No Fault Compensation for "Birth-Related Neurological Injuries?"

Today I went to testify before a State Senate Judiciary Subcommittee that is proposing legislation for a no-fault “Birth-Related Neurological Injuries” bill. Currently such legislation is in place in only two states, Virginia and Florida. The former was the first and is struggling to survive, financially, and the latter is currently in better shape fiscally, but that fiscal stability is highly dependent on the investments they have made at the times when there were surplus dollars in the coffers. If I understood what the Florida director said at today’s hearing, they only brought in about $22,000,000 in revenue this year and actually paid out $35,000,000. Obviously, that cannot go on forever (unless you are part of the federal government). Both of these programs provide compensation only for babies who are severely damaged “physically and mentally” in the peripartum period (during labor, delivery, and immediately postpartum) and only if their providers and hospital are participants in the program. I think there are problems with this approach for reasons that will be clear later on.

The gist of my testimony was the following: The affected children are the ‘innocent victims’ regardless of the cause of their neurological injury. These children will need special education, ongoing rehabilitation, special services, and medical care the rest of their lives. Costs of these programs are beyond the means of most families. If families go through the tort system, the process may take many years even though their need is NOW, they run the risk of getting nothing, and if there is a settlement or a judgment in their favor, attorney’s compensation may eat up 60% of the final dispensation.

At the same time, liability insurance premiums are continuing to rise for OB providers. This rise in premiums is driving good providers out of obstetrical practice, especially in rural areas where the low OB volume and the small profit margin of providing obstetrical care make it impossible to continue to do so and keep their heads above water. This will inevitably lead to an increase in both fetal and maternal complications during pregnancy for patients who have to travel longer distances for care. Legal settlements for OB cases can also be astronomical and well beyond reason. Indeed, the average settlements in OB cases are about $2,500,000, more than twice the average of other medical specialties. No one I know practices obstetrics with the intent of maliciously causing damage to the baby, yet ridiculously large settlements have been handed out by juries even in circumstances where there was absolutely no evidence of malpractice in the peripartum period on the part of the provider. So, for all the reasons above, the concept of a true “no-fault” program is worthy and should be pursued.

There are some other issues of which the general public may not be aware. About 90% of “birth-related neurological injuries” occur at some time BEFORE the labor and delivery process and are, therefore, outside the control of the provider (I can address some of those causes in another post). If the programs in Virginia and Florida cover only those babies who clearly suffered damage during the peripartum period that means only 1 out of every 10 neurologically damaged babies will derive some benefit from the program. Yet, ALL of these babies may require and deserve comparable services. That also means that 9 out 10 could still put the provider “at risk” for litigation, even if the outcome was completely outside their control. And, being “at risk” means that at least some of these providers will have judgments decided against them simply by the process of jury roulette.

To make matters worse, despite the knowledge that most of the neurological damage is outside provider control, the programs in both Florida and Virginia put the bulk of the financial burden for financing their programs on the shoulders of the providers and the hospitals in which these babies are born. If you believe even a portion of my preceding comments, such an approach seems difficult to justify. Except in cases of gross negligence (which unfortunately do occur), the care and support for these children and their families is really a problem for society as a whole, and shouldn’t be purely the responsibility of those of us who continue to provide obstetrical care. The hours (and reimbursement per hour) are bad enough, but charging us an extra $5,000 per year for the privilege to practice obstetrics seems only to add insult to injury. (At least in Florida, the insurance carriers may reduce your premiums by a like dollar amount, but at $200,000+ per year premiums, that seems to be hardly generous). At the least there should be some mandate built into any “no-fault” program that the insurance industry, which will undoubtedly be prime beneficiaries of such an approach, is required to help underwrite a portion of the program funding. I certainly don’t think we can expect ANY support from the plaintiff’s attorneys in this regard!

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The Best Prenatal Care Begins Before Conception

I was talking with a reporter the other day about routine pregnancy care and the first question she asked me was, “When in pregnancy is it best to make your first doctor’s appointment?” She was quite caught off guard when I told her, “That’s easy. Before you ever get pregnant!” We have preached for a long time that the best prenatal care begins prior to conception. This is especially true for women planning to have their first babies, women with known medical problems, and women who had complications during a previous pregnancy.

A preconceptional visit is a lot more than meeting the person with whom you will be very intimate over the course of a year and during one of the most vulnerable periods of your life, although that is important too. It is an opportunity to review past medical, obstetrical, family, and social history that could have a significant impact on the outcome of a pregnancy. A woman should come to a preconceptional visit prepared to be open and forthright with her provider about her past and current problems, medications, sexual history, obstetrical history and the like. Ideally, she should come with her partner; however, if there are things about the past that she does not want her partner to know, then that first visit may be better made alone. Under those circumstances, it is most helpful if she can gather pertinent personal, genetic, and family history regarding her significant other so that this can be integrated into the counseling session. Let me provide just a few examples of where preconceptional counseling can make a big difference.

• If not offered at the time of the visit, ask your provider for a prescription prenatal vitamin. These are ‘well-balanced’ and most contain 400mcg of folic acid. Folic acid taken prior to conception can significantly reduce the risk for neural tube defects (failure of complete closure of the spine) and may also reduce the risk for other ‘midline defects’ involving the face, abdominal wall, and even the heart. If you or any other family member has had a baby with a neural tube defect, the dosage of folic acid can be safely increased to 4000mcg and may reduce your risk for a baby with such a problem by 70% or more. The spine closes between 24 and 28 days after conception, about 6 weeks from the start of the last normal menstrual period, and usually weeks before someone will get to see their provider for the first obstetrical visit. So, if folic acid is not begun prior to conception, the opportunity to derive a benefit from its use may be easily missed.

• Prenatal vitamins also contain appropriate amounts of the ‘fat soluble vitamins,’ vitamins A, D, and E. Taken in excess, these vitamins can be harmful to a baby, so if you are currently supplementing your diet with ‘megadoses’ of these or any other over-the-counter preparations (yes, even ‘natural herbal’ compounds), you should make your provider aware of what these are and, if there is any question of safety, discontinue them prior to conception. In fact, if you have been on high doses of vitamin A for a prolonged period, or taken a medicinal vitamin A derivative such as Accutane(TM) for acne, you should probably not get pregnant for at least 3 months after discontinuing the drug.

