bluuebunny/crossref_metadata_2025_split huggingface dataset:
Endometrial Evaluation in Elagolix-Treated Women With Uterine Fibroids and Heavy Menstrual Bleeding [25G]
Authors: Carr Bruce R. , Bradley Linda D. , Owens Charlotte D. , Gao Jingjing , Chwalisz Kristof , Simon James A. 
Published: April 2018

INTRODUCTION:
Elagolix, an oral gonadotropin-releasing hormone antagonist, with and without add-back therapy, was evaluated in premenopausal women with heavy menstrual bleeding (HMB; >80mL/month) associated with uterine fibroids (UF).

METHODS:
This double-blind phase-2b study (NCT01817530) enrolled women 18–51y in 2 cohorts, with 4 arms/cohort: elagolix alone as 300mg twice daily (cohort 1) and 600mg once daily (cohort 2) and, in both cohorts, placebo and elagolix with add-back therapy of estradiol (E2)/norethindrone acetate (NETA) at low dose (0.5mg E2/0.1mg NETA [LDA]) or standard dose (1.0mg E2/0.5mg NETA [SDA]). Endometrial thickness and biopsies were evaluated at baseline and month 6.

RESULTS:
567 randomized patients were treated. Mean baseline endometrial thickness evaluated with transvaginal ultrasound was 6.6–7.9mm across both cohorts. At treatment month 6, mean change in endometrial thickness in both placebo groups ranged from 0.4–2.1mm, but decreased in all elagolix groups in both cohorts (–0.5 to –1.5mm), reaching significance vs placebo for elagolix 300mg+LDA (P=.018) and elagolix 600mg alone (P=.039). Mean endometrial thickness at month 6 ranged from 8.2–9.7mm in both placebo groups and 5.7–6.9mm across elagolix groups. Baseline endometrial biopsies in both cohorts were categorized as normal-quiescent/minimally-stimulated (3.1%–13.8%), proliferative (44.2%–57.1%), and normal-secretory/mixed/breakdown/menstrual (32.5%–45.5%). At month 6, there were more normal-quiescent/minimally-stimulated biopsies in all elagolix arms vs placebo: elagolix alone, 33.8%–43.1%; LDA, 21.1%–39.1%; SDA, 36.4%–41.5%; placebo, 2.6%–6.2%. No endometrial biopsies were abnormal.

CONCLUSION:
After 6 months of treatment, in both cohorts, elagolix with and without add-back therapy was associated with benign endometrial pathology and reduction in endometrial thickness vs placebo in women with HMB associated with UF.
Case Report: Topical Tranexamic Acid as Novel Treatment of Refractory Bleeding After Excisional Cervical Procedure [27G]
Authors: Burns Rebecca , Kucera Calen , Parsons Arlene , Bannon Lindsey 
Published: April 2018

INTRODUCTION:
Tranexamic acid (TXA) is a derivative of the amino acid lysine that inhibits fibrinolysis by blocking binding sites of plasminogen and preventing its conversion into plasmin. It is conventionally used intravenously or orally for management of bleeding related to menorrhagia, dental extraction, epistaxis or trauma. Topical use is well established in orthopedic and otolaryngologic surgery and has been described in cardiac and dental procedures. While intravenous use has been shown to reduce hemorrhage, the use of topical TXA treatment for cervical bleeding after excisional procedure has not been described.

METHODS:
A 37-year-old woman on lifelong anticoagulation due to a prosthetic mitral valve was followed for persistent cervical dysplasia progressing despite cryotherapy. She underwent an uncomplicated loop electrocautery excisional procedure (LEEP), however she suffered continued bleeding from the surgical site and failed management with repeat electrocautery, packing, sutures, and hemostatic agents. TXA solution was directly applied to the cervix daily as a bedside procedure for ten days.

RESULTS:
Topical application of TXA to the surgical site was ultimately successful in maintaining continued hemostasis.

CONCLUSION:
For a patient in whom systemic anticoagulation cannot be held obtaining continued hemostasis of mucosal bleeding sites can be difficult. Topical use of TXA should be considered as an option for treatment in patients with refractory bleeding from biopsy sites as its application is not difficult, is well tolerated, and appears to have minimal side effects. Further study is indicated to determine ideal treatment protocols.
Bimanual Pelvic Examination is Not Sensitive for Fibroid Diagnosis [30G]
Authors: Ahmed Farah , Green Isabel , Stewart Elizabeth A. , Laughlin-Tommaso Shannon 
Published: April 2018

INTRODUCTION:
Bimanual pelvic examination is often performed for symptoms related to uterine fibroids (UF). We evaluated the clinical utility of this exam at the time of UF diagnosis in a community setting.

