A long, urgent search for proteins in the blood of pregnant women that could be used in early diagnosis of ectopic pregnancy (EP) has resulted in discovery of biomarkers that seem to be specific enough to begin testing in clinical trials, scientists are reporting in a new study in ACS’s Journal of Proteome Research.

David Speicher and colleagues explain that ectopic pregnancy happens when an embryo does not attach normally inside the mother’s uterus, but instead attaches and begins growing elsewhere. Most occur inside one of the Fallopian tubes, which link the ovaries to the uterus. Left undiagnosed, EP can burst the Fallopian tube and result in bleeding that is the second most common cause of maternal death early in the first trimester of pregnancy. EP is difficult for doctors to diagnose, and scientists long have searched for substances present in the blood of women with EP that could be the basis for a test.

The scientists describe discovery of such proteins in blood analyzed from women with ectopic pregnancies and compared it to blood of women with normal pregnancies. They identified almost 70 proteins occurring in unusual levels in the blood in EPs. One of those proteins is called Adam12 and it might be a particularly good early warning sign for EP, since it appears at levels that are 20 times lower than in normal pregnancies. “The next step is clearly to test the candidate biomarkers on a larger, independent patient group, both individually and in multi-biomarker panels,” the report states.

ARTICLE: “Systematic Discovery of Ectopic Pregnancy Serum Biomarkers Using 3-D Protein Profiling Coupled with Label-free Quantitation”

Source:
Michael Bernstein
American Chemical Society

Women who labor with a dedicated support companion are less likely than women without such support to experience a series of risky birth procedures, according to a review published in the current issue of The Cochrane Library. The comprehensive study of experiences of 15,061 women who participated in 21 randomized controlled trials confirms previously known benefits for maternal health, identifies an additional benefit for newborns, and finds no downsides. The study was carried out through the prestigious Cochrane Collaboration, an independent international organization that prepares and keeps up to date rigorous systematic reviews of evidence from the best available studies.

Overall, women who received supportive care from a companion throughout labor were less likely than women without such support to have a cesarean section, to use narcotics or any other pain medication, to use regional pain medication such as epidural analgesia, to give birth with vacuum extraction or forceps, and to rate their childbirth experience poorly. Having continuous support shortened labor and increased the likelihood of having a “spontaneous” birth with neither cesarean nor vacuum extraction nor forceps. These results confirm previous research. With the inclusion of six new randomized controlled trials, the present systematic review, identified another benefit of continuous labor support: reduced likelihood of a baby with a poor “Apgar score” rating of well being five minutes after birth. The authors conclude that all women should have continuous support while giving birth.

Ellen D. Hodnett, RN, PhD, Professor and Heather M. Reisman Chair of Perinatal Nursing Research, University of Toronto, and co-authors of “Continuous Support for Women During Childbirth” limited the study to randomized controlled trials. This type of research helps ensure that study groups are similar and that results are a true reflection of the effects of the care being studied — here, continuous labor support.

“Cesarean section, vacuum extraction and forceps, and pain medications are interventions that increase the likelihood of adverse short- and longer-term effects in women and babies. Continuous labor support is an important way for women to avoid overuse and harms of these practices, and to have a positive experience at this special time,” said Carol Sakala, PhD, MSPH, Director of Programs at Childbirth Connection. Dr. Sakala is a co-author of the report.

Supportive care during labor and birth does not involve clinical care, and may include:

– helping women with physical comfort

– providing emotional support

– offering information

– helping women communicate their wishes to caregivers

– engaging women’s husbands or partners, as desired by the couple.

Impact Depends on Type of Caregiver

The study provides new knowledge about effects of continuous labor support under different conditions. A major finding is that the impact of this care appears to differ, according to the type of person providing the care. Effects were strongest when the caregiver was neither a member of the hospital staff nor a person in the woman’s social network, and was present solely to provide one-to-one supportive care, such as a doula. Compared with women who had no continuous support, women with companions who were neither on the hospital staff nor in the woman’s social network were:

– 28% less likely to have a cesarean section

– 31% less likely to use synthetic oxytocin to speed labor

– 9% less likely to use any pain medication

– 34% less likely to rate their childbirth experience negatively.

When compared with no continuous support, continuous support by members of the hospital staff did not appear to reduce the likelihood of having a cesarean section or improve ratings of the childbirth experience and may have increased the likelihood of using synthetic oxytocin. These results may reflect the fact that hospital staff can experience divided loyalties, additional duties, and constraints of institutional policies when providing continuous support. Continuous support from a person in the mother’s social network (for example, her partner, husband, other relative, or friend) appeared to increase the mother’s satisfaction with her childbirth experience, but did not seem to impact her likelihood of undergoing a series of labor and birth interventions.

