Christina Raker

Topical gabapentin in the treatment of localized and generalized vulvodynia.

OBJECTIVE: To evaluate the clinical efficacy and tolerability of topical gabapentin in the treatment of women with vulvodynia. METHODS: A retrospective study was designed to ascertain clinical responses to topical gabapentin. Patient demographic and medical characteristics, including present and prior treatment for vulvodynia, were routinely collected. The final outcome was defined by a comparison between pretreatment and posttreatment mean pain scores based on a discrete visual analog scale of 0 to 10. Categorical data were compared by Fisher exact test, continuous variables between groups by the Wilcoxon rank sum test, and mean change in pain score between pretreatment and posttreatment by paired Student t test. RESULTS: Between January 2001 and December 2006, 51 women with vulvodynia (19 or 37% with generalized vulvodynia, 32 or 63% with localized) were treated with 2% to 6% gabapentin. After a minimum of 8 weeks of therapy, the mean pain score among the 35 evaluable women was significantly reduced from 7.26 to 2.49 (mean change –4.77, 95% confidence interval –5.47 to –4.07). Overall, 28 of 35 (80%) demonstrated at least a 50% improvement in pain scores. Among patients with localized vulvodynia, sexual function improved in 17 of 20 with evaluable results (6 of 9 reinstituted vaginal intercourse, whereas all 11 patients experiencing decreased frequency of intercourse reported increased frequency after treatment). Discontinuations occurred in 7 of 50 (14%) treated. CONCLUSION: Topical gabapentin seems to be well-tolerated and associated with significant pain relief in women with vulvodynia. LEVEL OF EVIDENCE: III

Outcomes from a labor and delivery team training program with simulation component

We evaluated the implementation of a labor and delivery unit team training program that included didactic sessions and simulation training with an active clinical unit. Over an 18-month follow-up time period, our team training program showed improvements in patient outcomes as well as in perceptions of patient safety including the dimensions of teamwork and communication.

Neonatal characteristics and outcomes of pregnancies complicated by influenza infection during the 2009 pandemic.

The purpose of this study was to describe the neonatal characteristics and outcomes of infants who were born during the 2009 H1N1 influenza pandemic. A prospective cohort of pregnant women with influenza-like illness (ILI) was enrolled between the months of June 2009 and March 2010. Neonatal characteristics, complications, and outcomes were recorded. Forty-five women were included in the study. Birth outcomes were available in 41 cases; 16 women had 2009 H1N1 infection, and the remaining 25 women who tested negative were included in the ILI group. Live births were similar in both groups. Average gestational age at delivery was >39 weeks; Apgar scores and cord gas pH values were similar. Birthweights in the 2009 H1N1 group were on average 285 g lower (3186 vs 3471 g; P = .04). Three infants were admitted to the neonatal intensive care unit. In this cohort, 2009 H1N1 infection during pregnancy was associated with a lower birthweight when compared with ILI in pregnancy.

Randomized controlled trial to prevent postpartum depression in adolescent mothers

OBJECTIVE The purpose of this study was to estimate the effect of an interpersonally oriented intervention on the reduction of the risk of postpartum depression in primiparous adolescents. STUDY DESIGN We conducted a randomized controlled trial of 106 pregnant primiparous adolescents who were ≤17 years old at their first prenatal visit. Participants were assigned randomly to the intervention program (n = 54) or the attention and dose-matched control program (n = 52). Each program included 5 sessions that were delivered during the prenatal period. A structured diagnostic interview was administered to assess for the primary outcome and depression at 6 weeks, 3 months, and 6 months after delivery. RESULTS Participants included Hispanic (53%), non-Hispanic black (17%), and non-Hispanic white (16%) adolescents. The overall rate of depression in the intervention group (12.5%) was lower than the control group (25%) with a hazard rate ratio of 0.44 (95% confidence interval, 0.17-1.15) at 6 months after delivery. CONCLUSION An intervention that is delivered during the prenatal period has the potential to reduce the risk for postpartum depression in primiparous adolescent mothers.

