Posterior Tibial Nerve Stimulation With versus Without Mirabegron: A Randomized Controlled Trial.

INTRODUCTION AND HYPOTHESIS: To compare change in urgency urinary incontinence episodes (UUIEs) in women undergoing posterior tibial nerve stimulation (PTNS) plus mirabegron versus PTNS plus placebo for the treatment of refractory urgency urinary incontinence (UUI). The primary hypothesis was that combination therapy is superior to monotherapy. METHODS: A randomized controlled trial was performed in individuals identifying as female aged ≥ 18 years with UUI symptoms refractory to second-line treatment or who could not tolerate antimuscarinic medications. Both participants and providers were blinded to medication treatment allocation. Participants were randomized (1:1) to PTNS plus mirabegron or PTNS plus placebo. Participants completed a 3-day bladder diary prior to and after 12-week treatment. Validated symptom distress and impact questionnaires were obtained pre- and post-treatment. The primary outcome was change in mean number of UUIEs on a 3-day bladder diary pre- versus post-treatment between arms. Primary and secondary outcomes were analyzed via sample t tests. RESULTS: Fifty-four subjects were randomized, mean ± SD baseline age 56.2±15.6 years and body mass index 35.0±9.4 (kg/m2); no differences were noted in any clinical-demographic characteristics. There was a significant difference between arms in mean pre- to post-treatment UUIEs, 9.4±3.9, mirabegron versus 5.3±5.5, placebo (p=0.007). Significant differences were found pre- compared with post-treatment in urinary frequency, Overactive Bladder Questionnaire Short Form Symptom Bother and Symptom Health-Related Quality of Life scores. CONCLUSIONS: In subjects undergoing PTNS treatment for refractory UUI and OAB-wet symptoms, the addition of a ß-3 agonist produced significant improvement in both objective and subjective overactive bladder symptom outcomes compared with PTNS plus placebo.

Utilization of Immediate Postpartum Contraception and Its Association with Interpregnancy Interval: 10-Year Experience at a Single Center.

OBJECTIVE: Increasing availability of immediate postpartum long-acting reversible contraception (LARC) has added contraceptive alternatives to bilateral tubal ligation (BTL) in the immediate postpartum period. The resultant access to long-term contraception has provided patients with improved control over the timing of pregnancies. Our objective is to evaluate changes in the utilization of immediate postpartum contraceptive methods over a 10-year period and its association with interpregnancy interval (IPI). STUDY DESIGN: Retrospective cohort study of 36,445 patients delivered at a single academic hospital center from 2012 to 2020. Deliveries <23 weeks gestation and patients who underwent a cesarean hysterectomy or postpartum hysterectomy for obstetric indications were excluded. The primary outcome was the utilization of postpartum BTL, intrauterine devices, contraceptive implants, and Depo-Provera over the study time period. The secondary outcomes were IPI and interdelivery interval (IDI). Outcomes were compared using appropriate tests of trend. We adjusted for significant covariates as assessed in baseline characteristics. RESULTS: A total of 35,281 patients were included in our study. Groups were different in baseline characteristics including age, race/ethnicity, parity, BMI, insurance status, comorbidity risk, and attendance at postpartum exam. Over the study period, there was a significant difference in utilization of Depo-Provera, LARC, intrauterine device (IUD), and implant (p < 0.001). There was a significant increase in IPI (p < 0.001) and IDI (p < 0.001). CONCLUSION: We observed a significant increase in utilization of immediate postpartum LARC over the study period which corresponded to a significant increase in IPI and IDI. Our findings emphasize the importance of the availability of immediate postpartum contraception as well as its effectiveness in improving family planning options for reproductive-aged patients. We found significantly increased IPI and IDI associated with increased utilization of long-acting reversible contraceptives immediately postpartum. Our findings emphasize the importance of providers offering these options to patients as well as being comfortable initiating immediate postpartum contraception. KEY POINTS: · Immediate postpartum LARC access has increased over the past 10 years.. · Access to more methods of contraception allows patients more options for family planning.. · Increased utilization of LARC led to increased IPI and IDI..

The Association between the Social Vulnerability Index and Adverse Neonatal Outcomes.

OBJECTIVE: Identifying underlying social risk factors for neonatal intensive care unit (NICU) admission is important for designing interventions to reduce adverse outcomes. We aimed to determine whether a patient's exposure to community-level stressors as measured by the social vulnerability index (SVI) is associated with NICU admission. STUDY DESIGN: Retrospective cohort study (2014-2018) of patients delivering a liveborn ≥ 22 weeks' gestation at a quaternary care center. Patient addresses were used to assign each individual a composite SVI and theme score. The primary exposure was a composite SVI score categorized into tertiles. The primary outcome was NICU admission. Secondary outcomes included NICU length of stay and neonatal morbidity composite. Multivariable logistic regression was performed to estimate the association between composite SVI and outcomes (low SVI as referent). We secondarily compared mean composite and theme SVI scores; individual components of each theme were also compared. RESULTS: From 2014 to 2018, 13,757 patients were included; 2,837 (21%) had a neonate with NICU admission. Patients with higher SVI were more likely to self-identify as Black race and have medical comorbidities. Living in areas with moderate or high SVI was not associated with NICU admission (moderate SVI adjusted odds ratio [aOR]: 1.13, 95% confidence interval [CI]: 0.96-1.34; high SVI aOR: 1.12, 95% CI: 0.95-1.33). Moderate SVI was associated with increased neonatal morbidity (aOR: 1.18, 95% CI: 1.001-1.38). In an analysis of SVI as a continuous variable, mean SVI scores were significantly higher in individuals who had an infant admitted to the NICU. Those requiring NICU admission lived in areas with lower per capita income and a higher number of mobile homes (p < 0.001). CONCLUSION: Patients living in areas with moderate or high SVI were not shown to have higher odds of having a neonate admitted to the NICU. Neonatal morbidity was higher in those living in areas with moderate SVI. Increased access to social services may improve neonatal outcomes. KEY POINTS: · Mean SVI scores are higher in those with a neonate admitted to the NICU.. · There was no observed association between moderate and high SVI scores and NICU admission.. · Moderate SVI is associated with an increased odds of overall neonatal morbidity.. · Greater exposure to low income may be associated with NICU admission..

