bluuebunny/crossref_metadata_2025_split huggingface dataset:
Liposomal Bupivacaine Block at the Time of Cesarean Delivery to Decrease Postoperative Pain
Authors: Prabhu Malavika , Clapp Mark A. , McQuaid-Hanson Emily , Ona Samsiya , O'Donnell Taylor , James Kaitlyn , Bateman Brian T. , Wylie Blair J. , Barth William H. 
Published: June 2018

OBJECTIVE:
To evaluate whether a liposomal bupivacaine incisional block decreases postoperative pain and represents an opioid-minimizing strategy after scheduled cesarean delivery.

METHODS:
In a single-blind, randomized controlled trial among opioid-naive women undergoing cesarean delivery, liposomal bupivacaine or placebo was infiltrated into the fascia and skin at the surgical site, before fascial closure. Using an 11-point numeric rating scale, the primary outcome was pain score with movement at 48 hours postoperatively. A sample size of 40 women per group was needed to detect a 1.5-point reduction in pain score in the intervention group. Pain scores and opioid consumption, in oral morphine milligram equivalents, at 48 hours postoperatively were summarized as medians (interquartile range) and compared using the Wilcoxon rank-sum test.

RESULTS:
Between March and September 2017, 249 women were screened, 103 women enrolled, and 80 women were randomized. One woman in the liposomal bupivacaine group was excluded after randomization as a result of a vertical skin incision, leaving 39 patients in the liposomal bupivacaine group and 40 in the placebo group. Baseline characteristics between groups were similar. The median (interquartile range) pain score with movement at 48 hours postoperatively was 4 (2–5) in the liposomal bupivacaine group and 3.5 (2–5.5) in the placebo group (P=.72). The median (interquartile range) opioid use was 37.5 (7.5–60) morphine milligram equivalents in the liposomal bupivacaine group and 37.5 (15–75) morphine milligram equivalents in the placebo group during the first 48 hours postoperatively (P=.44).

CONCLUSION:
Compared with placebo, a liposomal bupivacaine incisional block at the time of cesarean delivery resulted in similar postoperative pain scores in the first 48 hours postoperatively.

CLINICAL TRIAL REGISTRATION:
ClinicalTrials.gov, NCT02959996.
Salpingectomy Compared With Tubal Ligation at Cesarean Delivery
Authors: Garcia Christine , Moskowitz Olivia M. , Chisholm Christian A. , Duska Linda R. , Warren Amy L. , Lyons Genevieve R. , Pettit Kate E. 
Published: June 2018

OBJECTIVE:
To estimate whether performance of salpingectomy compared with standard tubal ligation for sterilization at the time of cesarean delivery increases operating time or complication rates.

METHODS:
A randomized controlled noninferiority trial was performed at a single academic institution. Women undergoing planned cesarean delivery who desired sterilization were randomized to salpingectomy or standard tubal ligation. The primary outcome was length of time of the sterilization procedure, with the noninferiority margin set at 5 minutes. With a one-sided independent sample t test, to achieve a power of 90% with an α of 0.05, 18 women needed to complete each intervention.

RESULTS:
Forty-four women were enrolled, with 19 successfully undergoing salpingectomy and 18 undergoing standard tubal ligation. Salpingectomy could not be completed in 1 of 20 patients (as a result of adhesions). Baseline demographics were equivalent between groups. Salpingectomy procedure time was noninferior to standard tubal ligation, with a mean difference of 0.5 minutes, with a mean sterilization procedure time of 5.6 minutes in the salpingectomy group and 6.1 minutes in the standard tubal ligation group (P <.05, one-sided 95% CI upper bound 1.8 minutes). There was no difference between cesarean delivery with salpingectomy compared with cesarean delivery with standard tubal ligation in median total operating time (60 vs 68 minutes, P=.34) or estimated blood loss (600 vs 700 mL, P=.09). No patients in either group required reoperation or readmission.

CONCLUSION:
Salpingectomy procedure time was not longer than standard tubal ligation during cesarean delivery, with a mean difference of 30 seconds. There was a high completion rate for salpingectomy (95%) and no apparent increase in complications.