METHODS:
Retrospective sample of women diagnosed with UF between 2006 and 2010 in the Rochester Epidemiology Project, a population-based records-linkage system. Cohort includes a sample of women who had a pelvic examination within 12 months of UF diagnosis (n=141). Abnormal pelvic exam was defined as abnormal uterine size or shape, or any adnexal mass or fullness recorded by healthcare provider. We examined clinical and imaging characteristics using chi-squared for categorical and t tests for continuous data. Data reported as percentage or mean ± standard deviation. Volumes of the uterus and largest fibroid were calculated using the prolate ellipsoid formula.

RESULTS:
Women with UF and a normal pelvic exam (n=73) were younger than women with abnormal exam (n=68) (44.7±7.1 vs 46.9±5.4 years, P=.05), and had a higher BMI (29.4 ± 6.5 vs 26.6 ± 5.0 kg/m2, P=.007). Women with abnormal exam had significantly larger uterine volumes (226.0 ± 151.8 vs 150.9 ± 97.9 cm³, P=.005) and fibroid volumes (61.1±81.1 vs 19.9±52.8 cm³, P=.005). Abnormal examination was more frequently documented by gynecology providers (57.4%) than other providers (42.7%, P=.04). Fibroid symptoms were not associated with abnormal examination.

CONCLUSION:
Fifty-two percent of women with fibroids had a normal bimanual examination. Thus, a high suspicion of fibroids should prompt imaging. Lower BMI and larger uterine and fibroid dimensions increase fibroid diagnosis on pelvic examination.
Elagolix Reduces Fatigue in Patients With Moderate-to-Severe Endometriosis Pain [34G]
Authors: Diamond Michael , Soliman Ahmed M. , Castelli-Haley Jane , Thomas James W. , Snabes Michael 
Published: April 2018

INTRODUCTION:
Endometriosis-associated symptoms like menstrual and non-menstrual pelvic pain can be associated with fatigue. This study evaluated the impact of elagolix, an oral gonadotrophin-releasing hormone antagonist, on fatigue among endometriosis patients.

METHODS:
We conducted a phase III double-blind randomized placebo-controlled trial that enrolled premenopausal women with surgically-confirmed endometriosis diagnosis and moderate to severe endometriosis-related pain. A total of 872 patients were randomly assigned to placebo, elagolix 150 mg once daily (QD) or elagolix 200 mg twice daily (BID) for 6 months. Fatigue was assessed using Patient Reported Outcome Measurement Information System (PROMIS) Fatigue short form 6a at baseline, months 1, 3 and 6. Raw scores were converted to T- scores that are standardized based on a mean of 50 and a standard deviation (SD) of 10 for the general population (lower scores indicates less fatigue). Changes from baseline T-scores were compared between elagolix treatments and placebo using 1-way analysis of covariance using baseline scores as a covariate.

RESULTS:
At baseline, mean T-scores were more than one SD worse than population average [Least squared (LS) Means: 62.37, 64.16 and 63.93] for placebo, elagolix 150 mg QD and elagolix 200 mg BID, respectively. At month 3, elagolix 150 mg QD and elagolix 200 mg BID had greater improvements from baseline T-scores [LS mean change: -6.26 and -8.84 respectively; all p<0.05] compared to placebo [LS mean change:-4.61]. Improvements observed at month 3 persisted at month 6 (Each elagolix vs. placebo comparisons had p<0.01).

CONCLUSION:
Elagolix reduces fatigue in endometriosis patients with moderate to severe pain.
Long-term Effect of Elagolix on Bone Mineral Density in Women with Endometriosis-Associated Pain [38G]
Authors: Archer David , Watts Nelson , Duan W. Rachel , Peloso Paul , Wang Hui , Chwalisz Kristof 
Published: April 2018

INTRODUCTION:
To evaluate the long-term effect of elagolix, an oral, non-peptide GnRH antagonist, on bone mineral density (BMD) in two 6-month (M) extension studies (Elaris EM-III and IV) of the pivotal, 6M, phase 3 studies (12M overall treatment with 150mg once daily [QD] or 200mg twice daily [BID]).

METHODS:
Women with moderate/severe endometriosis-associated pain and a baseline BMD Z-score >-1.5 were randomized to receive elagolix in the pivotal studies and continued elagolix treatment in the extension studies (treated: Elaris EM-III, n=287; Elaris EM-IV, n=282). Total hip BMD was measured by dual energy X-ray absorptiometry and reviewed/evaluated by a blinded central reader. Baseline was before dosing in pivotal studies.

