Uterine fibroids and longitudinal profiles of the vaginal microbiota in a cohort presenting for transvaginal ultrasound.

Bacterial vaginosis, characterized in part by low levels of vaginal Lactobacillus species, has been associated with pro-inflammatory cytokines which could fuel uterine fibroid development. However, prior work on the associations between uterine fibroids and vaginal bacteria is sparse. Most studies have focused on assessment of individual taxa in a single sample. To address research gaps, we sought to compare short, longitudinal profiles of the vaginal microbiota in uterine fibroid cases versus controls with assessment for hormonal contraceptives (HCs), a possible confounder associated with both protection from fibroid development and increases in Lactobacillus-dominated vaginal microbiota. This is a secondary analysis of 83 reproductive-age cisgender women who presented for transvaginal ultrasound (TVUS) and self-collected mid-vaginal swabs daily for 1-2 weeks before TVUS (Range: 5-16 days, n = 697 samples). Sonography reports detailed uterine fibroid characteristics (N = 21 cases). Vaginal microbiota was assessed by 16S rRNA gene amplicon sequencing and longitudinal microbiota profiles were categorized by hierarchical clustering. We compared longitudinal profiles of the vaginal microbiota among fibroid cases and controls with exact logistic regression. Common indications for TVUS included pelvic mass (34%) and pelvic pain (39%). Fibroid cases tended to be older and report Black race. Cases less often reported HCs versus controls (32% vs. 58%). A larger proportion of cases had low-Lactobacillus longitudinal profiles (48%) than controls (34%). In unadjusted analysis, L. iners-dominated and low-Lactobacillus profiles had higher odds of fibroid case status compared to other Lactobacillus-dominated profiles, however these results were not statistically significant. No association between vaginal microbiota and fibroids was observed after adjusting for race, HC and menstruation. Results were consistent when number of fibroids were considered. There was not a statistically significant association between longitudinal profiles of vaginal microbiota and uterine fibroids after adjustment for common confounders; however, the study was limited by small sample size.

Comparison of Computer-Assisted Self-Interview Versus Clinician Interview for Self-Reported Vulvovaginal Symptoms.

ABSTRACT: This secondary analysis (N = 43) compared computer-assisted self-interview (CASI) to clinician interview for self-report of 8 vulvovaginal symptoms. Concordance was moderate between interview modes (range, 70-86%) with itching and odor having highest agreement. Although prior reports suggest more responses on CASI, we found CASI did not significantly increase self-report of symptoms over clinician interview.

Patient Perceptions of Three Substance Use Screening Tools for Use During Pregnancy.

OBJECTIVES: The purpose of this study was to understand pregnant women's perceptions of three validated substance use screening tools and identify a preferred tool for use during pregnancy. The three screening tools studied included the 4P's Plus, the NIDA Quick Screen/ NIDA-Modified Alcohol, Smoking and Substance Involvement Screening Test, and the Substance Use Risk Profile-Pregnancy Scale. METHODS: A total of 493 cognitive interviews were completed with a diverse sample of pregnant women presenting to two obstetrics practices in Baltimore, MD from January 2017 to January 2018. This study served as a qualitative companion to a larger study comparing the accuracy and acceptability of substance use screening tools in prenatal care. After completing each screening tool, participants were asked their perceptions of the tool and to choose their preferred tool. Interviews were recorded, transcribed verbatim, coded, and analyzed using NVivo software. RESULTS: The plurality of participants (43.4%) reported they preferred the 4P's Plus. Fewer participants preferred the NIDA Quick Screen (32.5%) and the SURP-P (24.1%). Participants felt that the 4P's Plus was both comprehensive and concise. While many participants felt that disclosure of substance use would vary by individual, participants also suggested that when screening is confidential, includes questions about a patient's background, and administered by a non-judgmental provider, pregnant people may be more likely to answer honestly. CONCLUSIONS FOR PRACTICE: The 4P's Plus is a promising and acceptable substance use screening tool for use in prenatal care. Clinicians can use several methods to increase acceptability of substance use screening and encourage disclosure of prenatal substance use.

Bacterial vaginosis diagnosis and treatment in postmenopausal women: a survey of clinician practices.

