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Volume 6, No. 6, June 2008
Hot Topics
Obstetrics | Gynecology | Child Health | Chronic Disease and Illness
Obstetrics
HAPO Study Cooperative Research Group: Hyperglycemia and adverse pregnancy outcomes
BACKGROUND: It is controversial whether maternal hyperglycemia less severe than that in diabetes mellitus is associated with increased risks of adverse pregnancy outcomes.
METHODS: A total of 25,505 pregnant women at 15 centers in nine countries underwent 75-g oral glucose-tolerance testing at 24 to 32 weeks of gestation. Data remained blinded if the fasting plasma glucose level was 105 mg per deciliter (5.8 mmol per liter) or less and the 2-hour plasma glucose level was 200 mg per deciliter (11.1 mmol per liter) or less. Primary outcomes were birth weight above the 90th percentile for gestational age, primary cesarean delivery, clinically diagnosed neonatal hypoglycemia, and cord-blood serum C-peptide level above the 90th percentile. Secondary outcomes were delivery before 37 weeks of gestation, shoulder dystocia or birth injury, need for intensive neonatal care, hyperbilirubinemia, and preeclampsia.
RESULTS: For the 23,316 participants with blinded data, we calculated adjusted odds ratios for adverse pregnancy outcomes associated with an increase in the fasting plasma glucose level of 1 SD (6.9 mg per deciliter [0.4 mmol per liter]), an increase in the 1-hour plasma glucose level of 1 SD (30.9 mg per deciliter [1.7 mmol per liter]), and an increase in the 2-hour plasma glucose level of 1 SD (23.5 mg per deciliter [1.3 mmol per liter]). For birth weight above the 90th percentile, the odds ratios were 1.38 (95% confidence interval [CI], 1.32 to 1.44), 1.46 (1.39 to 1.53), and 1.38 (1.32 to 1.44), respectively; for cord-blood serum C-peptide level above the 90th percentile, 1.55 (95% CI, 1.47 to 1.64), 1.46 (1.38 to 1.54), and 1.37 (1.30 to 1.44); for primary cesarean delivery, 1.11 (95% CI, 1.06 to 1.15), 1.10 (1.06 to 1.15), and 1.08 (1.03 to 1.12); and for neonatal hypoglycemia, 1.08 (95% CI, 0.98 to 1.19), 1.13 (1.03 to 1.26), and 1.10 (1.00 to 1.12). There were no obvious thresholds at which risks increased. Significant associations were also observed for secondary outcomes, although these tended to be weaker.
CONCLUSIONS: Our results indicate strong, continuous associations of maternal glucose levels below those diagnostic of diabetes with increased birth weight and increased cord-blood serum C-peptide levels.
HAPO Study Cooperative Research Group Hyperglycemia and adverse pregnancy outcomes. N Engl J Med. 2008 May 8;358(19):1991-2002.
http://www.ncbi.nlm.nih.gov/pubmed/18463375
OB/GYN CCC Editorial comment:
We have been waiting an even longer time for this study
Dr. Donald Coustan explained the HAPO process to the assembled group at the American Indian Women’s Health and MCH Conference in August 2007. (See Featured Website, below) The HAPO group will now discuss whether these findings can help delineate a new set of GDM criteria. The discussion will take place at the International Association of the Diabetes and Pregnancy Study Group June 11, 2008 - June 12, 2008 in Pasadena, CA.
(Conference link below)
Here are few comments from the Ecker and Greene NEJM Editorial:
Pregnancy is associated with relative carbohydrate intolerance and insulin resistance. Gestational diabetes mellitus (carbohydrate intolerance first diagnosed during pregnancy) has long been recognized as a risk factor for a number of adverse outcomes during pregnancy, including excessive fetal growth, an increased incidence of birth trauma and cesarean delivery, and neonatal metabolic abnormalities such as polycythemia, hyperbilirubinemia, and hypoglycemia. This recognition has led to recommendations to screen all pregnant women for gestational diabetes mellitus and to treat those whose glucose-tolerance tests exceed threshold criteria.
The threshold criteria for diagnosing gestational diabetes were initially specified rather arbitrarily as values greater than 2 SD above the mean for the original study population. There are now alternative expert recommendations for the test and thresholds that should be used to diagnose gestational diabetes mellitus, but regardless of the definition chosen, there is evidence that lesser degrees of carbohydrate intolerance might increase risks for perinatal complications.
The Toronto Tri- Hospitals Study, for example, showed that values on glucose-tolerance testing higher than the normal range, but not high enough to warrant the diagnosis of gestational diabetes mellitus, are associated with outcomes similar to those in women with gestational diabetes mellitus (e.g., having larger babies). Similarly, others have found that even a single abnormal value on a 100-g, 3-hour oral glucose-tolerance test, rather than the two abnormal values needed to diagnose gestational diabetes mellitus, is associated with an increased risk of excessive fetal growth. Critics have argued, however, that observational studies have not appropriately accounted for varying diagnostic criteria for gestational diabetes mellitus, provider expectations and biases, and confounding variables such as the patient’s age and body-mass index (BMI) and other medical complications.
The Hyperglycemia and Adverse Pregnancy Outcome (HAPO) study reported in this issue of the Journal is an elegantly designed, very large, international study that answers previous questions by clearly demonstrating that there is a continuum of risk, without clear thresholds, between carbohydrate intolerance in pregnancy and adverse pregnancy outcomes.
