bluuebunny/crossref_metadata_2025_split huggingface dataset:
Opioid Use After Laparoscopic Hysterectomy: Prescribing Practices and Preoperative Predictors [5Q]
Authors: Wong Marron C. , Isaacson Keith B. , Morris Stephanie 
Published: April 2018

INTRODUCTION:
Gynecologists can address the prescription opioid epidemic by prescribing appropriate quantities of postoperative opioids. Our goals were to measure opioid use after laparoscopic hysterectomy (LH) and to survey patients to identify factors that are predictive of higher opioid use.

METHODS:
We prospectively followed 60 patients undergoing LH for benign indications. Patients completed a preoperative survey including demographics, medical history, and standardized surveys measuring pain catastrophizing (PCS), anxiety (GAD-7), and depression (PHQ-9). Pain scores and pain medication usage were assessed at one and two weeks after surgery. Postoperative opioids were converted to morphine milligram equivalents (MME). Non-parametric statistical methods (Spearman correlation coefficient or Wilcoxon rank-sum test) were used to test for correlations between predictors and postoperative MME.

RESULTS:
A median of 20 opioid pills were prescribed (150 MME). Median use was 37.5 MME, equivalent to 5 tabs of 5mg oxycodone. 30% used opioids for <24 hours; 90% used no opioids after one week. 88.3% had leftover opioids (median 15 pills). Only 22.6% of leftover opioids were stored securely. Factors that were significantly associated (p<0.005) with increased opioid use included preoperative pain score, expected postoperative pain level, predicted pain medication requirement, PCS, GAD-7, PHQ-9, history of endometriosis or pelvic pain, preoperative pain medication use, and smaller uterine size.

CONCLUSION:
The average LH patient uses minimal opioids and leftover opioids are usually kept unsecured, illustrating a need to decrease prescribed opioids and educate patients about opioid disposal. Our preoperative survey shows promise for building a model to predict which patients are at risk for requiring more opioids.
Efficacy of Bremelanotide for HSDD in Women: RECONNECT Open-Label Extension Phase Results [8Q]
Authors: Clayton Anita H. , Kingsberg Sheryl A. , Simon James A. , Jordan Robert , Lucas Johna 
Published: April 2018

INTRODUCTION:
Bremelanotide, an investigational new drug, is a melanocortin 4 receptor agonist that has demonstrated efficacy in treatment of hypoactive sexual desire disorder (HSDD) in premenopausal women. The objective of this analysis was to evaluate sustained maintenance of bremelanotide effect on HSDD during the open-label extension (OLE) phase of the RECONNECT Study.

METHODS:
After completion of the double-blinded, placebo-controlled, core phase of RECONNECT (301 and 302 studies), premenopausal women with HSDD were eligible to enroll in the 52-week OLE. Bremelanotide 1.75 mg was self-administered as desired via auto-injector pen. Efficacy was assessed via FSFI and FSDS-DAO questionnaires. FSFI desire domain (FSFI-D) and FSDS-DAO distress resulting from low desire (Item 13) were co-primary endpoints. Data were collected during clinic visits occurring at 4- to 8-week intervals. OLE baselines for the bremelanotide and placebo groups were core study baseline and end of core study, respectively.

RESULTS:
For the 301 study OLE, 124 subjects from the bremelanotide arm and 239 subjects from the placebo arm were enrolled. At week 4, subjects who received bremelanotide or placebo in the core phase demonstrated respective mean changes from group baseline of 1.11 and 0.80 in FSFI-D, and -1.20 and -0.60 in FSDS-DAO Item 13. The 302 study had similar OLE results. For all subjects, improvements were consistently maintained until week 52. Similar trends were also observed for multiple secondary endpoints.

CONCLUSION:
Regardless of core phase treatment, bremelanotide provided treatment benefits in women with HSDD for the duration of the year-long RECONNECT OLE.
Low Rates of Insomnia Associated With Flibanserin in Premenopausal Women With Hypoactive Sexual Desire Disorder [21Q]
Authors: Simon James A. , Kupferer Elizabeth , Yuan James , Pfaus James G. , Kissling Robert , Goldstein Irwin 
Published: April 2018

INTRODUCTION:
Flibanserin, a 5-HT1A agonist and 5-HT2A antagonist, is approved for treatment of acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women. Insomnia is a common side effect of medications that affect central serotonergic mechanisms. This analysis examined the incidence of insomnia associated with flibanserin and other representative medications that affect central serotonergic systems.