Postpartum Outcomes in Patients Receiving Venous Thromboembolism Prophylaxis during Antepartum Admission.

OBJECTIVE: We evaluated if venous thromboembolism (VTE) prophylaxis in the inpatient antepartum period was associated with wound hematomas, VTE occurrence, and other adverse outcomes. STUDY DESIGN: This study is a secondary analysis of a retrospective cohort of patients who delivered at University of Alabama at Birmingham (UAB). Patients receiving outpatient anticoagulation (AC) were excluded. We grouped patients into those who received inpatient antepartum prophylactic AC and those who did not. The primary outcome was wound hematomas from delivery to 6 weeks postpartum (PP). Secondary outcomes included VTE occurrence and select adverse outcomes, including other wound complications, unplanned procedures, mode of anesthesia, and intensive care unit (ICU) admission. Analyses were performed with no AC group as the reference. A sensitivity analysis excluding those who received inpatient PP AC was performed. RESULTS: Of 1,035 included patients, only 169 patients received inpatient prophylactic AC. They were older, had higher body mass indices, and more comorbidities. Patients receiving inpatient antepartum AC had higher wound hematomas (adjusted odds ratio [aOR] 23.81; 95% confidence interval [CI] 7.04-80.47). They had similar risk for developing VTE as the control group (aOR 2.68; 95% CI 0.19-37.49) but were more likely to have wound complications (aOR 2.36; 95% CI 1.24-4.47), maternal deaths (p < 0.05), and require PP ICU admission (aOR 13.38; 95% CI 4.79-37.35). When excluding those receiving any PP AC, there was no difference in bleeding complications between the two groups and VTE rates remained unchanged. Rates of maternal deaths and PP ICU admissions remained higher in those who received inpatient antepartum AC prophylaxis. CONCLUSION: In this small cohort study, increased wound hematomas were found in those who received inpatient antepartum AC prophylaxis with no difference in VTE occurrence. While adverse events were increased in the inpatient AC group, this was mostly associated with PP AC prophylaxis. Larger studies should be conducted to describe the true benefits and risks of antepartum AC prophylaxis and determine efficacy of this widely used practice. KEY POINTS: · Peripartum chemoprophylaxis is associated with increased wound hematomas.. · VTE is rare, despite its association with significant peripartum morbidity/mortality.. · Large studies are needed to guide practices that optimize the risk/benefit ratio of chemoprophylaxis..

A More Selective vs a Standard Risk-Stratified, Heparin-Based, Obstetric Thromboprophylaxis Protocol.

Importance: In 2016, our institution adopted a pregnancy-related venous thromboembolism (VTE) prophylaxis protocol based on American College of Obstetricians and Gynecologists guidelines that recommended postpartum heparin-based chemoprophylaxis (enoxaparin) based on a risk-stratified algorithm. In response to increased wound hematomas without significant reduction in VTE using this protocol, a more selective risk-stratified approach was adopted in 2021. Objective: To evaluate outcomes of the more selective risk-stratified approach to heparin-based obstetric thromboprophylaxis (enoxaparin) protocol. Design, Setting, and Participants: Retrospective observational study of 17 489 patients who delivered at a single tertiary care center in the southeast US between January 1, 2016, and December 31, 2018 (original protocol), and between December 1, 2021, and May 31, 2023 (more selective protocol). Patients receiving outpatient anticoagulation for active VTE or high VTE risk during pregnancy were excluded. Exposure: Standard risk-stratified and more selective postpartum VTE chemoprophylaxis protocols. Main Outcomes and Measures: The primary outcome was clinical diagnosis of wound hematoma up to 6 weeks pos tpartum. The secondary outcome was new diagnosis of VTE up to 6 weeks post partum. We compared baseline characteristics and outcomes between groups and estimated adjusted odds ratios with 95% CIs of primary and secondary outcomes using the original protocol group as reference. Results: Of 17 489 patients included in the analysis, 12 430 (71%) were in the original protocol group and 5029 (29%) were in the more selective group. Rates of chemoprophylaxis decreased from 16% (original protocol) to 8% (more selective protocol). Patients in the more selective group were more likely to be older, be married, and have obesity or other comorbidities (hypertension, diabetes, cardiac disease). Compared with the original protocol, the more selective protocol was associated with a decrease in any wound hematoma (0.7% vs 0.3%; adjusted odds ratio [aOR], 0.38; 95% CI, 0.21-0.67), specifically due to a lower rate of superficial wound hematomas (0.6% vs 0.3%; aOR, 0.43; 95% CI, 0.24-0.75). There was no significant increase in VTE or individual types of VTE (0.1% vs 0.1%; aOR, 0.40; 95% CI, 0.12-1.36). Conclusions and Relevance: A more selective risk-stratified approach to an enoxaparin thromboprophylaxis protocol for VTE was associated with decreased rates of wound hematomas without increased rates of postpartum VTE.