The HAPO study investigators assessed the pregnancy outcomes of more than 23,000 women with glucose values of less than 200 mg per deciliter 2 hours after a 75-g glucose load. Some, but not all, of these women (those with values of 140 to 200 mg per deciliter) would meet World Health Organization criteria for the diagnosis of gestational diabetes mellitus but, because hyperglycemia was considered to be mild and because at the time the study was organized the merits of treating such mild abnormalities were uncertain, it was considered ethical to observe these women without treatment. The subjects’ care providers were unaware of the results of the glucose-tolerance tests, but they could not be blinded to variables such as BMI or previous gestational diabetes, which are known to correlate with higher glucose values and thus might conceivably have affected provider behavior. Women whose glucose values were measured for other clinical purposes (and whose providers might have altered their treatment of the patients on the basis of the results) were excluded from the study.
The HAPO study showed that outcomes such as birth weight, umbilical cord-blood C-peptide level (a proxy for fetal insulin levels), incidence of cesarean delivery, and incidence of neonatal hypoglycemic episodes all changed in direct proportion to maternal glucose levels, after an overnight fast and 1 hour and 2 hours after a 75-g glucose load. These associations held in analyses adjusted for potential confounders, including maternal BMI, previous macrosomia, and previous gestational diabetes.
Given the results of the HAPO study, should we lower our threshold for the diagnosis and treatment of gestational diabetes? This is a testable hypothesis, but it will be very difficult to show that treating lesser degrees of carbohydrate intolerance will provide meaningful improvements in clinical outcomes. For many, the debate about whether to screen for or treat gestational diabetes mellitus was settled by the results of the Australian Carbohydrate Intolerance Study in Pregnant Women (ACHOIS), which demonstrated moderate improvement in neonatal outcomes after treating women with glucose values of 140 to 200 mg per deciliter 2 hours after a 75-g glucose load. The number needed to treat to avoid one adverse outcome was 43. It is likely that any advantage to treating lesser degrees of hyperglycemia is even smaller. Furthermore, in the HAPO study the outcome measure that showed the strongest association with maternal carbohydrate intolerance was the cord-blood C-peptide level, a surrogate marker that itself would generally not be considered of clinical concern. In contrast, the HAPO outcome of potentially greatest concern, cesarean delivery, was only moderately increased with increased maternal glucose levels (adjusted odds ratio, 1.07 to 1.10 per standard deviation, depending on which element of glucose-tolerance testing was studied).
Echoing these findings, the ACHOIS trial did not show any reduction in the rate of cesarean delivery with treatment of maternal hyperglycemia. In addition, in the HAPO study, women with higher glucose levels had higher rates of delivering large infants but lower rates of delivering infants who were small for gestational age. Whether treating mild degrees of hyperglycemia would increase the risk for poor fetal growth and attendant complications should be carefully determined before such treatment is implemented at lower glucose thresholds. Finally, there is the possibility that the associations of mild carbohydrate intolerance with adverse outcomes during pregnancy are just that— associations that are not causally mediated.
Until trials show clinical benefits from expanding the diagnostic criteria for “gestational diabetes,” we would not favor any change. Although both the HAPO study and the Metformin in Gestational Diabetes Trial (see Abstract of the Month) address adverse outcomes associated with maternal hyperglycemia, gestational diabetes first received attention as a predictor of future diabetes in women. Identifying women at risk for diabetes offers the possibility of intervention to reduce risk, yet frequently these women do not receive recommended follow-up and surveillance. This failure results, perhaps, from a breakdown in communication between obstetricians who diagnose gestational diabetes mellitus and primary care providers who subsequently treat these patients. Recognizing the continuum of risk between hyperglycemia in pregnancy and associated outcomes, we should recommit ourselves to sharing this information so that it can meaningfully affect a woman’s health long after she has completed childbearing.
Ecker JL, Greene MF. Gestational diabetes--setting limits, exploring treatments. N Engl J Med. 2008 May 8;358(19):2061-3.
http://www.ncbi.nlm.nih.gov/pubmed/18463383
International Association of the Diabetes and Pregnancy Study Group June 11, 2008 - June 12, 2008 in Pasadena, CA.
http://www.usc.edu/schools/medicine/education/continuing_education/calendar/courses.html
Summary of ACIP Recommendations for Prevention of Pertussis, Tetanus and Diphtheria among Pregnant and Postpartum Women and Their Infants
Use of Td or Tdap in Women Who Have Not Received Tdap Previously
- Routine postpartum Tdap. Pregnant women (including women who are breastfeeding) who have not received a dose of Tdap previously should receive Tdap after delivery and before discharge from the hospital or birthing center if 2 years or more have elapsed since the most recent administration of Td; shorter intervals may be used (see Special Situations). If Tdap cannot be administered before discharge, it should be administered as soon as feasible thereafter. The dose of Tdap substitutes for the next decennial dose of Td.
- Simultaneous administration. Tdap should be administered with other vaccines that are indicated. Each vaccine should be administered using a separate syringe at a different anatomic site.