Background

Historically, laboring women routinely received support from female companions. However, more recently in hospitals worldwide, continuous labor support has become the exception rather than the norm. “There is concern about widespread dehumanization of women’s birth experiences,” said Dr. Hodnett. “Concern about institutional routines, high rates of intervention in healthy women and newborns, limits on women’s autonomy and control, unfamiliar personnel, and lack of privacy is leading to calls for making continuous labor support widely available to childbearing women.”

Leading options for continuous labor support in the United States include trained labor support companions known as doulas and — for satisfaction with the childbirth experience — the help of a friend or family member who is invited to be present when a woman gives birth. Childbirth Connection’s second national Listening to Mothers survey found that just 3% of women who gave birth in U.S. hospitals in 2005 experienced the most beneficial type of labor support, in the form of doula care. Although insurance coverage of doula services is limited, trained doulas are available in many communities throughout the United States. Typically, a woman (and her partner, if she has one) selects a doula during pregnancy, and they discuss the woman’s goals, preferences, and concerns. Some hospitals sponsor doula programs to increase access to continuous labor support. In addition to continuous presence during labor, birth doulas may provide some support in the days after birth.

“Hiring a doula was one of the best decisions my husband and I made during pregnancy,” said new mom Jenny McElroy. “Though we prepared by reading books, taking childbirth classes, and practicing comfort techniques, we were inexperienced with childbirth. Our doula knew exactly how to help my husband support me, help me cope with the pain, and help us stay calm and have the birth experience we wanted.”

Effective Strategy for Improving Maternity Care Quality and Value

Medicaid programs and taxpayers cover about 42% of the nation’s births, and private insurers and employers cover about half. The review authors encourage policy makers to provide coverage and hospitals to provide programs for continuous labor support. “The benefits of continuous labor support for mothers and babies are numerous, well established, and compelling, and warrant economic analyses of the relative costs and benefits,” said Maureen Corry, MPH, Executive Director of Childbirth Connection. “Medicaid programs and others seeking ways to improve maternity care quality and value and women’s experiences of care should consider continuous labor support as a key component of a high-quality, high-value maternity care system.”

Resources for Childbearing Women, Health Professionals and Policy Makers

Childbirth Connection’s website includes an in-depth evidence-based section to help childbearing women understand the benefits of continuous labor support, decide whether to have a continuous labor support companion, and arrange for such care (see here.) The professional area of the website includes a summary of results of the updated review and provides access to the full review, here.

Source:

Childbirth Connection

A rare bleeding disorder that can lead to life-threatening bleeding episodes is misdiagnosed in 15 per cent of cases according to findings from a new international research project led by a Queen’s professor.

“Correct diagnosis is critical because it determines the treatment decision,” says Maha Othman, a professor in the Department of Anatomy and Cell Biology who led the three-year research project on the rare platelet type of von Willebrand disease (VWD).

Patients with VWD are commonly treated with drugs that help control their condition. However, these drugs aggravate bleeding in patients with the rarer platelet form of the disease, and misdiagnosis can leave these patients vulnerable to severe life-threatening bleeding episodes in situations like pregnancy and surgical operations.

Although both forms of VWD are genetic disorders that share many diagnostic features, the defect actually lies in two different genes. A correct diagnosis can only be made by closely examining certain areas of both genes to determine where the defect lies.

Dr. Othman’s study is the first large study to investigate the occurrence of the two types of VWD worldwide and to evaluate DNA analysis as a diagnostic tool.

In addition to pioneering this international project, Dr. Othman has also created an online registry aimed at determining the frequency of the rare platelet form of VWD and to collect data about the disorder. Despite its relative rarity, VWD is actually the most common genetically inherited bleeding disorder, affecting about one per cent of the general population.

Dr. Othman’s research will be published in the March issue of the Thrombosis and Haemostasis Journal.

Source:
Christina Archibald
Queen’s University

Terbutaline (Brethine) is one of the most frequently used drugs in the treatment of preterm labor. A new form of giving terbutaline, the continuous subcutaneous infusion pump, allows terbutaline to be easily given around the clock without the need for an IV. There are, however, disadvantages: the pump is expensive and is more invasive than the oral or subcutaneous route. Now even more seriously, the FDA has warned that terbutaline administered by injection or through such a pump should not be used in pregnant women for prevention or prolonged treatment of preterm labor due to the potential for serious maternal heart problems and death.

Terbutaline is derived from a hormone called epinephrine, which is released when a woman is under stress, a response that’s commonly called the “fight or flight” response. Stress causes many of the muscles in a woman’s body to contract, so that she is ready to respond quickly. One type of muscle in the body (smooth muscle) however, relaxes when a woman is under stress. Since most of the uterus is made up of smooth muscle, the uterus will relax in response to a drug that contains substances like epinephrine.

