Executive Summary of the reVITALize Initiative: Standardizing Gynecologic Data Definitions.

Effective care coordination across the women's health continuum is critically important. Unlike obstetric care, which tends to be more episodic and limited to pregnant and postpartum women, women receive health care, whether around pregnancy or for nonobstetric issues, in a variety of care settings by members of multiple health disciplines. Having access to standardized clinical data is imperative to providing optimal patient care. The reVITALize Gynecology Data Definitions Initiative leads a national multidisciplinary movement to offer standard gynecologic data definitions for use in written and verbal clinical communication, electronic health record data capture, quality improvement, and clinical research.

Chronic Actinomyces Infection Caused by Retained Cervical Cerclage: A Case Report.

BACKGROUND: Historically, Actinomyces infection has been associated primarily with the intrauterine device. Recently, case reports associating Actinomyces with other implants have been described, including nonwoven polypropylene mesh used for urethral slings and Mersilene cerclage placements. However, there are no reported cases of chronic Actinomyces infections associated with retained Mersilene cerclage. CASE: A 51-year-old woman, gravida 3, para 3, presented with a 10-year history of vaginal discharge and Actinomyces identified on endometrial biopsy. After failing medical treatment and undergoing a hysterectomy, the patient was found to have a retained Mersilene cerclage. CONCLUSION: This is the first case to report persistent Actinomyces infection with a retained Mersilene cerclage. No current recommendations exist for assessing full removal of cerclage. Clinicians should have a high suspicion of Actinomyces infection in a patient who presents with persistent vaginal discharge and history of cerclage placement.

Strategies for improving perinatal depression treatment in North American outpatient obstetric settings.

OBJECTIVE: To identify core barriers and facilitators to addressing perinatal depression and review clinical, programmatic, and system level interventions that may optimize perinatal depression treatment. METHOD: Eighty-four MEDLINE/PubMed searches were conducted using the terms perinatal depression, postpartum depression, antenatal depression, and prenatal depression in association with 21 other terms. Of 7768 papers yielded in the search, we identified 49 papers on barriers and facilitators, and 17 papers on interventions in obstetric settings aimed to engage women and/or providers in treatment. RESULTS: Barriers include stigma, lack of obstetric provider training, lack of resources and limited access to mental health treatment. Facilitators include validating and empowering women during interactions with health care providers, obstetric provider and staff training, standardized screening and referral processes, and improved mental health resources. CONCLUSION: Specific clinical, program, and system level changes are recommended to help change the culture of obstetric care settings to optimize depression treatment.

Progression of female reproductive stages associated with bipolar illness exacerbation.

OBJECTIVES: Late perimenopause and early postmenopause confer an increased risk of depression in the population, yet bipolar disorder mood course during these times remains unclear. METHODS: Clinic visits in 519 premenopausal, 116 perimenopausal (including 13 women transitioning from perimenopause to postmenopause), and 133 postmenopausal women with bipolar disorder who received naturalistic treatment in the multisite Systematic Treatment Enhancement Program for Bipolar Disorder (STEP-BD) study over 19.8 ± 15.5 months were analyzed for mood state. History of postpartum and perimenstrual mood exacerbation and current hormone therapy were evaluated as potential mood predictors. RESULTS: A progression in female reproductive stage (premenopause, perimenopause, and postmenopause) was significantly associated with percent of visits decreasing in euthymia (29.3%, 27.0%, 25.0%, respectively, p < 0.05), decreasing in syndromal mood elevation (5.3%, 4.1%, and 3.0%, respectively, p < 0.001), and increasing in subsyndromal symptoms (47.3%, 50.7%, and 52.7%, respectively, p = 0.05). Thirteen women transitioning from peri- to postmenopause had a significantly greater proportion of visits in syndromal depression (24.4%, p < 0.0005) compared to premenopausal, perimenopausal, and postmenopausal women, while depression in the latter three groups (18.1%, 18.1%, and 19.3%, respectively) did not differ. Perimenstrual and/or postpartum mood exacerbation, or hormone therapy did not significantly alter depression during perimenopause. CONCLUSIONS: A progression in female reproductive stages was associated with bipolar illness exacerbation. A small number of women transitioning from perimenopause to postmenopause had significantly greater depression than other female reproductive groups. Euthymia and mood elevation decreased with progressing female reproductive stage. Menstrual cycle or postpartum mood exacerbation, or current hormone therapy use, was not associated with perimenopausal depression. Future studies, which include hormonal assessments, are needed to confirm these preliminary findings.