Contraindications to Administration of Td and Tdap
The following conditions are contraindications to administration of Td and Tdap:
- a history of serious allergic reaction (i.e., anaphylaxis) to any component of the vaccine, or
- for Tdap (but not Td), a history of encephalopathy (e.g., coma or prolonged seizures) not attributable to an identifiable cause within 7 days of administration of a vaccine with Pertussis components.
Precautions and Reasons to Defer Administration of Td or Tdap
The following conditions are reasons to defer administration of Td or Tdap:
- Guillain-Barré syndrome with onset 6 weeks or less after a previous dose of tetanus toxoid--containing vaccine;
- moderate or severe acute illness;
- a history of an Arthus reaction to tetanus toxoid-- and/or diphtheria toxoid--containing vaccine less than 10 years previously;
- for adults, unstable neurologic conditions (e.g., cerebrovascular events or acute encephalopathic conditions); or
- for adolescents, any progressive neurologic disorder, including progressive encephalopathy or uncontrolled epilepsy (until the condition has stabilized).
Special Situations
Deferring Td during Pregnancy to Substitute Tdap in the Immediate Postpartum Period
ACIP recommends administration of Td for booster vaccination during pregnancy if 10 years or more have elapsed since a previous Td booster. To add protection against Pertussis, health-care providers may defer the Td vaccination during pregnancy and substitute Tdap as soon as feasible after delivery if the woman is likely to have sufficient tetanus and diphtheria protection until delivery. Sufficient tetanus protection is likely if:
- a pregnant woman aged <31 years has received a complete childhood series of immunization (4--5 doses of pediatric DTP, DTaP, and/or DT) and >1 Td booster dose during adolescence or as an adult (a primary series consisting of 3 doses of Td (or TT) administered during adolescence or as an adult substitutes for the childhood series of immunization),*
- a pregnant woman aged >31 years has received a complete childhood series of immunization (4--5 doses of pediatric DTP, DTaP, and/or DT) and >2 Td booster doses,
- a primary series consisting of 3 doses of Td (or TT) was administered during adolescence or as an adult substitute for the childhood series of immunization,* or
- a pregnant woman has a protective level of serum tetanus antitoxin (>0.1 IU/mL by ELISA).
A woman should receive Td during pregnancy if she
- does not have sufficient tetanus immunity to protect against maternal and neonatal tetanus, or
- requires booster protection against diphtheria (e.g., for travel to an area in which diphtheria is endemic†).
Alternatively, health-care providers may choose to administer Tdap instead of Td during pregnancy (see Considerations for Use of Tdap in Pregnant Women in Special Situations).
Postpartum Tdap When <2 Years Have Elapsed Since the Most Recent Dose of Td
Health-care providers should obtain a history of adverse reaction after previous doses of vaccines containing tetanus and diphtheria toxoids. Limited information is available concerning the risk for local and systemic reactions after Tdap at intervals of <2 years. Providers may choose to administer Tdap to these women postpartum for protection against Pertussis after excluding a history of moderate to severe adverse reactions following previous tetanus and diphtheria-toxoids--containing vaccines.
Health-care providers should encourage vaccination of household and child care provider contacts of infants aged <12 months. Women should be advised of the symptoms of Pertussis and the effectiveness of early antimicrobial prophylaxis, if Pertussis is suspected.
Considerations for Use of Tdap in Pregnant Women in Special Situations
ACIP recommends that Td be administered when booster protection is indicated during pregnancy. Health-care providers may choose to administer Tdap instead of Td during pregnancy to add protection against Pertussis in situations when Td cannot be delayed until delivery or when the risk for Pertussis is increased. In such cases, the women should be informed of the lack of data on safety, immunogenicity, and pregnancy outcomes for pregnant women who receive Tdap. Whether administration of Tdap to pregnant women results in protection of the infant against Pertussis through transplacental maternal antibodies is unknown. Maternal antibodies might interfere with the infant's immune response to infant doses of DTaP or conjugate vaccines containing tetanus toxoid or diphtheria toxoid.
If Tdap is administered, the second or third trimester is preferred unless protection is needed urgently. Providers are encouraged to report Tdap administrations regardless of trimester to the appropriate manufacturers' pregnancy registry: for ADACEL,® to sanofi pasteur, telephone 1-800-822-2463 (1-800-VACCINE) and for BOOSTRIX,® to GlaxoSmithKline Biologicals, telephone 1-888-825-5249.
Tetanus Prophylaxis for Wound Management
ACIP recommends administration of a Td booster for wound management in pregnant women in certain situations if >5 years have elapsed since the previous Td. Health-care providers may choose to administer Tdap instead of Td during pregnancy to add protection against Pertussis in these situations. In such cases, the women should be informed of the lack of data on safety, immunogenicity, and pregnancy outcomes for pregnant women who receive Tdap (see Considerations for Use of Tdap in Pregnant Women in Special Situations).
Pregnant Women with Unknown or Incomplete Vaccination
Pregnant women who have not received 3 doses of a vaccine containing tetanus and diphtheria toxoids should complete a series of three vaccinations, including 2 doses of Td during pregnancy, to ensure protection against maternal and neonatal tetanus. The preferred schedule in pregnant women is 2 doses of Td separated by 4 weeks and 1 dose of Tdap administered 6 months after the second dose (postpartum). Health-care providers may choose to substitute a single dose of Tdap for a dose of Td during pregnancy. In such cases, the women should be informed of the lack of data on safety, immunogenicity, and pregnancy outcomes for pregnant women who receive Tdap (see Considerations for Use of Tdap in Pregnant Women in Special Situations).