OBJECTIVE: Some diagnostic features of the genitourinary syndrome of menopause (GSM) and bacterial vaginosis (BV) overlap, such as low levels of vaginal Lactobacillus and pH > 5. We sought to determine clinicians' diagnostic and treatment practices for postmenopausal women presenting with BV and GSM scenarios and how commercial molecular screening tests are utilized. METHODS: Anonymous surveys were sent to practicing women's health clinicians to evaluate assessment and treatment strategies for postmenopausal women presenting with BV and GSM scenarios. RESULTS: When given a scenario of a postmenopausal woman with symptoms overtly positive for BV, a majority of providers (73%) would conduct a wet mount, though only 35% would evaluate full Amsel's criteria. A majority (89%) recommended treatment with antibiotics, 28.2% recommended vaginal estrogen in addition to antibiotics, and 11.8% recommended vaginal estrogen alone. Of providers who would use a molecular swab, 30% would wait for results before treating the patient's symptoms. When given a scenario of a postmenopausal woman presenting with GSM, a majority (80%) recommended vaginal estrogen, and only 4.6% recommended antibiotics. Few (16%) responders would evaluate with a molecular swab, half of whom would wait for results before prescribing treatment. Clinicians in practice for less than 10 years were more likely to rely on molecular swabs than those who had been practicing longer (P < 0.0003). CONCLUSIONS: Methods used to evaluate postmenopausal women with vaginal symptoms vary. Future studies of postmenopausal women that differentiate diagnostic criteria between BV and GSM, and validate commercial molecular testing for BV in women over age 50 are needed.

Prenatal Practice Staff Perceptions of Three Substance Use Screening Tools for Pregnant Women.

OBJECTIVE: There is a need to identify an acceptable and comprehensive substance use screening tool for pregnant women in the United States. This qualitative study sought to better understand prenatal practice staff perceptions of three existing substance use screening tools for use among pregnant women in an outpatient practice setting. METHODS: Eight focus groups with 40 total participants were conducted with clinical and administrative staff of 2 diverse Maryland prenatal practices to determine the acceptability and usability of 3 substance use screening tools (4P's Plus, NIDA-Modified Alcohol, Smoking and Substance Involvement Screening Test, and the Substance Use Risk Profile-Pregnancy scale). The focus groups were digitally recorded, transcribed, coded, and analyzed using thematic analysis. RESULTS: Participant perceptions of screening tools were dependent upon screening tool length, tone, comprehensiveness, subjectivity, time frame of questions, and scoring and clinician instructions. Most participants preferred the 4P's Plus screening tool because it is brief, comprehensive, easy for the patient to understand, and excludes judgmental language and subjective questions. CONCLUSIONS: These results provide valuable insight into the specific needs and preferences of prenatal practice staff as it relates to prenatal substance use screening and provides evidence that the 4P's Plus may be a preferred screening tool for standardized use in prenatal care.

Nonoptimal Vaginal Microbiota After Azithromycin Treatment for Chlamydia trachomatis Infection.

We characterized the composition and structure of the vaginal microbiota in a cohort of 149 women with genital Chlamydia trachomatis infection at baseline who were followed quarterly for 9 months after antibiotic treatment. At time of diagnosis, the vaginal microbiota was dominated by Lactobacillus iners or a diverse array of bacterial vaginosis-associated bacteria including Gardnerella vaginalis. Interestingly, L. iners-dominated communities were most common after azithromycin treatment (1 g monodose), consistent with the observed relative resistance of L. iners to azithromycin. Lactobacillus iners-dominated communities have been associated with increased risk of C. trachomatis infection, suggesting that the impact of antibiotic treatment on the vaginal microbiota could favor reinfections. These results provide support for the dual need to account for the potential perturbing effect(s) of antibiotic treatment on the vaginal microbiota, and to develop strategies to protect and restore optimal vaginal microbiota.

Chlamydia in adolescent/adult reproductive management trial study (CHARM): Clinical core protocol.