RESULTS:
After 6M of elagolix treatment in the pivotal studies, the proportion of women with a decrease in total hip BMD ≥8% ranged 0–1.1% across doses/studies; these women were not eligible for extension study. Following 12M treatment, the proportion of women with a total hip BMD decrease from baseline ≥8% was 1.8% (n=2) at 150mg QD and 0.9% (n=1) at 200mg BID in Elaris EM-III and 0% (n=0) at 150mg QD and 4.6% (n=5) at 200mg BID in Elaris EM-IV. For total hip, the mean BMD Z-score at extension-M6 was within the normal range of -2.0 to +2.0 across doses/studies; no women had a total hip BMD Z-score ≤-2.

CONCLUSION:
In women with endometriosis-associated pain, long-term elagolix treatment was associated with decreases in total hip BMD, while the mean total hip BMD Z-score was within the normal range and no women had a total hip BMD Z-score ≤-2.
Towards Personalized Breast Imaging Pathways: Initial Findings from a Learning Health System [39G]
Authors: Dabbous Firas , Su Zhaohui , Donadio Gregory , Menon Vandana , Dolan James , Alsheik Nila 
Published: April 2018

INTRODUCTION:
Recent advances in mammography screening demonstrate dual benefits of decreased recall rates and increased cancer detection. We describe findings from an ongoing learning health system whose goal is to develop personalized breast imaging pathways.

METHODS:
A cloud-based big data platform and robust technology infrastructure are being used to integrate and transform data from EMRs, radiology management systems, and tumor registries. The current study cohort includes data from 181,649 women (239,888 examinations) screened, between June 2015 and March 2017, at multiple centers within a large healthcare organization.

RESULTS:
The racially diverse study cohort was 60% Caucasian and 23% African American with median age 59 years; 54% of the exams were 2D and 46% were 3D screening mammography. Fifty four percent of 3D screens were in women with dense breasts (heterogeneously dense or extremely dense) compared to 40% of 2D screens. Recall rates were higher among African Americans compared to Caucasians and women of other races (11.6% versus 10.3% versus 10.1%, respectively; p<0.001), were higher in younger women [40-50y=14.8%, 50-60y=10.4%, 60-70y=9.2%, 70-80y=7.9%, 80-90y=7.1%], those with higher breast density and with higher lifetime Tyrer-Cusick Risk scores.

CONCLUSION:
This data driven platform enables large scale assessment (outcomes by pathway, and variation in care) of screening mammography in a real-world population. Initial analyses demonstrate significant differences in choice of screening modalities and outcomes by patient demographic and breast risk profile. Future analyses will focus on optimizing diagnostic pathways on the basis of risk profiles with the goal of improving outcomes in breast cancer screening.
Depth Matters: The Use of Radiofrequency for the Treatment of Gynecologic Conditions [40G]
Authors: Krychman Michael , Wilkerson Debbie , Finnieston Arica , Tomasetti Perry , Bell Stacie 
Published: April 2018

INTRODUCTION:
The use of radiofrequency (RF) energy administration to the vaginal canal has been increasing, but questions regarding safety and mechanism of action remain. The type of RF, mode of administration and protocol will impact treatment outcomes. Submucosa cellular changes require that energy penetrate deep into the tissue without causes damage to the mucosal tissue. Data indicate that cryogen-cooled monopolar radiofrequency (CMRF) treatment elicits changes such as fibroblast activation and neocollagenesis while being safe to patients

METHODS:
Ovine ex vivo and in vivo studies were performed to investigate the depth of penetration and safety of CMRF treatment. Ex vivo treatment was performed on isolated vaginal and peri-vaginal tissue at different regions of the vagina. Gross observations and histopathological analyses were performed. Tissue was isolated following RF treatment and analyzed for tissue effects. Outcome measures include temperature monitoring and histopathology to evaluate the extent of treatment, cellular changes and safety.

RESULTS:
Data indicate that there are a number of cellular changes in the submucosal layers of the vagina following elevated temperature of these tissues and that these modifications result in increased structural integrity and function. Such changes are likely responsible for clinical benefit reported. In addition, when an energy titration experiment was performed with ex vivo tissue, there were no adverse tissue effects observed.

CONCLUSION:
The type of RF energy and mode of delivery will have an impact on the tissue affected and the potential clinical benefit. CMRF energy affects the deeper connective tissue in the vaginal canal while protecting the mucosal tissue
Contraceptive Use Among Reproductive Age Women with Cardiomyopathy [1H]
Authors: Krinock Derek , Louis Judette 
Published: April 2018

INTRODUCTION:
We sought to evaluate the rates and predictors of contraception in reproductive age women with cardiomyopathy.