• If you work with young children, immunosuppressed individuals, or have a young child in a day care setting, you should consider serologic screening for previous exposure to parvovirus B19 (the cause of “Fifth’s disease”) and for cytomegalovirus (CMV) before conception. Both of these viruses are very common, especially in young children, and both can cause serious problems for a fetus if the mother develops a “primary infection’ during a pregnancy. Also, both viruses can cause unrecognized or completely “asymptomatic” primary infections in the mother that may have just as severe consequences for the baby. If you have protective IgG antibody to these viruses, indicating previous exposure, you are at as low a risk as possible for serious fetal infection. If you do not, since no vaccine is available for either virus, you should minimize risk of exposure during a pregnancy to potential sources of infection, and even consider repeat serologic screening in each trimester to see if you have “seroconverted” as the result of an asymptomatic infection. Any respiratory tract illness with fever during pregnancy might also be seen as a reason to rescreen the known seronegative woman.

• If a woman has a chronic medical condition, the goal should be to optimize therapy prior to conception. This involves evaluating current disease status and stabilizing the condition, making the woman as ‘normal’ as possible, with treatment that has the highest likelihood of minimizing fetal risk (from standpoints of both the disease and the therapy) in the first trimester. The most common problems we deal with are hypertension, thyroid disease, and diabetes. Of these, diabetes is probably the greatest concern for the baby during the first 6-8 weeks of development. For reasons that are still not clear, poorly-controlled diabetes in first trimester is associated with at least a 2-4-fold risk for major anomalies, especially of the heart, spine, and abdominal wall. Bringing maternal blood sugars into normal range during ‘embryogenesis’ has been shown to lower the anomaly rate to levels close to those of the general population. Again, unless the woman is seen prior to conception, the opportunity to achieve this level of diabetic control is often missed. (By the way, diabetics are one group of patients I will routinely offer 4000mcg folic acid daily to prior to conception).

• If there have been problems with the past obstetrical history, this is a major reason for seeking preconceptional counseling since, even if we sometimes aren’t smart enough to figure out why, we do know that obstetrical history tends to repeat itself. The issues of concern here range from hypertensive disorders, gestational diabetes, small babies, large babies, blood clots, and bleeding problems to the most common repetitive complication, preterm labor and delivery. We have devoted several posts to the latter, but I wanted to revisit it again briefly here. Yesterday, I took care of a woman who presented to our service for the first time at 24 weeks’ pregnant with a cervix that had dilated to 3 cm and was almost completely ‘effaced,’ or thinned out. She was barely contracting and had come in because she was feeling “pressure like when I had delivered before.” The kicker here is that she had delivered early before at 26 weeks’ after spending 4 weeks in a hospital for premature cervical change without labor. Despite the fact that she had told her physician about this past obstetrical history, she had not been plugged into any special care during the current pregnancy to evaluate the possibility of “cervical incompetence” that was strongly suggested by the past, and now reaffirmed by the current, pregnancy. We may have salvaged a better outcome for the current pregnancy with the ‘rescue cerclage’ we placed yesterday (although we are far from ‘out of the woods’), but that would have been much better (and safer) if it had been placed at the end of first trimester or with the first real evidence of loss of integrity at the internal cervical os that could have been readily detected by serial ultrasound assessment.

• Finally, I just want to provide one more example that some women may and others may not consider being a ‘benefit’ of preconceptional counseling. I really enjoy talking with women planning to have their first babies. Within the past year, I saw a couple who had decided that “the time was right to start a family.” They just wanted to talk with a doctor before she stopped her birth control pills. She had absolutely no identifiable ‘risk factors.’ She was healthy, she had no medical problems, she had no ‘vices, such as smoking or excessive alcohol use, there was no significant family or genetic history on either side that could be elucidated, she exercised regularly, and best of all she was excited about getting pregnant. We talked about the basic care given in pregnancy, expected weight gain, recommended and ‘optional’ laboratory studies, ultrasound and a host of other more routine things. I gave her a prescription for a prenatal vitamin and instructed her to start taking them regularly. She was going to “stop my pills and can’t wait to tell my friends the minute I think I am pregnant.” She had actually anticipated my next comment and it was the perfect segue for the one caution I always give to women planning their first pregnancies. “You might want to wait on that,” I said. “Getting pregnant, or telling my friends?” she asked. I told her it was the latter and the reason for that is there is an extraordinarily high spontaneous miscarriage rate (perhaps as high as 40-70%) among women having their true first pregnancies and for that reason, she “might want to wait until she was nearing the end of the first trimester before “telling the world.” “It sometimes can make things easier if it doesn’t turn out,” I told her. To make a long story short, I saw her back in the office for an ultrasound about 8 months later when she was 20 weeks’ pregnant. Her first comment was that she wanted to thank me for the “words of caution.” When I asked her what she meant, she told me that she had gotten pregnant within the month after we had first talked but had miscarried that baby very early in the pregnancy. She told me that she had followed my advice and “would have been devastated” if she had told all her friends and then lost the baby. To her, this was clearly a benefit of preconceptional counseling, and one that she was quite grateful to have gotten…

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Will We Ever See 17-P for PTB?

On August 31, I posted a note entitled "Preterm Birth: An American Tragedy." In that post, I reported that Adeza Biomedical Corp. had filed application with the FDA to have exclusive rights to the production of 17-hydroxy-progesterone caproate ("17-P"), a synthetic progesterone that had been shown to reduce preterm birth rates by about one-third in 'high risk' women with histories of preterm deliveries. Over the past few years, Adeza had been supplying the drug to pharmacies which were then compounding the formulation and selling it to providers at a fairly reasonable cost. My immediate concern was that if Adeza got exclusive rights to production and distribution, the cost of the drug would skyrocket. On the other side of the coin, they would also then be held to higher quality standards of production and probably assume a large share of the liability that could be incurred by unexpected deleterious side-effects of its use.

Adeza announced today that the FDA had determined that "Gestiva (TM)...is approvable subject to the completion of an additional animal study..." to assess the safety of 17-P. The primary reason for this is that in the sentinel placebo-controlled trial, there did appear to be a slightly higher rate of fetal loss in the 17-P group during the first two months of administration of the drug (Meis P, et al., NEJM. 2003; 348:2379-85). Interestingly, an animal study published almost 20 years ago also demonstrated a dose-response embryolethality, but not teratogenicity (i.e., killed fetuses, but did not cause birth defects) with long-term in utero administration of 17-P to pregnant rhesus and cynomolgus monkeys at doses ranging between 0.1 and and 10 times the "human therapeutic dose" (Hendrickx AG, et. al., Teratology 1987;35:129-136). An explanation for the higher rate of fetal wastage was not determined.