CLINICAL TRIAL REGISTRATION:

Clinicaltrials.gov, NCT03028623.
Long-Term Outcomes of Elagolix in Women With Endometriosis
Authors: Surrey Eric , Taylor Hugh S. , Giudice Linda , Lessey Bruce A. , Abrao Mauricio S. , Archer David F. , Diamond Michael P. , Johnson Neil P. , Watts Nelson B. , Gallagher J. Chris , Simon James A. , Carr Bruce R. , Dmowski W. Paul , Leyland Nicholas , Singh Sukhbir S. , Rechberger Tomasz , Agarwal Sanjay K. , Duan W. Rachel , Schwefel Brittany , Thomas James W. , Peloso Paul M. , Ng Juki , Soliman Ahmed M. , Chwalisz Kristof 
Published: June 2018

OBJECTIVE:
To evaluate the efficacy and safety of elagolix, an oral, nonpeptide gonadotropin-releasing hormone antagonist, over 12 months in women with endometriosis-associated pain.

METHODS:
Elaris Endometriosis (EM)-III and -IV were extension studies that evaluated an additional 6 months of treatment after two 6-month, double-blind, placebo-controlled phase 3 trials (12 continuous treatment months) with two elagolix doses (150 mg once daily and 200 mg twice daily). Coprimary efficacy endpoints were the proportion of responders (clinically meaningful pain reduction and stable or decreased rescue analgesic use) based on average monthly dysmenorrhea and nonmenstrual pelvic pain scores. Safety assessments included adverse events, clinical laboratory tests, and endometrial and bone mineral density assessments. The power of Elaris EM-III and -IV was based on the comparison to placebo in Elaris EM-I and -II with an expected 25% dropout rate.

RESULTS:
Between December 28, 2012, and October 31, 2014 (Elaris EM-III), and between May 27, 2014, and January 6, 2016 (Elaris EM-IV), 569 participants were enrolled. After 12 months of treatment, Elaris EM-III responder rates for dysmenorrhea were 52.1% at 150 mg once daily (Elaris EM-IV=50.8%) and 78.1% at 200 mg twice daily (Elaris EM-IV=75.9%). Elaris EM-III nonmenstrual pelvic pain responder rates were 67.8% at 150 mg once daily (Elaris EM-IV=66.4%) and 69.1% at 200 mg twice daily (Elaris EM-IV=67.2%). After 12 months of treatment, Elaris EM-III dyspareunia responder rates were 45.2% at 150 mg once daily (Elaris EM-IV=45.9%) and 60.0% at 200 mg twice daily (Elaris EM-IV=58.1%). Hot flush was the most common adverse event. Decreases from baseline in bone mineral density and increases from baseline in lipids were observed after 12 months of treatment. There were no adverse endometrial findings.

CONCLUSION:
Long-term elagolix treatment provided sustained reductions in dysmenorrhea, nonmenstrual pelvic pain, and dyspareunia. The safety was consistent with reduced estrogen levels and no new safety concerns were associated with long-term elagolix use.

CLINICAL TRIAL REGISTRATION:

ClinicalTrials.gov, NCT01760954 and NCT02143713.
Association of Obstetrician Gender With Obstetric Interventions and Outcomes
Authors: Yee Lynn M. , Miller Emily S. 
Published: June 2018

OBJECTIVE:
To estimate whether there are differences in obstetric interventions or outcomes by the gender of the delivering physician.

METHODS:
We conducted a retrospective cohort study of all nulliparous women delivering singleton, vertex, live births at 37 weeks of gestation or greater at a tertiary care institution (2014–2015). Patient clinical characteristics were analyzed by delivering physician gender. The primary outcomes were delivery mode and episiotomy. Secondary outcomes included major perineal laceration, postpartum hemorrhage, 5-minute Apgar score less than 7, cord umbilical artery pH less than 7.0, and neonatal intensive care unit admission. Univariable and hierarchical multivariable analyses including physician as a random effect were utilized for analyses.

RESULTS:
Of the 7,027 women who met inclusion criteria, 81.3% (n=5,716) were delivered by a female physician. Women delivered by female physicians were slightly younger than those delivered by male physicians and were more likely to be publicly insured (11.7% vs 7.1%, P<.001). Mode of delivery did not differ by physician gender; the cesarean delivery rate was 20.6% for male physicians and 20.5% for female physicians (P=.61). Although the episiotomy rate did differ by physician gender, with 5.9% of patients delivered by male physicians undergoing episiotomy compared with 3.6% of patients delivered by female physicians (P=.001), this finding did not persist in the multivariable model after accounting for potential confounders (adjusted odds ratio 0.87, 95% CI 0.49–1.56). There were no differences by physician gender regarding any of the examined secondary outcomes in univariable or multivariable analyses.