METHODS:
Patient-level data from five 24-week, randomized, double-blind, placebo-controlled, studies in premenopausal women with HSDD were pooled to evaluate the incidence, time to onset, and duration of insomnia with flibanserin treatment. Incidence of insomnia was obtained from clinical trial data reported in the prescribing information for a commonly prescribed selective serotonin reuptake inhibitor (sertraline, steady-state treatment), serotonin-norepinephrine reuptake inhibitor (venlafaxine, steady-state treatment), and triptan (sumatriptan, acute treatment).

RESULTS:
In the pooled data (flibanserin 100 mg at bedtime, n=1,543; placebo, n=1,905), most patients (88.2%) were white and mean age was 35.8 years. Mean exposure was 139.0 days with flibanserin and 147.4 days with placebo. The incidence of insomnia was 4.9% with flibanserin and 2.4% with placebo. As context, the incidence of insomnia reported for some commonly used medications that affect the central serotonergic mechanisms ranges from <2% to 21%. Median time to onset of insomnia with flibanserin was 11.0 days from drug initiation and lasted for a median duration of 31 days (range, 1-186 days).

CONCLUSION:
The incidence of insomnia with flibanserin was 4.9%, toward the lower end of the range seen with other medications with central serotonergic effects; onset was typically within 2 weeks and resolution within 31 days.
Restoring Function with Neonatal Fluid Allograft in Cases of Endometriosis or Other Ovarian Destructive Conditions [23Q]
Authors: Karon Magdalene 
Published: April 2018

INTRODUCTION:
Endometriosis, in particular endometriomas, can cause impairments in folliculogenesis or other damage to ovarian tissue in patients trying to achieve pregnancy. These patients are often tested for levels of anti-Mullerian hormone (AMH), follicle stimulating hormone, and antral follicle counts to assess “ovarian reserve” and fertility potential. Here we present use of a fluid neonatal allograft in laparoscopy to improve AMH levels and chances of conception. The allograft has a multi-specialty indication for the correction of soft tissue defects, and current research suggests it may have the potential to aid in restoration of ovarian function.

METHODS:
Three patients with moderate to severe endometriosis underwent laparoscopic resection of endometriosis and ovariolysis. Patients’ fallopian tubes were patent and fimbria intact. An amniotic fluid allograft was injected in the areas of tissue defects. Patients had blood work tested pre-operatively and 1 and 3mo post-operatively. Ultrasound was also performed pre- and post-operatively to assess antral follicle count in the beginning and middle of menstruation cycle.

RESULTS:
One patient had a rise of AMH level from 0.5ng/ml (pre-op) to 1.5ng/ml (post-op). This patient also had mature follicle on day 12 of her cycle whereas pre-operatively there was no evidence of folliculogenesis by ultrasound even with Clomid therapy. Assessments of two other patients are on-going.

CONCLUSION:
Preliminary findings show an improvement in AMH levels and folliculogenesis after ovarian treatment with a neonatal-derived fluid allograft, suggesting that this treatment may aid in restoration of ovarian function and achievement of a successful pregnancy.
Reducing Surgical Site Infections after Non-Hysterectomy Abdominal Gynecologic Surgery [25Q]
Authors: Dejbakhsh Sheila Z. , Maisonet Axeline , Allen Antoinette , Zhou Xinkai , Holschneider Christine 
Published: April 2018

INTRODUCTION:
Surgical site infections (SSI) are common and a significant source of preventable morbidity in gynecologic surgery. Of the gynecological SSIs at our urban tertiary care safety-net hospital >50% had no indication for preoperative antibiotics based on current ACOG guidelines, which do not recommend antibiotics for abdominal surgeries outside of hysterectomy. In July 2016, we implemented a Quality Improvement (QI) initiative whereby Cefazolin was administered to all patients undergoing non-hysterectomy abdominal gynecologic surgery.

METHODS:
The purpose of this study is to perform a one-year interim analysis to assess whether pre-operative antibiotics administered for non-hysterectomy abdominal gynecologic surgery decreased the incidence of SSI as compared to a pre-intervention control group. The primary outcome was incidence of SSI, as defined by CDC guidelines. Data were collected on type of surgery, antibiotics, SSIs, and potential confounders for cases performed between November 2013 and June 2017 (n=507).

