Obstetrics and Gynecology Commons^™

Tx-004hr Vaginal Estradiol Has Negligible To Very Low Systemic Absorption Of Estradiol., David F Archer, Ginger D Constantine, James A Simon, Harvey Kushner, Philip Mayer, Brian Bernick, Shelli Graham, Sebastian Mirkin, Rejoice Study Group.

Obstetrics and Gynecology Faculty Publications

OBJECTIVE: To evaluate the pharmacokinetics of TX-004HR vaginal estradiol softgel capsules when used for treating moderate-to-severe dyspareunia in postmenopausal women with vulvar and vaginal atrophy.

METHODS: A substudy of the REJOICE trial (multicenter, double-blind, placebo-controlled, phase 3) evaluated the pharmacokinetics of 4, 10, and 25-μg TX-004HR doses once/d for 2 weeks, followed by twice/wk for 10 weeks. Serum samples obtained at 2, 4, 6, 10, and 24 hours postdose on days 1 and 14, and once on day 84, were analyzed for area under the serum concentration-time curve, tmax, Cmin, Cavg, and Cmax for estradiol, estrone, and estrone conjugates.

RESULTS: …

Tx-004hr Improves Sexual Function As Measured By The Female Sexual Function Index In Postmenopausal Women With Vulvar And Vaginal Atrophy: The Rejoice Trial., Sheryl A Kingsberg, Leonard Derogatis, James A Simon, Ginger D Constantine, Shelli Graham, Brian Bernick, Gina Gasper, Sebastian Mirkin

Obstetrics and Gynecology Faculty Publications

INTRODUCTION: TX-004HR is an investigational, applicator-free, vaginal soft gel capsule containing low-dose solubilized 17β-estradiol. The phase 3, randomized, double-blinded, placebo-controlled, multicenter REJOICE trial has shown TX-004HR to be safe and effective for the treatment of moderate to severe dyspareunia in postmenopausal women with vulvar and vaginal atrophy (VVA).

AIM: To evaluate the effect of TX-004HR on female sexual dysfunction in postmenopausal women with VVA.

METHODS: The REJOICE study compared the effects of 12-week treatment with TX-004HR (4, 10, or 25 μg) with placebo in postmenopausal women (40-75 years old) with VVA and a most bothersome symptom of moderate to severe …

Performance Of Sentinel Lymph Node Biopsy In High-Risk Endometrial Cancer, Jessie Ehrisman, Angeles Alvarez Secord, Andrew Berchuck, Paula S. Lee, Nicola Di Santo, Micael Lopez-Acevedo, Gloria Broadwater, Fidel A. Valdea, Laura J. Havrilesky

Obstetrics and Gynecology Faculty Publications

Objective

To determine the rate and performance of sentinel lymph node (SLN) mapping among women with high-risk endometrial cancers.

Methods

Patients diagnosed between 2012 and 2015 with uterine cancer of grade 3 endometrioid, clear cell, serous or carcinosarcoma histology and who underwent SLN mapping prior to full pelvic lymph node dissection were included. Subjects underwent methylene blue or ICG injection for laparoscopic (N = 16) or robotic-assisted laparoscopic (N = 20) staging. Outcomes included SLN mapping rates, SLN and non-SLN positive rates, false negative SLN algorithm rate, and the negative predictive value (NPV) of the SLN algorithm. Fisher's exact test …

Probability Of Fallopian Tube And Ovarian Detection With Transvaginal Ultrasonography In Normal Women, Jason R. Lefringhouse, Erin Neward, Frederick R. Ueland, Lauren A. Baldwin, Rachel W. Miller, Christopher P. Desimone, Richard J. Kryscio, John R. Van Nagell, Edward J. Pavlik

Obstetrics and Gynecology Faculty Publications

Objective: Some ovarian malignancies may originate in the fallopian tube. The feasibility of ultrasonographically visualizing the fallopian tube is presented. Methods: In total, 549 normal women participated in the fallopian tube visualization trial, while ovarian visualization was studied in 43,521. Chi-square analysis, t-tests and multivariate analysis determined significance and interactions. Results: Ovaries were observed in 82.7% while fallopian tubes were detected in 77.2% of women and 85.2% of the time when an ovary was detected. Age, BMI or parity was not significantly different when one or both fallopian tubes were visualized. Elevated BMI had slightly greater influence …

Partner Interfering Behaviors Affecting Cancer Quality Of Life, Ann L. Coker, Diane R. Follingstad, Lisandra S. Garcia, Heather M. Bush