It is also interesting to me that the FDA has requested another 'animal study' and not another clinical trial in humans. The FDA usually requires two adequate and well-controlled clinical trials proving efficacy of a drug before granting approval for a specific indication. The only adequate trial to date performed in the U.S. has been the one mentioned above, and that was aborted prematurely (now isn't that ironic) because the investigators felt that it was unethical to continue the trial in view of the efficacy demonstrated at the time of an interim analysis of the data. With the new questions that have been raised regarding fetal wastage, if that should again be confirmed in another animal study, will the FDA then require another large clinical trial in humans before we can hope to see 17-P on the market???? The last one took several years to complete. And what will the cost of any further trials add to the final cost of the drug???? Guess we will have to wait and see....

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Group B Streptococcus (GBS) in Pregnancy: Hold the Vancomycin?

Group B Streptococcus (GBS) is a bacterium that colonizes the vagina and lower gastrointestinal tract in as many as one-third of all healthy reproductive age women. It is the leading cause of serious bacterial infection in newborns. Most babies contract the organism at the time of delivery, but in utero infections can occur, even in the absence of membrane rupture. Babies are at greater risk for this in the presence of heavy maternal colonization, especially when GBS urinary tract infection is present. GBS can cause septicemia, pneumonia, and meningitis. Serious neonatal infections are recognized in 8,000-12,000 babies per year in the U.S. and approximately 2,000 infants will die from their infections. It is also estimated that GBS causes at least 50,000 maternal infections of the uterus and the genitourinary tract requiring treatment as well in the postpartum period.

Far many more babies become “colonized” at delivery than ever go on to develop serious complications. The reason for this is unclear but it is probably a function of the extent of maternal colonization, the ‘quality’ of the maternal immune response to the organism (and the degree to which maternal antibody has been transferred to the fetus), and the gestational age of the baby (although serious infections can occur at any gestational age, premature babies are highly susceptible). About two-thirds of serious GBS infections are apparent at the time of delivery and 90% of babies who will develop complications do so within the first 48 hr after delivery. This is generally referred to as “early-onset” GBS infection and technically is used to define disease occurring in the first week of life. “Late-onset” disease affects another 10% of newborns, often presents as meningitis with septicemia, and rarely occurs after one month of age. Up to one-third of the survivors of GBS meningitis will develop long-term physical and/or neurological handicaps and in 1 of every 8 of these babies, the handicaps will be severe.

Because of the high morbidity associated with neonatal GBS infections, the American College of Obstetricians and Gynecologists (ACOG), the American Academy of Pediatrics (AAP), and the Centers for Disease Control (CDC) endorse routine screening of all pregnant women for GBS at 35-37 weeks’ gestation, and prophylactic antibiotic treatment at the time of labor in those found to be colonized with GBS. Screening is performed by swabbing the lower vagina and rectum and culturing for the organism on ‘selective’ media. GBS may come and go, but a negative test within 5 weeks of delivery has a ‘negative predictive value’ of about 95%. This implies that only 5% of women are likely to acquire GBS between the time of screening and delivery. Interestingly, if GBS is detected at routine screening, the ‘positive predictive value’ of the bacteria actually being found at delivery is only about 87%.


The goal of prophylactic antibiotic therapy is to deliver antibiotics to the mother early enough in the course of labor that sufficient drug can be transferred across the placenta to achieve protective levels in the baby prior to birth. That means, the antibiotic selected must not only be able to kill GBS, but it must also be able to cross the placenta. Fortunately, GBS has not yet been found to have developed resistance to the antibiotic of choice, penicillin G, and this drug also readily crosses the placenta. It also has a long and proven safety record for the baby. Ideally, antibiotic therapy is begun, intravenously, at least 4 hr prior to delivery so that at least one or two doses can be administered before the baby is born.

Unfortunately, about 12% of the population report “allergies” to penicillin. If the risk of serious allergic reaction (anaphylaxis) to penicillin is deemed significant, traditionally, prophylaxis has been attempted with either erythromycin or clindamycin. Both of these cross the placenta (clindamycin much better than erythromycin), although they do so more slowly than penicillin. The larger problem with these antibiotics is that GBS resistance rates are as high as 35-40% for erythromycin and range between 15% and 30% for clindamycin. If a woman is suspected to be allergic to penicillin, and known to be a carrier, or at risk for GBS colonization, susceptibility testing should be requested at the time culture is performed for GBS.

The dilemma becomes apparent when a pregnant woman is allergic to penicillin and also has GBS that is resistant to these other antibiotics, particularly clindamycin. Vancomycin is highly active against GBS and has been suggested as an alternative under these circumstances, although effective dosage regimens are not yet clear. Dr. Joann Laiprasert recently reported at the meeting of the Infectious Diseases Society for Obstetrics and Gynecology that vancomycin, given to 13 healthy pregnant volunteers, achieved therapeutic levels in the fetuses, but not without maternal complications. An attempt was made to administer 1 gram of the drug intravenously over 60 minutes and 90 minutes. More than half of the women did not complete the full course of therapy because they developed a complication common to vancomycin recipients termed “Red Man’s Syndrome.” Symptoms include itching, rash, shortness of breath and hypotension. One woman required oxygen therapy, but no apparent fetal complications developed. More work will obviously have to be done here before vancomycin can be considered to be the ‘alternative of choice.’ By the way, did I mention what vancomycin COSTS$$$$$$$$

There are several other high risk situations in which prophylactic GBS therapy is also currently recommended including:
• Premature labor or rupture of membranes before 37 weeks
• Prolonged rupture of membranes (18 hr or longer) before delivery
• Fever in labor (100.4F or higher)
• History of GBS urinary tract infection during the pregnancy (4-fold risk)
• Previous baby affected by GBS disease (increases risk 10-fold!!!)
Some practitioners will also treat all women who present in labor and have not received prenatal care or who missed routine screening for GBS at 35-37 weeks, although the risk/benefit ratio of this approach is not necessarily proven. According to the CDC, women who are GBS positive, and not in one of the ‘high risk’ groups above, have about a 1 in 200 chance of having a baby who develops GBS disease if antibiotics are NOT given and only 1 in 4000 risk if they are given. Cesarean delivery is NOT indicated to prevent GBS transmission to the baby.

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300,000,000 Deliveries!!!