Estradiol treatment altered anticholinergic-related brain activation during working memory in postmenopausal women.

Estradiol has been shown to affect cholinergic modulation of cognition in human and nonhuman animal models. This study examined the brain-based interaction of estradiol treatment and anticholinergic challenge in postmenopausal women during the performance of a working memory task and functional MRI. Twenty-four postmenopausal women were randomly and blindly placed on 1mg oral 17-ß estradiol or matching placebo pills for three months after which they participated in three anticholinergic challenge sessions. During the challenge sessions, subjects were administered the antimuscarinic drug scopolamine, the antinicotinic drug mecamylamine, or placebo. After drug administration, subjects completed an fMRI session during which time they performed a visual verbal N-back test of working memory. Results showed that scopolamine increased activation in the left medial frontal gyrus (BA 10) and mecamylamine increased activation in the left inferior frontal gyrus (BA 46). Estradiol treatment compared to placebo treatment significantly reduced the activation in this left medial frontal region during scopolamine challenge. Estradiol treatment also increased activation in the precuneus (BA 31) during mecamylamine challenge. These data are the first to show that estradiol modulated antimuscarinic- and anitnicotinic-induced brain activity and suggest that estradiol affected cholinergic system regulation of cognition-related brain activation in humans.

Increased memory load-related frontal activation after estradiol treatment in postmenopausal women.

Prior research shows that menopause is associated with changes in cognition in some older women. However, how estrogen loss and subsequent estrogen treatment affects cognition and particularly the underlying brain processes responsible for any cognitive changes is less well understood. We examined the ability of estradiol to modulate the manipulation of information in working memory and related brain activation in postmenopausal women. Twenty healthy postmenopausal women (mean age (SD)=59.13 (5.5)) were randomly assigned to three months of 1mg oral 17-ß estradiol or placebo. At baseline and three months later each woman completed a visual verbal N-back sequential letter test of working memory during functional magnetic resonance imaging (fMRI). The fMRI data showed that women who were treated with estradiol for three months had increased frontal activation during the more difficult working memory load conditions compared to women treated with placebo. Performance on the verbal working memory task showed no difference between estradiol and placebo treated subjects. These data are consistent with prior work showing increases in frontal activation on memory tasks after estrogen treatment. However, this is the first study to show that estrogen-induced increases in brain activity were tied to cognitive load during a verbal working memory task. These data suggest that estradiol treatment effects on cognition may be in part produced through modulation of frontal lobe functioning under difficult task conditions.

Correlation of serum androgens with anthropometric and metabolic indices in healthy, nonobese postmenopausal women.

OBJECTIVE: The role of testosterone in the regulation of metabolic and physiological function in men is well defined, but its role in women remains enigmatic. Thus, the present study sought to assess the contribution of endogenous circulating androgens to the regulation of metabolic function, body morphometry, and physical function in normal naturally postmenopausal women. METHODS: Using a cross-sectional design, we measured serum androgens in a cohort of 29 naturally postmenopausal women and correlated the results with metabolic, morphometric, and functional outcome parameters. These included insulin sensitivity, whole-body fat and lean body mass, visceral/abdominal fat areasm and aerobic capacity. RESULTS: Higher serum testosterone levels were related to greater maximal aerobic capacity and reduced adiposity. Additionally, higher serum dihydrotestosterone, dehydroepiandrosterone sulfate, androstenedione, and androstenetriol glucuronidate levels were correlated to greater insulin sensitivity. CONCLUSION: In naturally postmenopausal women, endogenous androgens may play a role in the maintenance of beneficial patterns of metabolic, morphometric, and functional parameters.