Terbutaline is a bronchodilator, a medication that dilates (expands) air passages in the lungs. It attaches to beta adrenergic receptors on muscles surrounding the air passages, causing the muscles to relax and dilate the air passages. Wider air passages allow more air to flow in and out of the lungs. Increased airflow reduces shortness of breath, wheezing, and cough.

The drug is currently on the World Anti-Doping Agency’s list of prohibited drugs for Olympic athletes, except when administered by inhalation and a Therapeutic Use Exemption (TUE) has been obtained in advance.

Women respond differently to terbutaline, so its effects and how long they last vary from woman to woman. When a woman has a good response, terbutaline reduces the number and frequency of contractions. And yet, like all tocolytic drugs, terbutaline has not been shown to consistently prevent or delay preterm delivery for a significant period of time.

Even so, studies have shown that terbutaline can usually delay delivery for at least several days (depending on how much a woman’s cervix is dilated before beginning medication). This isn’t a lot of time, but it can make a big difference for the fetus if the mother is given steroids along with terbutaline. After 48 hours, steroids improve a baby’s lung function and reduce his or her risk of dying by 40%.

The FDA is now stating that oral terbutaline tablets should not be used for prevention or treatment of preterm labor. The FDA is requiring the addition of a Boxed Warning and Contraindication to the drug prescribing information (labeling) to warn against these uses.

Scott Monroe, M.D., director of FDA’s Division of Reproductive and Urologic Products states:

“Women should be aware that serious and sometimes fatal side effects have been reported after prolonged use of terbutaline in pregnant women. It is important for patients and health care professionals to consider all the potential risks and known benefits of any drug before deciding on its use.”

FDA warning relates to safety concerns about the prolonged use of terbutaline injection beyond 48-72 hours, and against any use of oral terbutaline in pregnant women for prevention or treatment of preterm labor.

The FDA’s reviewed cases of heart problems and even death associated with terbutaline use for obstetric indications, as well as data from medical literature documenting the lack of safety and effectiveness of terbutaline for preventing preterm labor. It has been concluded that the risk of serious adverse events outweighs any potential benefit to pregnant patients for either prolonged use of terbutaline injection beyond 48-72 hours or use of oral terbutaline for prevention or treatment of preterm labor.

Source: The Food and Drug Adminstration

Sy Kraft, B.A.

Scientists at The Wistar Institute and the University of Pennsylvania School of Medicine report the discovery of protein markers that could provide physicians with the first reliable blood test to predict ectopic pregnancies. Their findings are presented in the February 16 issue of the Journal of Proteome Research, currently available online. In a related small-scale study of clinical samples, published recently in the journal Fertility and Sterility, the researchers found that one of the proteins-ADAM12-showed a nearly 97 percent correlation with ectopic pregnancy.

Ectopic pregnancies occur when a fertilized embryo fails to implant in the womb, often getting caught in the Fallopian tubes. As the embryo grows, the tube could rupture, which results in the loss of the embryo and threatens the life of the pregnant woman. Ectopic pregnancies occur in about one in 40 to 100 pregnancies, and it is a leading cause of death in the first trimester of pregnancy. There is no single proven blood test for ectopic pregnancy, and current diagnosis relies on the use of ultrasound.

“Here we describe a group of proteins that, with further refinement, could make a simple blood test for ectopic pregnancy,” said David W. Speicher, Ph.D., professor and co-leader of Wistar’s Molecular and Cellular Oncogenesis Program and director of Wistar’s Center for Systems and Computational Biology. “This is also a proof-of-principle demonstration of a new method for the discovery of new blood-borne markers that may serve as diagnostic blood tests to detect or predict a variety of clinical conditions and diseases, from ectopic pregnancy to cancer.”

According to Speicher, their study points to the power of proteomics-the study of the sum total of proteins that the body is making at a given time-in understanding the state of health or disease in people. Proteomics provides researchers an “unbiased” approach to the discovery of biomarkers, proteins in this case, which could be used to signal the presence of a particular clinical disorder or disease.

“Most biomarkers being used clinically today were first discovered by focused studies of proteins known to be associated with a disease, such as the prostate-specific antigen, PSA, test for prostate cancer,” Speicher explained. “Proteomics is unbiased in the sense that we are not trying to confirm the presence of a known protein, we simply compare the entire protein profile of people in a particular clinical condition or disease state to the protein profile of people in a healthy state.”

“Instead of a single biomarker, we can define a panel of such markers, creating a test that weighs the relative importance of individual proteins,” Speicher said. “It makes for more sensitive, reliable tests.”