Prevention of Pertussis, Tetanus, and Diphtheria among Pregnant and Postpartum Women and Their Infants: Recommendations of the Advisory Committee on Immunization Practices (ACIP) MMWR May 14, 2008 / 57(Early Release);1-47
http://www.cdc.gov/mmwr/preview/mmwrhtml/rr57e0514a1.htm?s_cid=rr57e0514a1_e
Prevalence of Self-Reported Postpartum Depressive Symptoms --- 17 States, 2004--2005
The CDC released PRAMS survey results about postpartum depression recently. An excerpt from the editorial comment follows. The full report is available from the link below.
The findings in this report can be used to estimate the number of women in each state requiring a more complete evaluation (and thus the potential burden on health-care services for those with suspected PPD). Although some states (e.g., Maryland) have already implemented methods for addressing PPD, more targeted screening and interventions for PPD could be directed at women at higher risk for developing PPD and incorporated into existing public health programs (e.g., those that address women who were physically abused). These women also could be more effectively targeted for public health interventions developed according to state and local needs and resources. Adolescent mothers or women who received Medicaid for their delivery are examples of subsets of the population at increased risk for developing PPD that could be easily identified at delivery for interventions in the postpartum period.
The American College of Obstetricians and Gynecologists includes screening for PPD among the essential parts of a woman's 4--6 week postpartum visit. Postpartum women also can be screened for PPD by pediatricians at their infants' well-child visits (10). Women who are considered to have self-reported PDS based on these screenings should be administered a full diagnostic interview because they are most likely to develop PPD. State and local health departments and other health-care providers can use these screening results in their maternal and child health needs assessments and in planning for the provision of appropriate mental health services to new mothers. Additionally, the effectiveness of targeting services to mothers at higher risk for PPD should be evaluated.
Prevalence of Self-Reported Postpartum Depressive Symptoms --- 17 States, 2004—2005, MMWR, April 11, 2008 / 57(14);361-366.
http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5714a1.htm?%20s_cid=mm5714a1_e
The Pfannenstiel incision as a source of chronic pain
OBJECTIVE: To estimate prevalence, risk factors, and etiology of post-Pfannenstiel pain syndromes.
METHODS: All women (n _ 866) with a Pfannenstiel incision for cesarean delivery or abdominal hysterectomy performed between January 2003 and December 2004 received a questionnaire evaluating pain located in the Pfannenstiel region. A multivariate logistic regression analysis was done to determine predictors for chronic pain development. Patients with moderate or severe pain were interviewed and underwent a physical examination.
RESULTS: The response rate was 80% (690 of 866 patients). Subsequent to a follow-up after 2 years, one third (223 of 690) experienced chronic pain at the incision site. Moderate or severe pain was reported by 7%, and in 8.9% of respondents, pain impaired daily activities. Numbness, recurrent Pfannenstiel surgery, and emergency caesarean delivery were significant predictors of chronic pain. Nerve entrapment was present in over half the examined patients with moderate-to-severe pain (17 of 32).
CONCLUSION: Chronic pain occurs commonly after a Pfannenstiel incision. Nerve entrapment was found to be a frequent cause of moderate-to-severe pain.
Loos MJ, Scheltinga MR, Mulders LG, Roumen RM, The Pfannenstiel incision as a source of chronic pain. Obstet Gynecol. 2008 Apr;111(4):839-46.
http://www.ncbi.nlm.nih.gov/pubmed/18378742
Increasing exposure to angiotensin-converting enzyme inhibitors in pregnancy
OBJECTIVE: The objective of the study was to identify angiotensin-converting enzyme (ACE) inhibitor prescription-filling trends in pregnant women.
STUDY DESIGN: This was a retrospective cohort study in women continuously enrolled in Tennessee Medicaid during pregnancy who delivered a live infant or had a fetal death between 1986-2003 (n = 262,179).
RESULTS: ACE inhibitor exposures increased more than 4-fold: from 11.2 per 10,000 pregnancies in 1986-1988 to 58.9 per 10,000 pregnancies by 2003 (adjusted risk ratio [RR], 4.49; 95% confidence interval [CI], 2.78-7.25). Exposures in the second and third trimesters nearly tripled (RR, 2.88; 95% CI, 1.45-5.75) and did not decrease following a US Food and Drug Administration black box warning against such use in 1992. Exposures were most common among women 35 years of age or older.
CONCLUSION: Despite evidence of fetal complications associated with ACE inhibitor use during pregnancy, the number of pregnant women with pregnancy-related ACE inhibitor exposures increased steadily between 1986-2003. Better methods are needed to reduce fetal exposure to potentially teratogenic prescribed medications.
