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Obstetrics
Paroxetine’s pregnancy category changed from C to D
FDA MedWatch
Paroxetine HCl - Paxil and generic paroxetine
The FDA has determined that exposure to paroxetine in the first trimester of pregnancy may increase the risk for congenital malformations, particularly cardiac malformations. At the FDA’s request, the manufacturer has changed paroxetine’s pregnancy category from C to D and added new data and recommendations to the WARNINGS section of paroxetine’s prescribing information. FDA is awaiting the final results of the recent studies and accruing additional data related to the use of paroxetine in pregnancy in order to better characterize the risk for congenital malformations associated with paroxetine.
Physicians who are caring for women receiving paroxetine should alert them to the potential risk to the fetus if they plan to become pregnant or are currently in their first trimester of pregnancy. Discontinuing paroxetine therapy should be considered for these patients. Women who are pregnant, or planning a pregnancy, and currently taking paroxetine should consult with their physician about whether to continue taking it. Women should not stop the drug without discussing the best way to do that with their physician.
There are two main levels to approach this
1.) Patient notification phase
2.) Patient management phase (cognitive behavioral therapy, other medications)
Phase 1 Noftification
In a way we have had this type of event happen before, e. g., Vioxx earlier this year and hormone replacement therapy in 2000
This time we have the added element that some of the patients need to be managed immediately, e.g., the first trimester patients should be notified this week.
The non-first trimester patients and all other reproductive age women need to be managed in a timely fashion, but don’t have the same ramped up element of immediacy.
The second added element is that one simply can’t stop this drug immediately, plus there can be significant negative downstream long term effects to discontinuation.
We need to utilize a paroxetine drug tapering method to avoid withdrawal syndrome
and
We need to be aware that some patients may develop worse depression symptoms that may lead to hospitalization, drug abuse, pregnancy termination, or suicide.
Here are some possible approaches to the Notification Phase:
-Notify all the health care providers who care for women of reproductive age
E-mails (send it to all stakeholders)
Schedule urgent staff meetings
-Create a multi-disciplinary team to manage various aspects
Make sure all stakeholders are represented
Family Medicine, Pharmacy, Mental Health, Women’s Health, Internal Medicine, Emergency Room, Administration, Pediatrics, Urgent Care, Social Service
Who did we miss?
If it is too big a group, it might be hard to manage
Who ‘owns’ this problem? Primary care staff? Mental Health staff? Women’s Health Staff? Pharmacy staff?
-Search RPMS for a list of patients on all forms of the product on your formulary
1 PAXIL PAROXETINE 30MG TAB INITIAL RX FOR MAX 30 DAY SUPPLY *D-A
SK LMP
2 PAXIL PAROXETINE 20MG TAB INITIAL RX FOR MAX 30 DAY SUPPLY *
D-ASK LMP
3 PAXIL PAROXETINE 40MG TAB INITIAL RX FOR MAX 30 DAY SUPPLY *D-A
SK LMP
4 PAXIL PAROXETINE 10MG TAB INITIAL RX FOR MAX 30 DAY; UNABLE TO G
ET, SAVE FOR 5MG DOSES *D-ASK LMP
5 PAXIL PAROXETINE 10MG/5ML SUSP *D-ASK LMP
-Contact the patients on the above list
Create a spread sheet from the above list of patients…
Sort by EDC
Make sure it has all paroxetin patients, their contact info (phone and address) and Rx and Issue/Fill date
Make sure it has the patient’s Primary Care Provider (PCP) and PCP clinic if applicable for case management work distribution
-Contact first trimester patients by phone
Many patients don’t have phones
Who does this? Pharmacy staff? Primary Care case managers?
Should the provider call the patients?
-Contact all others by letter
Many of these letters get returned because of address changes
-Discuss paroxetine’s effects with each patient as they come in for their appointments
It is a bit of complicated physiology that may, or may not, ultimately ?effect all SSRIs
-Provide patient education handouts
Here is one, but it is it appropriate for your clients
FDA Patient Ed page
http://www.fda.gov/cder/drug/InfoSheets/patient/paroxetinePT.htm
-Document your discussion
Should you create an overlay PCC or PCC+ that has a checklist of the above elements to streamline the documentation
Phase 2
Management
-Discuss treatment options and risk with the pregnancy-age or pregnant patient,
-Encourage converting to alternative antidepressants or stopping meds where indicated and
-Get consultation for the conversion or discontinuation as paroxetine has a significant withdrawal syndrome associated with it (a possible contributor to increased suicidal behavior).
Where available, cognitive behavioral therapy for mild to moderate depressive symptoms is as effective as meds - unfortunately it requires time and commitment on part of both patients and providers.
The question is how to get the info out . . .unfortunately the antidepressants are not reliably interchangeable and for some patients who have arrived at paroxetine after a trial of a number of other antidepressants there may be few other effective options (though this number will be small) . . . if that is the case referral/consultation would definitely be in order.
Tapering paroxetine from 20 to 10 to 5, each for a week… although this is still rapid for some patients) or going to fluoxetine first and then tapering can be helpful in decreasing discontinuation effects which can be wicked with paroxetine. It is also important to remember that developmental effects of being raised by a very depressed mother can be significant as well.
Try to avoid
….that some patients may get the message and stop the drug without appropriate consultation with their physician and develop worse depression symptoms that may lead to hospitalization, drug abuse, pregnancy termination or suicide. There is a danger in taking the warning too literally.