RESULTS:
The rate of SSI decreased after the implementation of the QI initiative from 7.5% (29/383) in the pre-intervention group to 3.2% (4/124) in the intervention group (P=.06). There was a significant decrease in the incidence of SSI from 8.5% (23/270) in patients that did not receive pre-operative antibiotics to 4.2% (10/237) in those that received pre-operative antibiotics (P=.03). Peri-operative variables associated with an increased incidence of SSI included increased surgical time, ASA class III and IV, and open vs laparoscopic surgical entry.

CONCLUSION:
The use of pre-operative antibiotics in non-hysterectomy abdominal gynecologic surgery resulted in a significant decrease in SSI incidence.
Methadone vs Methadone and Smoking Effect on Fetal Growth [35Q]
Authors: Farhi Farnaz , Cruz Yury , Rodriguez Alison , Berghella Vincenzo , Mercier Rebecca , Roman Amanda 
Published: April 2018

INTRODUCTION:
To evaluate the incidence of intrauterine fetal growth restriction (IUGR) and small for gestational age (SGA) at birth in women on methadone maintenance therapy who smoke cigarettes compared to those on methadone maintenance therapy who do not smoke cigarettes.

METHODS:
A retrospective cohort study of women delivered at Thomas Jefferson University Hospital from 2012 to 2015. We excluded non-singleton pregnancies. We evaluated demographic and obstetric information, ultrasound measurements, including estimated fetal weight (EFW), EFW percentile, head circumference, and abdominal circumference from last ultrasound, as well as delivery and neonatal outcomes, including gestational age at delivery, birth weight (BW), BW percentile, NICU admission, and length of stay in NICU. Smoking history was collected (number of cigarettes, if quit during pregnancy, use per trimester). Primary outcome: incidence of IUGR by last ultrasound and SGA. Secondary outcomes: preterm birth <37 weeks. Adjustment for confounders for fetal growth restriction was performed.

RESULTS:
We identified 70 women in the methadone maintenance therapy, 88.5% of whom reported smoking cigarettes and 11.4% of whom did not report smoking. Demographics were not significantly different. The incidence of IUGR and SGA were not significantly different: 4.8% vs 0% P:1.0 and 24.2% vs 25.0% P:1.0, respectively. There were no significant differences in preterm birth, birth weight, NICU admission and length of stay in NICU.

CONCLUSION:
In women on methadone maintenance therapy, there is a high incidence of IUGR and SGA; however, IUGR and SGA were not significantly different during pregnancy in women who smoked cigarettes compared to those who did not smoke cigarettes.
Mifepristone and Misoprostol Labor Induction in Intrauterine Fetal Demise: Meta-Analysis [38Q]
Authors: Kanninen Tomi T. , Nasioudis Dimitrios , Moretti Michael , Lakhi Nisha 
Published: April 2018

INTRODUCTION:
Systematic review and meta-analysis was conducted to assess the effectiveness of combination mifepristone and misoprostol compared to misoprostol alone for induction of labor (IOL) for intrauterine fetal demise (IUFD) after 20 gestational weeks.

METHODS:
Medline, Scopus, ClinicalTrials.gov, Embase, Science Direct, Cochrane Central Register of Controlled Trials, and Scielo were searched for the following terms: “mifepristone”, “misoprostol”, and “IUFD” from inception until September 2017. All randomized controlled trials (RCTs) examining misoprostol versus the combination of misoprostol and mifepristone were included. Primary outcome was induction to delivery interval. Intragroup differences in parity, gestational age and bishop score was examined. Meta-analysis (Review Manager v.5.3) was performed using a fixed effects model to produce summary treatment effects in terms of mean difference, with 95% confidence intervals. Heterogeneity was measured using Chi-square and I2 statistics. GRADE approach was used to assess the quality of evidence.

RESULTS:
Two RCTs, including 140 women met inclusion criteria. The combination of mifepristone and misoprostol lead to a shorter interval to delivery mean difference -4.19 hours (95% CI, -5.58, -2.81). Chi-square 0.39, I2 =0%. There was no significant difference between groups in regard to parity, gestational age and bishop score. The quality of evidence was judged as low due to lack of clear randomization, allocation concealment, and blinding.