Ambulatory procedures for female pelvic floor disorders in the United States

OBJECTIVE The aim of this study was to estimate the number of women undergoing ambulatory surgical procedures for female pelvic floor disorders (PFDs) in the United States and to compare age-adjusted ambulatory surgical case rates between 1996 and 2006. STUDY DESIGN We analyzed data from the 1996 and 2006 National Survey of Ambulatory Surgery, a federal public access de-identified database. Procedures for PFDs were identified using International Classification of Diseases-9th revision Clinical Modification procedure codes for urinary incontinence, fecal incontinence, and pelvic organ prolapse. RESULTS The number of women undergoing ambulatory surgical procedures for urinary incontinence increased from 34,968 (95% confidence interval, 25,583-44,353) in 1996 to 105,656 (95% confidence interval, 79,033-132,279) in 2006. The age-adjusted ambulatory surgical case rates for all PFDs increased from 7.91 per 10,000 in 1996 to 12.10 per 10,000 in 2006 (P = .0006). CONCLUSION Ambulatory procedures for urinary incontinence increased between 1996 and 2006, as well as the age-adjusted ambulatory case rate for all PFDs.

Reproductive coercion and co-occurring intimate partner violence in obstetrics and gynecology patients.

OBJECTIVE Reproductive coercion is male behavior to control contraception and pregnancy outcomes of female partners. We examined the prevalence of reproductive coercion and co-occurring intimate partner violence among women presenting for routine care at a large, urban obstetrics and gynecology clinic. STUDY DESIGN Women aged 18-44 years completed a self-administered, anonymous survey. Reproductive coercion was defined as a positive response to at least 1 of 14 questions derived from previously published studies. Women who experienced reproductive coercion were also assessed for intimate partner violence in the relationship where reproductive coercion occurred. RESULTS Of 641 women who completed the survey, 16% reported reproductive coercion currently or in the past. Among women who experienced reproductive coercion, 32% reported that intimate partner violence occurred in the same relationship. Single women were more likely to experience reproductive coercion as well as co-occurring intimate partner violence. CONCLUSION Reproductive coercion with co-occurring intimate partner violence is prevalent among women seeking general obstetrics and gynecology care. Health care providers should routinely assess reproductive-age women for reproductive coercion and intimate partner violence and tailor their family planning discussions and recommendations accordingly.

Porcine subintestinal submucosal graft augmentation for rectocele repair: a randomized controlled trial.

OBJECTIVE: To estimate the effect of porcine subintestinal submucosal graft augmentation on improving anatomic and subjective rectocele repair outcomes compared with native tissue repair. METHODS: We conducted a randomized controlled trial at two sites, including women with at least stage 2 symptomatic rectocele. Anatomic and subjective outcomes (vaginal bulge and defecatory) were collected 12 months postoperatively, including blinded Pelvic Organ Prolapse Quantification (POP-Q) examinations. Anatomic failure was defined as points Ap or Bp −1 or greater on POP-Q. Subjective failure was defined as no improvement or worsening of symptoms. We estimated number needed to treat and adjusted odds ratios (ORs). Assuming graft use is associated with 93% anatomic success, 63 women per group would be needed to detect a 20% difference at &agr;=.05 and &bgr;=.20. RESULTS: One hundred sixty women were randomized; 137 had 12-month anatomic data (67 graft; 70 control). There was no difference in anatomic failure (12% compared with 9%, P=.5), vaginal bulge symptom failure (3% compared with 7%, P=.4, number needed to treat=26) or defecatory symptom failure (44% compared with 45%, P=.9, number needed to treat=91) for graft compared with control, respectively. Both groups reported improvement in vaginal bulge and defecatory symptoms (P<.05 for all). On multiple logistic regression, graft use was not associated with a decreased odds of anatomic failure (adjusted OR 1.36, 95% confidence interval [CI] 0.44–4.25), vaginal bulge symptoms (adjusted OR 0.46, 95% CI 0.08–2.68), or defecatory symptoms (adjusted OR 0.98, 95% CI 0.48–2.03). CONCLUSION: Although rectocele repair by either approach is associated with improved symptoms, subintestinal submucosal graft augmentation was not superior to native tissue for anatomic or subjective outcomes at 12 months. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT00321867. LEVEL OF EVIDENCE: I

Higher dose cervical 2% lidocaine gel for IUD insertion: a randomized controlled trial