Yesterday the U.S. population reportedly reached the 300,000,000 mark. It is probably more than that if one considers all of the ‘illegal aliens’ that call this home as well. You know, those people who live here, work here, spend money here, have babies here, raise children here, pay (some) taxes here, but sometimes have to share Social Security cards to get medical care and, so we are told, really aren’t citizens(?), Americans(?). Forgive my sarcasm. In our own area we have seen the Hispanic population increase from 4% of our deliveries to more than 30% over the past 5 years. Many of these are young, hard-working women, who show a genuine interest in the health of their babies, want to make the most of their lives in the ‘land of opportunity,’ and have no funding, except for the willingness to pay what they can out of pocket, but an ethic that also tells them that that is the right thing to do.

Anyway, I have digressed from the original topic_ 300,000,000 Americans and, I had the thought as I was falling asleep the other night, someone had to deliver all those babies! The scary thing from my perspective is that I have been around long enough to remember when there were just 200,000,000! In the U.S., most of those deliveries over the past 50 years have been by physicians. Today, even though the overall “birth rate” is reportedly down, we are still having to care for more pregnant women than ever before because of the population growth (and that influx of young reproductive age women who barely speak English). Business is great! So, why am I worried? Well the bottom line is that we do not have enough OB providers.

Many factors have contributed to this crisis. Fewer medical students are choosing OB as a profession (too many long hours and hungry, but never greedy, attorneys). Reimbursement for the many hours spent in total care during pregnancy is very poor compared to other specialties. (My dermatologist makes more money doing a few cases of ‘acne surgery’ than we get for an entire pregnancy, labor, delivery, and postpartum care). We face a growing percentage of Medicaid patients and never know when the next ‘check will be in the mail’ and reimbursement certainly hasn’t kept up with inflation or the liability insurance premiums over the years.

A greater percentage of medical students entering OB/GYN are women. That is great on the surface but, unfortunately, an unexpectedly high percentage of these women are choosing not to include obstetrics in their practices (or give it up after only a few years) so, there has actually been a relative dilution in the OB work force. And, as insurance premiums rise, well-established practitioners, who already have a large and loyal patient base, find it easy to give up obstetrics to stay solvent and sane rather than face the constant fear of capricious litigation. Furthermore, providers in rural areas, often family practitioners, are being driven to give up OB because they cannot cover the added expense of the liability insurance with the volume of their practices and current levels of reimbursement. The net effect of this is a worsening of the maldistribution of OB providers that is already present in the U.S. Pregnant women in rural areas will have to travel longer distances to get prenatal care, which will reduce their incentive to do so, and will inevitably result in an increase in maternal and fetal morbidity.

It is also my impression that the pregnant patients are getting sicker! When I began in Maternal-Fetal Medicine, most MFMs had fairly large practices with patients they followed for the duration of their pregnancies. There were even many ‘low risk’ patients thrown into the mix. As such, we often antagonized the general providers, and it took us years of coming to our senses to overcome that stigma of ‘competitiveness.’ Now, most of us have dropped longitudinal care, except for the highest risk women, and we still find it hard to keep up with even the ‘consultative’ side of our practices. There are more women waiting until they are older to get pregnant. There is an epidemic of obesity, diabetes, and hypertension. Preterm labor rates, primary cesarean section rates, and repeat cesareans (with greater risks of placenta previa, placenta accreta, uterine rupture, and difficult operative procedures) are all rising. As a result, we are not only short on general providers, but also short in the area of subspecialty care as well.

Anyway, argue with me if you want to, but something has to give. We have fewer OB providers (not to mention, residents finishing residencies with less OB experience due to multiple factors), a maldistribution of providers (exodus from rural obstetrics), more patients, a higher percentage of ‘at risk’ patients, lower reimbursement, and rising insurance premiums. Seems to me that we have the recipe for real disaster here. In fact, I went to a meeting today and had some of my concerns justified by one of the speakers who reported that there was evidence that there has actually been a slight rise in maternal and perinatal mortality rates in the last few years. Unless we can come up with some well-thought out solutions, the quality of obstetrical care will eventually suffer and the next 100,000,000 deliveries may not go quite as smoothly as the last, even if we end up having a cesarean section rate of 100% sometime in the next 50 years!!!!!!

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Thanks Kim at Emergiblog!

Thanks Kim for mentioning my recent post “The "Flu" and Pregnancy: Get Smart, Get Vaccinated NOW” in your weekly Emergiblog Grand Rounds. Honored to be included among the contributors and love your format. Tall Chocolate though, I'm not! Maybe a little Pumpkin Spice Latte! Keep up the great work!
Best regards,
Ken

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The "Flu" and Pregnancy: Get Smart, Get Vaccinated NOW

Well, the flu season is underway, and every pregnant woman wants to know, “Should I get the flu shot?” The simple answer is “YES (with few exceptions),” no matter how early or far along you are in your pregnancy, and the optimal time to receive the vaccine is now, during October and November (Obstet Gynecol. 2004;104:1125-6).

During an average flu season (October-May; peak December-March) in the U.S., 10-20% of individuals will contract the virus that causes the flu, 20-40,000 will die from it, and about 300,000 will be hospitalized due to complications. The flu is spread via the respiratory route by coughing, sneezing, and even speaking, and by self-inoculation from contact with surfaces that have been contaminated with respiratory tract fluids from an infected individual. Not every “cold” people get during the flu season is actually the result of infection with the influenza virus. There are MANY other “cold” viruses. Influenza usually causes a more severe illness than many of these and is often associated with high fever, headache, sore throat, cough (usually ‘dry’ and ‘nonproductive’), extreme fatigue, and muscle aches. Occasionally, people will have nausea, vomiting, and diarrhea as well, but these are not really typical of the flu, especially in adults.

Pregnant women are no more likely to contract the virus than other women, but they are more susceptible to developing more complicated infections, including influenza pneumonia, that may require hospitalization for respiratory compromise, high fever, and dehydration, as well as more serious complications associated with superimposed bacterial pneumonia. The latter was first recognized during the Great Flu (“Spanish flu”) Pandemic of 1918 that claimed 20-40,000,000 people worldwide. Indeed, it is now thought that many of these deaths were related to secondary infections with Staphylococcus aureus and not Streptococcus pneumonia, the more common cause of ‘milder’ bacterial pneumonia. This is a frightening prospect as this and future flu seasons loom because of the increasing prevalence of antibiotic-resistant Staphylococcus (MRSA) in the community (see my recent post “Postmortem Postscript: Staphylococcal Pneumonia”).