METHODS:
A retrospective cohort study of women age 18-45 who were admitted with a known diagnosis of cardiomyopathy at a single urban tertiary care center between 5/2010 and 6/2016 was performed. Clinical charts were reviewed for clinical course, medication use and demographic data. The data was analyzed using chi-square and Mann Whitney U test. P less than 0.05 was considered significant.

RESULTS:
Among the 45 women with cardiomyopathy, 29% had an ejection fraction ≤30% and 80% were taking a medication recognized as potentially teratogenic. These included ACE inhibitors, Coumadin and others. Only 37% of the women were taking birth control. These included tubal ligation (n=11) and long acting reversible contraception (n=2). Women with a hysterectomy (n=4) were considered to have contraception. Women with contraception when compared to women without contraception were more likely to be married (53 vs 14%, p=0.04) and have a higher BMI (33 vs 27 kg/m2, p=0.04) but there was no difference in the utilization of public insurance (82 vs 75%, p=.71). They were more likely to have chronic hypertension (94 vs 50%, p=0.003) but less likely to be taking a medication which was potentially teratogenic (89 vs 64%, p=0.04). Overall, 30% of women taking a potentially teratogenic medication were on birth control.

CONCLUSION:
Among women with cardiomyopathy, contraception is underutilized. A focus in this population is warranted in order to prevent maternal and infant morbidity and mortality.
The Influence of Oral Contraceptive Hormones on Anterior Cruciate Ligament Strength [7H]
Authors: Konopka Jaclyn A. , Hsue Lauren J. , Dragoo Jason L. 
Published: April 2018

INTRODUCTION:
Females are up to eight times more likely to injure anterior cruciate ligaments (ACLs) than males, and hormonal differences predispose women to ACL injury. Various hormones—including relaxin and estrogen—impact ACL strength. Oral contraceptives (OCs) alter these hormone levels; however, studies have not yet compared different OCs’ influences on ACL strength.

METHODS:
Untreated and pregnant rats were compared to rats treated with Norethindrone only, Etynodiol Diacetate-plus-Ethinyl Estradiol, or Norgestimate-plus-Ethinyl Estradiol. OC doses adjusted for bioavailabilty and body weight were administered daily via oral gavage for four estrous cycles (20 days). Thirty-two rats were sacrificed; specimens were assessed for maximum load before failure and ultimate stress. Data were analyzed with One-Way ANOVA and post-hoc Bonferroni-Holm calculations.

RESULTS:
Ultimate stress of ACLs from Norethindrone (43.46 ± 3.47 MPa) and Etynodiol Diacetate-plus-Ethinyl Estradiol-treated rats (43.62 ± 9.70 MPa) was significantly increased when compared to untreated rats (28.20 ± 7.28 MPa) (P = .0203 and P = .0298 respectively). Maximum ACL load before failure from Norethindrone-treated rats (39.14 ± 2.75 N) was increased compared to untreated rats (33.10 ± 3.70 N) (P = .0414) and Norgestimate-plus-Ethinyl Estradiol-treated rats (31.27 ± 3.43 N) (P = .0406). Pregnant rats weren’t significantly different from other rats.

CONCLUSION:
OCs influence ACL strength differently depending on formulation. Norethindrone and Etynodiol Diacetate-plus-Ethinyl Estradiol increase ACL strength compared to Norgestimate-plus-Ethinyl Estradiol, pregnant, and untreated conditions. Formulations lacking estrogen or with high progestin:estrogen ratios, like Etynodiol Diacetate-plus-Ethinyl Estradiol, may better protect the ACL than formulations with smaller ratios, like Norgestimate-plus-Ethinyl Estradiol.
Implementation of Evidence-Based Cesarean Section (CS) Technique [10H]
Authors: Kaye Madeline R. , Rieger Mary , Gavrizi Sarah , Harkins John , Keller Whitney , White Amanda 
Published: April 2018

INTRODUCTION:
Despite evidence supporting specific CS operative techniques, usage is poor. We aimed to observe the effect of a QI initiative on evidence-based operative techniques uptake and its impact on postoperative pain, operative time and estimated blood loss (EBL).

METHODS:
Literature review identified blunt fascial dissection, lack of bladder flap, passive placental delivery, no peritoneal closure, and sutured skin closure as best practice operative techniques. The QI initiative identifying these practices was disseminated through written communication and large group discussion, including both faculty and trainees. Chart review abstracted demographic data, adherence to evidence-based techniques, operative time, post-operative pain scores at 48 hours, and pre- and post-operative hemoglobin for the 6 months before and after the QI initiative.