CONCLUSION:
Outcomes of nulliparous women undergoing a trial of labor did not differ by delivering physician gender.
Three Lymphadenectomy Strategies in Low-Risk Endometrial Carcinoma
Authors: Suidan Rudy S. , Sun Charlotte C. , Cantor Scott B. , Mariani Andrea , Soliman Pamela T. , Westin Shannon N. , Lu Karen H. , Giordano Sharon H. , Meyer Larissa A. 
Published: June 2018

OBJECTIVE:
To evaluate the cost-utility of three lymphadenectomy strategies in the management of low-risk endometrial carcinoma.

METHODS:
A decision analysis model compared three lymphadenectomy strategies in women undergoing minimally invasive surgery for low-risk endometrial carcinoma: 1) routine lymphadenectomy in all patients, 2) selective lymphadenectomy based on intraoperative frozen section criteria, and 3) sentinel lymph node mapping. Costs and outcomes were obtained from published literature and Medicare reimbursement rates. Costs categories consisted of hospital, physician, operating room, pathology, and lymphedema treatment. Effectiveness was defined as 3-year disease-specific survival adjusted for the effect of lymphedema (utility=0.8) on quality of life. A cost-utility analysis was performed comparing the different strategies. Multiple deterministic sensitivity analyses were done.

RESULTS:
In the base-case scenario, routine lymphadenectomy had a cost of $18,041 and an effectiveness of 2.79 quality-adjusted life-years (QALYs). Selective lymphadenectomy had a cost of $17,036 and an effectiveness of 2.81 QALYs, whereas sentinel lymph node mapping had a cost of $16,401 and an effectiveness of 2.87 QALYs. With a difference of $1,005 and 0.02 QALYs, selective lymphadenectomy was both less costly and more effective than routine lymphadenectomy, dominating it. However, with the lowest cost and highest effectiveness, sentinel lymph node mapping dominated the other modalities and was the most cost-effective strategy. These findings were robust to multiple sensitivity analyses varying the rates of lymphedema and lymphadenectomy, surgical approach (open or minimally invasive surgery), lymphedema utility, and costs. For the estimated 40,000 women undergoing surgery for low-risk endometrial carcinoma each year in the United States, the annual cost of routine lymphadenectomy, selective lymphadenectomy, and sentinel lymph node mapping would be $722 million, $681 million, and $656 million, respectively.

CONCLUSION:
Compared with routine and selective lymphadenectomy, sentinel lymph node mapping had the lowest costs and highest quality-adjusted survival, making it the most cost-effective strategy in the management of low-risk endometrial carcinoma.
Outpatient Foley Catheter for Induction of Labor in Parous Women
Authors: Kuper Spencer G. , Jauk Victoria C. , George David M. , Edwards Rodney K. , Szychowski Jeff M. , Mazzoni Sara E. , Wang Michelle J. , Files Pamela , Tita Alan T. , Subramaniam Akila , Harper Lorie M. 
Published: June 2018

OBJECTIVE:
To assess whether outpatient cervical ripening with a transcervical Foley catheter in parous women undergoing elective induction of labor shortens the total duration of time from admission to the labor ward until delivery.

METHODS:
We performed an open-label randomized controlled trial at a single academic center in parous women at 39 weeks of gestation or greater with a cervix 3 cm or less dilated, or, if 2–3 cm dilated, less than 80% effaced and reassuring fetal heart rate monitoring (defined as moderate variability with a normal baseline and absence of decelerations). Exclusions were obstetric and neonatal conditions deemed unsuitable for outpatient cervical ripening, contraindications to vaginal delivery, or conditions that required immediate hospitalization. Women were randomized in the ambulatory setting to either an outpatient transcervical catheter (with immediate placement) or inpatient transcervical catheter placement and concomitant oxytocin infusion on the labor ward. Women in the outpatient group were instructed to return to the hospital the next day or sooner if labor occurred. Induction of labor was managed per institutional protocol, and once participants were admitted, oxytocin was initiated. The primary outcome was the duration of time from labor ward admission until delivery. Based on a prior study in our institution, a total of 128 women were needed for 80% power to detect a 12-hour difference in total duration spent from labor ward admission until delivery with a two-sided α of 0.05.

RESULTS:
Of 743 women screened, 129 provided consent and were randomized from May 2016 to October 2017. Baseline characteristics were balanced between groups. Outpatient cervical ripening did not significantly shorten the time from labor ward admission until delivery (12.4±7.4 vs 13.5±7.0 hours, P=.38).