OBJECTIVE To determine the effectiveness of 6 mL of 2% lidocaine cervical gel for pain during intrauterine device (IUD) insertion. STUDY DESIGN This is a randomized double-blind placebo controlled trial of 6 mL of 2% lidocaine gel for IUD insertion pain among first-time IUD users. No other analgesia other than the study intervention was provided. The study was conducted at a university-based obstetrics and gynecology clinic. The primary outcome, pain during IUD insertion on a 0 to 100-mm visual analog scale, was analyzed using the t test. RESULTS Seventy-three women received placebo gel, and 72 women received 2% lidocaine gel. The groups had similar sociodemographic and clinical characteristics. Baseline pain scores with speculum insertion were no different between the two groups. The lidocaine group reported a mean pain score with tenaculum placement of 37.5 (median: 39) compared to the placebo group of 41.6 (median: 37) (p=.4). Similarly, pain with IUD insertion was no different with a mean pain score of 35.2 (median: 34) in the lidocaine group and 36.7 (median 36) in the placebo group (p=.8). CONCLUSIONS Two percent lidocaine gel placed on the anterior lip of the cervix and at the internal os did not reduce pain with tenaculum placement and IUD insertion compared to placebo gel. IMPLICATIONS Among first-time IUD users, including both nulliparous and multiparous women, 6 mL of 2% lidocaine gel placed on the anterior lip of the cervix and at the internal os for 3 min did not reduce pain with tenaculum placement and IUD insertion compared to placebo gel.

Addressing clinical trials: Can the Multidisciplinary Tumor Board improve participation? A study from an academic women's cancer program☆

OBJECTIVE The Tumor Board (TB) allows for an interdisciplinary approach to cancer treatment designed to encourage evidence-based treatment. However, its role in facilitating clinical trial participation has not been reported. We aimed to determine whether a prospective TB is an effective strategy for trial recruitment and to identify steps within the TB process that facilitate discussion of trial eligibility and optimize accrual. METHODS We conducted a retrospective cross-sectional analysis of women presented to Gynecologic Oncology TB between March and December 2008. Patient demographics, TB recommendations, and post-TB patient discussions were abstracted. These were compared to data derived from the Department of Oncology Research to determine research team awareness of eligible patients and confirm trial enrollment(s). Data analysis was completed with Chi-square test; risk ratios and confidence intervals were calculated as summary measures. RESULTS We reviewed 1213 case presentations involving 916 women. Overall, 358 TB recommendations (30%) identified eligible patients, of which enrollment consisted of 87 (24%) trials (6% therapeutic trials and 18% non-therapeutic trials). Compared to other types of TB recommendations, those involving trials were discussed less frequently at post-TB patient visits (79% vs. 44%). Documentation of trial discussion at the post-TB visit was more likely to result in trial participation, versus solely relying on the research staff to communicate enrollment eligibility with the treating team (RR 2.5, p=0.006). CONCLUSIONS Patients identified by the TB were 2.5-times as likely to enroll in a clinical trial, but trials were mentioned only 44% of the time. Interventions that facilitate trial discussions during post-TB meetings are needed to improve trial participation.

Preoperative genetic testing affects surgical decision-making in breast cancer patients

OBJECTIVES Our aim was to determine if BRCA mutation status changes surgical decision making in women who undergo genetic testing after the diagnosis of breast cancer. METHODS This is a retrospective cohort study of breast cancer patients who had BRCA mutation testing performed prior to surgery. We compared surgical choice and change in surgical choice in women who tested positive for a BRCA mutation with those who tested negative. Surgery was considered the most definitive surgery within a year of diagnosis. Other data collected included age, race, stage, histology, receptor status, adjuvant treatment, gravity, parity, and family history. Variables were compared by BRCA status using Fishers exact test and logistic regression. RESULTS Three hundred and two women were included. Thirty-two (10.6%) were identified as carrying a BRCA mutation. Most women had early stage disease (55.6% T1 lesions, 72.8% node negative); 55.6% had breast-conserving surgery, and the remaining had unilateral or bilateral mastectomy. BRCA mutation carriers were more likely to have both a personal history of breast cancer (RR 2.74, 95% CI=1.08-6.98) and hormone receptor-negative tumors (56.0% vs. 26.2%, p=0.002). BRCA mutation carriers were more likely to choose bilateral mastectomy with reconstruction (56.3% vs. 15.9%, p<0.0001); 71.9% of BRCA mutation carriers opted for a different surgery than what was initially planned by their surgeon as compared to 29% of mutation-negative patients (p<0.0001). CONCLUSIONS BRCA mutation testing strongly influences surgical decision making in newly diagnosed breast cancer patients. For women who meet NCCN referral guidelines, genetic evaluation should be performed prior to surgical intervention.