Five-year surgical outcomes of transvaginal apical approaches in women with advanced pelvic organ prolapse.

INTRODUCTION AND HYPOTHESIS: In women with advanced prolapse, differences in vaginal apex anchoring sites may impact surgical outcomes over time. The primary aim was to compare 5-year surgical outcomes of uterosacral ligament suspension (ULS) versus sacrospinous ligament fixation (SSLF) in women with advanced (stage III-IV) prolapse. METHODS: A secondary analysis was conducted in a subset of women with advanced prolapse from a multicenter randomized trial comparing ULS versus SSLF and its extended follow-up, using publicly accessible de-identified datasets. The primary outcome was time to failure, defined as any one of (1) apical descent > 1/3 into the vaginal canal or anterior/posterior compartment beyond the hymen, (2) bothersome vaginal bulge symptoms, or (3) re-treatment. Secondary outcomes include symptom severity measured by the Pelvic Organ Prolapse Distress Inventory (POPDI) and adverse events. RESULTS: Of 285 women, 90/147 (61.2%) in ULS and 88/138 (63.8%) in SSLF had advanced prolapse. Baseline characteristics did not differ between groups except for median-vaginal deliveries (3.0 [2.0, 5.0] versus 3.0 [2.0, 4.0], p < 0.01). The median time to failure was 1.7 years ULS versus 2.0 years SSLF (p = 0.42). Surgical failure increased over time in both groups with no intergroup difference; by year 5, the estimated failure rate was 67.7% ULS versus 71.5% SSLF (adjusted difference -3.8; 95%CI [-21.9, 14.2]). No differences were noted in individual failure components (p > 0.05). POPDI scores improved over 5 years without intergroup difference (ULS -68.0 ± 61.1 versus SSLF -69.9 ± 60.3, adjusted difference -0.1 [-20.0, 19.9]). No difference in adverse events were observed (p > 0.05). CONCLUSION: In women with advanced prolapse, surgical failure, symptom severity, and adverse events did not differ between ULS and SSLF over 5 years.

Defining a Strategy for Laboratory Evaluation with Expectant Management of Preeclampsia.

OBJECTIVE: The objective of this study was to compare the frequency and timing of laboratory abnormalities and evaluate optimal laboratory testing strategies in women with preeclampsia (PE) undergoing expectant management. STUDY DESIGN: Retrospective cohort study of women with inpatient expectant management of PE at ≥23 weeks at a tertiary center from 2015 to 2018 was conducted. Women ineligible for expectant management or with less than two laboratory sets (platelets, aspartate aminotransferase, and serum creatinine) before the decision to deliver were excluded. Women were categorized as per the American College of Obstetricians and Gynecologists' definitions by initial diagnosis: PE without severe features, superimposed preeclampsia (SiPE) without severe features, and their forms with severe features. The frequency and timing of laboratory abnormalities were compared across the four PE categories. Kaplan-Meier curves modeled time to a laboratory abnormality (event) with censoring for delivery and were compared using log-rank tests. Logistic regression analysis modeled the development of a laboratory abnormality as a function of testing time intervals (days) for each PE type. Receiver operating characteristic curves and areas under the curve (AUC) were calculated; optimal cut points were determined using the Liu method. RESULTS: Among 636 women who met inclusion criteria, laboratory abnormalities were uncommon (6.3%). The median time to a laboratory abnormality among all women was ≤10 days, time being shortest in women with PE with severe features. Time to laboratory abnormality development did not differ significantly between the four PE groups (p = 0.36). Laboratory assessment intervals were most predictive for PE and SiPE with severe features (AUC = 0.87, AUC = 0.72). Optimal cutoffs were every 4 days for PE without severe features, 2 days for PE with severe features, 8 days for SiPE without severe features, and 3 days for SiPE with severe features. CONCLUSION: Most laboratory abnormalities in PE occur earlier and more frequently in those with severe features. Individual phenotypes should undergo serial evaluation based on this risk stratification. KEY POINTS: · Most laboratory abnormalities occur within 10 days of diagnosis.. · Laboratory abnormalities occur more often with severe features.. · Laboratory testing should occur according to disease severity..

Outpatient Foley Catheter for Induction of Labor in Obese Nulliparous Patients: A Secondary Analysis of OFFSITE II Randomized Controlled Trial.