CONCLUSION:
Outpatient cervical ripening in parous women does not shorten the time from labor ward admission until delivery if oxytocin is initiated simultaneously with inpatient transcervical catheter placement.

CLINICAL TRIAL REGISTRATION:
ClinicalTrials.gov, NCT02756689.
Evaluation of a Quality Improvement Intervention to Increase Vaginal Birth for Twins
Authors: Easter Sarah Rae , Bibbo Carolina , Panelli Danielle , Little Sarah E. , Carusi Daniela , Robinson Julian N. 
Published: June 2018

OBJECTIVE:
To evaluate whether there was an association between the systematic promotion of twin vaginal delivery and an increase in the rates of twin vaginal birth.

METHODS:
We conducted a retrospective cohort study. We implemented a quality improvement initiative promoting twin vaginal delivery at an academic tertiary care center in 2013. The program included a needs assessment, simulation of vaginal twin delivery, online educational material, and the expansion of a dedicated twin clinic. We analyzed rates of twin vaginal birth in pregnancies at or beyond 24 weeks of gestation without a contraindication to labor, prior uterine surgery, or a demise or lethal anomaly of either twin. Using linear regression, we calculated annual adjusted rates of twin vaginal birth from 2010 to 2015 and in the 3 years before and after our intervention. We performed an interrupted time-series analysis estimating rates of change before and after the intervention to account for the influence of secular trend.

RESULTS:
Of 1,574 patients delivering twins, 897 (57%) were included, with 479 in the 3 years before and 418 in the 3 years after the intervention. Adjusted rates of vaginal delivery increased from 32.1% (n=153) to 44.2% (n=185) before and after the intervention (P<.01), with a decrease in elective cesarean delivery from 54.6% (n=479) to 44.3% (n=185) (P<.01). Rates of breech extraction increased after the intervention (5.7% vs 9.3%, P=.04). However, there was no difference in the rate of change in twin vaginal birth in the time period before (1.35% annual increase, P=.76) or after (5.8% annual increase, P=.40) the intervention.

CONCLUSIONS:
Although we observed an increased rate of twin vaginal birth in the time period after our intervention, because the rates of increase before and after the intervention were not statistically different, the increase is not attributable to our intervention and is more properly attributed to secular trend.
Tobacco Use and Prevalence of Human Papillomavirus in Self-Collected Cervicovaginal Swabs Between 2009 and 2014
Authors: Tarney Christopher M. , Beltran Thomas A. , Klaric John , Han Jasmine J. 
Published: June 2018

OBJECTIVE:
To evaluate relationships between an objective biomarker of current tobacco exposure and high-risk genital human papillomavirus (HPV) prevalence among adult women in the United States.

METHODS:
We performed a retrospective analysis of adult women (aged 18–59 years) using three consecutive 2-year cycles (2009–2014) from the cross-sectional National Health and Nutrition Examination Surveys. Women who provided self-collected cervicovaginal swabs and serum were included. Human papillomavirus genotyping was conducted on cervicovaginal samples with a Linear Array HPV assay. Cotinine, a major metabolite of nicotine, was assayed from serum to provide a biomarker of recent tobacco exposure. Participants were stratified into three levels of tobacco exposure (nonsmokers, secondhand smoke exposure, and smokers) based on serum cotinine concentration levels using previously published ethnic-specific cut points. Weighted percentages are provided to account for unequal selection probabilities among participants and adjustments for nonresponse.

RESULTS:
Among the 5,158 women analyzed, 2,778 were classified as nonsmokers (57.1%, 95% CI 54.5–59.6%), 1,109 classified as having secondhand smoke exposure (18.4%, 95% CI 16.5–20.3%), and 1,271 classified as smokers (24.6%, 95% CI 22.8–26.5%) using serum cotinine concentration levels. Prevalence of HPV infection differed between nicotine exposure groups (P<.001): 441 smokers (32.1%, 95% CI 29.6–34.7%), 322 women with secondhand smoke exposure (26.1%, 95% CI 22.7–29.7%), and 451 nonsmokers (15.1%, 95% CI 13.3–17.1%) had a high-risk genital HPV infection. Controlling for demographics and number of lifetime sexual partners, the risks compared with nonsmokers for infection with a high-risk HPV genotype for smokers (adjusted odds ratio [OR] 1.7, 95% CI 1.4–22) and secondhand smokers (adjusted OR 1.4, 95% CI 1.1–1.8) are similarly increased (P<.001).