Trends in the academic workforce of obstetrics and gynecology.

OBJECTIVE: The objective was to report results from the seventh survey that monitored trends in numbers of full-time department faculty and from a first survey on the current and anticipated numbers of part-time faculty. METHODS: A faculty workforce survey, drafted in the same format as the prior published questionnaire, was sent electronically to chairs of obstetrics and gynecology at all 125 U.S. medical schools. Each chair was asked to provide the number of current full-time and part-time (0.5-0.9 full-time equivalent) faculty in each specialty and the projected department size in 5 years. When accuracy of data were questioned, we reviewed the department's Web site and directly communicated with the chair. RESULTS: The mean number of full-time faculty per department increased from 25 in 1994 to 29 in 2008 (95% confidence interval 25-33). Most departments (84.0%) had part-time faculty, which constituted 21.2% of the total faculty. Growth was only substantial in the number of medical faculty. In 2008, half (50.1%) of all faculty were women. Private schools and research-oriented departments had the largest faculty sizes. Two-thirds of all chairs anticipated that the number of faculty will increase, especially for part-time faculty and entry-level assistant professors as generalists or maternal-fetal medicine specialists. CONCLUSION: Continued growth in department sizes was accompanied by considerably more women and more part-time faculty. The numbers of full-time and part-time faculty are anticipated to increase. LEVEL OF EVIDENCE: III.

Effects of oral and transdermal hormonal contraception on vascular risk markers: a randomized controlled trial.

OBJECTIVE: To compare the effects of oral and transdermal contraceptives containing similar hormone formulations on vascular risk markers. METHODS: We conducted a randomized, investigator-blinded, crossover, clinical trial with 24 healthy women, aged 18-35 years, who received 2 months of transdermal or oral contraceptive, 2 months washout, then 2 months of the alternative medication. The transdermal contraceptive contained 0.75 mg ethinyl estradiol and 6 mg norelgestromin. The oral contraceptive contained 35 mcg ethinyl estradiol and 250 mcg norgestimate. Blood samples taken before and after each treatment were analyzed in batch for D-dimer, von Willebrand factor, factor VIII, total and free protein S, antithrombin, fibrinogen, C-reactive protein, and normalized activated protein C sensitivity ratio (nAPCsr) determined with two thrombin generation-based assays, the alpha2macroglobulin-thrombin end point method (alpha2M-IIa) and calibrated automated thrombinography. Repeated measures analysis of variance was used for analysis. RESULTS: For both contraceptives (transdermal, oral) there were significant declines in free (19%, 11%) and total protein S (19%, 13%) and antithrombin (13%, 10%); increases in fibrinogen (8%, 10%), C-reactive protein (220%, 292%), nAPCsr alpha2M-IIa (81%, 61%), and nAPCsr calibrated automated thrombinography (102%, 68%), all P<.05. Transdermal contraceptives had a greater effect than oral contraceptives on free protein S (P=.07), nAPCsr alpha2M-IIa (P=.06), and nAPCsr calibrated automated thrombinography (P=.03). CONCLUSION: Oral and transdermal contraception with similar hormones had similar adverse effects on vascular risk markers. This suggests that this transdermal contraceptive has at least a similar thrombosis risk as its oral counterpart. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT00554632 LEVEL OF EVIDENCE: I.

Evaluation of extended and continuous use oral contraceptives.

Oral contraceptives are classically given in a cyclic manner with 21 days of active pills followed by 7 days of placebo. In the past 4 years, new oral contraceptives have been introduced which either shorten the placebo time, lengthen the active pills (extended cycle), or provide active pills every day (continuous). These concepts are not new; extended and continuous pills were first studied in the 1960s and 1970s and have been provided in an off-label manner by gynecologists to treat menstrual disorders, such as menorrhagia and dysmenorrhea, and gynecologic disorders, such as endometriosis. Now that extended and continuous combined oral contraceptives are available for all patients, it is critical for providers to understand the physiology, dosing, side effects, and benefits of this form of oral contraceptive. This article reviews the history and the potential uses of the new continuous combined oral contraceptive.