Background
Quick take: Reprotox
Although experimental animal studies do not suggest an increased risk of congenital anomalies, a preliminary case-control study and 2 other independent studies presented in abstract or letter-form have suggested a 2-fold increase in cardiovascular defects in children exposed antenatally to paroxetine. Use of paroxetine late in pregnancy can be associated with a mild transient neonatal syndrome of central nervous system, motor, respiratory, and gastrointestinal signs.
http://www.reprotox.org/Default.aspx
FDA Professional Ed page
http://www.fda.gov/cder/drug/InfoSheets/HCP/paroxetineHCP.htm
FDA Patient Education page
http://www.fda.gov/cder/drug/InfoSheets/patient/paroxetinePT.htm
Treatment of psychiatric disorders in pregnancy, UpToDate
http://www.uptodateonline.com/application/topic.asp?file=maternal/5976
Other paroxetine or depression related items in the literature this month
Exposure to selective serotonin reuptake inhibitors during pregnancy is not independently associated with adverse perinatal outcomes other than increased risk of needing treatment in special or neonatal intensive care unit.
CONCLUSION: Use of SSRIs during pregnancy is not independently associated with increased risk of adverse perinatal outcome other than need for treatment in neonatal special or intensive care unit. LEVEL OF EVIDENCE: II-2. Malm H, et al Risks associated with selective serotonin reuptake inhibitors in pregnancy. Obstet Gynecol. 2005 Dec;106(6):1289-96.
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=retrieve&db=pubmed&list_uids=16319254&dopt=Abstract
Meta-analysis: Light therapy similar effect on non-seasonal depression as medication.
CONCLUSIONS: Many reports of the efficacy of light therapy are not based on rigorous study designs. This analysis of randomized, controlled trials suggests that bright light treatment and dawn simulation for seasonal affective disorder and bright light for non-seasonal depression are efficacious, with effect sizes equivalent to those in most antidepressant pharmacotherapy trials. Adopting standard approaches to light therapy's specific issues (e.g., defining parameters of active versus placebo conditions) and incorporating rigorous designs (e.g., adequate group sizes, randomized assignment) are necessary to evaluate light therapy for mood disorders.
Golden RN, et al The efficacy of light therapy in the treatment of mood disorders: a review and meta-analysis of the evidence. Am J Psychiatry. 2005 Apr;162(4):656-62.
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=15800134&query_hl=4
Other
Do you work with a low HIV prevalence population? Here is a strategy to keep it that way
CONCLUSION: In a low prevalence population, the universal use of Oraquick rapid testing is cost-effective because of the low rate of false-positive results, thus preventing the emotional and economic costs of unnecessary treatment for human immunodeficiency virus to the new mother and her family
Doyle NM, et al Rapid HIV versus enzyme-linked immunosorbent assay screening in a low-risk Mexican American population presenting in labor: a cost-effectiveness analysis. Am J Obstet Gynecol. 2005 Sep;193(3 Pt 2):1280-5.
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=16157152&query_hl=1
OB/GYN CCC Editorial comment:
HIV screening is a routine test in pregnancy. It is initially performed in an ‘opt out’ mode at the first prenatal visit. No additional written consent is necessary, but it a critical ‘teachable moment’ during which HIV patient education should be delivered. If the patient is unable to obtain HIV screening at that time and presents in labor without screening, then HIV screening should be routinely performed at that time. In selected cases high risk individuals should be re-screened in labor. Depending on the logistics of your facility rapid testing may be the best choice.
Bulterys M et al Rapid HIV-1 testing during labor: a multicenter study. JAMA 2004 Jul 14;292(2):219-23.
Kallenborn JC; Price TG; Carrico R; Davidson AB Emergency department management of occupational exposures: cost analysis of rapid HIV test. Infect Control Hosp Epidemiol 2001 May;22(5):289-93.
Evidence-based surgery for cesarean delivery
RESULTS: US Preventive Services Task Force recommendations favor blunt uterine incision expansion, prophylactic antibiotics (either ampicillin or first-generation cephalosporin for just 1 dose), spontaneous placental removal, non-closure of both visceral and parietal peritoneum, and suture closure or drain of the subcutaneous tissue when thickness is > or =2 cm. CONCLUSION: Cesarean delivery techniques that are supported by good quality recommendations should be performed routinely. All technical aspects that have recommendations with lower quality should be researched with adequately powered and designed trials.
Berghella V et al Evidence-based surgery for cesarean delivery. Am J Obstet Gynecol. 2005 Nov;193(5):1607-17.
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=16260200&query_hl=14
Umbilical cord blood is a proven source of hematopoietic stem cells: You can bank on it
Until recently, blood that remained in the umbilical cord and placenta after delivery was routinely discarded. Now that this blood is known to contain both hematopoietic stem cells and pluripotent mesenchymal cells, there has been a substantial increase in the clinical use and research investigation of umbilical cord blood in hematopoietic transplantation and regenerative medicine. Until now, standards for collection and processing were not well established. The debate continues regarding the private banking of autologous blood for "biologic insurance" versus public banking for access by the general population. Obstetricians should support the acquisition of cord units for public banking in their geographic location where cord blood banks have established collection procedures. Issues related to cost, quality control, and the need for ethnic diversity in public banks preclude the universal collection of units from all obstetric deliveries. Directed donation of cord blood should be considered when there is a specific diagnosis of a disease within a family known to be amenable to stem cell transplantation.
Moise KJ Jr. Umbilical cord stem cells. Obstet Gynecol. 2005 Dec;106(6):1393-407.
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=retrieve&db=pubmed&list_uids=16319269&dopt=Abstract
Other resources
Research News On Cord Blood Stem Cells
http://www.cord-blood-stem-cells.info/Site_Map.html
Cord Blood Guide: Links
http://www.cord-blood-stem-cells.info/links.html
Women with a prior cesarean should be offered VBAC, and women with a prior cesarean and prior vaginal delivery should be encouraged to VBAC
CONCLUSION: Women with a prior cesarean should be offered VBAC, and women with a prior cesarean and prior vaginal delivery should be encouraged to VBAC. Although other studies have suggested that prostaglandins should be avoided, we suggest that inductions requiring sequential agents be avoided
Macones GA, et al Maternal complications with vaginal birth after cesarean delivery: a multicenter study. Am J Obstet Gynecol. 2005 Nov;193(5):1656-62.