Obstetrics and Gynecology Faculty Publications

Objective: Because partners are an important and unpaid resource in cancer care, understanding how destructive, controlling or interfering partner behaviors influence women's cancer care may be particularly relevant for health care providers seeking to provide cancer care and enhance recovery. Using a new measure of partner interfering behaviors in cancer care (PIB-C), we investigated whether women with a recent cancer diagnosis who additionally endorsed any PIB-C would report (a) more symptoms of depression and stress, and (b) lower Functional Assessment of Cancer Therapy (FACT-G) and lower Functional Assessment of Chronic Illness Therapy-Spiritual Well-being (FACIT-SP) scale scores indicating poorer quality of …

Urethral Solitary Fibrous Tumor: A Rare Pathologic Diagnosis Of A Periurethral Mass, Gaby N. Moawad, Elias Abi Khalil, Cheryl Silverbrook, Stephanie Barak, Alice Semerjian, Michael Phillips

Obstetrics and Gynecology Faculty Publications

Solitary fibrous tumors (SFTs) may occur at any site in the body. SFTs can only be conclusively diagnosed based on histopathologic and immunohistochemical characteristics of the tumor. The presence of SFTs in the abdomen and pelvis is extremely rare. To our knowledge no cases of urethral solitary fibrous tumor in the literature have been reported so far. We present a case of a solitary fibrous tumor arising from the urethra in a twenty-three-year-old female presenting with vaginal mass.

Flibanserin Approval: Facts Or Feelings?, James A. Simon, Irwin Goldstein, Noel Kim, Murray Freedman, Sharon Parish

Obstetrics and Gynecology Faculty Publications

No abstract provided.

A Medical Malpractice Trial Where The Residents And Faculty Are The Judge And The Jury, Kelly A. Rabah

Obstetrics and Gynecology Faculty Publications

At the conclusion of this session, the learner should be able to:

• Name 3- 5 of the most common reasons for a medical malpractice claim

• Describe and compare negligence, types of error, and recklessness

• Explain 3-5 steps that should be taken to minimize risk for a malpractice suit

• Discuss the emotional toll that litigation causes and the personal and professional risks that may result

Changing The Algorithm In The Evaluation Of Pelvic Anatomy In The Infertile Patient: Is Hysterosalpingo Contrast Sonography With Saline-Air Device The Appropriate Test For Everyone?, Kathryn Coyne, Thomas C. Winter, Rose Maxwell, Steven Lindheim

Obstetrics and Gynecology Faculty Publications

The evaluation of the fallopian tubes is an essential part of the infertility workup, with abnormalities related to the fallopian tubes accounting for up to 40% of female subfertility.1 Laparoscopy is still considered the gold standard in the diagnostic evaluation of fallopian tubes, though the hysterosalpingogram (HSG) has long been recognized as complementary to laparoscopy, since tubal anatomy can be distinctly be seen.2 That said, previous investigations using laparoscopy as the gold standard demonstrate HSG has a sensitivity and specificity of 53% and 87%, respectively, for any tubal pathology and 46% and 95%, respectively, for bilateral tubal pathology.3

Performance Of Sentinel Lymph Node Biopsy In High-Risk Endometrial Cancer., Jessie Ehrisman, Angeles Alvarez Secord, Andrew Berchuck, Paula S Lee, Nicola Di Santo, Micael Lopez-Acevedo, Gloria Broadwater, Fidel A Valea, Laura J Havrilesky

Obstetrics and Gynecology Faculty Publications

OBJECTIVE: To determine the rate and performance of sentinel lymph node (SLN) mapping among women with high-risk endometrial cancers.

METHODS: Patients diagnosed between 2012 and 2015 with uterine cancer of grade 3 endometrioid, clear cell, serous or carcinosarcoma histology and who underwent SLN mapping prior to full pelvic lymph node dissection were included. Subjects underwent methylene blue or ICG injection for laparoscopic (N = 16) or robotic-assisted laparoscopic (N = 20) staging. Outcomes included SLN mapping rates, SLN and non-SLN positive rates, false negative SLN algorithm rate, and the negative predictive value (NPV) of the SLN algorithm. Fisher's exact test …

Effect Of Ospemifene On Moderate Or Severe Symptoms Of Vulvar And Vaginal Atrophy., N. Bruyniks, R. E. Nappi, C. Castelo-Branco, T. J. De Villiers, James A. Simon

Obstetrics and Gynecology Faculty Publications

Objectives To determine whether assessment of all moderate-to-severe symptoms at baseline gives a more accurate evaluation of the treatment effect of ospemifene in vulvovaginal atrophy (VVA) than the most bothersome symptom (MBS) approach. Methods Data were pooled from two pivotal phase-III clinical trials evaluating the efficacy and safety of oral ospemifene 60 mg/day for the treatment of symptoms of VVA (n = 1463 subjects). Symptoms of vaginal dryness, dyspareunia, and vaginal and/or vulvar irritation/itching reported as moderate or severe at baseline were evaluated. Clinically relevant differences between ospemifene and placebo were analyzed using a four-point severity scoring system and presented …