OBJECTIVE: In the OFFSITE II randomized controlled trial, outpatient cervical ripening with a Foley catheter (CF) in nulliparous patients undergoing elective induction of labor (eIOL) shortened the time from admission to delivery. Given that patients with obesity have protracted labor and higher rates of failed IOL, we sought to determine if outpatient ripening with a CF may be even more beneficial for this high-risk group. STUDY DESIGN: We performed a secondary analysis of the OFFSITE II randomized controlled trial. For this analysis, all patients from the primary trial were classified by their intervention assignment (inpatient vs. outpatient) and also by their admission body mass index (BMI) class (BMI ≥ 30 and BMI < 30 kg/m2). The primary outcome was time from labor and delivery (L&D) admission to delivery. Secondary outcomes included cesarean delivery, time from admission to hospital discharge, and rates of clinically diagnosed chorioamnionitis and endometritis. RESULTS: In patients with BMI ≥ 30, the primary outcome, time from admission to delivery, (18.0 [13.5-20.9] vs. 20.4 [16.6-31.3] hours, p = 0.01), as well as total hospitalization length (3.2 [2.5-3.3] vs. 3.4 [3.1-4.3] days, p = 0.02) were shorter in the outpatient group. There were no differences in rates of chorioamnionitis or endometritis in outpatient compared with inpatient CF. Furthermore, in those with a BMI ≥ 30, the cesarean rate was significantly lower with outpatient CF (19.4% vs. 44.7%, p = 0.03); it was not statistically different in patients with BMI < 30. CONCLUSION: In this exploratory retrospective secondary analysis of the OFFSITE II randomized control trial, we found that in patients with BMI ≥ 30 undergoing eIOL, outpatient CF was associated with a lower time from L&D admission until delivery. This was also associated with a shorter time of total hospital duration and decreased the rate of cesarean, a benefit not detected in the overall analysis presented in the primary study. In nulliparas undergoing induction of labor, ripening with outpatient cervical Foley may even more significantly reduce labor duration, total hospital duration, and the rate of cesarean in patients with obesity. KEY POINTS: · Outpatient CF was associated with a lower time from L&D admission until delivery in obese nulliparas.. · Outpatient CF was associated with a shorter time of total hospital duration in obese nulliparas.. · Outpatient CF was associated with a decreased rate of cesarean birth in obese nulliparas..

Contemporary Trends in Cesarean Delivery Rates and Indications.

OBJECTIVE: This study aimed to describe cesarean delivery rates and indications at a single center in order to assess the impact of the guidelines published by the American College of Obstetricians and Gynecologists and the Society for Maternal-Fetal Medicine on trends in labor management. STUDY DESIGN: This is a retrospective cohort study of patients ≥23 weeks' gestation delivering at a single tertiary care referral center from 2013 to 2018. Demographic characteristics, mode of delivery, and main indication for cesarean delivery were ascertained by individual chart review. Cesarean delivery indications (mutually exclusive) were the following: repeat cesarean delivery, nonreassuring fetal status, malpresentation, maternal indications (e.g., placenta previa or genital herpes simplex virus), failed labor (any stage labor arrest), or other (i.e., fetal anomaly and elective). Polynomial (cubic) regression models were used to model rates of cesarean delivery and indications over time. Subgroup analyses further examined trends in nulliparous women. RESULTS: Of the 24,637 patients delivered during the study period, 24,050 were included in the analysis; 7,835 (32.6%) had a cesarean delivery. The rates of overall cesarean delivery were significantly different over time (p < 0.001), declining to a minimum of 30.9% in 2014 and peaking at 34.6% in 2018. With regard to the overall cesarean delivery indications, there were no significant differences over time. When limited to nulliparous patients, the rates of cesarean delivery were also noted to be significantly different over time (p = 0.02) nadiring at 30% in 2015 from 35.4% in 2013 and then rising up to 33.9% in 2018. As for nulliparous patients, there was no significant difference in primary cesarean delivery indications over time except for nonreassuring fetal status (p = 0.049). CONCLUSION: Despite changes in labor management definitions and guidelines encouraging vaginal birth, the rates of overall cesarean delivery did not decrease over time. The indications for delivery, particularly failed labor, repeat cesarean delivery, and malpresentation have not significantly changed over time. KEY POINTS: · The rates of overall cesarean deliveries did not decrease despite the 2014 published recommendations for the reduction in cesarean deliveries.. · There were no significant differences in the indications of cesarean deliveries among nulliparous or multiparous women.. · Despite the adoption of strategies to reduce the overall and primary cesarean delivery rates, these trends remain unchanged.. · Indications for delivery, particularly failed labor, repeat cesarean delivery, and malpresentation have also not significantly changed over time.. · Additional strategies to encourage and increase vaginal delivery rates must be adopted..

Feasibility, Safety, and Provider Perspectives of Bipolar Electrosurgical Cautery Device for (Opportunistic or Complete) Salpingectomy at the Time of Cesarean Delivery.