Bowen ME, Ray WA, Arbogast PG, Ding H, Cooper WO, Increasing exposure to angiotensin-converting enzyme inhibitors in pregnancy, Am J Obstet Gynecol. 2008 Mar;198(3):291.e1-5. Epub 2008 Jan 14.
http://www.ncbi.nlm.nih.gov/pubmed/18191803
Gynecology
Management of Trichomonas vaginalis in women with suspected Metronidazole hypersensitivity
BACKGROUND: Standard treatment for Trichomonas vaginalis is Metronidazole or Tinidazole. Hypersensitivity to these drugs has been documented but is poorly understood. Desensitization is an option described in limited reports of women with hypersensitivity to nitroimidazoles. The purpose of this analysis is to improve documentation of management for Trichomonas infections among women with Metronidazole hypersensitivity.
DESIGN: Clinicians who consulted Centers for Disease Control and Prevention concerning patients with suspected hypersensitivity to Metronidazole were provided with treatment options and asked to report outcomes.
RESULTS: From September 2003-September 2006, complete information was obtained for 59 women. The most common reactions were urticaria (47%) and facial edema (11%). Fifteen of these women (25.4%) were treated with Metronidazole desensitization and all had eradication of their infection. Seventeen women (28.8%) were treated with alternative intravaginal drugs, which were less successful; 5 of 17 infections (29.4%) were eradicated.
CONCLUSION: Metronidazole desensitization was effective in the management of women with nitroimidazole hypersensitivity.
Helms DJ, Mosure DJ, Secor WE, et al. Management of Trichomonas vaginalis in women with suspected Metronidazole hypersensitivity. Am J Obstet Gynecol 2008;198:370.e1-370.e7.
http://www.ncbi.nlm.nih.gov/pubmed/18221927
Clinical effects of the levonorgestrel-releasing intrauterine device in patients with adenomyosis
OBJECTIVE: The aim of this study was to evaluate the long-term clinical effects of a levonorgestrel-releasing intrauterine device (LNG-IUD) on adenomyosis.
DESIGN: A LNG-IUD was inserted into 47 patients who were diagnosed with adenomyosis. Uterine volume, uterine artery blood flow, pictorial blood loss assessment chart (PBAC) scores, and the degree of dysmenorrhea were evaluated before and 36 months after insertion of the LNG-IUD.
RESULTS: Pain scores and PBAC scores dropped dramatically in 6 months and showed significant decrease after 36 months. A significant decrease in mean uterine volume was noted 12 months (156.85 ± 49.79 mL to 118.64 ± 41.36 mL; P < .001) and 24 months (128.84 ± 48.70 mL; P < .001) after LNG-IUD insertion, but no significant differences were noted at 36 months. The mean pulsatility indices of both uterine arteries increased significantly 12 months after insertion (P = .002 for right; P = .011 for left) and decreased after 24 months without significance. Uterine volume and uterine blood flow were negatively correlated (Pearson’s correlation, P < .05). Significant increase of uterine volume, pain scores, and PBAC scores were noted at 36 months compared with 12 months after insertion(P = .034, .021, and .001, respectively).
CONCLUSION: For patients with clinical diagnosis of adenomyosis, the LNG-IUD is effective for the reduction of uterine volume with improvement of vascularity and relief of symptoms. However, the efficacy of LNG-IUD on uterine volume may begin to decrease 2 years after insertion.
Cho S, Nam A, Kim H, et al. Clinical effects of the levonorgestrel-releasing intrauterine device in patients with adenomyosis. Am J Obstet Gynecol 2008;198:373.e1-373.e7.
http://www.ncbi.nlm.nih.gov/pubmed/18177833
Treatment of vulvar intraepithelial neoplasia with topical imiquimod
BACKGROUND: Alternatives to surgery are needed for the treatment of vulvar intraepithelial neoplasia. We investigated the effectiveness of imiquimod 5% cream, a topical immune-response modulator, for the treatment of this condition.
METHODS: Fifty-two patients with grade 2 or 3 vulvar intraepithelial neoplasia were randomly assigned to receive either imiquimod or placebo, applied twice weekly for 16 weeks. The primary outcome was a reduction of more than 25% in lesion size at 20 weeks. Secondary outcomes were histologic regression, clearance of human papillomavirus (HPV) from the lesion, changes in immune cells in the epidermis and dermis of the vulva, relief of symptoms, improvement of quality of life, and durability of response. Reduction in lesion size was classified as complete response (elimination), strong partial response (76 to 99% reduction), weak partial response (26 to 75% reduction), or no response (< or =25% reduction). The follow-up period was 12 months. RESULTS: Lesion size was reduced by more than 25% at 20 weeks in 21 of the 26 patients (81%) treated with imiquimod and in none of those treated with placebo (P<0.001). Histologic regression was significantly greater in the imiquimod group than in the placebo group (P<0.001). At baseline, 50 patients (96%) tested positive for HPV DNA. HPV cleared from the lesion in 15 patients in the imiquimod group (58%), as compared with 2 in the placebo group (8%) (P<0.001). The number of immune epidermal cells increased significantly and the number of immune dermal cells decreased significantly with imiquimod as compared with placebo. Imiquimod reduced pruritus and pain at 20 weeks (P=0.008 and P=0.004, respectively) and at 12 months (P=0.04 and P=0.02, respectively). The lesion progressed to invasion (to a depth of <1 mm) in 3 of 49 patients (6%) followed for 12 months (2 in the placebo group and 1 in the imiquimod group). Nine patients, all treated with imiquimod, had a complete response at 20 weeks and remained free from disease at 12 months.