In 2004, the U.S. Advisory Committee on Immunization Practices (ACIP) recommended for the first time that all pregnant women annually receive the heat-inactivated (no live virus) trivalent influenza vaccine. This vaccine varies each year depending on the strains of the flu virus that are anticipated for the upcoming season. The influenza virus frequently ‘mutates’ so that even if you have had the flu before, you may not be immune to this year’s varieties. When the correct strains are chosen for vaccine production, it is estimated that both hospitalization and death among young, healthy recipients are reduced by 70-90%. It is not recommended that pregnant women take the live attenuated virus vaccine (LAIV).

It is especially important that you get the vaccine if you are pregnant and have medical conditions (diabetes, HIV, autoimmune disorders, organ transplant patients) that are accompanied by some degree of immunocompromise (by virtue of either the disease or the treatment), chronic lung disease (asthma, COPD, tobacco abuse), or anemia. Despite the recommendations, proven safety, and benefits of the flu vaccine, in recent studies generally less than 10% of pregnant women actually received the vaccine. The most common reason cited for this was “maternal concern” regarding vaccine safety for themselves and their babies (Naleway AL, et. al., Epidemiol Rev. 2006;28:47-53). However, this may also be the consequence of providers not doing their share in providing good information to their patients. A recent survey of OB/GYNs practicing in the U.S. revealed that only half would offer the flu vaccine to their pregnant patients in first trimester and more than one-third did not offer it at all in their practices (MMWR Morb Mortal Wkly Rep. 2005;54:1050-2).

The flu vaccine will not give you the flu. Some individuals will be sore at the site of injection (usually the deltoid muscle) and may even run a very low grade fever as their immune system mounts a response to the vaccine, but this is uncommon. Even if you have gotten the vaccine, and it was selected correctly for the strain of flu that season, you might still get the flu. However, symptoms are usually much milder and it is very unlikely that you will develop influenza pneumonia, require hospitalization, or die from the disease. A milder case of the flu probably reduces the risks to your baby as well. The vaccine also will not protect you from other viruses that can cause “colds” during flu season.

Contraindications to receiving the vaccine include allergies to chicken eggs (in which the vaccine is produced), thimerosal (preservative containing a small amount of mercury), and a history of allergic reaction to a flu vaccine in the past. You should also not get the vaccine in the rare event that you are the 1 in a million patient who suffered a condition called Giuillain-Barré Syndrome within 6 weeks of having previously received a flu vaccine. The vaccine during pregnancy is probably safer than waiting and relying on the use of drugs that might be used to treat an influenza infection once it is established.

The flu virus itself does not cross the placenta and infect the baby. However, maternal infection with the virus can be associated with fetal complications, particularly if contracted in the first trimester, as well as preterm labor and low birth-weight. Fetal anomalies are probably associated with maternal fever (hyperthermia), and perhaps inflammatory substances produced by the immune system in response to the organism, during the period of fetal organogenesis. The consequences of fever depend on the extent and duration of temperature elevation and the stage of fetal development when it occurs.

In experimental animals, hyperthermia has been shown to cause fetal abnormalities such as neural tube defects, small brains (micrencephaly), small eyes (microphthalmia), cataracts, facial clefts, skeletal, and heart abnormalities, among many others, as well as behavioral problems (Edwards MJ. Birth Defects Res A Clin Mol Teratol. 2006;76:507-16). Nearly all of these have been found in epidemiological studies following maternal fever during pregnancy. A recent study confirmed a higher prevalence of facial clefting, neural tube defects, and heart abnormalities among babies whose mothers had the flu during the 2nd and 3rd months of pregnancy (Acs N. Birth Defects Res A Clin Mol Teratol. 2006;73:989-96). There is some suggestion that the developing brain and nervous system might be sensitive to hyperthermia even beyond first trimester. Several studies have shown behavioral problems and, possibly, an increased risk for schizophrenia among offspring of women who have had the flu during pregnancy.

So, if you are pregnant, get the flu vaccine, encourage other family members to be vaccinated as well, avoid other people who may have the flu, wash your hands often when in ‘public places,’ and try not to touch your eyes, nose, and mouth when you have come in contact with surfaces that have a high risk of contamination! And, if you do get the flu, make sure you let your provider know, especially if you run a high fever, develop a ‘productive’ cough, or have any respiratory difficulties whatsoever….

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Breast Cancer and Pregnancy: Miscellaneous Concerns

In my introductory comments “Breast Cancer During Pregnancy - Overview” there were several important questions for which I have not yet offered answers. Each of these could be a blog unto themselves, but to keep things moving along, let me address several of these with simple bulleted comments:

• If I have had breast cancer treated before pregnancy, will pregnancy increase the risk of recurrence?: No. Pregnancy by itself does not appear to increase the risk of recurrence or poorer long-term prognosis above that expected by the type of cancer and the stage at detection and initiation of treatment.
• Can breast cancer be transmitted to my baby?: I am not aware of any publications that suggest breast cancer can cross the placenta and affect the baby. Babies may be at greater risk for developing breast cancer during their lives for genetic reasons, but not as the result of ‘catching the disease’ from their mothers.
• Can I breast feed my baby if I have had, or am undergoing treatment for, breast cancer?: There are several considerations for this question. First, if you are currently undergoing chemotherapy for breast cancer, then it is not recommended that you breastfeed. If you have completed chemotherapy, then you can consider breastfeeding. (Ask your breast specialist how long you should wait after completion of the chemotherapy that was chosen for your care). If you have had a large portion of a breast removed and/or had radiation therapy to a breast, then that breast may not produce much milk, although milk production by the remaining breast will usually be sufficient to support the baby at least in early infancy, if not longer. If you have chosen to defer therapy until after delivery, it is usually recommended that lactation be suppressed in anticipation of surgery, radiation, or chemotherapy.
• If I have had breast cancer treated, how long should I wait before getting pregnant?: This depends on many factors, including stage of disease, response to therapy, type of therapy received, prognosis, and personal concerns (age, risk tolerance, desire for more children, etc…). The usual recommendation is that you wait at least two years after the diagnosis has been made before attempting conception. Recurrent disease often declares itself within this time frame. If you may be interested in pregnancy after a diagnosis of breast cancer has been made, you should bring that up with your physician when treatment options are discussed because certain chemotherapeutic agents, or pelvic radiation for metastatic disease, might impair future fertility. Technologic advances in assisted reproductive technologies are occurring daily and options for preservation of eggs or embryos should also be discussed with your providers if you would consider this and have the resources for the same.

I hope this series of posts has helped to answer many of your general questions related to breast cancer and pregnancy. If you have other questions that were not addressed, feel free to ask these in the comments section of this blog and I will do my best to respond. And, if I cannot answer a question myself, this is one topic on which I would be delighted to help you find an answer, even if it means referring the query to someone more expert in the field.