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=16260206&query_hl=9
Most women not screened for diabetes after a pregnancy with gestational diabetes
CONCLUSION: In the population studied, only 37% of women with a history of GDM were screened for postpartum DM according to guidelines published by the American Diabetes Association. Efforts to improve postpartum DM screening in this high-risk group are warranted. LEVEL OF EVIDENCE: II-2.
Smirnakis KV, et al Postpartum Diabetes Screening in Women With a History of Gestational Diabetes. Obstet Gynecol. 2005 Dec;106(6):1297-1303
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=retrieve&db=pubmed&list_uids=16319255&dopt=Abstract
An Approach to the Postpartum Office Visit
The postpartum period (typically the first six weeks after delivery) may underscore physical and emotional health issues in new mothers. A structured approach to the postpartum office visit ensures that relevant conditions and concerns are discussed and appropriately addressed. Common medical complications during this period include persistent postpartum bleeding, endometritis, urinary incontinence, and thyroid disorders. Breastfeeding education and behavioral counseling may increase breastfeeding continuance. Postpartum depression can cause significant morbidity for the mother and baby; a postnatal depression screening tool may assist in diagnosing depression-related conditions. Decreased libido can affect sexual functioning after a woman gives birth. Physicians should also discuss contraception with postpartum patients, even those who are breastfeeding. Progestin-only contraceptives are recommended for breastfeeding women. The lactational amenorrhea method may be a birth control option but requires strict criteria for effectiveness. (Am Fam Physician 2005;72:2491-6, 2497-8.
http://www.aafp.org/afp/20051215/2491.html (Also see Patient Education)
Stepwise oral misoprostol (50 microg then 100 microg) as effective as vaginal
CONCLUSION: Stepwise oral misoprostol (50 microg followed by 100 microg) appears to be as effective as vaginal misoprostol (25 microg) for cervical ripening with a low incidence of hyperstimulation, no increase in side effects, a high rate of patient satisfaction, and is associated with a lower cesarean section rate.
Colón I, et al. Prospective randomized clinical trial of inpatient cervical ripening with stepwise oral misoprostol vs vaginal misoprostol. Am J Obstet Gynecol March 2005;192:747-52.
Untreated Maternal Gingivitis Raises Risk of Preterm/low Birth Weight
Conclusions: Periodontal treatment significantly reduced the PT/LBW rate in this population of women with pregnancy-associated gingivitis. Within the limitions of this study, we conclude that gingivitis appears to be an independent risk factor for PT/LBW for this population
Lopez NJ, et al Periodontal Therapy Reduces the Rate of Preterm Low Birth Weight in Women With Pregnancy-Associated Gingivitis. J Periodontol. 2005 Nov;76(11-s):2144-2153.
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=16277587&query_hl=10
Postpartum Physical Activity Levels Low in Women With Recent Gestational Diabetes
CONCLUSIONS: The prevalence of sufficient physical activity was found to be low and strongly related to social support and self-efficacy. This is an important group to whom diabetes prevention strategies can be targeted.
Smith BJ, et al Postpartum physical activity and related psychosocial factors among women with recent gestational diabetes mellitus. Diabetes Care. 2005 Nov;28(11):2650-4.
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=16249534&query_hl=12
3 in 10 Gave Birth by Cesarean in 2004: Sharp, Rise Defies Evidence and Best Practice
The Maternity Center Association (MCA) has prepared three new Web pages that contain information about cesarean section, including information about recent changes in the U.S. cesarean section rate recently reported by the National Center for Health Statistics. The Web pages are intended for use by women, health professionals, the media, and others in their efforts to promote evidence-based maternity care.
The first Web page summarizes factors associated with the increase, discusses health costs and financial implications, and challenges assumptions. http://www.maternitywise.org/cesarean_response.html
The second page presents a brief overview of MCA's advice for pregnant women about cesarean section, vaginal birth, and vaginal birth after cesarean. http://www.maternitywise.org/cesarean_advice.html
The third page, which addresses myths about cesarean section, is available at http://www.maternitywise.org/cesarean_myth_vs_reality.html
National Center for Health Statistics' Preliminary Births for 2004: Infant and Maternal Health, ihttp://www.cdc.gov/nchs/products/pubs/pubd/hestats/prelimbirths04/prelimbirths04health.htm
Complications Differ After Forceps- and Vacuum-Assisted Deliveries
Infant shoulder dystocia rates are higher with vacuum-assisted deliveries than with forceps deliveries, while women undergoing forceps deliveries are more likely to suffer third- or fourth-degree lacerations, according to a report in the November Obstetrics and Gynecology.
CONCLUSION: Vacuum-assisted vaginal birth is more often associated with shoulder dystocia and cephalohematoma. Forceps delivery is more often associated with third- and fourth-degree perineal lacerations. These differences in complications rates should be considered among other factors when determining the optimal mode of delivery. LEVEL OF EVIDENCE: II-2
Caughey AB, et al Forceps compared with vacuum: rates of neonatal and maternal morbidity. Obstet Gynecol 2005;106:908-912.
40% of maternal deaths were preventable
Using multiple methods to identify pregnancy-related deaths in North Carolina in 1995-1999, we found that 40% of these deaths could potentially have been prevented. Though the risk of dying from pregnancy in the United States decreased dramatically during the 20th century, evidence suggests that further reductions are possible. The authors found that:
* Of the 102 deaths deemed preventable, 41 (40%) were deemed preventable through changes in at least one of the study areas.
* Approximately 90% of deaths due to hemorrhage or to complications of chronic diseases were deemed preventable, compared with none of the deaths due to cerebrovascular accident, amniotic fluid emboli, or microangiopathic hemolytic syndromes.
* Improved medical care (quality of care) was most important in preventing deaths due to hemorrhage and infection, whereas preconception care could have prevented more than half of the deaths due to chronic medical conditions.
* Forty-six percent of the deaths among African American women were deemed preventable, compared with 33% of the deaths among white women, a difference that was statistically significant.