CONCLUSION:
In this large cross-sectional, population-based study, we show a relationship between an objective biomarker of current tobacco use and genital HPV infection. Cigarette smoking and exposure to secondhand smoke are associated with increased odds of infection with high-risk genital HPV independent of lifetime number of sexual partners.
Industry Payments to Obstetricians and Gynecologists Under the Sunshine Act
Authors: Muffly Tyler M. , Giamberardino Whitney L. , Guido Joseph , Weterings Robbie , Bastow Brittney , Sheeder Jeanelle 
Published: June 2018

OBJECTIVE:
To evaluate financial relationships between obstetrician–gynecologists (ob-gyns) and industry, including the prevalence, magnitude, and the nature of payments.

METHODS:
We conducted a cross-sectional study in which we obtained a list of industry contributions to U.S. obstetricians and gynecologists through the Centers for Medicare and Medicaid Services Open Payments Database from August 1, 2013, to December 31, 2015. These data were cross-referenced with the entire cohort of practicing obstetricians and gynecologists, who were identified using the National Provider Identification database, because not all practicing ob-gyns received payments. These payments were analyzed with respect to 1) types of payments, 2) demographic attributes of health care providers receiving payments, and 3) comparisons between obstetrician and gynecologist subspecialties. Continuous data were compared using the Mann-Whitney test for variables that were not normally distributed and with the t test for variables that are normally distributed.

RESULTS:
A total of 517,077 nonresearch payments, totaling $79,965,244, were made to 23,292 ob-gyns. Physicians receiving payments were predominantly female, younger than 65 years old, allopathic physicians who graduated from U.S. medical schools in the late 1990s, and were board-certified subspecialists (P<.001 for all). Half of all ob-gyns received payments of varying amounts from drug manufacturers, device manufacturers, or both, with most of the payments for honoraria, faculty compensation, or consulting. Female pelvic medicine and reconstructive surgery physicians received the largest median dollar amount; maternal–fetal medicine physicians received the smallest.

CONCLUSION:
Obstetricians and gynecologists receive a substantial amount of payments from industry. Most of these payments were for honoraria, faculty compensation, or consulting and totaled less than $400 per health care provider. Although this total amount is less than typically received by surgical providers, including orthopedic surgeons who account for the highest compensated group in total and mean industry payments, the median payment value for obstetrics and gynecology subspecialists surpasses the median payment to orthopedic surgeons. These financial relationships warrant further exploration with future research.
Use of Antihypertensive Medications and Uterotonics During Delivery Hospitalizations in Women With Asthma
Authors: Booker Whitney A. , Siddiq Zainab , Huang Yongmei , Ananth Cande V. , Wright Jason D. , Cleary Kirsten L. , D'Alton Mary E. , Friedman Alexander M. 
Published: June 2018

OBJECTIVE:
To estimate whether the diagnosis of asthma is associated with the use of specific uterotonic and antihypertensive medications during delivery hospitalizations.

METHODS:
We used Perspective, an administrative database, to determine whether women hospitalized for delivery complicated by postpartum hemorrhage or preeclampsia received uterotonics and antihypertensive medications differentially based on the absence or presence of asthma from 2006 to 2015. Given that carboprost and intravenous (IV) labetalol may be associated with asthma exacerbation, adjusted models for receipt of these medications were created with adjusted risk ratios with 95% CIs as measures of effect. Risk for status asthmaticus based on receipt of carboprost and IV labetalol was analyzed.

RESULTS:
Over the study period, a total of 5,691,178 women were analyzed, of whom 239,915 (4.2%) had preeclampsia and 139,841 postpartum hemorrhage (2.5%). Carboprost was used less frequently in patients with asthma compared with patients with no asthma (11.4% vs 18.0%) in comparison with IV labetalol, which was used more commonly when a diagnosis of asthma was present (18.5% vs 16.7%). In unadjusted analysis, the presence of asthma was associated with a 37% decrease in likelihood of carboprost use and an 11% increase in likelihood of labetalol use. In adjusted analysis, the presence of asthma was associated with a 32% decrease in likelihood of carboprost use (adjusted risk ratio 0.68, 95% CI 0.62–0.74) compared with a 7% decrease in labetalol use (adjusted risk ratio 0.93, 95% CI 0.90–0.97). Risk for status asthmaticus was significantly increased with use of IV labetalol compared with other antihypertensive medications (6.5 vs 1.7/1,000 delivery hospitalizations, P<.01).

CONCLUSION:
There may be an opportunity to reduce use of β-blockers and carboprost among patients with asthma. Given their association with status asthmaticus, these drugs should be used cautiously in women with asthma.