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Breast Cancer in Pregnancy: Considerations for Therapy

In addition to establishing the tissue diagnosis of breast cancer, typically, your treating physicians will want to determine the molecular characteristics of the tumor cells. This information helps in counseling with regard to prognosis and, also, to direct the most appropriate course of treatment. Currently, the two features most frequently screened for are ‘hormone receptor status’ and ‘HER2’ status of the tumor cells. Hormone receptor-positive cancers tend to respond well to drugs that target these receptors. Cancers that have multiple copies of the HER2 gene, or have high concentrations of HER2 receptors, are typically more aggressive tumors, associated with rapid growth and increased risk of metastasis. Determination of either hormone receptor or HER2 status can be more difficult during pregnancy, mainly due to the presence of high hormone levels and their effects on circulating blood proteins, but there are diagnostic techniques currently available to help circumvent these interfering effects.

Once the extent of the breast cancer is determined, the ‘stage’ of the disease is assigned for purposes of directing therapy. Detailed discussion of staging is beyond the scope of this review, but as in most cancers, the earlier the stage at diagnosis, the greater the prospects of long-term survival. The overall impression has been that the prognosis for breast cancer detected during pregnancy carries a poorer prognosis than that detected in the nonpregnant state. Recent studies have shown, however, that when women are compared by age, type, and stage of breast cancer, those who are pregnant do as well as those who are not if appropriate treatment is instituted in a timely fashion. Unfortunately, breast cancers found during pregnancy are more likely to be metastatic at the time of detection due to the delay in diagnosis and most studies have shown that 5-year survival of stage III and IV disease is no more than about 10%. Furthermore, some women may choose to delay therapy for fear of harming their babies.

Therapy during pregnancy is best if it is individualized in consultation with an experienced, multidisciplinary support team. In general, recommended treatment in early stage (I and II) disease during pregnancy is surgical. Approaches range from modified radical mastectomy to simple lumpectomy and sentinel node biopsy, and can be followed by chemotherapy. If early stage disease is picked up late in pregnancy, conservative surgery (lumpectomy with lymph node sampling), followed by radiation therapy after delivery, may be an option. Radiation therapy during pregnancy is generally not advised at any time, and especially in first trimester, due to potentially harmful effects on the baby.

When chemotherapy is indicated, the general approach has been to delay this until completion of the first trimester of pregnancy. Selected chemotherapy (such as fluorouracil, adriamycin, and cyclophosphamide) after first trimester is generally not associated with fetal birth defects, but carries a slightly increased risk for premature delivery and pregnancy loss for reasons that are unclear. A few case reports of the use of ‘neoadjuvant’ taxanes (paclitaxel or docetaxel) have been recently published that suggest these agents may also be safe if used in second and third trimesters. Hormonal therapy is generally not offered during pregnancy due to potential fetal risks.

In late stage (III or IV) disease, both patient (and family) and provider are placed in a very difficult position. Prognosis for 5-year survival is poor, but aggressive therapy may also jeopardize the baby. If the diagnosis of late stage disease is made in later pregnancy, early delivery can be considered at a time when the baby is less likely to suffer the more severe consequences of prematurity before starting radiation therapy or chemotherapeutic regimens that might be more dangerous to the baby. Although terminating a pregnancy early is not associated with increased prospects for maternal survival, when late stage cancer is detected early in pregnancy, the woman might consider this option if she wants aggressive therapy but does not want to risk having a baby that might be damaged by the same, or does not want to risk bringing a baby into the world that she will be unlikely to be available to care for over time. On the other hand, some women with very poor prognosis disease may choose to carry their pregnancies without any adjuvant treatment to maximize the chance of a good outcome for their baby.

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Breast Cancer Diagnosis During Pregnancy

More than 4 million births are expected in the U.S. this year and at current estimated rates, breast cancer will be diagnosed in at least 1300 of these pregnancies. While this constitutes only a small percentage of the total number of cases diagnosed annually, this percentage will probably rise due to the trend toward delay of childbearing. Although pregnancy at an early age, and repeated pregnancies, actually appears to decrease the lifetime risk of developing breast cancer, even among higher risk groups, finding the disease during a pregnancy seems to be associated with a poorer prognosis. However, the poorer outcomes do not appear to be due to the pregnancy itself, or to the type of breast cancer that develops, but due to the fact that when breast cancer is found during pregnancy, it has a greater likelihood of being at a more advanced stage. Indeed, about 50% of breast cancer cases found during pregnancy already have metastatic disease at the time of diagnosis

Since routine mammography is not recommended during pregnancy, breast cancer is usually suspected by detection of a painless 'lump’ in the breast. Unfortunately, the breasts normally become ‘lumpier’ throughout pregnancy as the soft tissues and milk ducts enlarge in preparation for lactation. Even when a more prominent ‘lump’ is detected, it is often ignored at first (and more than 80% are likely to be ‘benign’), thereby, instilling some delay in early diagnosis. The index of suspicion rises if there is bloody discharge from the nipple, pain in the breast, skin changes over the lump or nipple, or prominent lymph nodes found in the axilla. A thorough breast and lymph node exam by your provider at your earliest obstetrical visit, ongoing self-assessment, and a low threshold of changes you consider to be significant, can help improve the prospects for an earlier diagnosis during pregnancy.

Once a suspicious ‘lump’ is detected, it is very important that efforts at diagnosis are undertaken, immediately, and not delayed until after delivery, regardless of the gestational age at which the ‘lump’ is found. A variety of noninvasive imaging studies are available to assess the location and appearance of a breast mass, but in the end, if cancer is suspected, or ‘cannot be ruled out,’ some kind of invasive diagnostic study is necessary to provide a ‘tissue diagnosis.’

The same noninvasive diagnostic studies that are available for women who are not pregnant, are often used with some special precautions taken with regard to the fetus during pregnancy. The first technique that is usually offered is ultrasound. Ultrasound of the breast is considered completely ‘safe’ for the fetus and can be used to distinguish between a simple fluid-filled cyst and a solid mass. Although many imaging specialists do not rely on ultrasound to assess whether a solid mass appears benign or malignant during pregnancy, one recent study suggested that it was highly effective when used to follow-up known cancers and lymph node metastases in pregnant women undergoing chemotherapy (Yang WT, et al., Radiology 2006;239:52-60).