Conclusion The process of in-depth review of pregnancy-related deaths may provide guidance to help reduce the number of these events.
Berg CJ, Harper MA, Atkinson MS, et al. 2005. Preventability of pregnancy-related deaths: Results of a state-wide review. Obstetrics & Gynecology 106(6):1228-1234. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=retrieve&db=pubmed&list_uids=16319245&dopt=Abstract
Should all Indian Health facilities offer Level II US to pre-gestational pregnant diabetics
Or should the need for targeted ultrasounds just be done on those with elevated HbA1c?
CONCLUSIONS: No cases of congenital heart disease were observed in patients with a normal initial HbA1c value. Among patients with abnormal HbA1c values, no critical level of glycohemoglobin was identified that provided optimal predictive power for congenital heart disease screening. We recommend detailed fetal echocardiographic imaging in all patients with initial HbA1c levels above the upper limit of normal of 6.1%.
Shields LE et al The prognostic value of hemoglobin A1c in predicting fetal heart disease in diabetic pregnancies. Obstet Gynecol. 1993 Jun;81(6):954-7.
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=8497362&query_hl=23
Other thoughts
Ultrasound examination — Ultrasound examination at approximately 18 weeks of gestation is a routine procedure in pregnancies complicated by pregestational diabetes because of the higher probability of congenital anomalies and need to establish accurate dates to facilitate the timing of induced labor, if required. This examination confirms or is used to revise the estimated date of confinement and screens for structural anomalies. Early fetal growth delay was thought to be predictive of the development of congenital anomalies and low birth weight; however, this observation has been refuted by subsequent analyses.
The ultrasound examination should include a fetal survey with a four-chamber view of the heart and visualization of the outflow tracts. Detailed fetal echocardiographic examination is important because congenital heart disease occurs more frequently in the offspring of diabetic women than in the general population. Conotruncal and ventricular septal defects are the most common cardiac defects found in these fetuses.
The utility of sonographic examination is illustrated by the following large studies:
- In one series of 432 pregestational diabetic gravidas evaluated at 12 to 23 weeks of gestation, the prevalence of major congenital abnormalities at delivery was 7 percent . Sonographic identification of major birth defects before 24 weeks had sensitivity, specificity, and positive and negative predictive values of 56, 99.5, 90, and 97 percent, respectively. The lesions most commonly missed were ventricular septal defect, an abnormal hand or foot, unilateral renal abnormality, and cleft palate without cleft lip.
- In another report, 289 gravid women with pregestational diabetes underwent comprehensive prenatal diagnostic testing including glycosylated hemoglobin, maternal serum AFP, comprehensive fetal ultrasonography with a standard four-chamber cardiac view at 18 weeks, and detailed multiimage echocardiography at 22 weeks of gestation. Sensitivity, specificity, and positive and negative predictive values for the diagnosis of major noncardiac fetal abnormalities was 59, 100, 100, and 98 percent, respectively. The test performance (sensitivity, specificity, and positive and negative predictive values) of the standard four-chamber view was 33, 100, 100, and 97 percent; the majority of missed cardiac defects were septal and outflow tract lesions. The addition of echocardiography improved the detection of cardiac defects.
See "Prenatal sonographic diagnosis of fetal cardiac anomalies
http://www.uptodateonline.com/application/topic.asp?file=pregcomp/15923&type=A&selectedTitle=20~62
Can Ginger Relieve Nausea and Vomiting in Pregnancy?
Up to 85 percent of women who are pregnant experience nausea, and nearly one half report vomiting. These symptoms (morning sickness) usually resolve by the end of the third month, but symptoms persist in an estimated 20 percent of pregnant women. Two percent report nausea and vomiting throughout pregnancy, and the condition is severe (hyperemesis gravidarum) in 0.3 to 3 percent of these women. Although many medications are available to relieve morning sickness, interventions are limited by concerns about adverse effects on the developing fetus. These concerns have led to interest in alternative remedies. Borrelli and colleagues reviewed the evidence regarding the safety and effectiveness of ginger, one of the most commonly used alternative preparations for morning sickness. The authors conclude that ginger may be a safe and effective treatment for nausea and vomiting for morning sickness, but more studies are needed. Borrelli F, et al. Effectiveness and safety of ginger in the treatment of pregnancy-induced nausea and vomiting. Obstet Gynecol April 2005;105:849-56
Night work is associated with preterm delivery. Standing, lifting, and long hours are not
CONCLUSION: Physically demanding work does not seem to be associated with adverse pregnancy outcomes, whereas working at night during pregnancy may increase the risk of preterm delivery. Studies to examine the effect of shift work on uterine activity would help to clarify the possibility of a causal effect on preterm birth. LEVEL OF EVIDENCE: II-2.
Pompeii LA, et al Physical Exertion at Work and the Risk of Preterm Delivery and Small-for-Gestational- Age Birth Obstet Gynecol. 2005 Dec;106(6):1279-88.
Second Trimester Cervical Changes and Preterm Delivery
Transvaginal ultrasonography of the cervix can assist physicians in determining cervical length and funneling and also may help identify women at high risk of preterm delivery. De Carvalho and colleagues assessed the predictive performance of cervical changes and obstetric history for preterm delivery. The authors conclude that the risk of preterm delivery was 7 percent for women with a second trimester cervical length of 20 mm. The risk increased to 34 percent in patients who also had funneling, and the risk increased to 59 percent in women who also had a history of preterm delivery. Mothers with a cervical length of 20 mm and a history of prematurity had a risk of approximately 18 percent. The authors recommend that physicians consider second trimester cervical length when identifying mothers at risk for preterm delivery, especially in patients with a history of preterm birth. De Carvalho MH, et al. Prediction of preterm delivery in the second trimester. Obstet Gynecol March 2005;105:532-6.