Effect of depomedroxyprogesterone acetate on coagulation parameter: a pilot study.

OBJECTIVE: Recent studies have shown changes in coagulation factors, suggesting an increased risk of thrombotic events, in women on progestin-containing contraceptives. To investigate this, we studied the effects of injectable depomedroxyprogesterone acetate (DMPA), given as a contraceptive, on coagulation and inflammation markers. DESIGN: Prospective nonrandomized study. SETTING: Department of Obstetrics and Gynecology, University of Vermont College of Medicine. PATIENT(S): In this substudy of subjects undergoing a phase III trial comparing IM and SC DMPA, 14 healthy reproductive-age women were randomly assigned to receive either IM or SC DMPA every 3 months during a pharmaceutical trial. INTERVENTION(S): All subjects had blood samples obtained at baseline and 6 and 12 months. MAIN OUTCOME MEASURE(S): D-Dimer, C-reactive protein (CRP), antithrombin (AT), factor VIIIc, activated partial thromboplastin time (aPTT), and aPTT plus activated protein C (APC) were analyzed on all samples. RESULT(S): D-Dimer concentration was significantly decreased at 6 and 12 months with injectable DMPA compared t degrees o baseline. There was also a modest decrease in aPTT. The CRP, AT, factor VIIIc, and aPTT + APC were not significantly altered by the use of DMPA. CONCLUSION(S): In this preliminary study the decline in D-dimer represents a potentially beneficial change in coagulation function following the use of DMPA given SC or IM. A slight decrease in aPTT may reflect a prothrombotic tendency with this contraceptive, but in contrast with previous studies examining the effect of oral contraceptive this injectable progestin contraceptive did not demonstrate the adverse effect on markers for thrombosis risk.

Perceived infertility-related stress correlates with in vitro fertilization outcome.

To determine the effect of perceived infertility-related stress on IVF outcome, all couples undergoing their first cycle of IVF were administered the Fertility Problem Inventory from May 2002 and April 2005 at our institution. Couples who conceived during their first cycle of IVF had significantly higher measures of need for parenthood and loss of sexual enjoyment, compared with couples who did not conceive. Couples who achieved ongoing pregnancies had higher scores on measures of a negative view of a child-free lifestyle, need for parenthood, and total stress than those who did not.

Endometrial histology following 1 year of a continuous daily regimen of levonorgestrel 90 micro g/ethinyl estradiol 20 micro g.

OBJECTIVE: The objective of this study was to evaluate the effect of a continuous daily regimen of levonorgestrel (LNG) 90 micro g/ethinyl estradiol (EE) 20 micro g on endometrial histology. METHODS: This was a substudy of a large phase 3 trial conducted in six sites in North America. Healthy and sexually active women aged between 18 and 49 years took LNG 90 micro g/EE 20 micro g daily for 1 year. Results from endometrial biopsies performed at pretreatment baseline and those after at least 6 months of treatment were compared. RESULTS: Of the 146 participants, 93 had a baseline biopsy and completed at least six pill packs. Before treatment, 56 subjects (60%) had an endometrial biopsy with findings classified as "weakly proliferative or proliferative." During the last on-therapy visit, 48 subjects (52%) had an endometrium categorized as "other," which included primarily an inactive or benign endometrium (n=42). No hyperplasia or malignancy was observed during the study. CONCLUSION: The results of a 1-year continuous regimen of LNG 90 micro g/EE 20 micro g were shown to have a good endometrial safety profile.

Evaluation of a continuous regimen of levonorgestrel/ethinyl estradiol: phase 3 study results.