Mammography is an x-ray study that could potentially expose the baby to small amounts of radiation. The total radiation dose required for the average mammogram falls well below usual limits of concern for a baby, but the added precaution of a lead shield placed on the maternal abdomen is usually taken, especially in early pregnancy. Routine mammography during pregnancy is not recommended, but even when a ‘lump’ is felt, mammography helps to correctly identify no more than about three-fourths of cancers under optimal conditions.

Magnetic resonance imaging (MRI) is also probably safe for the fetus during pregnancy, especially when directed at the breast, because it does not use any form of ‘ionizing radiation,’ although there is limited experience with this modality in pregnant women for this purpose. It is also extraordinarily expensive when compared to ultrasound and mammography. If your provider feels that this will help to rule out the possibility of malignancy, then it can be considered, but if either ultrasound or mammography has raised concerns of malignancy, the next best step is to proceed with a ‘tissue diagnosis.’

A tissue diagnosis can usually be accomplished by a simple fine-needle aspiration or core biopsy. These can be done with direct ultrasound guidance to improve the prospects that the sample is taken from the ‘lump’ of concern or the greatest area of abnormality detected by the imaging studies. Occasionally, it is necessary to perform an open, excisional biopsy, but if this is necessary, it can often be done under local anesthesia, posing minimal risk to the fetus.

If a cancer diagnosis is established, your doctor will probably want to perform other studies to establish the actual ‘stage’ of disease. This may be necessary so that proper advice regarding treatment options during and after the pregnancy can be discussed. As part of this evaluation, a chest x-ray is often done to look for evidence of metastatic disease in the chest. Again, the total dose of radiation to the baby is low and can be further reduced by abdominal shielding. Ultrasound can be used to look for metastatic disease in the liver and, if necessary, an MRI can be done to look for brain metastases. A ‘bone scan’ can be done to look for metastatic disease and also requires very low doses of radiation.

Even in the absence of overt metastatic disease, it is usually important to know if the cancer has spread to the local lymph nodes draining the breast. For years, breast cancer specialists have looked for ‘sentinel lymph node’ involvement as a means of staging the disease, minimizing surgical intervention, and providing recommendations for therapy. Another recent study has shown that using a radioactive compound (99mTc-sulfur colloid) can successfully accomplish identification of the sentinel lymph node even during pregnancy with minimal risk of radiation exposure to the baby (Pandit-Taskar N, et. al., J Nucl Med 2006;47:1202-8).

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Breast Cancer During Pregnancy - Overview

This month is “Breast Cancer Awareness Month.” According to 2005 American Cancer Society estimates, 211,240 women developed breast cancer and 40,410 died from the disease that year. The risk for breast cancer rises with age and the lifetime risk for a woman developing the disease is 1 in 8. At age 20, the risk of developing breast cancer over the next 10 years is only about 1 in 2000, but by age 30 that risk increases to 1 in 200. Approximately 1 out of every 3000 pregnancies is complicated by breast cancer and, as a growing number of women delay childbearing into their 30’s, we are seeing an increase in this problem during pregnancy.

There are not too many of us that do not have our lives touched by breast cancer. Dr. Paul Auerbach (author of the Healthline blog Medicine for the Outdoors) and I went to medical school with a guy who had married his high school sweetheart. She was the ‘salt of the earth’ and stuck by his side in support, financially and emotionally, through college, medical school, graduate school, and post-graduate training. It is my understanding that, when they finally decided to start a family late in this process, infertility issues delayed things further. At this point she was in her mid to late 30’s. She finally conceived, and early in the pregnancy found out that she had breast cancer. I do not know the details of her treatment, options, or choices during the pregnancy, but I do know that she succumbed to the disease not long after giving birth to their daughter. I did not hear about this for some time after the fact, and to this day I have the same gut-wrenching feeling I had the first time, whenever I am reminded of this tragic event.

Breast cancer during pregnancy raises many issues and it is one of those conditions that can place the fetus and the mother at odds. What are the signs of breast cancer during pregnancy? How is the condition diagnosed? Does pregnancy make the diagnosis of breast cancer more difficult or less certain? Are the diagnostic procedures safe for my baby? Does pregnancy shorten my survival or worsen the chances for an optimal outcome from therapy? What are the options for therapy during pregnancy? What treatments are safest for the baby? When can those treatments be started during the pregnancy or is it safer to wait until after delivery? Does terminating the pregnancy help? Does delivering early help? Can breast cancer itself be transmitted to my baby? Can I breast feed my baby if I have had, or am undergoing treatment for, breast cancer? If I have had breast cancer treated before a pregnancy, will pregnancy increase the risk of recurrence?

In the memory of my friends above, and the tremendous love and respect they shared for each other, I will try to answer some of these questions in the next couple of posts…..

Labels: breast cancer and pregnancy

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This Weeks' Best of Health Matters

The Health Matters HealthBlog Network consists of a dozen independent and unfiltered medical professionals blogging about the topics that matter to you. Each week, Healthline's Editors select the three top posts from the network to share with all of our readers in one convenient post. We hope you'll enjoy them!

Infertility Stress Reduction Tips
If you, or someone you know, has struggled with infertility you know what a stressful time that can be. Visit The ART of Conception where expert Carl “Rusty” Herbert MD offers some tips for getting through these rough patches … read more

What Should Cancer Patients and Family Do About the Flu Vaccine?
Vaccinations can be a lifesaver. Most vaccines contain inactive viruses, but others contain a small amount of a live virus. Tune into Cyndy King’s Cancer Treatment and Survivorship blog to learn what people undergoing cancer treatment that can compromise their immunity should do…read more.

Throw a Stronger Punch (or Push a Car or Stroller)
People don’t always realize how many times a day they are hurting their backs. Read on to learn more about what Dr. Jolie Bookspan of the Fitness Fixer blog says is one of the most common misconceptions in fitness….read more.

Additionally, we're pleased to announce the launch of two new blogs this week! Freedom from Smoking with expert Lowell Kleinman, MD and Straight Talk from the ER with expert Robert L. Norris, MD.

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The Best of the Medical Blogosphere

If you are new to the healthcare blog world, you know it can be hard to find interesting blogs addressing health issues. One good way to find other healthcare bloggers is to look at the online posts of "Grand Rounds." Here a host gathers some interesting posts each week from around the medical blogosphere. This week my post discussing Staphylococcal pneumonia appeared with other notable posts. A note of thanks to this week's host for including me. To read this week's favorite posts click here:
RDoctor Medical

To learn more about Grand Rounds click here: http://blogborygmi.blogspot.com/2004/09/grand-rounds-submission-guidelines.html

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Preterm Birth: Mortality Rates Doubled!