CONCLUSION:
Combination mifepristone and misoprostol is effective and leads to a shorter induction to delivery interval as compared to misoprostol alone for IOL for IUFD after 20 gestational weeks. Further well-designed RCTs are necessary given the low quality of evidence.
Responses to Fetal Heart Rate Alarms on a Busy Tertiary Labor and Delivery Unit [12R]
Authors: Ona Samsiya , Greenberg James A. 
Published: April 2018

INTRODUCTION:
Alarm fatigue is a well-recognized phenomenon that has been demonstrated to impede rather than promote patient safety. This study investigates the incidence of electronic fetal heart rate (FHR) monitor alarms and staff responses.

METHODS:
The FHR monitor database from the labor and delivery (L&D) unit was queried to determine the number and duration of alarms/day over the course of 7 consecutive days. In addition, a survey was sent to L&D care providers to determine their subjective impression of how often the alarms were activated and their action if any.

RESULTS:
Over 7 consecutive days, there were 130 deliveries associated with 4981 alarm events with a cumulative total of 103 hours of alarms (average 15 alerts/hr totaling cumulative average 7.4 hrs/day). Surveys were sent to 322 staff with responses from 159 (49%). Thirty-four (21.4%) surveys were incomplete. Of respondents 69% (110) had the subjective impression that the alarms were ringing either “often” or “almost all the time.” Of those only 59% took some action while 41% ignored or hardly noticed the alarms.

CONCLUSION:
In this study of a high-volume academic hospital L&D unit, our data show that FHR monitor alarms are ringing every 4 minutes for a cumulative total of about 1/3 of the day. However, these alerts are ignored by almost half of the staff. Consequently, we believe that either the use of FHR monitor alarms or the policies and procedure regarding those alarms should be reviewed to ensure that their use is having a positive impact on patient safety.
Gestational Weight Gain and the Risk for Operative Vaginal Delivery [13R]
Authors: Vignes Katherine S. , Williams Corrine M. , McDaniel Honour , Chavan Niraj R. 
Published: April 2018

INTRODUCTION:
This study evaluates the impact of gestational weight gain (GWG) on the risk for operative vaginal delivery across the spectrum of maternal pre-pregnancy body mass index (PPBMI).

METHODS:
Vital statistics data collected by the National Center for Health Statistics (NCHS) were utilized. Using the 2015 data, GWG was calculated and the birth cohort consisting of singleton gestations delivering vaginally was classified into inadequate, adequate and excess GWG categories as per the 2009 Institute of Medicine (IOM) guidelines. Each PPBMI category was further stratified based on the adequacy of GWG. Multivariate logistic regression analyses were used to predict the risk for operative vaginal delivery in each PPBMI and GWG group while adjusting for age, race, ethnicity, education, marital status, insurance and smoking status.

RESULTS:
The rate of operative vaginal delivery in this study cohort was 4.63% (116,610/2,517,605 singleton vaginal deliveries). Excess GWG significantly increased the risk for an operative vaginal delivery (OR 1.074 [95% CI 1.060 - 1.089]) irrespective of the PPBMI, in the adjusted regression analyses. In the PPBMI specific analyses - the risk for operative vaginal delivery was significantly increased in women with excess GWG in women classified as underweight OR 1.118 (95% CI 1.047-1.194), normal weight OR 1.112 (95% CI 1.092-1.134), overweight OR 1.145 (95% CI 1.112-1.179), and obese OR 1.148 (95% CI 1.108-1.189) as compared to those in the same weight categories with adequate GWG.

CONCLUSION:
Our findings demonstrate that women with excess GWG, regardless of their pre-pregnancy maternal weight category, are at increased risk of undergoing operative vaginal delivery.
Screening for Appendicitis in Pregnancy: A Cost-Effectiveness Analysis [15R]
Authors: Shields Michelanne , Chatroux Louisa R. , Hersh Alyssa R. 
Published: April 2018

INTRODUCTION:
The purpose of this study was to estimate the cost effectiveness of ultrasonography and magnetic resonance imaging (MRI) as diagnostic modalities for suspected appendicitis in pregnancy. We examined the cost of ultrasound as the first-line modality with sequential MRI in the setting of a non-visualized appendix versus MRI alone.