OBJECTIVES: The aim of the study is to evaluate the use of a bipolar electrocautery device for complete salpingectomy at cesarean to improve procedure completion rates, operative time, and surgeon reported satisfaction as compared with standard bilateral tubal ligation (BTL) and suture-cut-tie salpingectomy. STUDY DESIGN: This is a prospective cohort study of women undergoing planned, non-emergent cesarean with desired sterilization with complete salpingectomy utilizing a bipolar electrocautery device. Study patients were compared with historic controls from a randomized controlled trial (RCT) of complete salpingectomy via suture-cut-tie method versus BTL conducted at our institution (SCORE trial, NCT02374827). Outcomes were compared with groups from the original RCT. RESULTS: Thirty-nine women were consecutively enrolled (12/2018-11/2019) into the device arm of the study and compared with the original SCORE cohort (n = 40 BTL, n = 40 salpingectomy without a device). Salpingectomy performance with the bipolar electrocautery device was successfully completed in 100% (39/39) of enrolled women, with one device failure requiring the use of a second device, as compared with 95% (38/40) in the BTL (p = 0.49) and 67.5% (27/40) in salpingectomies without a device (p < 0.001). Mean operative time of sterilization procedure alone demonstrated device use as having the shortest operative time of all (device salpingectomy 5.0 ± 3.6 vs. no device 18.5 ± 8.3 minutes, p < 0.001; and vs. BTL 6.9 ± 5.0, p = 0.032). Mean sterilization procedure endoscopic band ligation (EBL) was demonstrated to be significantly different between each group, least amongst BTL followed by device (6.3 ± 4.8 vs. 8.4 ± 24.8, p < 0.001), and most by suture-cut-tie method (17.7 ± 14.3, p < 0.001 compared with device). Surgeon reported attitudes of complete salpingectomy performance in general practice outside an academic setting was greater with a device than without (79.5 vs. 35.3%; p < 0.001). CONCLUSION: Use of a bipolar electrocautery device improved operative times and surgeon satisfaction for salpingectomy at cesarean over standard suture ligation. Device use improved surgeon reported outcomes and may improve incorporation of complete salpingectomy at cesarean. KEY POINTS: · Electrocautery bipolar device use was safe at the time of salpingectomy during cesarean.. · Greater surgeon satisfaction occurs using a device than without.. · Decreased surgical time with device use is seen making the procedure equal to BTL..

Factors Associated with Appropriate Gestational Weight Gain among Women with Obesity.

OBJECTIVE: This study aimed to compare attendance of nutritional counseling, dietary composition, exercise patterns, and socioeconomic factors among obese women with inappropriate gestational weight gain (iGWG) versus appropriate GWG (aGWG). STUDY DESIGN: Medicaid-eligible women receiving prenatal care at a tertiary care center from January 2013 to December 2015 were offered individualized nutritional counseling by a registered dietitian encouraging well-balanced meals and 150 min/wk of exercise. We conducted a prospective case-control study of obese women (body mass index or BMI ≥30) with a singleton gestation with iGWG (<11 or >20 pounds) versus aGWG (11-20 pounds). Dietary intake, activity level, and socioeconomic factors were compared with Chi-square, Fisher's exact, Student's t-test, and Wilcoxon Rank Sum tests as indicated, and odds ratios with 95% confidence intervals were calculated. Multivariate regression analysis for significant variables was performed. A subgroup analysis of women with BMI ≥40 was planned. RESULTS: A total of 401 women were analyzed: 78% (n = 313) with iGWG and 22% (n = 88) with aGWG. Demographics were similar between groups. Women with iGWG less frequently reported physician reinforcement of counseling and reported more physical inactivity and unemployment; there were no differences in caloric intake or macronutrient profile between groups. Multivariate regression identified physician reinforcement and employment as independent predictors of aGWG. Among women with BMI ≥40 (n = 133), those with iGWG (78%) were less likely to attend counseling, report physician reinforcement of counseling, and have adequate caloric and protein intake when compared with those with aGWG (22%). Activity level and socioeconomic factors were not different between groups. CONCLUSION: Physician reinforcement of nutritional counseling, greater activity level, and employment are associated with aGWG in women with BMI ≥30, while individualized professional nutritional counseling and dietary modifications were further associated with aGWG in women with BMI ≥40. Thus, greater focus should be placed on enhancing exposure to counseling and altering nutritional and exercise choices to optimize aGWG. KEY POINTS: · Physician reinforcement of nutritional counseling by a dietitian is crucial for obese women.. · Physical inactivity and unemployment are associated with inappropriate gestational weight gain.. · Nutritional counseling is associated with appropriate gestational weight gain in women with BMI ≥40..

Contemporary Test Performance of the Random Urine Protein-to-creatinine Ratio.

OBJECTIVE: The random urine protein-to-creatinine ratio (UPCR) is a screening test used for predicting clinically significant proteinuria (urine protein ≥ 300 mg) during pregnancy. No consensus exists on the optimal random UPCR cutoff for performing follow-up 24 hour urine (24H) total protein collection. We aim to evaluate the test performance of random UPCR in predicting proteinuria in a contemporary cohort. STUDY DESIGN: This was a retrospective cohort study of pregnant patients at our institution from 2014 to 2018 with a random UPCR and follow-up 24H protein collection. The primary analysis estimated the test characteristics (sensitivity, specificity, positive and negative predictive values) of using random UPCR for the detection of proteinuria defined as urine protein ≥300 mg on 24H protein collection. UPCR cutoffs from 0.10 to 0.30 mg/dL were evaluated, receiver operator characteristic (ROC) curve was constructed, and area under the curve (AUC) was determined. A secondary analysis examined the correlation between UPCR and 24H protein using least squares regression and Pearson correlation. RESULTS: Paired UPCR and 24H collection results were available for 1,120 patients. Mean gestational age at time of UPCR was 31.1 ± 5.1 weeks and 687 (61.3%) of patients had a 24H ≥300 mg. UPCR <0.10 mg/dL effectively excluded proteinuria ≥300 mg on 24H collection, while UPCR ≥0.18 mg/dL correctly classifies proteinuria with 91% sensitivity, 57% specificity, 77% positive predictive value, and 79% negative predictive value. UPCR ≥1.07 mg/dL had 100% specificity for 24 hour proteinuria. The area under ROC curve was 0.86. UPCR and 24H collection were highly correlated with a Pearson correlation coefficient of 0.85. After our institution lowered the threshold to obtain a 24H from UPCR ≥0.20 mg/dL to ≥0.10 mg/dL in May 2017, the percentage of patients meeting criteria for 24H collection increased from 57.8 to 84.4%. CONCLUSION: The AUC and Pearson correlation suggest random UPCR is a high performance test for the prediction of proteinuria on 24H. Optimal test performance is dependent upon clinical consideration and upon the implications of the disease or condition. A random UPCR screen positive threshold of 0.18 mg/dL maximizes sensitivity to identify clinically significant proteinuria. KEY POINTS: · Random urine protein to creatinine ratio is a high performance test for proteinuria.. · A random UPCR threshold of 0.18 mg/dL maximizes sensitivity to identify proteinuria.. · Optimal test performance is dependent on the disease or clinical condition..