Intrahepatic Cholestasis Of Pregnancy With Severe Elevation Of Bile Acids In The Setting Of Acute Hepatitis C Infection, Megan L. Lawlor, Agatha S. Critchfield

Obstetrics and Gynecology Faculty Publications

Intrahepatic cholestasis of pregnancy (ICP) is a complication of pregnancy resulting in elevation of serum bile acid levels. ICP is often associated with underlying liver disease, including hepatitis C. Bile acids in relationship to the acute infection of hepatitis C virus have not yet been delineated in the literature. A 26-year-old gravida 4 para 2103 with dichorionic, diamniotic twin gestation and history of intravenous drug abuse developed ICP in the setting of acute hepatitis C infection. In addition to clinical symptoms of pruritus and right upper quadrant pain, she developed severe elevation in bile acids, 239 micromol/L, and transaminitis aspartate …

A Case Of Recurrent Rudimentary Horn Ectopic Pregnancies Managed By Methotrexate Therapy And Laparoscopic Excision Of The Rudimentary Horn, Gaby N. Moawad, Elias D. Abi Khalil

Obstetrics and Gynecology Faculty Publications

This report presents a case of a 31-year-old woman successfully treated medically for a noncommunicating rudimentary horn ectopic pregnancy who presented with a second, successive rudimentary horn pregnancy. Patient underwent laparoscopic excision of right rudimentary horn and right salpingectomy after failed methotrexate therapy. Given the potential for rupture and recurrence, serious efforts should be made to excise a uterine rudimentary horn.

First Described Case Of Group B Streptococcus Pelvic Abscess In A Patient With No Medical Comorbidities, Paul Tyan, Elias Abi-Khalil, Karthik Dwarki, Gaby N. Moawad

Obstetrics and Gynecology Faculty Publications

Background. Group B Streptococcus is an organism that commonly infects a wide range of hosts including infants in the first week of life, pregnant women, and older age adults as well as adults with underlying medical comorbidities.

Case. Large pelvic abscess in a nonpregnant patient found to be caused by Group B Streptococcuswas treated successfully with IR guided drainage and antibiotics.

Conclusion. Though rare, GBS can still be a cause of invasive infection even in individuals who are nonpregnant and have no underlying comorbidities. Empiric antibiotic coverage for this organism should be kept in mind when treating an abscess.

Testing The Feasibility Of Remote Patient Monitoring In Prenatal Care Using A Mobile App And Connected Devices: A Prospective Observational Trial, Kathryn Marko, Jill M. Krapf, Andrew C. Meltzer, Julia Oh, Nihar Ganju, Anjali Martinez, Sheetal Sheth, Nancy D. Gaba

Obstetrics and Gynecology Faculty Publications

BACKGROUND:

Excessive weight gain and elevated blood pressure are significant risk factors for adverse pregnancy outcomes such as gestational diabetes, premature birth, and preeclampsia. More effective strategies to facilitate adherence to gestational weight gain goals and monitor blood pressure may have a positive health benefit for pregnant women and their babies. The impact of utilizing a remote patient monitoring system to monitor blood pressure and weight gain as a component of prenatal care has not been previously assessed.

OBJECTIVE:

The objective of this study is to determine the feasibility of monitoring patients remotely in prenatal care using a mobile phone …

Promoting The Use Of Elective Single Embryo Transfer In Clinical Practice., Tamara Tobias, Fady I Sharara, Jason M Franasiak, Patrick W Heiser, Emily Pinckney-Clark

Obstetrics and Gynecology Faculty Publications

BACKGROUND: The transfer of multiple embryos after in vitro fertilization (IVF) increases the risk of twins and higher-order births. Multiple births are associated with significant health risks and maternal and neonatal complications, as well as physical, emotional, and financial stresses that can strain families and increase the incidence of depression and anxiety disorders in parents. Elective single embryo transfer (eSET) is among the most effective methods to reduce the risk of multiple births with IVF.

MAIN BODY: Current societal guidelines recommend eSET for patientsprognosis, yet even this approach is not widely applied. Many patients and clinicians have been reluctant to …

The Changing Tides In Gynecologic Surgery Minimally Invasive Options: What We Know And How Do We Improve Use, Training, Michael L. Galloway

Obstetrics and Gynecology Faculty Publications

Over the past twenty years gynecologic surgery has evolved from primarily abdominal approach to the current focus on minimally invasive surgical techniques. Minimally invasive techniques include vaginal and laparoscopic techniques. Evolution in laparoscopic technology and equipment has exploded to include multiple vessel sealing instruments of varying modalities, instruments with “wristed” capabilities and robotic assisted technology. Single port laparoscopy and natural orifice transluminal endoscopic surgery are other variations of laparoscopic technology.

Vaginal surgery is still touted as the “ultimate” minimally invasive surgery by ACOG; however, its use has not grown over this time. Many surgeons have had limited training in vaginal …