Heather Z. Sankey

Use of an Immunochromatographic Assay for Rapid Detection of Trichomonas vaginalis in Vaginal Specimens

ABSTRACT Trichomonas vaginalis infection is estimated to be the most widely prevalent nonviral sexually transmitted infection in the world. Wet-mount microscopy is the most common diagnostic method, although it is less sensitive than culture. The OSOM Trichomonas Rapid Test (Genzyme Diagnostics, Cambridge, Mass.) (referred to here as OSOM) is a new point-of-care diagnostic assay for T. vaginalis that uses an immunochromatographic capillary flow (dipstick) assay and provides results in 10 min. The purpose of this study was to determine the test characteristics of OSOM compared to those of a composite reference standard (CRS) comprised of wet-mount microscopy and T. vaginalis culture. This multicenter cross-sectional study enrolled sexually active women ≥18 years of age who presented with symptoms of vaginitis, exposure to T. vaginalis, or multiple sexual partners. Vaginal-swab specimens were obtained for T. vaginalis culture, wet mount, and rapid testing. The prevalence of T. vaginalis in this sample was 23.4% (105 of 449) by the CRS. The sensitivity and specificity of OSOM vaginal-swab specimens were 83.3 and 98.8%, respectively, while wet mount had a sensitivity and specificity of 71.4 and 100%, respectively, compared to the CRS. OSOM performed significantly better than wet mount (P = 0.004) and detected T. vaginalis in samples that required 48 to 72 h of incubation prior to becoming culture positive. The performance of the rapid test was not affected by the presence of coinfections with chlamydia and gonorrhea. The OSOM Trichomonas Rapid Test is a simple, objective test that can be expected to improve the diagnosis of T. vaginalis, especially where microscopy and culture are unavailable.

Nicotine Gum for Pregnant Smokers A Randomized Controlled Trial

OBJECTIVE: To estimate the safety and efficacy of treatment with 2-mg nicotine gum for smoking cessation during pregnancy. METHODS: Pregnant women who smoked daily received individualized behavioral counseling and random assignment to a 6-week treatment with 2-mg nicotine gum or placebo followed by a 6-week taper period. Women who did not quit smoking were instructed to reduce the number of cigarettes smoked by substituting with gum. Measures of tobacco exposure were obtained throughout the study. RESULTS: Participants in the nicotine (nequals;100) and placebo (nequals;94) groups were comparable in age, race/ethnicity, and smoking history. Biochemically validated smoking-cessation rates were not significantly higher with nicotine gum compared with placebo (after 6 weeks of treatment: 13% compared with 9.6%, P=.45; at 32–34 weeks of gestation: 18% compared with 14.9%, P=.56). Using a completer analysis, nicotine gum significantly reduced the number of cigarettes smoked per day (nicotine gum: −5.7 [standard deviation (SD)=6.0]; placebo: −3.5 [SD=5.7], P=.035), and cotinine concentration (nicotine gum: −249 ng/mL [SD=397]; placebo: −112 ng/mL [SD=333]; P=.04). Birth weights were significantly greater with nicotine gum compared with placebo (3,287 g [SD=566] and 2,950 g [SD=653], respectively, P<.001). Gestational age was also greater with nicotine-replacement therapy than with placebo (38.9 weeks [SD=1.7] and 38.0 weeks [SD=3.3], respectively; P=.014). CONCLUSION: Although nicotine gum did not increase quit rates, use of nicotine gum increased birth weight and gestational age, two key parameters in predicting neonatal wellbeing. CLINICAL TRIAL REGISTRATION: Clinicaltrials.gov, www.clinicaltrials.gov, NCT00115687 LEVEL OF EVIDENCE: I

Multicenter trial of a simplified mifepristone medical abortion regimen

OBJECTIVE: To provide evidence regarding the safety, efficacy, and acceptability of 200 mg mifepristone followed by home administration of 400 &mgr;g oral misoprostol METHODS: The 376 women enrolled in this prospective, open-label, multicenter trial were administered mifepristone in the clinic and were given 2 tablets of 200 &mgr;g misoprostol to swallow at home 48 hours later. On day 15, women returned to the clinic for a gynecologic examination. Success was defined as a complete termination without surgical intervention or additional misoprostol by day 21. All participants completed an exit interview before discharge from the study RESULTS: Of the women enrolled, 58.8% had gestations of between 43 and 49 days, 54.7% had had a previous abortion, and 76% had had a previous pregnancy. Of the 354 women included in the efficacy analysis, 324 (91.5%) had a successful termination. The most common adverse effects reported by patients were pain or cramps (93.2%) and nausea (66.6%), followed by weakness (54.7%), headache (46.2%), and dizziness (44.4%). Overall acceptability of the regimen was high, with 63.3% of women reporting that it was very satisfactory and an additional 23% reporting that it was satisfactory CONCLUSION: A regimen of 200 mg mifepristone followed in 48 hours by home administration of 400 &mgr;g oral misoprostol is effective, associated with rare severe adverse effects or adverse events, and acceptable for women seeking medical abortion of pregnancies of up to 49 days duration as compared with the regimen currently approved by the Food and Drug Administration. LEVEL OF EVIDENCE: III