In the present study, the Speicher laboratory compared the proteomic signature of blood samples taken from known cases of ectopic pregnancy with blood samples taken from women who experienced a normal pregnancy. They discovered about 70 candidate biomarkers that could signal ectopic pregnancy, which stringent statistical analysis whittled down to the 12 most promising biomarkers. While some of the proteins had previously known associations with ectopic pregnancies, the researchers found at least two, including ADAM12, which had never been previously associated with ectopic pregnancy.

Speicher and his team worked in collaboration with Kurt T. Barnhart, M.D., a professor of obstetrics and gynecology at the University of Pennsylvania School of Medicine. In a study recently published online by the journal Fertility and Sterility, Barnhart, Speicher and colleagues at Penn and two other urban academic medical centers reported on elevated ADAM12 levels in women seen in emergency rooms for bleeding resulting from an undiagnosed ectopic pregnancy.

The next step is to further confirm and validate the usefulness of their panel of biomarkers using additional patient samples in order to create a practical, reliable blood test for ectopic pregnancy, Speicher says. Among their goals is to identify particular isoforms-that is, variations of a given protein-that are most relevant to identifying ectopic pregnancy. Many proteins exhibit different isoforms in the body; that is, proteins that come from related genes, differences in processing the gene or modification of the protein in some way by cellular processes.

“The great power of biomarkers is to detect clinical disorders such as ecotopic pregnancy or diseases, such as cancer, early when it is often easiest to treat the patient,” Speicher said. “Here we can envision a useful blood test that could, as part of routine early prenatal care, save the lives of many women.”

Funding for this studied was provided through grants from the National Institutes of Health and the Philadelphia Health Care Trust. The lead author of the study is Lynn A. Beer, a research assistant in the Speicher laboratory. Co-authors also include Hsin-Yao Tang, Ph.D., a Wistar staff scientist, and Sira Sriswasdi, a Penn graduate student, both of whom are also members of the Speicher laboratory.

Source:
Wistar Institute

Many people know someone with cancer, a friend, a relative or a colleague at work and want to help, but don’t know how to
go about offering it or what kind of support they can give. There are lots of things you can do, but perhaps a good place to start is
to recognize that you should do only what feels right for you, whether that’s just listening, or giving practical help.
Listening
It may come as a surprise to know that one of the most valuable ways you can support a person with cancer is simply to
listen.

However, being a good listener is not something that comes easily to everyone, so here are a few tips.

Check that they want to talk: is it the right time? Would they prefer to leave it for now? Or is this the wrong place? Try not
to be offended if they don’t want to talk to you.
They may not want to talk at all or they may prefer to talk to somebody else, so ask them if they want you to arrange for
someone else to visit.
Also, on another day they may feel differently, so do check again.
If they do want to talk, make sure you you give them 100% of your attention: switch off the mobile phone, choose a place
where you can both feel comfortable and private, and you won’t be interrupted.
Keep listening and show you are listening: the gift that you bring is letting them say what they want without being
interrupted, or judged.
Listening is not a passive activity of hearing what they are saying while your mind is elsewhere – for instance waiting for them
to finish so you can interrupt and say what is on your mind – that is more about getting them to listen to you.
When you are listening properly to someone, your job is to make sure you understand them and show that you are
attempting to grasp what they are saying.
For example, waiting for a diagnosis, or for test results, is a harrowing time and your relative or friend may become anxious and frustrated. They may repeat their concerns again and again, like a stuck record, and this can feel frustrating for you too, especially you are the sort of person who likes to be able to solve problems. Often in these circumstances listening is more about BEING there than DOING things.
Other family members and friends are also trying to adjust and come to terms with what has happened and may also need to talk.

Understanding emotions and reactions
Being diagnosed with cancer is a huge event in a person’s life, and at first they may not even believe it has happened: the shock
of the news is followed by the reluctance to accept it.

As well as difficulty accepting and processing the news, the shock can be followed by strong emotions such as anger or guilt.

Anger, perhaps triggered by anxiety or feelings of helplessness or fear, can be expressed in different ways; sometimes close
friends, family members, the doctors and nurses at the hospital or surgery can become targets.

Guilt can arise as feelings of letting down their family, or being a burden on others, or regrets about the past.

They may also be frightened about being in pain or undergoing treatment. And of course, they may be scared about
dying.

Having cancer can also make people feel lonely and isolated. They may feel too sick or tired to continue with social activities, or
they may just feel that nobody understands what they are going through.

Other times they may feel very sad, as they consider the loss of their health, the fact things may never be the same again; it can
be hard to be hopeful or optimistic when the future seems so uncertain.

These emotions can come and go, different people react differently and the same person can have different feelings from one day
to the next.