Use of dexamethasone for treatment of HELLP syndrome not supported
STUDY DESIGN: A prospective, double-blind clinical trial CONCLUSION: The results of this investigation do not support the use of dexamethasone for treatment of HELLP syndrome.
Fonseca JE, et al Dexamethasone treatment does not improve the outcome of women with HELLP syndrome: a double-blind, placebo-controlled, randomized clinical trial. Am J Obstet Gynecol. 2005 Nov;193(5):1591-8.
and
Editorial
Therefore, there is definite need for placebo-controlled trials with adequate sample size to answer these questions. Until then, the use of high-dose dexamethasone to improve maternal outcome in women with HELLP syndrome beyond 34 weeks' gestation and/or in the postpartum period remains experimental.
Sibai BM, Barton JR Dexamethasone to improve maternal outcome in women with hemolysis, elevated liver enzymes, and low platelets syndrome. Am J Obstet Gynecol. 2005 Nov; 193(5):1587-90.
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=16260196&query_hl=23
Controversies Related to Gestational Diabetes
Screening artificially increases the prevalence of gestational diabetes but does not conclusively improve outcomes. The authors hope that the HAPO study of 25,000 pregnancies will answer some of the questions about gestational diabetes. In the meantime, making a diagnosis at 24 to 28 weeks of gestation appears to only modestly lower rates of macrosomia but has little clear additional advantage Kelly L, et al. Controversies around gestational diabetes. Practical information for family doctors. Can Fam Physician May 2005;51:688-95.
Both maternal and paternal ethnicity affect preeclampsia rates
http://www.ahrq.gov/research/oct05/1005RA14.htm
Women who smoke have nearly 2 X risk of Graves' hyperthyroidism than nonsmokers
http://www.ahrq.gov/research/oct05/1005RA21.htm
Elective primary cesarean delivery rates show a rising trend
http://www.ahrq.gov/research/oct05/1005RA22.htm
Gynecology
Urinary incontinence: Familial association stronger than that of vaginal delivery
CONCLUSION: Vaginal birth does not seem to be associated with urinary incontinence in postmenopausal women. Considering the high concordance in continence status between sister pairs, and considering that the majority of parous women are continent, an underlying familial predisposition toward the development of urinary incontinence may be present. LEVEL OF EVIDENCE: II-2.
Buchsbaum GM, et al Urinary incontinence in nulliparous women and their parous sisters. Obstet Gynecol. 2005 Dec;106(6):1253-8.
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=retrieve&db=pubmed&list_uids=16319249&dopt=Abstract
Handle abnormal Pap smears differently in adolescents
Despite the high incidence of HPV infection in women less than 21 years of age, only a fraction of HPV positive adolescents develop cytologic abnormalities. Most infections are transient, e. g., 8 – 18 months. Use ablative techniques sparingly in adolescents. Here are some helpful resources for ACOG and ASCCP.
“Adolescents with ASC who are HPV positive or with LSIL results may be monitored with repeat cytology tests at 6 and 12 months or a single HPV test at 12 months, with colposcopy for a cytology result of ASC or higher-grade abnormality or a positive HPV test result.”
Other exceptions for adolescents
When the results of cervical cytology are reported as atypical squamous cells, how should the patient be treated?
"....The exception to this recommendation for HPV follow-up is the adolescent, for whom the risk of invasive cancer approaches zero and the likelihood of HPV clearance is very high. As an alternative to immediate colposcopy, adolescents with ASC HPV-positive test results may be monitored with cytology tests at 6 and 12 months or with a single HPV test at 12 months, with colposcopy for any abnormal cytology result or positive HPV test result. The recommendation and the rationale are similar for follow-up of LSIL in adolescents...."
When the results of cervical cytology are reported as LSIL or atypical squamous cells cannot exclude HSIL (ASC-H), how should the patient be treated?
".. The risk of CIN 2/3+ at initial colposcopy following an LSIL result is between 15% and 30% in most studies. This level of risk of CIN 2/3+ is similar to results of initial colposcopy associated with an ASC HPV-positive cytology result in other studies (17.8% versus 17.9%) (4, 67). Therefore, colposcopy is recommended for evaluation of LSIL. For adolescents with LSIL results, it may be reasonable to follow up without immediate colposcopy. Low-grade squamous intraepithelial lesions are very common in sexually active adolescents because of the recent onset of sexual activity in this group, but clearance of HPV is high and cancer rates are extremely low. Therefore, follow-up recommendations are similar to those for adolescents with ASC HPV-positive results...."
“When the initial evaluation of an HSIL cytology result is a diagnosis of CIN 1 or less, how should the patient be treated?
Interpretations of HSIL and CIN 2 or CIN 3 are poorly reproducible (6, 78, 89, 90). One study reported that less than half of HSIL results and 77% of CIN 2 or CIN 3 results were confirmed on quality control review. As a consequence, experts have recommended review of the cytology and histology results in cases with HSIL diagnoses and discrepancies in colposcopic results, although this approach has not been tested in clinical studies. If review is not undertaken or colposcopy results are not satisfactory, excision is recommended. This approach is favored because (as discussed previously) a single colposcopy can miss CIN 2 or CIN 3, particularly small lesions, and because reports have documented CIN 2/3+ when examining excision specimens in up to 35% of women with HSIL cytology results and either negative or noncorrelating (CIN 1) colposcopy results.
Adolescents are exceptions to this recommendation because interobserver variability is most pronounced in younger women, the risk of invasive cancer is extremely low, and the likelihood of spontaneous resolution of CIN 1 or CIN 2 is high. Therefore, follow-up with colposcopy and cytology tests at 4–6 months may be undertaken, as long as the colposcopy results are adequate and the endocervical curettage is negative….”
“How should CIN 2 and CIN 3 be managed?