Making it work: Successful collaborative practice

There are three major examples of collaborative programs between certified nurse-midwives (CNMs) and obstetrician-gynecologists at Baystate Medical Center in Springfield, Massachusetts, within the Department of Obstetrics and Gynecology. One program is a midwifery practice that serves a diverse population in a hospital-based office, four neighborhood health centers, and a correctional facility. Another program provides a triage function for patients who present to the hospital with obstetric or gynecologic problems. The third program introduces a team approach to the education of residents with a CNM having primary responsibility for teaching normal obstetrics to first-year residents and medical students in collaboration with attending physicians. Keys to success include an understanding of the principles of collaborative practice, the use of a detailed practice agreement between midwives and attending physicians, keeping open lines of communication, understanding and accepting differing philosophies of practice, and, most importantly, maintaining trust across all levels of providers.

Correlates of Electronic Cigarettes Use Before and During Pregnancy

Introduction Electronic cigarette use is rapidly gaining in popularity. However, little is known about correlates and reasons for electronic cigarette use by women of reproductive age, a group for which the safety and efficacy of electronic cigarette use is of particular interest. Methods As part of a clinical trial for smoking cessation, we surveyed pregnant smokers about their lifetime use of electronic cigarettes, previous use of any adjunctive treatments for smoking cessation, and use of electronic cigarettes during pregnancy. We examined associations between electronic cigarette use and participant characteristics. Results Fifty-three percent (55/103) of participants had previously tried electronic cigarettes. Ever users smoked more cigarettes per day before pregnancy (p = .049), had a greater number of previous quit attempts (p = .033), and were more likely to identify as being Hispanic or non-Hispanic white than never users (p = .027). Fifteen percent of participants (15/103) reported previous use of electronic cigarettes for smoking cessation, which was more common than the use of any specific FDA-approved smoking cessation medication. Fourteen percent of participants (14/103) reported electronic cigarette use during pregnancy, most commonly to quit smoking. A history of substance abuse (p = .043) and more previous quit attempts (p = .018) were associated with electronic cigarette use during pregnancy. Conclusions Use of electronic cigarettes to quit smoking may be common in women of reproductive age, including those who are pregnant. More research is needed to determine the risks and benefits of electronic cigarette use in this population of smokers. Implications This study shows that electronic cigarettes are used by women of reproductive age, including pregnant smokers. The implications of this finding are that there is an urgent need to examine the risks and benefits of electronic cigarette use, especially by pregnant women. The study also shows that electronic cigarettes are commonly used as a smoking cessation aid in women of reproductive age. The greater likelihood of electronic cigarette use compared to proven adjunctive smoking treatments suggests that electronic cigarettes should be examined as a potential aid to cessation in this population.

The Obstetrics Team: Midwives Teaching Residents and Medical Students on the Labor and Delivery Unit

In response to the new standards for resident work hours issued in 2003, Baystate Medical Center in Springfield, MA developed a program for midwifery involvement in resident and medical education. The Obstetrics Team consists of a midwife teaching first-year residents in obstetrics/gynecology and emergency medicine and third-year medical students on the labor and delivery unit. This program has successfully addressed the need for resident and medical education as well as service provision created by reduced resident work hours and provides a useful model for other institutions.