Not everyone appears to react emotionally. Some people seem to adjust very quickly to the shock and just “get on with it”. This
does not mean they don’t feel any emotions: it may just be their way of coping. They may even start seeing new opportunities
and start new hobbies.

Also, people who may appear to be strong “copers” may cope well at first, but then run out of energy and be too proud or
embarassed to admit they need help, and while everyone assumes they are fine, actually they are not.

If emotional support is not something you can offer or is helpful at this time, then perhaps what you can do is offer practical help.
There are lots of ways you can help, such as help with information, help with clinic visits and help with house and home.
Help with information
In these days of internet and the information age, you can access a massive amount of data in moments, and it is easy to be
overwhelmed with it. If you are someone who is good at internet searches, sorting out good from bad information, making phone
calls, and scanning books and libraries, then perhaps the most useful thing you can do is gather information and put it in a form
that is easy for the person with cancer to use.

But a word of warning: not everyone wants it. Some people would rather know nothing about their condition, while others want
to know everything, so make sure what you think is useful is what they actually want, and is given at a pace they can cope with.
Help with clinic visits
Another way you can help someone with cancer is to go with them to the clinic. If you do this then just check what it is that
would be most helpful for you to do.

Perhaps all they want is some company and they can deal with the rest, while other times perhaps they want you to be
with them when they see the specialist so you can take note of what is said, leaving them free to talk without worrying about
having to remember it all later.

It may also be helpful to organize their questions, perhaps write them out as a list in order of importance, and listen carefully to the answers
the doctor gives. Some doctors don’t mind if you record the session, so take a recorder with you and ask if they mind.
House and home
This is where a group of friends, each doing a small thing, adds up to big support: from helping with housework, cleaning and
washing, to making sure there is food in the house, meals in the freezer, and the kids have a lift to school and back.

For example, when preparing your own meals, perhaps now and again you could make some extra portions and freeze them, then when you
call round to see your friend, pop them in their freezer.

If there are lots of friends doing this, it might be useful to organize a rota, so that you don’t all do the same thing at the same time,
or all appear in the same week and then don’t offer any help for several weeks.

For some people, however, this might not be what they want. It could be that housework, cooking and cleaning are tasks they
enjoy, or these activities help them to keep a sense of “business as usual”, so not everyone needs or want this kind of help.

However, it is also important to keep checking, because it could be they start out not wanting this kind of support but then as
energy levels change, they may change their mind.
Checklist
Here are some further points, that the UK charity Macmillan Cancer Support suggest can help you think about offering support
and where to start:

Make your offer: is help wanted? If so, make your offer and be specific (don’t say “let me know if there is
anything you need”, say “can I go to the shops for you?”).
Gather (only) relevant information: in order to be useful, you will probably need to know something about their
medical condition, however, bear in mind that they may not wish to discuss it or share it, or may only wish to tell you as much as
is relevant to the sort of help you are offering. Respect their privacy and be careful about giving advice, it can put them under
unnecessary pressure, no matter how well it is meant.
Assess the needs: not only of the person who is ill but also the rest of their family. While this may be difficult to
predict, it can help you and your friends decide what to offer, to whom, and when. You may wish to find out, if the person is
very ill, things like who is going to take care of them durig the day, can they get to the toilet, can they make their own meals, will
they need help taking medication, where can they get financial help if necessary, and what equipment might they need? Even if
you are not offering to help with these things, it can help to clarify where you fit in.
Decide what you can and want to do: consider what you are good at, how much time you have, and what you want
and don’t want to do. It could be little things like finding films for them to watch, giving them a lift to the hospital, or picking up
medication from the pharmacy, calling round with a cooked meal, or helping them choose a wig or new clothes. Or it could be big
things like helping with childcare, doing things around the house, putting up handrails, or taking care of pets while they are in
hospital.
Start with small practical things: look at your list of things you can help with and offer just a few of the smaller ones
first: don’t overwhelm them with a huge offer, and especially if you are not sure you can keep it up. Take small steps, because on
both sides there are uncertainties, and balances to be struck, and things can change.
Involve others and care for yourself too: recognize your limitations and don’t promise more than you can offer.
Bring in others to help, with each person also only doing what is within their reach. Supporting someone else can be very
rewarding, and may you find your friendship grows closer, but it can also be tiring and distressing. Don’t be afraid to seek support for
yourself (in the same way as you are there for your friend, others will want to support you too). Seek out cancer support centers
in your area and don’t be afraid to call help lines or drop in for information or a chat.

And last but not least, remain flexible and willing to learn; whatever plans you make, be ready to adapt and change as the
situation demands. Cancer is unpredictable, and new treatments and information are emerging all the time, so don’t feel you have
to do everything perfectly or know all the answers.

