bluuebunny/crossref_metadata_2025 huggingface dataset:
A 17β-Estradiol–Progesterone Oral Capsule for Vasomotor Symptoms in Postmenopausal Women
Authors: Lobo Rogerio A. , Archer David F. , Kagan Risa , Kaunitz Andrew M. , Constantine Ginger D. , Pickar James H. , Graham Shelli , Bernick Brian , Mirkin Sebastian
Published: June 2018

OBJECTIVE:

To evaluate efficacy, endometrial safety, and overall safety of a single-capsule 17β-estradiol–progesterone (TX-001HR) for treating menopausal moderate-to-severe vasomotor symptoms.

METHODS:

REPLENISH was a phase 3, 12-month, randomized, double-blind, placebo-controlled, multicenter trial. Women (aged 40–65 years) with vasomotor symptoms and a uterus were randomized to daily estradiol (mg)–progesterone (mg) (1/100, 0.5/100, 0.5/50, or 0.25/50), and women in the vasomotor symptoms substudy (women with moderate-to-severe hot flushes [seven or greater per day or 50 or greater per week]) to those estradiol–progesterone doses or placebo. The primary safety endpoint was endometrial hyperplasia incidence at 12 months in all women (the total population), and the primary efficacy endpoints were frequency and severity changes (from daily diaries) in moderate-to-severe vasomotor symptoms with estradiol–progesterone compared with placebo at weeks 4 and 12 in the vasomotor symptoms substudy. A sample size of 250 women in each active treatment arm with two or less endometrial hyperplasia cases would result in 1% or less annual incidence (upper bound 2.5% or less, one-sided 95% CI).

RESULTS:

One thousand eight hundred forty-five women were enrolled and randomized from August 2013 to October 2015; 1,835 received medication (safety population); 1,255 were eligible for the endometrial safety population; 726 comprised the vasomotor symptoms substudy; their mean age and body mass index were 55 years and 27, respectively; one third were African American. No endometrial hyperplasia was found. Frequency and severity of vasomotor symptoms significantly decreased from baseline with 1 mg estradiol and 100 mg progesterone and 0.5 mg estradiol and 100 mg progesterone compared with placebo at week 4 (frequency: by 40.6 and 35.1 points [1 mg and 100 mg and 0.5 mg and 100 mg, respectively] vs 26.4 points [placebo]; severity: by 0.48 and 0.51 vs 0.34 points) and week 12 (by 55.1 and 53.7 vs 40.2; severity: by 1.12 and 0.90 vs 0.56); 0.5 mg estradiol and 50 mg progesterone improved (P<.05) frequency and severity at week 12, and 0.25 mg estradiol and 50 mg progesterone frequency but not severity at weeks 4 and 12.

CONCLUSION:

No endometrial hyperplasia was observed while single-capsule estradiol–progesterone provided clinically meaningfully improvements in moderate-to-severe vasomotor symptoms. This estradiol–progesterone formulation may represent a new option, using naturally occurring hormones, for the estimated millions of women using nonregulatory-approved, compounded hormone therapy.

CLINICAL TRIAL REGISTRATION:

ClinicalTrials.gov, NCT01942668.
Feasibility of Complete Salpingectomy Compared With Standard Postpartum Tubal Ligation at Cesarean Delivery
Authors: Subramaniam Akila , Blanchard Christina T. , Erickson Britt K. , Szychowski Jeff , Leath Charles A. , Biggio Joseph R. , Huh Warner K.
Published: June 2018

OBJECTIVE:

To evaluate the feasibility of salpingectomy compared with standard bilateral tubal ligation at the time of cesarean delivery in women with undesired fertility.

METHODS:

We included women at 35 weeks of gestation or greater desiring permanent sterilization at the time of cesarean delivery. Patients were randomized after skin incision to bilateral salpingectomy or bilateral tubal ligation by a computer-generated scheme. If salpingectomy could not be completed on one or both sides, bilateral tubal ligation was attempted. Primary feasibility outcomes were total operative time and bilateral completion of the randomized procedure. Secondary outcomes included clinically estimated blood loss and surgical complications up to 6 weeks postpartum. We estimated that 80 patients (40 per group) would provide greater than 80% power to identify a 10-minute difference in the primary outcome (time) with a SD of 15 minutes and a two-sided α of 0.05. Analysis was by intent to treat.