METHODS:
A cost-effectiveness model was created using TreeAge to compare the sequential ultrasound and MRI versus MRI alone in a theoretical cohort of 100,000 women. Outcomes examined included perforation of the appendix, cesarean delivery, maternal death, fetal death, cost, and quality-adjusted life years (QALY). Probabilities, utilities, and costs were derived from the literature, and a cost-effectiveness threshold was set at $100,000/QALY. One-way sensitivity analyses were used to evaluate the robustness of our results.

RESULTS:
When comparing sequential ultrasound and MRI versus MRI alone for diagnosis of appendicitis in pregnancy, there were 3.5 fewer fetal deaths with sequential screening. There was no difference in rate of maternal death. There were higher QALYs associated with sequential screening, but MRI alone was cost-effective. With sensitivity analysis, sequential screen became cost-effective below $200 (cost assumption in our model was $604).

CONCLUSION:
The sequential screening strategy led to fewer adverse neonatal outcomes. While this screening modality was not cost-effective, the higher QALYs make this screening algorithm worth considering in the clinical setting, especially due to improving clinician skills and the low cost of bedside ultrasound. Sequential screening is recommended as first-line imaging, and further investigation is warranted to better understand how these imaging modalities can improve clinical outcomes.
Relationships among Neonatal Mortality, Hospital Volume, Weekday Demand, and Weekend Birth [22R]
Authors: Restrepo Elizabeth , Hamilton Patti , Liu Fuqin , Mancuso Peggy 
Published: April 2018

INTRODUCTION:
Previous research indicated weekend birth and mid-range hospital volume are associated with increased risk of neonatal mortality. This study investigated how the proportion of births occurring Monday through Friday affects risk for neonatal mortality from low birth volume and weekend birth.

METHODS:
For this retrospective, population-based, cohort-study design, data were obtained from 32,140 electronic birth certificate records matched with 92 death certificate records from the Texas Department of State Health Statistics. The data represented all births and neonatal deaths in one metropolitan county in Texas for the year 2012. Statistical analyses included descriptive procedures, ANOVA, t-test, logistic regression, and chi square tests of association.

RESULTS:
After adjusting for birth weight and maternal ethnicity, we found the proportion of births occurring Monday through Friday, in hospitals, remained a significant factor affecting odds of neonatal mortality, whereas hospital birth volume and weekend birth did not remain significant predictors.

CONCLUSION:
The way in which hospitals respond to demand (e.g., allocating staff and other resources) across the week plays an important role in determining neonatal mortality risk, regardless of infants’ birth weight or maternal ethnicity. The study findings could raise awareness of system-level factors and stimulate more thorough, careful assessment and planning by hospital administrators and care providers. More research is needed to determine exactly how acuity and quality interact to increase weekend risk.
Food Deserts and Gestational Weight Gain: An Urban Problem? [24R]
Authors: Braightmeyer Kelli , Beausang Jasjit 
Published: April 2018

INTRODUCTION:
Over 48% of women in the United States gain more than the recommended amount of weight in pregnancy, and poor access to healthy foods has been proposed to contribute to this. Philadelphia has many food deserts, neighborhoods with poor access to affordable healthy food. These areas have been studied before; however, no studies have focused on pregnant women. The purpose of this study was to identify whether food access impacts gestational weight gain.

METHODS:
A survey detailing food access was administered to 197 postpartum women. Electronic medical record data was collected regarding gestational weight gain and basic demographic data. Primary analysis looked at gestational weight gain as influenced by the frequency of produce shopping. We also analyzed gestational weight gain based on distance to the nearest grocery store. Data was analyzed using chi-square tests, chi-square for linear associations, and Spearman’s correlations.

RESULTS:
Mean BMI of participants was 27.86, with 32.5% having a BMI of 30 or greater, and 59.3% gaining appropriate gestational weight. Produce shopping frequency did not significantly impact gestational weight gain, P=0.08. Participants who shopped for produce less frequently were least likely to gain excess weight; however, this trend is not a significant, rho=-0.09. There was no significant correlation of appropriate weight gain and distance to the nearest grocery store, (p=0.97).

CONCLUSION:
Sixty percent of participants in this study gained the recommended amount of weight during pregnancy. Residency within a food desert and frequency of produce shopping had no impact on weight gain during pregnancy.