Sources: Canadian Cancer Society, Macmillan Cancer Support (UK).

: Catharine Paddock, PhD

The U.S. Food and Drug Administration is warning that terbutaline administered by injection or through an infusion pump should not be used in pregnant women for prevention or prolonged (beyond 48-72 hours) treatment of preterm labor due to the potential for serious maternal heart problems and death. In addition, oral terbutaline tablets should not be used for prevention or treatment of preterm labor. The FDA is requiring the addition of a Boxed Warning and Contraindication to the drug prescribing information (labeling) to warn against these uses.

Terbutaline is FDA-approved to prevent and treat narrowing of the airways (bronchospasm) associated with asthma, bronchitis, and emphysema. The drug is used off-label for obstetric purposes, including treating preterm labor and treating uterine hyperstimulation. Terbutaline has also been used in an attempt to prevent recurrent preterm labor. There is no evidence, however, that use of terbutaline to prevent preterm labor improves infant outcomes. Serious adverse events, including maternal deaths, have been reported with such use in pregnant patients.

“Women should be aware that serious and sometimes fatal side effects have been reported after prolonged use of terbutaline in pregnant women,” said Scott Monroe, M.D., director of FDA’s Division of Reproductive and Urologic Products. “It is important for patients and health care professionals to consider all the potential risks and known benefits of any drug before deciding on its use.”

The FDA is aware that administration of terbutaline by injection to pregnant women is used in hospital settings in certain urgent situations. The FDA warning relates to safety concerns about the prolonged use of terbutaline injection beyond 48-72 hours, and against any use of oral terbutaline in pregnant women for prevention or treatment of preterm labor.

The decision to require a Boxed Warning and Contraindication is based on the FDA’s review of post-market safety reports of heart problems and even death associated with terbutaline use for obstetric indications, as well as data from medical literature documenting the lack of safety and effectiveness of terbutaline for preventing preterm labor, and animal data suggesting potential risks. Based on this information, the FDA concluded that the risk of serious adverse events outweighs any potential benefit to pregnant patients for either prolonged use of terbutaline injection beyond 48-72 hours or use of oral terbutaline for prevention or treatment of preterm labor.

These changes to the drug labeling are consistent with statements from the American College of Obstetricians and Gynecologists discouraging use of terbutaline for preventing preterm labor.

There are multiple generic versions of terbutaline oral tablets and injectable formulations available. The brand name products were previously discontinued by the companies that made them.

The FDA encourages patients to talk to their health care professional if they have concerns about any treatment they are receiving. Patients and health care professionals should report any side effects from the use of terbutaline to the FDA’s MedWatch adverse event reporting program here.

Source:

U.S. Food and Drug Administration

In view of the unacceptable rates of injury, including deaths, in babies and young children that are linked to cribs, playpens
and bassinets, US researchers are calling for greater efforts to increase awareness of their dangers, for products to be better
designed for safety and for standards to be enforced more rigorously.

The first study to use a nationally representative sample to analyze injuries associated with cribs, playpens, and bassinets in the
US appeared online on 17 February in the journal Pediatrics.

In December 2010, the United States Consumer Product Safety Commission (CPSC), after issuing recalls for more than 11
million cribs and receiving reports of more than 30 infant and toddler deaths in the past decade, voted unanimously to ban drop-sided cribs, the sort where a side rail can be lowered to allow a child to be lifted in and out more easily.

From June 2011 it will be against the law in the US to manufacture, sell or lease drop-sided cribs.

In a first study of its kind, researchers from the Center for Injury Research and Policy of The Research Institute at Nationwide
Children’s Hospital in Columbus, Ohio, analyzed data covering 1990 to 2009 on children under 2 years old who received
treatment in emergency rooms in the US for injuries related to cribs, playpens, and bassinets. The data came from the National
Electronic Injury Surveillance System which is operated by the CSPC.

Dr Gary Smith, who is director of the Center for Injury Research and Policy and senior author of the study, told the media
that:

“Despite the attention given to crib safety over the past two decades, the number of injuries and deaths associated with these
products remains unacceptably high.”

For the 19-year period they reviewed, he and his colleagues found that:

Each year, an average of 9,500 injuries and more than 100 deaths occuring in US emergency departments among children
under 2 years old were linked to cribs, playpens, and bassinets.
Most of the injuries involved cribs (83%).
The most common injury was soft-tissue injury (34%), followed by concussion or head injury (21%).
The most frequently injured part of the body was the head or neck (40%), followed by the face (28%).
Two thirds of injuries were due to falls, and the percentage attributed to falls went up with age.
Babies under 6 months old were nearly 3 times more likely to be hospitalized than older children.