RESULTS:

Of 221 women screened from June 2015 to April 2017, 115 (52%) consented to the study; 80 were randomized—40 to salpingectomy and 40 to bilateral tubal ligation. Groups were similar at baseline. A total of 27 bilateral salpingectomies were successfully completed compared with 38 bilateral tubal ligations (68% compared with 95%, P=.002). Total operative time was on average 15 minutes longer for salpingectomies (75.4±29.1 compared with 60.0±23.3 minutes, P=.004). No adverse outcomes directly related to the sterilization procedure were noted in either group. Although estimated blood loss of only the sterilization procedure (surgeon estimate) was greater for the salpingectomy group (median 10 [interquartile range 5–25] compared with 5 [interquartile range 5–10] cc, P<.001), total estimated blood loss and safety outcomes were similar for both groups.

CONCLUSION:

Adding 15 minutes to total operative times, salpingectomy can be successfully completed in approximately two thirds of women desiring permanent contraception with cesarean delivery.

CLINICAL TRIAL REGISTRATION:

Clinicaltrials.gov, NCT02374827.
Management Strategy for Breast Cancer in Pregnancy
Authors: Kuo Kelly , Caughey Aaron B.
Published: June 2018

A 34-year-old primigravid woman presents for a routine prenatal visit at 18 weeks of gestation with a breast lump. On examination, she has a painless, firm breast mass measuring 3–4 cm in diameter with overlying skin dimpling. A diagnostic mammogram shows findings suspicious for malignancy (Breast Imaging Reporting and Data System [BI-RADS] 4), and core biopsy demonstrates an invasive ductal carcinoma with both estrogen and progesterone receptor-positive staining. The patient asks: “How will this affect my pregnancy, and what is the safest course of action?”
Clinical Variables Associated With Adverse Maternal Outcomes in Puerperal Group A Streptococci Infection
Authors: Kaiser Jennifer E. , Bakian Amanda V. , Silver Robert M. , Clark Erin A. S.
Published: June 2018

OBJECTIVE:

To identify clinical variables associated with increased risk of composite adverse outcome in a cohort of women with puerperal group A streptococci infection.

METHODS:

Our prospective case registry enrolled patients between 1991 and 2017. Chart abstraction was conducted for admission demographic and clinical data in patients with culture-proven puerperal group A streptococci infection. We created a composite variable of signs of capillary leakage including pulmonary edema, pleural effusion, ascites, and abdominal distention. The composite adverse outcome included death, hysterectomy, intensive care unit admission, mechanical ventilation, and blood transfusion. Clinical characteristics were compared between those with a composite adverse outcome and those without. We fit unadjusted log-linear models with robust error variance to measure the relative risk of a composite adverse outcome associated with clinical and demographic variables among patients with group A streptococci.

RESULTS:

Thirty-five of 71 (49%) patients had an adverse outcome. Women who had adverse outcomes had higher admission heart rates (126±19 vs 112±22 beats per minute, P=.008) and respiratory rates (26±10 vs 20±5 breaths per minute, P=.01), lower systolic blood pressure (98±24 vs 114±19 mm Hg, P=.004), and were more likely to have signs of capillary leakage (77% vs 20%, P<.001) and symptoms of capillary leakage (dyspnea, cough, shoulder pain, abdominal bloating, and chest pain) (40% vs 17%, P=.03) compared with those without adverse outcomes. Log-linear models indicated that these clinical variables were individually associated with increased risk of a composite adverse outcome. The relative risk of an adverse outcome was 3.5 times higher among women with signs of capillary leakage (relative risk 3.67, 95% CI 1.94–6.94, P<.001).

CONCLUSION:

Vital sign parameters consistent with severe infection correlate with adverse outcomes in women with puerperal group A streptococci infection. Signs of capillary leakage are most strongly associated with a composite adverse outcome. These clinical characteristics, particularly signs of capillary leakage, are potentially useful to guide clinical care.
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.
Simulation in Obstetrics
Authors: Satin Andrew J.
Published: June 2018