In contrast to CIN 1, CIN 2 and CIN 3 are recognized potential cancer precursors, although CIN 2 is associated with significant spontaneous regression. Evidence from ALTS suggests that approximately 40% of CIN 2 cases regressed over 2 years, whereas regression of CIN 3, if present, was too rare to measure accurately during the study. Reports of significant regression of CIN 3 generally are based on cytology and not histology or are associated with multiple follow-up biopsies, which influence the natural history of the disease. Even when histology is assessed, only 77% of CIN 2 and CIN 3 diagnoses were verified on quality control review in ALTS, making assertions about regression more difficult to interpret in studies without rigorous pathology review (6). In addition, histologic differentiation between CIN 2 and CIN 3 is not sufficiently reliable to permit clear stratification of risk. As a consequence, immediate treatment of CIN 2 and CIN 3 with excision or ablation in the nonpregnant patient is recommended. The only exception to this recommendation is that follow-up similar to CIN 1 may be considered in the adolescent with CIN 2, whose likelihood of spontaneous clearance is substantial and whose risk of cancer approaches zero. Therefore, care of the adolescent with CIN 2 may be individualized…”
Management of abnormal cervical cytology and histology. ACOG Practice Bulletin No. 66. American College of Obstetricians and Gynecologists. Obstet Gynecol 2005;106:645–64.
Another good resource
ASCCP Consensus Guidelines http://www.asccp.org/pdfs/consensus/algorithms.pdf
Simplifying the Diagnosis of Bacterial Vaginosis
The Gram stain is a common method for diagnosing bacterial vaginosis. However, Gram stain results are not routinely available right away, and treatment cannot be initiated at the time of the office visit. The Amstel criteria are used to quickly diagnose bacterial vaginosis. These criteria require at least three findings (thin homogenous vaginal discharge, a vaginal pH greater than 4.5, a positive "whiff" test, or a saline wet preparation that microscopically shows clue cells). Gutman and colleagues examined whether further simplifying the diagnosis by using fewer criteria would be as effective as using three criteria. The authors conclude that using any two of the four clinical findings is equivalent to the current recommendation of using at least three. They recommend that physicians initially perform a pH test, followed by any of the other tests. If the pH is 4.5 or greater and one other test is positive, the patient can be diagnosed with bacterial vaginosis and treated accordingly. Gutman RE, et al. Evaluation of clinical methods for diagnosing bacterial vaginosis. Obstet Gynecol March 2005;105:551-6.
Certain factors predict chronic pelvic pain after pelvic inflammatory disease
http://www.ahrq.gov/research/sep05/0905RA22.htm
Uterine artery embolization: Low complication rate, reduced length stay
CONCLUSION: UAE is a procedure similar to hysterectomy with a low major complication rate and with a reduced length of hospital stay. Higher readmission rates after UAE stress the need for careful postprocedural follow-up.
Hehenkamp WJ, et al Uterine artery embolization versus hysterectomy in the treatment of symptomatic uterine fibroids (EMMY trial): peri- and postprocedural results from a randomized controlled trial. Am J Obstet Gynecol. 2005 Nov;193(5):1618-29.
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=16260201&query_hl=12
Child Health
Two RCTs show promising results with hypothermia for neonatal encephalopathy
Hypoxic ischemic encephalopathy is a rare condition associated with high neonatal mortality and morbidity. Two randomized clinical trials have recently been published showing potentially promising results with hypothermia for neonatal encephalopathy. Additional clinical trials are underway to test cooling as a therapeutic modality for hypoxic ischemic encephalopathy. Outcome information about infants treated with hypothermia is available for children up to approximately 2 years of age. Longer-term outcome (ie, school age information) is currently lacking with respect to benefit and risk. Therapeutic hypothermia offers a potentially promising therapy for hypoxic ischemic encephalopathy. Hypothermia for encephalopathy should be considered an evolving therapy because of lack of long-term safety and efficacy data.
Higgins RD Hypoxic ischemic encephalopathy and hypothermia: a critical look. Obstet Gynecol. 2005 Dec;106(6):1385-7.
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=retrieve&db=pubmed&list_uids=16319267&dopt=Abstract
Guidelines for Identifying and Referring Persons with Fetal Alcohol Syndrome
This report summarizes the diagnostic guidelines drafted by the scientific working group, provides recommendations for when and how to refer a person suspected of having problems related to prenatal alcohol exposure, and assesses existing practices for creating supportive environments that might prevent long-term adverse consequences associated with FAS. The guidelines were created on the basis of a review of scientific evidence, clinical expertise, and the experiences of families affected by FAS regarding the physical and neuropsychologic features of FAS and the medical, educational, and social services needed by persons with FAS and their families. The guidelines are intended to facilitate early identification of persons affected by prenatal exposure to alcohol so they and their families can receive services that enable them to achieve healthy lives and reach their full potential. This report also includes recommendations to enhance identification of and intervention for women at risk for alcohol-exposed pregnancies.
http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5411a1.htm
CNS Abnormalities Associated with FAS http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5411a2.htm
National Conference on Juvenile Issues
January 9–13, 2006 (see pre-conference below*)
Washington, DC
Coordinating Council on Juvenile Justice and Delinquency Prevention
Office of Juvenile Justice and Delinquency Prevention
http://www.juvenilecouncil.gov/2006NationalConference/index.html
*One day Pre-Conference
Monday, January 9, 2006 9 a.m. - 5 p.m. Preconference Training
-Addressing Disproportionate Minority Contact (DMC) and Confinement
-Community Assessment and Planning for Juvenile Justice Programs
-Leadership for Truancy Reduction: Practices, Partnerships, and Policies
-Addressing the Needs of Juvenile Female Offenders
AAP Report on Assessment of Sexual Abuse in Children
The American Academy of Pediatrics (AAP) has released recommendations for the recognition of possible sexual abuse in children, the need for diagnostic testing for sexually transmitted diseases (STDs) in these children, and determination of the need to inform child protective services. http://www.pediatrics.org/cgi/content/full/116/2/506
Heads Up: Concussion in High School Sports
On behalf of the Centers for Disease Control and Prevention (CDC), it is my pleasure to announce the availability of the final version of the Heads Up: Concussion in High School Sports tool kit. We are grateful for your valuable assistance in the development of these materials and we hope that we can count on you to help us promote the tool kit to athletic staff (coaches, athletic directors and trainers) across the country. You should be receiving a copy of the tool kit in the mail soon.