Racial disparities in reliable contraceptive use in women with heart disease.

OBJECTIVE: The aim of the study was to investigate the differences in reliable contraceptive use between black women and white women with maternal cardiac disease. METHODS: The study comprised a retrospective cohort of women with maternal cardiac disease managed by the University of Alabama at Birmingham (UAB) Comprehensive Pregnancy and Heart Program (CPHP). Women were included if they had attended one or more prenatal visits at the UAB CPHP and delivered at the UAB hospital between March 2015 and June 2019. The primary outcome was reliable contraceptive use within 2 months postpartum, defined by receipt of long-acting reversible contraception (i.e., an intrauterine contraceptive device or an etonogestrel implant) or female sterilisation. All outcomes were compared based on self-reported race. RESULTS: One hundred and forty-nine women met the inclusion criteria. Black women (n = 63) were more likely than white women (n = 86) to use reliable contraception (65% vs 43%; p = 0.008). Black women were less likely than white women to be undecided or decline contraception at the time of admission (13% vs 27%; p = 0.037). There was no difference in reliable contraceptive use between black women (n = 20, 63%) and white women (n = 23, 72%) with modified World Health Organisation (WHO) class III/IV lesions (p = 0.42). CONCLUSION: Black women with maternal cardiac disease were more likely than white women to receive reliable contraception. Interventions to prevent unintended pregnancy in women with maternal cardiac disease should focus on improving reliable contraceptive use, especially for women with modified WHO class III/IV lesions.

Characterization of symptom severity and impact on four fecal incontinence phenotypes in women presenting for evaluation.

AIM: To characterize symptom-specific distress and impact on quality of life (QOL) among women with urge, passive, and combined urge/passive fecal incontinence (FI) phenotypes. A secondary aim was to characterize FI symptom-specific distress and impact on women with a novel fourth phenotype, stress FI. METHODS: Women with at least monthly FI from 2003 to 2017 were included. Participants completed the Modified Manchester Health Questionnaire (MMHQ) including MHQ and Fecal Incontinence Severity Index (FISI). Anorectal manometry (ARM) and endoanal ultrasound (EAUS) testing was performed. Total MHQ and FISI scores were compared across FI subtypes controlling for pertinent baseline covariates. RESULTS: The cohort included 404 subjects, 220 meeting criteria for urge FI, 67 passive FI, and 117 combined urge/passive FI. On MHQ, women with combined urge/passive FI were most impacted (p < 0.01). FISI scores were significantly different from combined urge/passive FI having the greatest impact (38.1 ± 12.5) and urge FI (31.1 ± 11.3), p < 0.01 having the least. No differences were observed in ARM measurements or anal sphincter defects among the three groups (all p > 0.05). Twenty-nine subjects were identified with stress FI. There were no differences in overall MHQ or FISI scores or anal sphincter evaluation among the urge, passive, and stress FI groups (all p > 0.05). CONCLUSION: Women with combined urge/passive FI have higher symptom distress and impact on QOL than urge or passive FI alone. Further research is needed to determine the significance of stress FI as a subtype and response to treatment.

Prenatal Tobacco Exposure and Childhood Neurodevelopment among Infants Born Prematurely.

OBJECTIVE: Nicotine is an established neuroteratogen, and prenatal tobacco exposure alters the structure of the developing nervous system. An association between prenatal tobacco exposure and impaired neurologic function is less well established. We examine the association between prenatal tobacco exposure and childhood neurodevelopment among infants born preterm. STUDY DESIGN: Secondary analysis of a multicenter randomized controlled trial assessing the benefits of magnesium sulfate for the prevention of cerebral palsy in preterm infants. Women were included if they delivered a singleton and nonanomalous infant before 37 weeks. Exposure was any self-reported prenatal tobacco use. Primary outcome was the original trial composite outcome of moderate or severe cerebral palsy at 2 years of age, or stillbirth, or infant death by 1 year of age. Secondary outcomes included components of the composite and mild cerebral palsy at 2 years, Bayley Scales of Infant Development II motor and mental scores, death before two years, and use of auditory aids or corrective lenses. Multivariable logistic regression models were performed to estimate adjusted odds ratios (aOR) with 95% confidence intervals. RESULTS: Of 1,826 women included, 503 (27.5%) used tobacco. Tobacco users were more likely to be older, unmarried, and white; have a prior preterm birth; have received no prenatal care; and to use illicit drugs or alcohol. Gestational age at delivery, betamethasone exposure, and magnesium exposure were not different between groups. There were no differences in the composite primary outcome or in rates of cerebral palsy by tobacco use. Moderate developmental delay was more common among tobacco exposed in bivariate but not adjusted analysis (20.5 vs. 15.9%, p = 0.035). In adjusted analysis, tobacco exposure was associated with increased use of corrective lenses (5.0 vs. 2.9%, aOR: 2.28, 95% confidence interval: 1.28-4.07). CONCLUSION: Prenatal tobacco exposure is not associated with neurodevelopmental impairment in infants born preterm. However, tobacco exposure may be associated with impaired vision. KEY POINTS: · Tobacco exposure is not associated with impaired neurodevelopment in this preterm population.. · Prenatal tobacco exposure is associated with increased need for corrective lenses.. · Tobacco use in pregnancy may be a risk factor for poorer visual acuity in children..