Simulation in obstetrics is a widely accepted and valuable tool that benefits all levels of learners from medical students to maternal–fetal medicine subspecialists. What began as an adjunct to medical education now has a rapidly expanding role in acquisition of new and innovative procedures, team and unit training, and safety and quality initiatives. The number of obstetric simulation peer-reviewed reports has increased exponentially in recent years, yet only a small percentage of reports primarily addresses clinical outcomes. Studies link simulation to a reduction in neonatal brachial plexus injury, maternal trauma related to forceps delivery, response to postpartum hemorrhage, efficiency in performing emergent cesarean delivery, and neonatal mortality. Simulation is a required component in accredited obstetrics and gynecology residency training programs. Obstetric simulation has a role in the certification of physicians, and simulation hands-on courses may be used to meet maintenance of certification requirements. As simulation platforms are validated, they are likely to be incorporated into the certification process as a means of assessing technical and communication skills. Accrediting, certifying, professional, quality, and safety organizations have invested in simulation committees, interest groups, curricula, and continuing medical education courses. Support for research, including large multicenter trials, are needed to inform further implementation. Research and development should lead to lower costs and improved simulators. As the public, government, licensing, and credentialing institutions explore means of improving patient safety, expansion of simulation in obstetrics is inevitable.
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.
Postpartum Testing to Detect Persistent Dysglycemia in Women With Gestational Diabetes Mellitus
Authors: Carson Michael P. , Ananth Cande V. , Gyamfi-Bannerman Cynthia , Smulian John , Wapner Ronald J.
Published: June 2018

The rate of gestational diabetes has doubled, and identifying the 30% with persistent postpartum dysglycemia (prediabetes or diabetes mellitus) is important because low-cost interventions have been proven to prevent overt diabetes mellitus, improve health for women, and potentially decrease the risk for birth defects in future pregnancies. Consensus guidelines continue to recommend a 4- to 12-week postpartum 2-hour oral glucose tolerance test (OGTT) despite persistent reports that only 35% of women complete the test. Physician ordering rates can improve, but the largest barriers to postpartum testing are clearly patient-related. Initiatives to improve OGTT testing rates have been only moderately effective and required allocation of staff time, diverting resources from other clinical areas. Alternative testing models using single-draw tests that bypass patient barriers show promise for improving the diagnosis of postpregnancy dysglycemia. Specifically, evidence is emerging in the pregnant and nonpregnant populations that, compared with the OGTT, the single-draw hemoglobin A1C test may identify more patients with prediabetes, bypasses patient barriers to testing such as the need for fasting, and has less laboratory variation compared with the OGTT or fasting plasma glucose. The risk–benefit focus should shift from comparing individual test performance statistics presuming the OGTT to be the “gold standard” to data reporting the ability of a test to facilitate identification of patients. We review the evidence regarding postpregnancy testing and make recommendations for strategies to improve the identification of dysglycemia and postpregnancy health.
Maternal Complications Associated With Periviable Birth
Authors: Rossi Robert M. , DeFranco Emily A.
Published: June 2018

OBJECTIVE:

To quantify the rate of maternal complications associated with a periviable birth in a contemporary population of live births in the state of Ohio.

METHODS:

We conducted a population-based retrospective cohort study of all live births in Ohio (2006–2015). Maternal, obstetric, and neonatal characteristics were compared between women who delivered in the periviable period (20–25 weeks of gestation) with those who delivered preterm (26–36 weeks of gestation) and at term (greater than 36 weeks of gestation). Women were also stratified by 3-week gestational age epochs (ie, 20–22, 23–25 weeks of gestation). The primary study outcome was a composite of individual adverse maternal outcomes (chorioamnionitis, blood product transfusion, hysterectomy, unplanned operation, and intensive care unit [ICU] admission). Multivariate logistic regression estimated the relative association of periviable birth with maternal complications.

RESULTS:

Of 1,457,706 live births in Ohio during the 10-year study period, 6,085 live births (0.4%) occurred during the periviable period (20–25 weeks of gestation). The overall rate of the composite adverse outcome was 17.2%. In multivariate analysis, periviable birth was associated with an increased risk of the composite adverse maternal outcome (adjusted relative risk [RR] 5.8, CI 5.4–6.2) and individual complications including transfusion (adjusted RR 4.4, CI 3.4–5.7), unplanned operative procedure (adjusted RR 2.0, CI 1.7–2.4), unplanned hysterectomy (adjusted RR 7.8, CI 4.6–13.0), uterine rupture (adjusted RR 7.1, CI 3.8–13.4), and ICU admission (adjusted RR 9.6, CI 7.2–12.7) compared with the term cohort. Delivery between 20–22 weeks and 23–25 weeks of gestation was associated with the highest risk of composite adverse outcome. The risk of composite adverse outcome decreased with advancing gestational age stratum.

CONCLUSION:

Periviable birth is associated with significant maternal morbidity. Nearly one in five women in this cohort had a serious morbidity associated with their periviable delivery.
Changes in Surgical Volume and Outcomes Over Time for Women Undergoing Hysterectomy for Endometrial Cancer
Authors: Wright Jason D. , Ruiz Maria P. , Chen Ling , Gabor Lisa R. , Tergas Ana I. , St. Clair Caryn M. , Hou June Y. , Ananth Cande V. , Neugut Alfred I. , Hershman Dawn L.
Published: June 2018

OBJECTIVE:

To examine changes over time in surgeon and hospital procedural volume for hysterectomy for endometrial cancer and explore the association between changes in volume and perioperative outcomes.