INTRODUCTION: Chlamydia trachomatis (CT) is a common sexually transmitted pathogen with significant reproductive health implications. Data are mounting that the bacterial communities that reside within the vagina, collectively termed the vaginal microbiota, aid in defense against sexually transmitted infections. Disruptions in the vaginal microbiota, such as during episodes of bacterial vaginosis, may increase susceptibility to infection. Herein, we describe the clinical core protocol for a NIH NIAID Cooperative Research Center titled Eco-Pathogenomic of Chlamydial Reproductive Tract Infection. The primary goals of the project are to describe the interrelationships between the urogenital microenvironment, the properties of the pathogen and immunologic responses of the host in men and women, and their association with clinical outcomes of CT infection in women. METHODS: Men and women with confirmed genital CT infections were recruited to a number of study protocols, including cross-sectional and longitudinal sub-studies. Participants completed a demographic and sexual health questionnaire and underwent a physical exam at baseline. In the longitudinal study arms, biologic samples were collected daily, weekly, and monthly to determine the relationships between the vaginal microbiota, prevalent CT infection, re-infection and treatment. DISCUSSION: The biological samples and the demographic and history information collected throughout this study will be used for various analyses evaluating genomics, metabolomics and host immune responses in the context of CT infection.

The Vaginal Microbiota and Behavioral Factors Associated With Genital Candida albicans Detection in Reproductive-Age Women.

BACKGROUND: Vulvovaginal candidiasis is commonly diagnosed and has been associated in prospective studies with the acquisition of HIV. Little data is available on how the composition of the vaginal microbiota, and other risk factors, are associated with the molecular detection of Candida albicans-a common cause of vulvovaginal candidiasis. METHODS: In a cross-sectional study, self-collected vaginal swabs were obtained from 394 nonpregnant, reproductive-age women. C. albicans was detected using polymerase chain reaction targeting C. albicans ITS1/2 region. Vaginal microbiota was characterized by 16S rRNA gene amplicon sequencing of the V3 to V4 hypervariable regions and clustered into community state types (CSTs). Multiple logistic regression identified factors associated with C. albicans detection. RESULTS: Twenty-one percent had C. albicans detected and 46% reported vaginal symptoms in the prior 60 days. There was a 2-fold increase in the odds of C. albicans if a woman was in a L. crispatus-dominated CST compared to CSTs with low-Lactobacillus levels (adjusted odds ratio, 2.05; 95% confidence interval, 0.97-4.37). History of self-treatment with antifungals, L. crispatus relative abundance, and receptive oral sex were also significantly associated with C. albicans detection. CONCLUSIONS: A L. crispatus-dominated vaginal microbiota is thought to protect women from both development of bacterial vaginosis and incidence of sexually transmitted infections; however, our data suggest that L. crispatus is associated with increased C. albicans detection. Receptive oral sex may also be a risk factor for vaginal C. albicans colonization.

The Cervicovaginal Microbiota-Host Interaction Modulates Chlamydia trachomatis Infection.

The mechanism(s) by which Lactobacillus-dominated cervicovaginal microbiota provide a barrier to Chlamydia trachomatis infection remain(s) unknown. Here we evaluate the impact of different Lactobacillus spp. identified via culture-independent metataxonomic analysis of C. trachomatis-infected women on C. trachomatis infection in a three-dimensional (3D) cervical epithelium model. Lactobacillus spp. that specifically produce d(-) lactic acid were associated with long-term protection against C. trachomatis infection, consistent with reduced protection associated with Lactobacillus iners, which does not produce this isoform, and with decreased epithelial cell proliferation, consistent with the observed prolonged protective effect. Transcriptomic analysis revealed that epigenetic modifications involving histone deacetylase-controlled pathways are integral to the cross talk between host and microbiota. These results highlight a fundamental mechanism whereby the cervicovaginal microbiota modulates host functions to protect against C. trachomatis infection.IMPORTANCE The vaginal microbiota is believed to protect women against Chlamydia trachomatis, the etiologic agent of the most prevalent sexually transmitted infection (STI) in developed countries. The mechanism underlying this protection has remained elusive. Here, we reveal the comprehensive strategy by which the cervicovaginal microbiota modulates host functions to protect against chlamydial infection, thereby providing a novel conceptual mechanistic understanding. Major implications of this work are that (i) the impact of the vaginal microbiota on the epithelium should be considered in future studies of chlamydial infection and other STIs and (ii) a fundamental understanding of the cervicovaginal microbiota's role in protection against STIs may enable the development of novel microbiome-based therapeutic strategies to protect women from infection and improve vaginal and cervical health.