Genetic Vulnerability to Menthol Cigarette Preference in Women

BACKGROUND Smokers may prefer menthol cigarettes to mask the bitter taste of nicotine. Variation in the taste receptor gene, TAS2R38, may contribute to preference for menthol cigarettes. AIMS To determine whether two common haplotypes of TAS2R38 (proline-alanine-valine [PAV] and alanine-valine-isoleucine [AVI]), which have been associated, respectively, with bitter taste or a lack of bitter taste produced by propylthiouracil, are associated with preference for menthol cigarettes. METHODS Data on smoking and blood for DNA extraction and genotyping were obtained from 323 pregnant non-Hispanic or Hispanic Caucasian smokers. We genotyped three TAS2R38 single nucleotide polymorphisms (rs713598, rs1726866, and rs10246939) and constructed haplotypes. We examined associations between menthol preference and the frequency and distribution of the AVI and PAV haplotypes among study participants. RESULTS Participants smoked an average of 16 cigarettes per day before pregnancy. The PAV and AVI haplotype frequencies were 48% and 45%, respectively. Non-Hispanic women were less likely than Hispanic women to smoke menthol cigarettes. As hypothesized, the frequency of the PAV haplotype was greater in menthol than non-menthol smokers in both non-Hispanics (54% vs. 30%; χ(2) = 13.04, P < .001) and Hispanics (53% vs. 25%; χ(2) = 5.77, P = .016). This effect persisted after controlling for potential confounders in multivariate logistic regression. Menthol smokers had a greater number of PAV haplotypes/individual than non-menthol smokers [non-Hispanics odds ratio (OR) = 3.02 (1.56-5.85); P = .001; Hispanics OR = 3.60 (1.23-10.56); P = .020]. CONCLUSIONS These preliminary data support the hypothesis that a genetic propensity to experience heightened bitter taste perception increases the preference for menthol cigarettes.

Major depression and PTSD in pregnant smokers enrolled in nicotine gum treatment trial.

BACKGROUND AND OBJECTIVES Pregnant women face considerable barriers to smoking cessation. The purpose of this study was to determine the prevalence of major depressive disorder (MDD) and post-traumatic stress disorder (PTSD) and response to smoking cessation treatment in pregnant smokers participating in a randomized, placebo-controlled trial of nicotine gum. METHODS Participants were 194 low-income, ethnically diverse pregnant smokers. RESULTS Utilizing a structured interview, 45% and 18% of the subjects met criteria for a lifetime diagnosis of MDD and PTSD, respectively. There was no difference in response to treatment, based on the presence of either of these psychiatric disorders. CONCLUSIONS Cumulatively, these findings provide evidence of the high degree of unmet mental health needs in pregnant smokers. SCIENTIFIC SIGNIFICANCE Pregnant women with a history of MDD and PTSD appear to be as likely to benefit from smoking cessation treatment as those without such a history.

Knowledge, Attitudes and Provider Advice by Pre-Pregnancy Weight Status: A Qualitative Study of Pregnant Latinas With Excessive Gestational Weight Gain

Latina women are at high risk of excessive gestational weight gain (GWG) during pregnancy; yet little is known about whether factors related to GWG differ by pre-pregnancy body mass index (BMI) within this population. We conducted in-depth interviews with 62 pregnant Latina women with pre-pregnancy BMIs in the healthy, overweight, and obese ranges, gestational age ≥22 weeks, and GWG for gestational age above Institute of Medicine (IOM) guidelines. Compared to healthy weight and obese women, overweight women least often reported viewing weight as important, making efforts to control their GWG, being aware of the role of diet on GWG, and receiving GWG advice from health-care providers. Among those who received GWG advice, overweight women more often recalled a target GWG above IOM guidelines. Obese women more often reported low acceptance of their GWG, concern about GWG, having received GWG advice from providers, difficulty following providers’ dietary advice, and emotional eating as a challenge for controlling GWG. Participants welcomed practical advice to manage GWG. Future interventions to prevent excessive GWG among Latina women should consider differences among women of varying pre-pregnancy BMIs and include multi-level strategies to address psychosocial as well as provider factors.

The Evolving Role of Midwives as Laborists.

This article examines the history and present state of the midwife as laborist. The role of the midwife and obstetrician laborist/hospitalist is rapidly evolving due to the need to improve patient safety and provide direct care due to reduced resident work hours, as well as practice demands experienced by community providers and other factors. Models under development are customized to meet the needs of different communities and hospitals. Midwives are playing a prominent role in many laborist/hospitalist practices as the first-line hospital provider or as part of a team with physicians. Some models incorporate certified nurse-midwives/certified midwives as faculty to residents and medical students. The midwifery laborist/hospitalist practices at Baystate Medical Center in Springfield, Massachusetts, are presented as an example of how midwives are functioning as laborists. Essential components of a successful midwife laborist program include interdisciplinary planning, delineation of problems the model should solve, establishment of program metrics, clear practice guidelines and role definitions, and a plan for sustained funding. This article is part of a special series of articles that address midwifery innovations in clinical practice, education, interprofessional collaboration, health policy, and global health.