METHODS:

We used the Statewide Planning and Research Cooperative System database to analyze women who underwent abdominal or minimally invasive hysterectomy from 2000 to 2014. Annualized surgeon and hospital volume was estimated. The association between surgeon and hospital volume and perioperative morbidity, mortality, and resource utilization (transfusion, length of stay, hospital charges) was estimated by modeling procedural volume as a continuous and categorical variable.

RESULTS:

A total of 44,558 women treated at 218 hospitals were identified. The number of surgeons performing cases each year decreased from 845 surgeons with 2,595 patients (mean cases=3) in 2000 to 317 surgeons who operated on 3,119 patients (mean cases=10) (P<.001) in 2014, whereas the mean hospital volume rose from 14 to 32 cases over the same time period (P=.29). When stratified by surgeon volume quartiles, the morbidity rate was 14.6% among the lowest volume surgeons, 20.8% for medium–low, 15.7% for medium–high, and 14.1% for high-volume surgeons (P<.001). In multivariable models in which volume was modeled as a continuous variable, there was no association between surgeon volume and the rate of complications, whereas excessive total charges were lowest and perioperative mortality highest for the high-volume surgeons (P<.001 for both).

CONCLUSION:

Care of women with endometrial cancer has been concentrated to a smaller number of surgeons and hospitals. The association between surgeon and hospital volume for endometrial cancer is complex with an increased risk of adverse outcomes among medium-volume hospitals and surgeons but the lowest complication rates for the highest volume surgeons and centers.
Safety of Deep Sedation Without Intubation for Second-Trimester Dilation and Evacuation
Authors: Aksel Sarp , Lang Laura , Steinauer Jody E. , Drey Eleanor A. , Lederle Lauren , Sokoloff Abby , Carlisle A. Sue
Published: June 2018

OBJECTIVE:

To estimate the incidence of pulmonary aspiration and other anesthesia-related adverse events in women undergoing dilation and evacuation (D&E) under intravenous deep sedation without tracheal intubation in an outpatient setting.

METHODS:

We reviewed all D&Es done under anesthesiologist-administered intravenous deep sedation without tracheal intubation between February 2009 and April 2013. The study's primary outcome was pulmonary aspiration; secondary outcomes included other anesthesia-related complications. We calculated the incidence of anesthesia-related adverse events as well as a 95% CI around the point estimate.

RESULTS:

During the 51-month study period, 4,481 second-trimester abortions were completed. Of these, 2,523 (56%) were done under deep sedation without tracheal intubation, 652 (26%) between 14 and 19 6/7 weeks of gestation, and 1,871 (74%) between 20 and 24 weeks of gestation. Seven cases of anesthesia-related complications were identified: two cases of pulmonary aspiration (0.08%, 95% CI 0.01–0.29%), four cases of upper airway obstruction (0.016%, 95% CI 0.04–0.41%), and one case of lingual nerve injury (0.04%, 95% CI 0.001–0.22%).

CONCLUSION:

Deep sedation without tracheal intubation for women undergoing D&E has a low incidence of anesthesia-related complications.
Hospital Readmission as a Poor Measure of Quality in Ovarian Cancer Surgery
Authors: Uppal Shitanshu , Spencer Ryan J. , Rice Laurel W. , del Carmen Marcela G. , Reynolds R. Kevin , Griggs Jennifer J.
Published: June 2018

OBJECTIVE:

To evaluate the role of 30-day readmission rate as a quality of care metric in patients undergoing ovarian cancer surgery.

METHODS:

We performed a retrospective cohort study of women diagnosed between 2004 and 2013 with advanced-stage, high-grade, serous carcinoma who underwent primary treatment. Using the National Cancer Database, we compared the performance of hospital risk-adjusted 30-day readmission rate to other quality of care metrics (risk-adjusted 30- and 90-day mortality, rates of adherence to guideline-based care, and overall survival) within hospitals categorized by yearly case volume (10 or less, 11–20, 21–30, and 31 cases per year or more).