Patterns in On-time, Daily Submission of a Short Web-Based Personal Behavior Survey in a Longitudinal Women's Health Study.

We evaluated compliance with submitting a short Web-based personal behavior survey daily during a 10-week study (n = 52 women/3419 diaries). Time-stamped forms revealed that 50% of diaries were submitted within 24 hours of the email prompt, and 19% were missing or submitted more than 3 days late. Late submissions may affect data quality.

A Pilot Randomized Controlled Trial of a Phone-based Intervention for Smoking Cessation and Relapse Prevention in the Postpartum Period.

OBJECTIVES: To pilot-test a Phone-based Postpartum Continuing Care (PPCC) protocol developed from existing evidence-based approaches to address both postpartum smoking relapse among low-income women who quit smoking during pregnancy and postpartum smoking increase among those who had cut down. METHODS: One hundred thirty low-income pregnant women who were current or recently quit tobacco smokers were recruited at their first prenatal appointment and randomized to either a Control (standard care) or Experimental (standard care + PPCC) group. An intent-to-treat analysis was conducted on biochemically verified data from 6 in-person interviews during pregnancy and postpartum. Feasibility with regard to recruitment, randomization, assessment, and implementation of PPCC were assessed, along with acceptability among the target population. RESULTS: PPCC was found to be feasible and acceptable to some participants, but not all. There were no significant differences in tobacco products per day at 6 months postpartum between groups; however, effect sizes differed at 6 weeks compared with 6 months postpartum. Similarly, there were no significant differences between groups in cessation rate (24% in each group) and past 90-day tobacco use (59 vs 55 days, for Control and Experimental groups, respectively). CONCLUSIONS: The PPCC intervention did not differentially reduce tobacco use postpartum compared with a controlled comparison group, though it was found to be acceptable among a subpopulation of low-income pregnant women and feasible with regard to recruitment, randomization, assessment procedures, and implementation. Further research is needed to identify an intervention that significantly improves smoking relapse rates postpartum.

Risk of complication during surgical abortion in obese women.

BACKGROUND: Surgical abortion is a generally safe procedure. Obesity is a known risk factor for complications in other surgical procedures, but insufficient information exists to determine the effects of increasing body mass index on the risk of surgical abortions. OBJECTIVE: The purpose of this study was to determine whether obesity is a risk factor for major complications in surgical abortions. METHODS: A quality control database from a single outpatient center was analyzed to determine rates of major complications during surgical abortions in relation to obesity class. Complications included hemorrhage, need for repeat evacuation, uterine perforation, cervical laceration, medication reaction, unexpected surgery, or unplanned admission to the hospital. Chi-squared and analysis of variance were used for analysis. RESULTS: We included 2468 procedures: 1475 procedures (59.8%) in the first trimester and 993 procedures (40.2%) in the second trimester. The overall complications rate was 2.2%. Second-trimester procedures were more likely than those in the first trimester to have complications (3.1% vs 1.6%; P=.009). Overall, 39.6% of the women were obese, and 9.6% of them met criteria for class 3 obesity (body mass index, >40 kg/m2). Women who underwent second-trimester abortions with class 3 obesity had a rate of complication of 8.7%, which was significantly more than normal weight women (odds ratio, 5.90; 95% confidence interval, 1.93-8.07; P<.001). COMMENT: Surgical abortions are overall safe procedures, but class 3 obesity increases the rate of complication in second-trimester procedures.

Primary Placement of Incisional Negative Pressure Wound Therapy at Time of Laparotomy for Gynecologic Malignancies.