We encourage your help in promoting the tool kit to your members by:
·Announcing the tool kit's availability through letters, e-mails, your list serve, newsletter, or website announcements;
·Linking your website announcement to CDC's tool kit site; http://www.cdc.gov/ncipc/tbi/Coaches_Tool_Kit.htm
·Announcing the kit's availability at appropriate meetings and conferences; and/or
·Making presentations at meetings.
To facilitate your promotion efforts, we are attaching a package of sample promotional materials, including; a CDC national news release, fact sheet, a newsletter or website article and a flyer that can be tailored to fit your organization's needs.
The Heads Up tool kit can be ordered or downloaded free-of-charge at: http://www.cdc.gov/ncipc/tbi/Coaches_Tool_Kit.htm
We would like to thank you again for your efforts and contributions to this project and we would appreciate your informing us about any promotional activities you undertake in support of our efforts. If you have any questions or comments, please feel free to contact me at janemitchko@cdc.gov
Minority-serving hospitals may be providing lower quality of care to VLBW infants
* The infant mortality rate among all white and black infants (before risk adjustment) was 11%.
* Fifty-seven percent of black infants (vs. 18% of white infants) were treated at minority-serving hospitals.
* For both black and white infants, neonatal mortality was higher at minority-serving hospitals than at other hospitals.
* Black and white infants were at similarly higher odds of mortality at minority-serving hospitals than at other hospitals. Interaction between race, other hospital characteristics, and process-of-care measures was not statistically significant.
This study suggests that minority-serving hospitals may be providing lower quality of care to VLBW [very low birth weight] infants than other hospitals. The study described in the article investigated whether the proportion of minority infants treated by hospitals is associated with neonatal mortality and, if it is, whether the differences are explained by hospital characteristics.
This study points to the importance of hospital characteristics in understanding racial disparities in infant mortality.
They conclude that "interventions to improve quality of care and reduce neonatal mortality at minority-serving hospitals may result in reduced racial disparities in infant mortality in the United States.
Morales LS, Staiger D, Horbar JD, et al. 2005. Mortality among very low-birthweight infants in hospitals serving minority populations. American Journal of Public Health 95(12):2206-2212 http://www.ajph.org/cgi/content/abstract/95/12/2206
Improving the safety of Older Child Passengers
New report assessing the nation's progress in improving the safety of older child passengers
has just been posted. Poster available http://www.nhtsa.dot.gov/people/injury/childps/BoosterSeatProgress/index.htm
AAP Releases Policy on Tetanus, Diphtheria, Acellular Pertussis (Tdap) Vaccine
To protect adolescents against pertussis and reduce the reservoir of pertussis within the population at large, the American Academy of Pediatrics (AAP) is releasing a new policy recommending adolescents, 11-18 years of age (preferably at the 11-to12-year visit) receive the newly licensed tetanus toxoid, diphtheria toxoid, and acellular pertussis (Tdap) vaccine. This policy also contains extensive information on special circumstances surrounding the use of the Tdap vaccine.
The Academy has prepared a number of resources to help pediatricians implement the new recommendations. The resources can be found on the AAP Member Center and include:
AAP policy on Tdap
AAP News article on the topic
Tdap Vaccine Implementation Information for 2005
Vaccine Reminder Recall Systems: A Practical Guide for Pediatric Practices
The AAP posts continually updated information on the licensure and recommendation status for new vaccines on Red Book Online at http://aapredbook.aappublications.org/news/vaccstatus.shtml
Youth Suicide: Two factors predict risk in youth emergency psychiatric hospitalization
http://www.ahrq.gov/research/oct05/1005RA19.htm
Chronic Disease and Illness
Quick Assessment of Literacy in Primary Care: The Newest Vital Sign
RESULTS The Newest Vital Sign (NVS), is a nutrition label that is accompanied by 6 questions and requires 3 minutes for administration. It is reliable (Cronbach 
>0.76 in English and 0.69 in Spanish) and correlates with the TOFHLA. Area under the ROC curve is 0.88 for English and 0.72 for Spanish versions. Patients with more than 4 correct responses are unlikely to have low literacy, whereas fewer than 4 correct answers indicate the possibility of limited literacy.
CONCLUSION The Quick Assessment of Literacy in Primary Care, the newest vital sign, is suitable for use as a quick screening test for limited literacy in primary health care settings.
Barry D. Weiss, et al Quick Assessment of Literacy in Primary Care: The Newest Vital Sign Annals of Family Medicine 3:514-522 (2005)
http://www.annfammed.org/cgi/content/full/3/6/514
Stroke preventive treatments are well understood and widely available: Why isn’t it used?
Cerebrovascular disease is the third leading cause of mortality and the leading cause of long-term neurological disability in the United States. Most strokes are of ischemic origin and, other than cardioembolic or small vessel strokes, are caused by the development of platelet-fibrin thrombi on an atherosclerotic plaque. This underlying disease mechanism shares important features with coronary artery disease and peripheral artery disease, highlighting the systemic nature of atherothrombosis and the elevated cross risk in stroke patients for ischemic events in other vascular beds. It has been estimated that up to 80% of ischemic strokes could be prevented with application of currently available treatments for blood pressure, cholesterol, and antithrombotic therapies. Stroke is not, like cancer, waiting for a scientific breakthrough; stroke preventive treatments are well understood and widely available. It is only the application of these treatments to patients, many of whom do not visit physicians, that is lacking. Clearly, better education of the public and active participation of primary care physicians is essential to get the message out to all those at risk. Kirshner HS, et al Long-term therapy to prevent stroke. J Am Board Fam Pract. 2005 Nov-Dec;18(6):528-40.