RESULTS:
509 cases met inclusion criteria; 256 prior to QI and 203 following. After QI, blunt facial dissection increased (13.4 to 41.6%, p=0.00), bladder flap creation decreased (25.4 to 12.3%, p=0.0002), manual placental extraction decreased (75.6 to 48.2%, p=0.00), peritoneal closure decreased (46.5 to 32.8%, p=0.0016), and subcuticular skin closure increased (77 to 89.7%, p=0.0001) (all controlled for baseline differences between groups). Operative time, postoperative pain measures, and EBL did not change after the QI initiative. Controlling for all other factors, blunt fascial dissection was associated with decreased operative time (p=0.00) and increased post-op pain at 48 hours (p=0.01).

CONCLUSION:
Dissemination of recommendations from a QI initiative resulted in increased uptake of best practice operative techniques, although with varying effects on measured operative outcomes. Our project demonstrates the need for continued efforts in standardization of operative technique.
Utilization of TVUS and fFN Screening, Antenatal Steroids Use and Risk of Preterm Delivery [11H]
Authors: Lauder Jhenette , Shen Xian , Petrilla Allison , Sullivan Erin , Troeger Kathleen , Sciscione Anthony 
Published: April 2018

INTRODUCTION:
This study measured use of fetal fibronectin (fFN) testing and transvaginal ultrasound (TVUS) among women with symptomatic preterm labor (PTL) and evaluated use of antenatal steroids and time to infant delivery.

METHODS:
A cohort of pregnant women with symptomatic PTL in 2012-2016 was identified; exclusion criteria included: premature rupture of membranes, pre-eclampsia, viral infection, and no record of delivery. Four patient groups were formed based on receipt of the combination of fFN testing and TVUS: fFN only, TVUS only, fFN and TVUS, neither fFN nor TVUS. Kaplan-Meier analysis and Cox Proportional Hazard model were performed to assess time to delivery following the PTL assessment.

RESULTS:
A total of 94,343 patients were included in the analysis; 6.7% patients received fFN test only, 13.3% received TVUS only, 3.2% received both fFN test and TVUS, and 76.8% received neither test. Antenatal steroids utilization ranged from 1.0% in the group receiving neither test to 7.9% in the group receiving both tests. The average time to delivery was shortest for patients who received neither test (12.1 days), followed by TVUS only (16.3 days), fFN only (31.2 days) and the fFN and TVUS (31.4 days) group. The adjusted risk for infant delivery within 7 days was approximately 50% lower for women who received fFN test and 10% lower for the TVUS only group compared to those who received neither test.

CONCLUSION:
Less than one in five eligible patients triaged for symptomatic PTL received TVUS or fFN. Among those who received fFN testing, a longer interval to birth was observed.
Is Diabetes Knowledge at Initial Prenatal Visit Associated with Maternal and Neonatal Outcomes? [12H]
Authors: Wernimont Sarah A. , Sheng Jessica , Fleener Diedre , Traore Fanta , Syrop Craig , Andrews Janet 
Published: April 2018

INTRODUCTION:
Diabetes knowledge is correlated with improved glucose control outside of pregnancy. However, associations between maternal diabetes knowledge and pregnancy outcomes have not been investigated.

METHODS:
This is a prospective cohort study of women with insulin-requiring diabetes enrolled in a team-based diabetes program. Women completed the validated Michigan Diabetes Knowledge Test at their initial visit. 53 women were categorized into high (>75%, N=32), moderate (60-74%, N=13) or low knowledge (< 59%, N=8) groups based on % correct responses. We referred women with low or moderate knowledge to diabetes education courses. The primary outcomes were glycosylated hemoglobin A1c (HbA1c) and a neonatal composite of hypoglycemia, large for gestational age, preterm birth and hyperbilirubinemia requiring phototherapy. All results were analyzed by Fisher exact test or ANOVA as indicated. p<0.05 was considered statistically significant.

RESULTS:
All groups had similar baseline characteristics with high, moderate and low knowledge groups having HbA1c of 8.1%, 7.9% and 7.9%, respectively. All three groups achieved an average HgbA1c of less than 6% at time of delivery. 39 women repeated the knowledge test in the third trimester and 71% improved their scores. Neonatal outcomes were similar among the three groups.

CONCLUSION:
Regardless of initial knowledge, women enrolled in a team-based diabetes program can achieve excellent glucose control in pregnancy. Similar glucose control at delivery in all groups may be associated with targeted referral to diabetes education programs. Overall, this study provides optimism for diabetes care teams that women with low diabetes knowledge can achieve glucose control in pregnancy.