OBJECTIVE: Wound complications are an important cause of postoperative morbidity amongst patient with gynecologic malignancies. We evaluated whether the placement of prophylactic negative pressure wound therapy (NPWT) at the time of laparotomy for gynecologic cancer surgery reduces wound complication rates. METHODS: A retrospective analysis of patients undergoing laparotomy with primary wound closure performed by a gynecologic oncologist at a single academic institution over a 5-year study period was performed. Patients who had placement of prophylactic NPWT dressing were compared with patients with a standard closure. Postoperative outcomes were examined. RESULTS: A total of 230 patients were identified: 208 women received standard wound care, 22 received NPWT. Groups were similar in age, prevalence of diabetes, tobacco use, and number of previous abdominal procedures. Intraoperative factors including length of procedure and transfusion requirements were similar. Body mass index for patients receiving standard treatment was 30.67 compared with 41.29 for NPWT group (P < 0.001). Incidence of all wound complications was 19.7% for those receiving standard treatment versus 27.3% for NPWT group (P = 0.40). Length of hospital stay was similar between the 2 groups (5.25 vs 6.22 days, P = 0.20). There were 3 hospital readmissions for wound complications-none occurred in women with a prophylactic NPWT dressing. CONCLUSIONS: Despite significantly higher obesity rates, patients with prophylactic NPWT dressing placement had similar rates of wound complications. Our findings suggest a potential therapeutic benefit in the use of prophylactic NPWT for the reduction of wound complications in this high-risk gynecologic oncology patient population.

Knowledge, Attitudes, and Practice of Electronic Cigarette Use Among Pregnant Women.

OBJECTIVE: Electronic cigarettes (e-cigarettes) are a relatively recent phenomenon, serving dual roles as an alternative vehicle for nicotine delivery and a smoking-cessation tool. The purpose of this study was to determine pregnant women's knowledge, attitudes, and practice regarding electronic cigarettes. STUDY DESIGN: A voluntary, anonymous survey was distributed to a convenience sample of pregnant women presenting to a university-based outpatient clinic. After survey completion, participants received information about smoking cessation and e-cigarettes. Data were examined using χ² and Fisher exact tests and analysis of variance. Stata was used for the analysis. RESULTS: Of the 326 surveys distributed, 316 were completed (97%). Of the 316 participants, 42 (13%) reported having ever used e-cigarettes. Only 2 (0.6%) reported current daily use. Ever users were slightly older (27.3 years vs 25.4 years; P = 0.007) and more likely to be current smokers (43% vs. 14%; P < 0.001) compared with women who had never used electronic cigarettes. Knowledge of the harms of smoking was similar between the 2 groups. Overall, 57% of all respondents believed that e-cigarettes contain nicotine, 61% that e-cigarettes can be addictive, and 43% that e-cigarettes are less harmful to a fetus than traditional cigarettes. Among ever users, the most common reasons given for the use of e-cigarettes were the perception of less harm than traditional cigarettes (74%) and help with smoking cessation (72%). CONCLUSIONS: Misconceptions about e-cigarettes are common among pregnant women, potentially motivating use that may pose risks to both maternal and child health. Screening and education regarding e-cigarettes should be included in prenatal care. Future research in this area is necessary, including research examining pregnancy outcomes among women who use e-cigarettes.

Incisional negative pressure therapy to prevent wound complications following cesarean section in morbidly obese women: a pilot study.

OBJECTIVE: We sought to evaluate the efficacy of incisional negative pressure therapy in decreasing postoperative wound complications when placed prophylactically over clean, closed incisions following cesarean section in obese patients. STUDY DESIGN: This was a retrospective cohort study comparing rates of wound complications following cesarean sections in morbidly obese women prior to and following the institution of standard use of prophylactic incisional negative pressure therapy. All women with a body mass index greater than 45 kg/m(2) undergoing cesarean section in a 2-year period in a single institution were included. The exposure was incisional negative pressure therapy, which began in September 2009, versus standard wound dressing used in the previous year. The main outcome was wound complication identified by ICD-9 codes. Demographic and wound outcomes were compared with χ(2) and t tests. Stata version 11.0 was used for all analysis. RESULTS: A total of 63 women met the inclusion criteria, 21 of whom received negative pressure wound therapy. The historical comparison and exposure groups were similar in all characteristics studied with the exceptions of length of surgery (64 vs 76 minutes, P = .03), length of labor (78 vs 261 minutes, P = .02), scheduled versus nonscheduled (77% vs 52%, P = .04), and mean age (29.5 vs 26.1 years, P = .04), respectively. There were 5 wound complications in the control group (10.4%) and none (0%) in the study group (P = .15). CONCLUSIONS: This pilot study suggests a decrease in wound complications in morbidly obese women receiving incisional negative pressure therapy following cesarean section.