In one of my first posts on preterm birth (PTB), Preterm Birth: An American Tragedy, it was mentioned that early delivery had surpassed birth defects and genetic abnormalities as the leading cause of death in the first year of life in the United States. A report published earlier this week in the journal Pediatrics indicates that we have grossly underestimated the contribution of PTB to neonatal mortality.

Callaghan and colleagues (Pediatrics 2006;118:1566-1573) sought to resolve the discrepancy that, although "two thirds of infant deaths occur among infants born preterm..., only 17% of infant deaths are classified as being attributable to preterm birth..." To accomplish this goal, they examined 27,970 neonatal death records from the year 2002 in the 'linked birth/infant death file,' looking not only for "preterm birth" as a listed cause of death, but complications (e.g., premature rupture of membranes; sepsis; respiratory distress syndrome; intraventricular hemorrhage) clearly related to PTB even if that was not actually recorded as an immediate cause. In their final analysis, they "classified 9,596 infant deaths (34.3% of all infant deaths) as attributable to preterm birth." Furthermore, "ninety-five percent of those deaths occurred among infants who were born at less than 32 weeks of gestation and weighed less than 1500 g, and two thirds of those deaths occurred during the first 24 hours of life." One frightening observation by the authors is that they still consider these estimates to be "conservative."

This study firmly establishes PTB as the irrefutable leading cause of neonatal mortality in the U.S. nearly doubling previous estimates. Let's just hope that convincing information like this helps to bolster support for the multidisciplinary programs that will be necessary if we ever hope to reverse the rising rates of PTB in this country. I look at any dollars spent as an investment in our future and the potential savings should far exceed the up-front costs.

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Postmortem Postscript: Staphylococcal Pneumonia

About a month ago, I posted a note ("It was the best of times, it was the worst of times...") about a mother's death the day following her delivery. Although she had had a fever in labor and after delivery, and had been started on broad spectrum antibiotics during labor, the rapidity of her death, and our inability to resuscitate her following cardiopulmonary arrest, led us to the presumptive diagnosis that she had had a massive pulmonary embolus. She was certainly at high risk for the same because of the pregnancy, delivery, and the fact that she "smoked 3-4 packs of cigarettes a day" according to family members. Indeed, shortly before she arrested, she had actually gone outside the hospital to smoke with her husband and missed the chest X-ray she had finally agreed to let us perform. As things turned out, the postmortem examination told a different story. She had actually died as the result of a rapidly progressive and tissue destructive (necrotizing) methicillin-resistant Staphylococcus aureus (MRSA) pneumonia. Technically, because she had not been hospitalized prior to her delivery admission, this pneumonia was categorized as a "community-acquired (or -associated)" MRSA illness.

Not two weeks after this womanss death, the lead article in Obstetrics and Gynecology addressed the increasing prevalence of Staphylococcal infections in pregnant women (Chen, KT, et al. Obstet Gynecol 2006;108:482-87), and was accompanied by a commentary on "Emerging Infections" (Obstet Gynecol 2006;108:480-81) by the journal editor, Dr. Ronald S. Gibbs, an internationally recognized expert in OB/GYN infectious diseases. The article by Chen and colleagues reported finding Staphylococcus aureus in 17.1% (507 of 2,963) rectovaginal cultures obtained for routine Group B Streptococcus (GBS) screening during pregnancy at 35-37 weeks. GBS screening has become a 'standard of care' in obstetrics because of the success of prophylactic maternal therapy in labor for known GBS carriers in reducing the risk of neonatal sepsis. Of the S aureus isolates, 14 (2.8%) were found to be methicillin-resistant, and 13 of these were considered to be "community-associated" by genetic characterization. Interestingly, there was also found to be an association between GBS-positivity and S aureus colonization.

S aureus is a very common and very adaptable organism. Many individuals carry it and are asymptomatic, and many others know it best for the more superficial skin and soft tissue infections with which it is often associated, and some individuals chronically plagued. However, the organism can cause serious, life-threatening problems, including bacteremia, endocarditis, necrotizing fasciitis, pneumonia, and 'toxic shock syndrome.' Like many other bacteria, S aureus has been quite successful in evolving strains that are resistant to the antibiotics commonly used to treat it. Traditionally, we think of MRSA as being confined to settings like hospitals where serious infectious diseases are concentrated, patients are more likely to be ill and immunocompromised, broad spectrum antibiotics are often used, and transmission can be readily perpetuated by contact between patients and hospital personnel. Indeed, it has been estimated that about 60% of Staph infections in hospital intensive care units are now MRSA. Unfortunately, it is also becoming increasingly apparent that MRSA is quickly moving into the community.

Community-acquired MRSA may rapidly become a problem once it is established because of the potential to be readily spread among family members where "good hand washing techniques" promoted within hospitals are unlikely to play a role to curb the spread. Patients who develop infectious complications related to Staph also often have multiple body sites affected. In a study of community-associated MRSA infections in pregnant women at one hospital, Laibl and colleagues (Obstet Gynecol 2005;106:461-5) reported patients with multiple sites of infection, including the buttocks, vulva, or groin (67%), extremities (44%), and breast (23%).

As Dr. Gibbs has cited in his editorial, MRSA strains have been implicated in "skin infections in otherwise healthy newborns and... sepsis in infants in neonatal intensive care units." It can cause mastitis and breast abscesses and can be transmitted to infants by breast milk. It can cause wound infections and infections at IV access sites. With the growing epidemic of obesity and diabetes in pregnancy (both of which probably increase risk for persistent colonization and risk of complications with S aureus), the persistently (and, abhorrently) high rates of cigarette smoking (ditto on the colonization and complications comment) among pregnant women, and the rising cesarean section rates, MRSA may well become a more serious factor in maternal and neonatal morbidity in the future.

In closing, I would have one other comment. We are moving into the flu season. Influenza carries its own higher morbidity for pregnant women; however, the virus has also been known to provide fertile ground for secondary infections by bacteria such as S aureus. Indeed, in the great flu epidemic of 1918, where 10's of millions died worldwide, superimposed Staph pneumonia is now thought to have played a significant role. If our obstetrical patients are now more likely to be colonized by MRSA, we may well need to be thinking of having a much lower threshold for rapid, early diagnosis of superimposed bacterial pneumonias, even in patients suspected of just having "the flu," so that appropriate antibiotic therapy might be employed in a timely fashion under circumstances where antibiotics are not ordinarily recommended.

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