CONCLUSIONS: Imiquimod is effective in the treatment of vulvar intraepithelial neoplasia.
van Seters M, et al, Treatment of vulvar intraepithelial neoplasia with topical imiquimod.
N Engl J Med. 2008 Apr 3;358(14):1465-73.
http://www.ncbi.nlm.nih.gov/pubmed/18385498
Topical Imiquimod Is Effective in Treatment of Vulvar Intraepithelial Neoplasia CME
http://www.medscape.com/viewarticle/572445
Child Health
Breastfeeding Promotion: A Rational and Achievable Target for a Type 2 Diabetes Prevention Intervention in Native American Communities
ABSTRACT: Type 2 diabetes is a serious, costly, and increasingly common disease among Native American communities. Increasing evidence suggests that early infant nutrition, particularly breastfeeding, may have a significant impact on the development of diabetes in later life. In this report, the authors describe the scientific basis and development of an innovative program that targets promotion of breastfeeding among Native women as a type 2 diabetes prevention intervention. The program materials, evaluation methods, and outcomes are presented. By developing and sharing strategies that effectively support breastfeeding, the impact of diabetes in Native American communities will be reduced.
Murphy S, Wilson C, Breastfeeding promotion: a rational and achievable target for a type 2 diabetes prevention intervention in Native American communities. J Hum Lact . 24(2):193-198.
http://www.ncbi.nlm.nih.gov/pubmed/18436971
OB/GYN CCC Editorial comment:
Diabetes Prevention Intervention in Native American Communities
Breastfeeding represents a unique opportunity for diabetes prevention. This report comes from the front lines of Indian Health Service Breastfeeding Advocacy and Diabetes Care, Phoenix Indian Medical Center. In fact our own CCC Corner columnist Suzan Murphy is one of the authors, please give it a careful look.
Epidemiology of Invasive Group B Streptococcal Disease in the United States, 1999-2005
OBJECTIVE: To describe disease trends among populations that might benefit from vaccination and among newborns during a period of evolving prevention strategies.
DESIGN AND SETTING: Analysis of active, population-based surveillance in 10 states participating in the Active Bacterial Core surveillance/Emerging Infections Program Network.
MAIN OUTCOME MEASURES: Age- and race-specific incidence of invasive group B streptococcal disease.
RESULTS: There were 14 573 cases of invasive group B streptococcal disease during 1999-2005, including 1348 deaths. The incidence of invasive group B streptococcal disease among infants from birth through 6 days decreased from 0.47 per 1000 live births in 1999-2001 to 0.34 per 1000 live births in 2003-2005 (P < .001), a relative reduction of 27% (95% confidence interval [CI], 16%-37%). Incidence remained stable among infants aged 7 through 89 days (mean, 0.34 per 1000 live births) and pregnant women (mean, 0.12 per 1000 live births). Among persons aged 15 through 64 years, disease incidence increased from 3.4 per 100 000 population in 1999 to 5.0 per 100 000 in 2005 (x 2 1 for trend, 57; P < .001), a relative increase of 48% (95% CI, 32%-65%). Among adults 65 years or older, incidence increased from 21.5 per 100 000 to 26.0 per 100 000 (x 2 1 for trend, 15; P < .001), a relative increase of 20% (95% CI, 8%-35%). All 4882 isolates tested were susceptible to penicillin, ampicillin, and vancomycin, but 32% and 15% were resistant to erythromycin and clindamycin, respectively. Serotypes Ia, Ib, II, III, and V accounted for 96% of neonatal cases and 88% of adult cases.
CONCLUSIONS: Among infants from birth through 6 days, the incidence of group B streptococcal disease was lower in 2003-2005 relative to 1999-2001. This reduction coincided with the release of revised disease prevention guidelines in 2002. However, the disease burden in adults is substantial and increased significantly during the study period.
Phares CR et al. Epidemiology of invasive group B streptococcal disease in the United States, 1999–2005. JAMA 2008 May 7; 299:2056.
http://www.ncbi.nlm.nih.gov/pubmed/18460666
Effect of a pediatric practice-based smoking prevention and cessation intervention for adolescents: a randomized, controlled trial.
OBJECTIVE. The purpose of this work was to determine whether a pediatric practice-based smoking prevention and cessation intervention increases abstinence rates among adolescents.
METHODS. Eight pediatric primary care clinics were randomly assigned to either intervention
or usual care control condition. The provider- and peer-delivered intervention tested was based on the 5A model recommended by the US Public Health Service clinical practice guidelines and the American Academy of Pediatrics and consisted of brief counseling by the pediatric provider followed by 1 visit and 4 telephone calls by older peer counselors aged 21 to 25 years. A consecutive sample of patients aged 13 to 17 years scheduled for an office visit was eligible regardless of smoking status. Of 2711 patients who agreed to participate, 2709 completed baseline assessments, and 2700 (99.6%) and 2690 (99.2%) completed 6- and 12-month assessments, respectively.
RESULTS. Compared with the usual care condition, nonsmokers who received the provider- and peer-delivered intervention were significantly more likely to self-report having remained abstinent at 6-month and 12-month follow-up; smokers who received the provider- and peer-delivered intervention were more likely to report having quit at the 6-month but not the 12-month follow-up. A number of adolescent characteristics (eg, age, peer smoking, tobacco dependence, and susceptibility) were found to be predictive of abstinence at follow-up.
