If you’re covering it, you’re covering it all.”

HHS has not weighed in on this question, but is expected to issue additional guidance in the coming months.

Julie Appleby reports on the implementation of the health care overhaul law, the interplay of health care treatments and costs, trends in health insurance, and policy issues affecting hospitals and other medical providers. Her KHN stories have appeared in USA Today, the Washington Post, the Philadelphia Inquirer and MSNBC, among others. Before joining KHN in March 2009, Appleby spent 10 years on the health care industry and policy beat for USA Today. She also worked at the San Francisco Chronicle, the Financial Times in London and the Contra Costa Times in Walnut Creek, Calif. She serves on the board of the Association of Health Care Journalists and her education includes a Master of Public Health degree. | Contact: JulieA@kff.org

4) Will insurers be required to cover all products in a class, such as all IUDs, or all birth control pills? Can insurers require a co-pay for a brand-name drug if a generic is available?

Many insurers have “tiered” pharmacy benefits under which patients pay differing amounts for brand-name, as opposed to generic, products. Some require patients who choose a brand-name drug, when an equivalent generic is available, to pay the price difference between the two. Insurers say HHS guidance allows them to use such “reasonable medical management” to help control costs. That would include allowing insurers to charge patients for brand name drugs, it says.

The HHS official confirmed that, but stressed the plan must “accommodate any individuals for whom it would be medically inappropriate by having a mechanism for waiving the otherwise applicable cost-sharing for the branded version.”

Advocacy groups and insurers are in discussions with HHS over those and other questions related to preventive care, says Lichtman. Her group hopes the agency will soon release additional guidelines that “are broad enough so that all methods prescribed by doctors necessary for women’s health will be covered.”

5) Who will be covered for contraceptives without co-payments?

The package of women’s preventive care benefits must be offered in all new insurance policies sold to individuals and employers starting Aug. 1, as well as in most policies that renew afterwards on the date that they renew. There is an exception for insurance provided by certain nonprofit religious employers who object to birth control.

Twenty-eight states already require insurers to cover contraceptives, although large, self-insured employers are generally exempted from state rules. But a 2010 Kaiser Family Foundation/HRET survey of employers found that 85 percent of large firms offered prescription contraceptives in their plans, although they often required a patient co-pay or deductible. (KHN is a program of the foundation)

As for the types of procedures covered, the IOM cites a 2011 Bureau of Labor Statistics analysis of 3,900 employer plans, which found that policy documents representing about 70 percent of participants did not mention sterilization. But when sterilization services were mentioned, nearly 90 percent of the policies covered both female and male surgical sterilization procedures.

PHOTO: Courtesy of Dan Shirley

KHN wants to hear from you: Contact Kaiser Health News

This article was reprinted from kaiserhealthnews.org with permission from the Henry J. Kaiser Family Foundation. Kaiser Health News, an editorially independent news service, is a program of the Kaiser Family Foundation, a nonpartisan health care policy research organization unaffiliated with Kaiser Permanente.

“It is time to sound the alarm,” said Dr. Judy Wasserheit, vice chair of the Department of Global Health at the University of Washington, who wrote the article with Dr. Gail Bolan of the U.S. Centers for Disease Control and Prevention and Dr. P. Frederick Sparling of the University of North Carolina School of Medicine, Chapel Hill.

Gonorrhea bacteria - Photo CDC

Gonorrhea is a sexually transmitted disease that can infect the genital tract, throat and anus.

There are more than 600,000 cases of gonorrhea a year in the U.S., making it one of the most common reportable infections in the country.

Untreated, gonorrhea can cause a number of serous complications, including infertility, a chronic painful pelvic condition in women called pelvic inflammatory disease, and ectopic pregnancy, a serious complication in which the fetus develops in the fallopian tube instead of the uterus.

In rare cases, the bacteria can travel through the bloodstream and infect joints, heart valves and the brain.