OBJECTIVE: This study was conducted to evaluate the safety and efficacy of a continuous daily regimen of levonorgestrel (LNG) 90 microg/ethinyl estradiol (EE) 20 microg (continuous LNG/EE). METHODS: Healthy women aged 18-49 years with regular menstrual cycles for 3 months enrolled in this single-treatment open-label study and took one pill of LNG 90 microg/EE 20 microg daily for 12 months. RESULTS: For the 2134 subjects enrolled, the Pearl Index method failure was 1.26, and user failure was 0.34. While on Pill Pack 13, 58.7% of subjects reported amenorrhea and 79.0% reported absence of bleeding. Overall, the number of bleeding and spotting days per pill pack declined progressively. Adverse events and discontinuations were comparable to those reported for cyclic oral contraceptive (OC) regimens, except for higher rates in those related to uterine bleeding. CONCLUSIONS: Continuous LNG/EE demonstrated a good safety profile and efficacy similar to cyclic OCs. The regimen continuously inhibited menses, increased the incidence of amenorrhea over time and, except for a subset of women, decreased the number of bleeding and spotting days.

A longitudinal study of the effects of free testosterone and other psychosocial variables on sexual function during the natural traverse of menopause.

OBJECTIVE: This study examines the effect of free T levels on sexual function during the natural traverse of menopause. Other psychosocial variables, which may also contribute to change in sexual function, are studied-including participant's job satisfaction, satisfaction with financial resources, confidence in ability to manage symptoms, stressful life events, exercise, body image, and quality of personal relationships. DESIGN: Prospective clinical study. SETTING: Clinical research center, university hospital. PATIENT(S): Fifty-seven women between the ages of 45 and 55 years were enrolled at the beginning of the study. Thirty-seven women completed all but the final measurement of free T and 23 completed all aspects of the study at year 1 and year 5. INTERVENTION(S): Questionnaires were administered and blood samples obtained in year 1 and year 5. MAIN OUTCOME MEASURE(S): Free T, sexual satisfaction, and other psychosocial variables. RESULT(S): Exercise is the only variable significantly associated with sexual satisfaction. There was a lack of association between free T and sexual satisfaction both at year 1 and year 5. CONCLUSION(S): Focus on the hormonal aspects of menopause has promoted a disregard of other important psychosocial factors affecting sexual function. This study shows no correlation between T levels and sexual function, whereas exercise is clearly associated with sexual satisfaction. A key area for future research is the effect of lifestyle changes on sexual function in menopausal women.

Postmenopausal uterine bleeding profiles with two forms of continuous combined hormone replacement therapy.

OBJECTIVE: This study was designed to compare the bleeding profiles of conjugated equine estrogens 0.625 mg in combination with 2.5 mg medroxyprogesterone acetate (Prempro; CEE/MPA group), the most widely prescribed continuous combined hormone replacement therapy (CCHRT) in the United States, with 17beta-estradiol 1 mg combined with 0.5 mg norethindrone acetate (Activella; E(2)/NETA group), a newly available CCHRT preparation, over a 6-month period. DESIGN: This study was a prospective, randomized, multicenter, double-blind, controlled trial. A total of 438 healthy postmenopausal women were randomized and received treatment (Activella n = 217, Prempro n = 221). Each woman recorded bleeding diaries daily. Total cholesterol, triglycerides, and endometrial biopsies were obtained at screening and end-of-trial visits. RESULTS: The more favorable bleeding profile was found in the E(2)/NETA (Activella) group. The differences in bleeding patterns were most marked in the first 3 months of treatment in women who were 1-2 years from last menses, with no bleeding in 71.4% vs. 40.0%; ( p = 0.005) and with no bleeding and no spotting in 54.8% vs. 17.1%; (p = 0.001). Triglycerides fell by 8.5% in the E(2)/NETA group and increased by 11.7% in the CEE/MPA group (p < 0.001). Total cholesterol declined by 9.1% and 6.9%, respectively. CONCLUSION: The most important factor in the continuation of HRT is uterine bleeding. E(2)/NETA has significantly less bleeding than the most commonly prescribed CCHRT CEE/MPA, therefore; E(2)/NETA should be associated with improved continuation rates. The patient taking E(2)/NETA will receive effective treatment for her menopausal symptoms with less bleeding.