CONCLUSIONS.A pediatric practice-based intervention delivered by pediatric providers and older peer counselors proved feasible and effective in discouraging the initiation of smoking among nonsmoking adolescents for 1 year and in increasing abstinence rates among smokers for 6 months.
Pbert L, et al. Effect of a pediatric practice-based smoking prevention and cessation intervention for adolescents: a randomized, controlled trial. Pediatrics. 2008 Apr;121(4):e738-47.
http://www.ncbi.nlm.nih.gov/pubmed/18381502
Intensive care for extreme prematurity--moving beyond gestational age
BACKGROUND: Decisions regarding whether to administer intensive care to extremely premature infants are often based on gestational age alone. However, other factors also affect the prognosis for these patients.
METHODS: We prospectively studied a cohort of 4446 infants born at 22 to 25 weeks' gestation (determined on the basis of the best obstetrical estimate) in the Neonatal Research Network of the National Institute of Child Health and Human Development to relate risk factors assessable at or before birth to the likelihood of survival, survival without profound neurodevelopmental impairment, and survival without neurodevelopmental impairment at a corrected age of 18 to 22 months.
RESULTS: Among study infants, 3702 (83%) received intensive care in the form of mechanical ventilation. Among the 4192 study infants (94%) for whom outcomes were determined at 18 to 22 months, 49% died, 61% died or had profound impairment, and 73% died or had impairment. In multivariable analyses of infants who received intensive care, exposure to antenatal corticosteroids, female sex, singleton birth, and higher birth weight (per each 100-g increment) were each associated with reductions in the risk of death and the risk of death or profound or any neurodevelopmental impairment; these reductions were similar to those associated with a 1-week increase in gestational age. At the same estimated likelihood of a favorable outcome, girls were less likely than boys to receive intensive care. The outcomes for infants who underwent ventilation were better predicted with the use of the above factors than with use of gestational age alone.
CONCLUSIONS: The likelihood of a favorable outcome with intensive care can be better estimated by consideration of four factors in addition to gestational age: sex, exposure or nonexposure to antenatal corticosteroids, whether single or multiple birth, and birth weight.
Tyson JE, Parikh NA, Langer J, Green C, Higgins RD; National Institute of Child Health and Human Development Neonatal Research Network, Intensive care for extreme prematurity--moving beyond gestational age, N Engl J Med. 2008 Apr 17;358(16):1672-81.
Abstract at: http://www.ncbi.nlm.nih.gov/pubmed/18420500
Full Text at: http://content.nejm.org/cgi/content/full/358/16/1672?query=TOC.
The NRN Web site contains a tool that clinicians can use to estimate the likelihood that intensive care will benefit individual infants (after considering the extent to which outcomes might differ from those identified by the NRN). The tool is available at http://www.nichd.nih.gov/neonatalestimates.Chronic Disease and Illness
Awareness of Stroke Warning Symptoms
Early recognition of the signs and symptoms of stroke and the need for victims or bystanders to immediately call 911 at the onset of symptoms is a matter of life and death. The five signs and symptoms of stroke include:
- Sudden numbness or weakness of the face, arms, or legs
- Sudden confusion or trouble speaking or understanding others
- Sudden trouble seeing in one or both eyes
- Sudden trouble walking, dizziness, or loss of balance or coordination
- Sudden severe headache with no known cause
Although the number of deaths from stroke have declined since the 1960s, more than half (54 percent) of U.S. stroke deaths occur outside a hospital. A new CDC study revealed that less than half (44 percent) of people when asked about their awareness of the signs and symptoms of a stroke knew all five symptoms of a stroke, and only 38 percent of respondents knew to call 911 if they thought someone was having a stroke. This study, Disparities in Adult Awareness of Stroke Warning Signs and Symptoms, analyzed 2005 Behavior Risk Factor Surveillance Study data from 13 states and the District of Columbia found there was no improvement in the publics′ awareness of stroke symptoms since a similar study conducted in 2001.
Awareness of Stroke Warning Symptoms --- 13 States and the District of Columbia, 2005
MMWR, May 9, 2008 / 57(18);481-485.
http://www.cdc.gov/mmwR/preview/mmwrhtml/mm5718a2.htm
Mammography combined with ultrasound vs. alone; improved detection but higher false positive rates
CONTEXT: Screening ultrasound may depict small, node-negative breast cancers not seen on mammography.
OBJECTIVE: To compare the diagnostic yield, defined as the proportion of women with positive screen test results and positive reference standard, and performance of screening with ultrasound plus mammography vs mammography alone in women at elevated risk of breast cancer.
DESIGN, SETTING, AND PARTICIPANTS: From April 2004 to February 2006, 2809 women, with at least heterogeneously dense breast tissue in at least 1 quadrant, were recruited from 21 sites to undergo mammographic and physician-performed ultrasonographic examinations in randomized order by a radiologist masked to the other examination results. Reference standard was defined as a combination of pathology and 12-month follow-up and was available for 2637 (96.8%) of the 2725 eligible participants.
CONCLUSIONS: Adding a single screening ultrasound to mammography will yield an additional 1.1 to 7.2 cancers per 1000 high-risk women, but it will also substantially increase the number of false positives.