The researchers concluded that:

“Given the consistently high number of observed injuries, greater efforts are needed to ensure safety in the design and
manufacture of these products, ensure their proper usage in the home, and increase awareness of their potential dangers to young
children.”

However, although there are risks, a crib is still considered the safest place in which to place a baby to sleep. Given this, there
are several things parents, childminders and caregivers should bear in mind when choosing a crib and placing a child to sleep in
one, says the Research Institute at Nationwide Children’s Hospital:

Look up www.recalls to make sure the crib has not been recalled.
Make sure the crib is not old, broken or modified, meets all current safety standards and does not have a drop side.
Avoid cribs with cutouts, decorative knobs or corner posts that stick up more than 1.6 mm (1/16th in).
Make sure the slats are no more than 6 cm (2 and 3/8 ins) apart.
Ensure the mattress fits tightly in the crib: if you can fit two fingers between the crib and the mattress it is too small – get a
bigger mattress.
Examine the crib frequently and make sure nothing is broken or loose and it is in good condition.
Read and follow the assembly instructions closely.
Always place babies on their backs to sleep.
Don’t add pillows, blankets, sleep positioners, cuddly toys or bumpers in
the crib. The safest crib is a bare crib.
Don’t put tents and mesh canopies over the crib: children can become tangled up in them and strangle
themselves trying to get out.
Don’t put the crib near a window, especially if it has sashes, cords and drawstrings for blinds, shades or curtains.
Children often develop faster than we think so keep checking what they can do: once a child can push up onto hands and
knees, and definitely by the age of 5 months, you should remove all mobiles and nearby hanging toys.
Once they can pull up to standing, move the mattress to the lowest position and make sure the sides of the crib are at least 66
cm (26 in) above the mattress to stop them falling out.
Your child will most likely be too big for his or her crib when they near 90 cm (about 35 in) in height. Check the
manufacturers’ information about their advice on when the crib will be too small for your child.
If you put your child in a bassinet or playpen, make sure it has a wide and sturdy base and it is within the safety limits for your
child’s height and weight.

Smith, who is also Professor of Pediatrics at The Ohio State University College of Medicine, said:

“Unlike other child products that require adult supervision for their safe use, cribs, playpens and bassinets must be held to a
higher standard because we expect parents to leave their child unattended in them and walk away with peace of mind.”

He said educating parents and carers about how to use these products safely and be alert to the possible dangers they pose would
not be enough. It was important also to improve their design so they provide automatic protection to keep children
safe.

“Injuries Associated With Cribs, Playpens, and Bassinets Among Young Children in the US, 1990-2008.”
Elaine S. Yeh, Lynne M. Rochette, Lara B. McKenzie, and Gary A. Smith.
Pediatrics published online 17 February 2011
DOI:10.1542/peds.2010-1537

Please Note: This article has been amended to correctly state that you should place babies on their backs to sleep. The previous version said the opposite, a typographic error in the text. We would remind readers always to check with their healthcare professional before following advice from articles: even though the current advice is to put babies to sleep on their backs, there may be a good reason why your pediatrician recommends another position in the case of your particular child.

Additional source: Nationwide Children’s Hospital (press release, 17 Feb 2011).

: Catharine Paddock, PhD

A study conducted at the University of Granada and at the University Hospital San Cecilio revealed that preterm mothers’ milk contains low concentrations of coenzyme Q10. This is a complex of great medical importance, due both to its antioxidant capacity and to its role as a component of the electron transport chain, among other functions.

This study counted with the participation of a group of researchers of the Institute of Nutrition and Food Technology “JosГ© Mataix” (from to the Andalusian Government research groups AGR-145 and CTS-627), and with the collaboration of the Department of Pediatrics of the University Hospital San Cecilio of Granada, Spain.

The main objective of this study was to analyze the presence of coenzyme Q10 in breast milk and to examine variation in Q10 concentrations in the three stages of breast milk (colostrum, transitional and mature milk). The second goal was to determine whether the milk of mothers at term and that of preterm mothers have different Q10 concentrations.

30 Breastfeeding Mothers

To carry out this study, researchers selected 30 nursing mothers, 15 of which had completed their gestation and 15 were preterm mothers. Three milk samples were taken from each mother: colostrum, transitional and mature milk. Participants were asked to complete a questionnaire about their eating habits, which was processed later with software developed by the Institute of Nutrition and Food Technology “JosГ© Mataix”, of the University of Granada. The milk samples were examined to measure -among other parameters- concentrations of coenzyme Q, tocopherol (isomers a, g and d) and the total antioxidant capacity of breast milk.

The study revealed colostrum CoQ10 concentrations of about 0.4 Вµmol/l in preterm mothers and 0.7 Вµmol/l in term mothers. This means that CoQ10 concentrations in mothers at term are 75% higher than in preterm mothers. Similar results were obtained regarding tocopherol.