The bacteria that causes gonorrhea, Neisseria gonorrhoeae, has a history of quickly acquiring the ability to resist antibiotics. In the 1940s it became resistant to sulfa drugs, in the 1980s to penicillins and tetracyclines, and by 2007 to flouroquinolones.

Today, treatment with a class of antibiotics called cephalosporins is considered the most reliable option, but resistance to this class of drugs is on the rise both abroad and in the U.S., raising concerns that doctors here will soon begin seeing cases they cannot cure.

Untreatable cases have not yet been reported in the U.S., but they have appeared in Asia and Europe and a worrying number of strains in the U.S. are showing signs of resistance to cephalosporins.

Resistance to one of the cephalosporins has risen 17-fold in the U.S. over the past few years, Dr. Wasserheit and her colleagues write, increasing from just 0.1 percent of cases in 2006 to 1.7 percent in the first part of last year.

Resistance has been increasing even faster in the western U.S., reaching 3.6 percent of all cases last year and 4.7 percent of cases among men who have sex with men.

Although higher doses may overcome the ability of these strains to resist cephalosporins for a time, Dr. Wasserheit and her colleagues write, urgent action is needed now to prevent the spread of these strains and to develop new treatments.

“There is much to do, and the threat of untreatable gonorrhea is emerging rapidly,” they conclude.

 To learn more:

• Visit the National Library of Medicine’s Medline Plus information page on gonorrhea.

• Visit the Public Health – Seattle & King County’s page on Sexually Transmitted Infections.

Photo: Sigurd Decroos

The good news: Teen pregnancies are at their lowest rate in nearly 40 years, resulting in fewer abortions and births, according to data from the Guttmacher Institute, a research organization focused on sexual and reproductive health.

The report shows that about 7 percent of U.S. teen girls between the ages of 15 to 19 were pregnant in 2008 — a decline from the high of more than 11 percent in 1990.

Abortions among teen girls fell from a peak of more than 4 percent in 1988 to about 1.8 percent in 2008, the lastest year for which data is available.

The bad news: While overall rates have dropped, there is still a major gap among white, Hispanic and black teenagers. Non-Hispanic white teen pregnancy rates fell by 50 percent from their peak; Hispanic teen pregnancy rates, 37 percent; black teen pregnancy rates, 48 percent.

Yet, according to the report, “the abortion rate among black teenagers was four times the rate for non-Hispanic whites, while the rate among Hispanic teenagers was twice the rate for non-Hispanic white teenagers.”

“The disparity has pretty much been unchanged,” said Kathryn Kost, co-author of the report. “If you think of these rates as lines on a graph, they are all going down, but the distance between them is pretty much unchanged.”

Kost said the increase in contraceptive marketing has helped to reduce pregnancies, but Heather Boonstra, a senior public policy associate at Guttmacher said the cost of contraceptives continues to be a factor. Boonstra said increasing the age limit for dependent health care coverage to 26 will increase access to birth control for many teens.

“There’s plenty of evidence that shows that if you take away cost in the equation,there is going to be better contraceptive use, fewer unintended pregnancies, fewer abortions, better birth outcomes,” she said. “The health care reform law was not designed with teens in mind, but … the more parents that are insured, the more teens or their dependents are insured, so certainly that will help.”

Bill Albert, the chief program officer of The National Campaign to Prevent Teen and Unplanned Pregnancy, said the decreased rates are a sign of progress, but more remains to be done. He noted that three out of 10 girls are pregnant by the age of 20.  Among the campaign’s initiatives is one focused on the Latino community and a new website geared to educating young women about birth control.

“In a way the message is let’s celebrate today, and then get back to work this afternoon,” Albert said. “I think this underscores the need to continue to invest as the current admin has in proven efforts to prevent teen pregnancy.”

Photo by Sigurd Decroos of CobraSoft.

This article was reprinted from kaiserhealthnews.org with permission from the Henry J. Kaiser Family Foundation. Kaiser Health News, an editorially independent news service, is a program of the Kaiser Family Foundation, a nonpartisan health care policy research organization unaffiliated with Kaiser Permanente.