Extensive financial hardship among gynecologic cancer patients starting a new line of therapy.

OBJECTIVE: Our objective was to evaluate the three domains of financial hardship (psychological response, material conditions, and coping behaviors) among gynecologic cancer patients receiving treatment. METHODS: We conducted a single-institution survey of gynecologic cancer patients starting a new line of therapy for primary or recurrent disease. Psychological response was measured using Comprehensive Score for Financial Toxicity, with score < 26 indicating financial distress. We measured material conditions by patient-reported changes in employment or spending and coping behaviors by patient-reported medication non-adherence. We performed descriptive statistics, bivariate analysis, and multivariate logistic regression. RESULTS: Among 121 participants, the mean age was 59 years, 28% were African-American, 50% reported income < $40,000, 74% had private insurance, 20% had only public insurance, and 7% were uninsured. Sixty-five (54%) participants screened positive for financial distress. Age < 65 years (aOR 2.61, 95% CI 1.04-6.52) and income < $40,000 (aOR 3.41, 95% CI 1.28-9.09) were associated with increased odds of screening positive for financial distress. Participants with financial distress were significantly more likely to report material hardship, including losing wages (46% vs. 18%, p < 0.01), not paying bills on time (40% vs. 7%, p < 0.01), and borrowing money (39% vs. 4%, p < 0.01). Financial distress was not associated with coping behaviors, such as not taking (6% vs. 2%, p = 0.37) or refilling medications (5% vs. 2%, p = 0.62). CONCLUSIONS: Financial distress affects over half of gynecologic cancer patients starting a new line of treatment and is associated with material hardship. Younger age and lower income can be used to identify patients at increased risk.

Resident Operative Vaginal Delivery Volume after Educational Curriculum Implementation.

OBJECTIVE: The percentage of operative vaginal deliveries (OVDs) in the United States has sharply declined. In May 2016, our institution's obstetrics and gynecology (OB/GYN) residency program implemented a twice-yearly OVD curriculum consisting of didactics and simulation. We sought to evaluate the impact of this curriculum. STUDY DESIGN: We performed a retrospective cohort study of all deliveries at our institution from July 2011 to May 2018. Deliveries were evaluated quarterly for the pre- (July 2011-April 2016) and postcurriculum (July 2016-May 2018) periods. Forceps-assisted vaginal delivery (FAVD), vacuum-assisted vaginal delivery (VAVD), and total OVD percentages, and the ratio of forceps to vacuums were calculated. Pre- and postcurriculum percentages were compared using Wilcoxon's rank-sum test. Cubic regression curves were fit to quarterly percentages to illustrate trends over time. RESULTS: The quarterly OVD percentage was unchanged following curriculum implementation (mean 3.2% [Q1-Q3: 2.6-3.5%] pre- vs. 3.1% [2.5-3.8%] post-, p > 0.99). The FAVD percentage was increased (1.2% [0.8-1.5%] vs. 2.0% [1.4-2.6%], p = 0.027) and the VAVD percentage was decreased (2.0% [1.6-2.2%] vs. 1.2% [0.9-1.3%], p < 0.001). This was accompanied by an increase in the ratio of FAVD to VAVD (0.6 [0.4-0.8] vs. 1.7 [1.3-2.2], p < 0.001). FAVD percentage (3.1%) was higher in the last quarter than any other quarter in the 7-year study period, and total OVD percentage (3.9%) was higher in 2018 than any other calendar year. CONCLUSION: The implementation of an OVD curriculum in our OB/GYN residency program resulted in an increase in the percentage of FAVD and the ratio of FAVD to VAVD. KEY POINTS: · OVD utilization in the United States continues to decline.. · We demonstrate real-world impact of an OVD curriculum.. · OVD curriculum implementation increases usage of FAVD..

The cost-effectiveness of opportunistic salpingectomy versus standard tubal ligation at the time of cesarean delivery for ovarian cancer risk reduction.