Berg, WA, et al., Combined Screening With Ultrasound and Mammography vs Mammography Alone in Women at Elevated Risk of Breast Cancer , JAMA . 2008;299(18):2151-2163.
Full text at: http://jama.ama-assn.org/cgi/content/full/299/18/2151
Once-Daily Basal Insulin as Effective as Prandial
BACKGROUND: As type 2 diabetes mellitus progresses, oral hypoglycemic agents often fail to maintain blood glucose control and insulin is needed. We investigated whether the addition of once-daily insulin glargine is non-inferior to three-times daily prandial insulin lispro in overall glycemic control in adults with inadequately controlled type 2 diabetes mellitus taking oral hypoglycemic agents.
INTERPRETATION: A therapeutic regimen involving the addition of either basal or prandial insulin analogue is equally effective in lowering hemoglobin A(1c). We conclude that insulin glargine provides a simple and effective option that is more satisfactory to patients than is lispro for early initiation of insulin therapy, since it was associated with a lower risk of hypoglycemia, fewer injections, less blood glucose self monitoring, and greater patient satisfaction than was insulin lispro. FUNDING: Sanofi-Aventis.
Bretzel RG, et al., Once-daily basal insulin glargine versus thrice-daily prandial insulin lispro in people with type 2 diabetes on oral hypoglycemic agents (APOLLO): an open randomized controlled trial. Lancet. 2008 Mar 29;371(9618):1073-84.
http://www.ncbi.nlm.nih.gov/pubmed/18374840
Arthritis as a Potential Barrier to Physical Activity Among Adults with Diabetes --- United States, 2005 and 2007
The following is the press release from the CDC about the recent study, reported in the MMWR, about the impact of arthritis on adults with diabetes and its interference with physical activity:
More than half of adults with diagnosed diabetes also have arthritis, a painful condition that can be a barrier to physical activity—an important health strategy for managing diabetes, according to a study released by the Centers for Disease Control and Prevention in today′s Morbidity and Mortality Weekly Report.
Nationwide, 46.4 million adults have arthritis and 20.6 million adults have diabetes, with nearly 7 in 10 having had diabetes diagnosed by a health professional. Research shows that engaging in joint-friendly activities such as walking, swimming, biking can help manage both conditions.
The study, “Arthritis as a Potential Barrier to Physical Activity among Adults with Diabetes: United States, 2005 and 2007,” analyzed data on the prevalence of physical inactivity among adults with arthritis and diabetes in all 50 states, the District of Columbia, and U.S. territories.
The study suggests that the presence of arthritis acts as an additional barrier to physical activity among those with diabetes. The study found that 29.8 percent of adults with arthritis and diabetes were inactive, compared with 21.0 percent of people with diabetes alone, 17.3 percent of those with arthritis alone, and 10.9 percent of adults with neither condition.
The study also found that the percentage of adults with diabetes and arthritis who are physically inactive varied among states, ranging from 20.2 percent in California to 46.4 percent in Tennessee.
“People who have arthritis, diabetes or both benefit from being physically active,” said Janet Collins, Ph.D., director, CDC′s National Center for Chronic Disease Prevention and Health Promotion. “We know it can be difficult, but regular physical activity helps in many ways. For people with diabetes, physical activity helps control blood glucose and risk factors for complications. For people with arthritis, physical activity reduces pain, and improves function.”
Adults with arthritis and diabetes have unique barriers to being physically active such as concerns about pain, aggravating or worsening joint damage, and not knowing how much or what types of physical activity are safe for them. These concerns must be addressed for adults with both conditions to become more physically active.
“These findings suggest more needs to be done to help people with diabetes and arthritis get physically active to improve their health,” said Chad Helmick, M.D., a CDC medical epidemiologist and co-author on the study. “Engaging in regular physical activity and maintaining a healthy weight can help alleviate the pain and disability that often accompany arthritis.”
Disease self-management classes, including exercise programs that address arthritis-specific barriers, may help adults with arthritis and diabetes better manage their disease. Programs proven to be effective in managing arthritis, such as the Chronic Disease Self-Management Program, the Arthritis Foundation′s Exercise Program, and Enhance Fitness, are available in many local communities nationwide. For more information, visit CDC′s Arthritis Web site at http://www.cdc.gov/arthritis/intervention.
The full article is available at the following link:
Arthritis as a Potential Barrier to Physical Activity Among Adults with Diabetes --- United States, 2005 and 2007, MMWR, May 9, 2008 / 57(18);486-489
http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5718a3.htm
A podcast about this topic, “Sit and Suffer or Move and Mend”, is also available:
http://www2a.cdc.gov/podcasts/player.asp?f=8970
The following resource can be helpful in planning physical activity for elders:
Reference Guide of Physical Activity Programs for Older Adults: A Resource for Planning Intervention http://www.cdc.gov/diabetes/pubs/pdf/refguideofactivity.pdf
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OB/GYN
Dr. Neil Murphy is the Obstetrics and Gynecology Chief Clinical Consultant (OB/GYN C.C.C.). Dr. Murphy is very interested in establishing a dialogue and/or networking with anyone involved in women's health or maternal child health, especially as it applies to Native or indigenous peoples around the world. Please don't hesitate to contact him by e-mail or phone at 907-729-3154.