RESULTS:

A total of 42,931 patients met the inclusion criteria. The overall unplanned 30-day readmission rate was 6.36% (95% CI 6.13–6.59). After adjusting for comorbidity, stage, histology, and sociodemographic and treatment factors, hospitals performing 31 cases per year or more had a 24% higher likelihood of readmission (adjusted odds ratio [OR] 1.25, 95% CI 1.06–1.46) when compared with those performing 10 cases per year or less. However, hospitals performing 31 cases per year or more had a significantly lower risk-adjusted 90-day mortality (adjusted OR 0.74, 95% CI 0.60–0.91) despite higher rates of complex surgical procedures and higher rates of guideline-concordant care delivery (86% vs 77%, P<.001). In the Cox proportional hazards regression model, care at a high-volume hospital was independently predictive of lower hazard of death (adjusted hazard ratio 0.86, 95% CI 0.82–0.90).

CONCLUSION:

Hospitals with 31 cases per year or more have a lower 30- and 90-day mortality despite performing more complex surgeries, are more likely to be adherent to guideline-based care, and achieved higher overall survival.
Risk of Spontaneous Abortion After Inadvertent Human Papillomavirus Vaccination in Pregnancy
Authors: Kharbanda Elyse O. , Vazquez-Benitez Gabriela , Lipkind Heather S. , Sheth Sangini S. , Zhu Jingyi , Naleway Allison L. , Klein Nicola P. , Hechter Rulin , Daley Matthew F. , Donahue James G. , Jackson Michael L. , Kawai Alison Tse , Sukumaran Lakshmi , Nordin James D.
Published: June 2018

OBJECTIVE:

To evaluate the risk of spontaneous abortion after quadrivalent human papillomavirus (4vHPV) vaccination before and during pregnancy across seven integrated health systems within the Vaccine Safety Datalink.

METHODS:

Within a retrospective observational cohort, we compared risks for spontaneous abortion after 4vHPV in three exposure windows: distal (16–22 weeks before the last menstrual period [LMP]), peripregnancy (within 6 weeks before the LMP), and during pregnancy (LMP through 19 weeks of gestation). Women 12–27 years of age with a pregnancy between 2008 and 2014, with continuous insurance enrollment 8 months before and through pregnancy end, and with a live birth, stillbirth, or spontaneous abortion were included. Pregnancies were identified through validated algorithms. Spontaneous abortions and stillbirths were verified by chart review with spontaneous abortions adjudicated by clinical experts. We excluded multiple gestations, spontaneous abortions before 6 weeks of gestation, and women using medications increasing risk of spontaneous abortion. Spontaneous abortion risk after 4vHPV during pregnancy was compared with distal vaccination using time-dependent covariate Cox models. Spontaneous abortion risk for peripregnancy compared with distal vaccination was evaluated with standard Cox models.

RESULTS:

We identified 2,800 pregnancies with 4vHPV exposure in specified risk windows: 919 (33%) distal, 986 (35%) peripregnancy, and 895 (32%) during pregnancy. Mean age was 22.4 years in distal and peripregnancy groups compared with 21.4 years among women vaccinated during pregnancy. Among women with distal 4vHPV exposure, 96 (10.4%) experienced a spontaneous abortion. For peripregnancy and during pregnancy exposures, spontaneous abortions occurred in 110 (11.2%) and 77 (8.6%), respectively. The risk of spontaneous abortion was not increased among women who received 4vHPV during pregnancy (adjusted hazard ratio 1.10, 95% CI 0.81–1.51) or peripregnancy 1.07 (0.81–1.41).

CONCLUSION:

Inadvertent 4vHPV exposure during or peripregnancy was not significantly associated with an increased risk of spontaneous abortion.
Using Cervical Length Measurement for Lower Spontaneous Preterm Birth Rates Among Women With Threatened Preterm Labor
Authors: Chiossi Giuseppe , Saade George R. , Sibai Baha , Berghella Vincenzo
Published: June 2018

Spontaneous preterm birth is a leading cause of perinatal morbidity and mortality; however, accurate identification of women who will deliver prematurely after the onset of uterine contractions is still challenging, because less than 10% actually give birth within 7 days of presentation. Risk stratification in women with preterm contractions would allow targeting of interventions such as corticosteroids, magnesium sulfate, and maternal transfer to a perinatal center to those who will indeed deliver preterm. Moreover, unnecessary treatments associated with potential complications could be avoided in symptomatic women who are unlikely to deliver preterm. Fetal fibronectin testing and cervical length measurement are the most used methods to assess the risk of preterm birth among symptomatic women. Interventional studies in singleton gestations suggest that assessment of cervical length, unlike fetal fibronectin testing, improves diagnostic accuracy and leads to better perinatal outcomes.