OBJECTIVES: Opportunistic salpingectomy is a cost-effective strategy recommended for ovarian cancer (OvCa) risk reduction at the time of gynecologic surgery in women who have completed childbearing. We aimed to evaluate the cost-effectiveness of opportunistic salpingectomy compared to standard tubal ligation (TL) during cesarean delivery. STUDY DESIGN: A cost-effectiveness analysis using decision modeling to compare opportunistic salpingectomy to TL at the time of cesarean using probabilities of procedure completion derived from a trial. Probability and cost inputs were derived from local data and the literature. The primary outcome was the incremental cost-effectiveness ratio (ICER) in 2017 U.S. dollars per quality-adjusted life year (QALY) at a cost-effectiveness threshold of $100,000/QALY. One- and two-way sensitivity analyses were performed for all variables. A probabilistic sensitivity analysis determined the proportion of simulations in which each strategy would be cost-effective. RESULTS: Opportunistic salpingectomy was cost-effective compared to TL with an ICER of $26,616 per QALY. In 10,000 women desiring sterilization with cesarean, opportunistic salpingectomy would result in 17 fewer OvCa diagnoses, 13 fewer OvCa deaths, and 25 fewer unintended pregnancies compared to TL - with an associated cost increase of $4.7 million. The model was sensitive only to OvCa risk reduction from salpingectomy and TL. Opportunistic salpingectomy was not cost-effective if its cost was >$3163.74 more than TL, if the risk-reduction of salpingectomy was <41%, or if the risk-reduction of TL was >46%. In probabilistic sensitivity analysis opportunistic salpingectomy was cost effective in 75% of simulations. CONCLUSIONS: In women undergoing cesarean with sterilization, opportunistic salpingectomy is likely cost-effective and may be cost-saving in comparison to TL for OvCa risk reduction.

Fecal Incontinence Symptoms and Impact in Older Versus Younger Women Seeking Care.

BACKGROUND: The differential impact of aging on fecal incontinence symptom severity and condition-specific quality of life remains unclear. OBJECTIVE: The purpose of this study was to characterize differences in symptom distress, quality of life, and anorectal physiology assessments in older versus younger women with fecal incontinence. DESIGN: This was a cross-sectional study. SETTINGS: This study was conducted at a tertiary genitorectal disorder clinic. PATIENTS: Women presenting for fecal incontinence evaluation between 2003 and 2016 were classified as older or younger based on age ≥65 or <65 years. MAIN OUTCOME MEASURES: The main outcomes were symptom-specific quality of life and distress measured by validated questionnaires (the Modified Manchester Health Questionnaire containing the Fecal Incontinence Severity Index); anorectal physiology and anatomy were assessed by manometry and endoanal ultrasound. RESULTS: Of 879 subjects, 286 and 593 were classified as older and younger (mean ages, 71.4 ± 5.3 y and 51.3 ± 10.5 y). Solid stool leakage was more frequent in older women (83.2% vs 76.7%; p = 0.03), whereas liquid stool leakage (83.2% vs 82.8%; p = 0.88) and fecal urgency (76.9% vs 78.8%; p = 0.54) did not differ between groups. Mean symptom severity scores were similar between groups (28.0 ± 11.9 and 27.6 ± 13.5; p = 0.69); however, there was greater negative impact on quality of life among younger women (46.3 ± 22.0 vs 51.8 ± 21.8; p < 0.01). Multivariable linear regression controlling for pertinent covariates revealed younger age as an independent predictor for worse condition-specific quality-of-life scores (p < 0.01). Squeeze pressures were similar between groups, whereas younger women had greater resting pressures and higher rates of sphincter defects (external, 7.7% vs 20.2%; internal, 12.2% vs 26.8%; both p < 0.01). LIMITATIONS: This study was limited by its lack of patient obstetric history and the duration of their incontinence symptoms. CONCLUSIONS: Characteristics differ between older and younger women seeking care for fecal incontinence. The differential impact and age-related phenotypes may provide useful information for patient counseling and developing management algorithms for women with fecal incontinence. See Video Abstract at http://links.lww.com/DCR/A910.

Does Time of Wound Complication after Cesarean Delivery Differ by Type of Skin Closure?

OBJECTIVE: A high proportion of postcesarean wound complications occur after patients have been discharged from the hospital, increasing personal and health care costs. We undertook this study to evaluate the association between skin closure methods (suture vs. staple) following a cesarean delivery and the frequency of wound complications occurring after hospital discharge. STUDY DESIGN: This is a secondary analysis of data from a randomized trial in which women undergoing cesarean delivery at ≥24 weeks' gestation were randomized to receive metallic staples or subcuticular suture for skin closure after surgery. Staples were removed at the time of hospital discharge on postoperative days 3 to 4 for Pfannenstiel incisions or days 7 to 10 for vertical. The primary outcome for this analysis was any wound complication occurring after hospital discharge. Wound complications were infections or any wound disruption without infection (including seromas and hematomas). Associations were examined using chi-square and Fisher's exact tests, as appropriate, and multivariable logistic regression. RESULTS: A total of 350 patients with follow-up through 4 to 6 weeks postpartum were included in the analysis: n = 171 received suture closure and n = 179 received staples. In the primary trial, wound complications occurred in 14.5% (n = 26) of individuals with staples and 5.9% (n = 10) with sutures (p = 0.008). Twenty-one (58.3%) of the 36 wound complications occurred after hospital discharge. The incidence of wound complications occurring after hospital discharge was 6.7% (n = 12) of patients receiving staples and 5.3% (n = 9) of those receiving sutures; p = 0.57; relative risk [95% confidence interval]: 1.27 [0.55-2.95]). After multivariable adjustment, type of skin closure method was not associated with wound complication after discharge from the hospital (odds ratio: 1.29; 0.52-3.17). CONCLUSION: Although suture closure compared with staples was associated with fewer wound complications after cesarean delivery, we found no significant differences between closure types in the frequency of wound complications occurring after hospital discharge.