Perfect Food

Scientists stress that while breast milk is the perfect food for all newborns, as it provides the nutrients needed for proper development and growth, “in some cases, breastfeeding is not possible and infants are fed with artificial nutrition. Artificial nutrition is intended to be as similar as possible to human breast milk, or at least, to have the same functional effects as breast milk. This requires a deeper understanding of the composition of human breast milk”. This is what makes the results obtained of this research so relevant.

Antioxidants

And, although some antioxidants as tocopherol, carotenoids, ascorbic acid, etc. are known, “there are components with antioxidant activity which concentration and presence in breast milk is completely unknown. Coenzyme Q10 – which is an antioxidant of great importance- belongs to this group”.

The researchers believe that their study will make an important contribution to the area of infant nutrition. “Having a deep understanding of the factors and components of human milk is paramount, as it can help in getting a better infant milk formula. This way, although a newborn can not benefit from breast milk, at least it will be given the opportunity to artificially benefit from the advantages of human milk” – the authors state.

The authors of this study are Julio JosГ© Ochoa Herrera, JosГ© Luis Quiles Morales, MarГ­a Del Carmen RamГ­rez Tortosa, Guillermo RodrГ­guez Navarrete, Magdalena LГіpez FrГ­as and the deceased Francisco JosГ© Mataix VerdГє (of the Institute of Nutrition and Food Technology “JosГ© Mataix”), and Eduardo Carbona and JosГ© Maldonado Lozano (of the University Hospital San Cecilio of Granada, Spain).

Sources: University of Granada, AlphaGalileo Foundation.

President Obama’s federal 2012 budget includes $250 million in grants over the next three years to fund state efforts to overhaul medical liability laws. This proposal authorizes the US Justice Department, in consultation with the Department of Health and Human Services, to award grants to states for implementing innovative reform measures such as health courts, “safe harbor” laws, and early disclosure and compensation programs.

“The American Congress of Obstetricians and Gynecologists (ACOG) has long endorsed measures to make health care safer for patients while also protecting access to the physicians who care for them. The President’s proposal is an important step in the right direction toward fostering a reliable system of medical justice and enacting common sense reforms that protect patients, halt lawsuit abuse, and keep doctors in practice,” said ACOG President Richard N. Waldman, MD.

“The medical liability situation for ob-gyns remains a chronic crisis and continues to deprive women of all ages-especially pregnant women-of experienced ob-gyns,” said Albert L. Strunk, JD, MD, deputy executive vice president of ACOG. According to an ACOG survey , 90% of ob-gyns have been sued at least once during their professional careers. Currently, the average age at which physicians cease practicing obstetrics is 48, an age once considered the midpoint of an ob-gyn’s career.

“Women’s health care suffers as ob-gyns further decrease obstetric services, reduce gynecologic procedures, and are forced to practice defensive medicine,” added Dr. Strunk. The ACOG survey also found:

– More than 63% of ob-gyns have changed their practice due to the risk or fear of liability claims or litigation.

– One in 12 obstetricians who have changed their practice has stopped delivering babies.

– 15% of ob-gyns have decreased gynecologic surgical procedures because of the risk or fear of being sued.

– Over half of all liability claims against ob-gyns were dropped or settled without payment on behalf of the ob-gyn.

ACOG is fully committed to the enactment of a national law patterned on The HEALTH Act (HR 5) and the Texas and California medical liability reforms. “While ACOG works to attain this goal, we support interim measures and alternatives that address the long delays, excessive costs, and the unpredictability and inequality of compensation in our current system. Successful alternatives could help guarantee that injured patients are compensated fairly and quickly while promoting quality of care and patient safety,” said Dr. Waldman.

One alternative in particular which is highlighted in President Obama’s budget is health care courts. These special courts would take injury claims out of the adversarial tort system, where facts are often poorly understood, and put them into the hands of experts whose goals are fairness and patient safety. “Health courts would allow for a bench or jury trial presided over by a specially trained judge to exclusively hear medical liability cases. A judge with specialized training would resolve disputes with greater reliability, consistency, and efficiency than would untrained judges or juries and could issue opinions that define standards of care or set legal precedent,” noted Dr. Strunk. Other promising alternatives that can make a difference include early offer systems and expert witness qualification programs.

“Without reform of America’s broken liability system, women will increasingly find that they cannot get the prenatal and obstetric care they need, and many pregnant women will not be able to find doctors to deliver their babies. Women will lose care that will help protect fertility, end pelvic pain, and detect and treat cancer early,” said Dr. Waldman. “Women deserve better.”

Source:

American Congress of Obstetricians and Gynecologists (ACOG)