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=retrieve&db=pubmed&list_uids=16322415&dopt=Abstract
USPHS Releases Updated Guidelines for Management of Occupational Exposure to HIV
The U.S. Public Health Service (USPHS) has issued updated guidelines for prophylaxis of health care professionals with occupational exposure to blood and other body fluids that might contain human immunodeficiency virus (HIV). The recommendations, "Updated U.S. Public Health Service Guidelines for the Management of Occupational Exposures to HIV and Recommendations for Postexposure Prophylaxis," were published in the Sept. 30, 2005, issue of Morbidity and Mortality Weekly Report Recommendations and Reports and are available online at http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5409a1.htm
Moderate Exercise Improves Breast Cancer Outcomes
Physical activity appears to be associated with a lower risk of developing breast cancer and an improved quality of life after breast cancer diagnosis. The mechanism may be hormonal, with lower levels of circulating ovarian hormones present in women who exercise. Holmes and colleagues examined the relationship between physical activity and recurrence and mortality outcomes after breast cancer diagnosis.
The authors conclude that women have improved survival by any measured outcome if they exercise more than 3.0 MET hours per week. Because the finding applied particularly to women with receptor-positive tumors in this study, the authors speculate that hormonal alterations are responsible for this benefit. Walking at an average pace for three to five hours per week is associated with the maximal benefit. Holmes MD, et al. Physical activity and survival after breast cancer diagnosis. JAMA May 25, 2005;293:2479-86.
Management of Active Tuberculosis
Although the overall incidence of tuberculosis has been declining in the United States, it remains an important public health concern, particularly among immigrants, homeless persons, and persons infected with human immunodeficiency virus. Patients who present with symptoms of active tuberculosis (e.g., cough, weight loss, or malaise with known exposure to the disease) should be evaluated. Three induced sputum samples for acid-fast bacillus smear and culture should be obtained from patients with findings of tuberculosis or suspicion for active disease. If the patient has manifestations of extrapulmonary tuberculosis, smears and cultures should be obtained from these sites. Most patients with active tuberculosis should be treated initially with isoniazid, rifampin, pyrazinamide, and ethambutol for eight weeks, followed by 18 weeks of treatment with isoniazid and rifampin if needed. Repeat cultures should be performed after the initial eight-week treatment. Am Fam Physician 2005;72:2225-32, 2235.
http://www.aafp.org/afp/20051201/2225.html
Acetaminophen-related liver failure rising sharply in US
In conclusion, acetaminophen hepatotoxicity far exceeds other causes of acute liver failure in the United States. Susceptible patients have concomitant depression, chronic pain, alcohol or narcotic use, and/or take several preparations simultaneously. Education of patients, physicians, and pharmacies to limit high-risk use settings is recommended.
Larson AM, et al Acetaminophen-induced acute liver failure: results of a United States multicenter, prospective study. Hepatology. 2005 Dec;42(6):1364-72.
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=16317692&query_hl=6
St. John's Wort
St. John's wort has been used to treat a variety of conditions. Several brands are standardized for content of hypericin and hyperforin, which are among the most researched active components of St. John's wort. St. John's wort has been found to be superior to placebo and equivalent to standard antidepressants for the treatment of mild to moderate depression. Studies of St. John's wort for the treatment of major depression have had conflicting results. St. John's wort is generally well tolerated, although it may potentially reduce the effectiveness of several pharmaceutical drugs. Am Fam Physician 2005;72:2249-54.
http://www.aafp.org/afp/20051201/2249.html
Management of Staphylococcus aureus Infections
Because of high incidence, morbidity, and antimicrobial resistance, Staphylococcus aureus infections are a growing concern for family physicians. Strains of S. aureus that are resistant to vancomycin are now recognized. Increasing incidence of unrecognized community-acquired methicillin-resistant S. aureus infections pose a high risk for morbidity and mortality. Although the incidence of complex S. aureus infections is rising, new antimicrobial agents, including daptomycin and linezolid, are available as treatment. S. aureus is a common pathogen in skin, soft-tissue, catheter-related, bone, joint, pulmonary, and central nervous system infections. S. aureus bacteremias are particularly problematic because of the high incidence of associated complicated infections, including infective endocarditis. Adherence to precautions recommended by the Centers for Disease Control and Prevention, especially handwashing, is suboptimal. (Am Fam Physician 2005;72:2474-81. http://www.aafp.org/afp/20051215/2474.html
Treatment of Irritable Bowel Syndrome
Irritable bowel syndrome affects 10 to 15 percent of the U.S. population to some degree. This condition is defined as abdominal pain and discomfort with altered bowel habits in the absence of any other mechanical, inflammatory, or biochemical explanation for these symptoms. Irritable bowel syndrome is more likely to affect women than men and is most common in patients 30 to 50 years of age. Symptoms are improved equally by diets supplemented with fiber or hydrolyzed guar gum, but more patients prefer hydrolyzed guar gum. Antispasmodic agents may be used as needed, but anticholinergic and other side effects limit their use in some patients. Loperamide is an option for treatment of moderately severe diarrhea. Antidepressants have been shown to relieve pain and may be effective in low doses. Trials using alosetron showed a clinically significant, although modest, gain over placebo, but it is indicated only for women with severe diarrhea-predominant symptoms or for those in whom conventional treatment has failed. Tegaserod has an advantage over placebo in constipation-predominant irritable bowel syndrome; it is indicated for up to 12 weeks of treatment in women. However, postmarketing reports of severe diarrhea and ischemic colitis further limit its use. Herbal therapies such as peppermint oil also may be effective in the treatment of irritable bowel syndrome. Therapies should focus on specific gastrointestinal dysfunctions (e.g., constipation, diarrhea, pain), and medications only should be used when nonprescription remedies do not work or when symptoms are severe. (Am Fam Physician 2005;72:2501-6. http://www.aafp.org/afp/20051215/2501.html
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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.
