ABSTRACT Intrauterine device (IUD) expulsion is more common among women with heavy menstrual bleeding, parity, higher body mass index (BMI), younger age, dysmenorrhea, or immediate postabortion or postpartum insertion. The APEX-IUD study was an observational cohort study of 326,658 individuals examining the association with breastfeeding, IUD type, and timing of postpartum IUD insertion with IUD expulsion and uterine perforation. This data set provides an opportunity to examine specific demographic, reproductive, and medical risk factors associated with IUD expulsion. This analysis of APEX-IUD data aimed to determine the associations of 6 risk factors (age, race/ethnicity, parity, BMI, heavy menstrual bleeding, and dysmenorrhea) and IUD expulsion, as well as the extent to which these associations differed for LNG-IUD compared with copper IUD users. Individuals aged 50 years or younger at the time of IUD insertion without a delivery 52 weeks or less before insertion were included. Individuals were followed from IUD insertion until IUD expulsion, uterine perforation, removal, reinsertion, expiration, pregnancy, hysterectomy, death, disenrollment from the health care system, or end of study period (June 2018). Crude incidence rates for each risk factor category were calculated using the number of expulsions during the time at risk divided by the total person-years at risk and were reported as the number of expulsions per 1000 person-years at risk. Hazards ratios (HRs) and 95% confidence intervals from Cox regression models were used to evaluate associations of the risk factors with IUD expulsion. These models were adjusted for potential confounding effects and were separately used to assess the association of covariates with IUD expulsion varied by IUD type. The total study cohort included 228,834 individuals (LNG-IUD: 184,733 [80.7%]; copper IUD: 41,123 [18.0%]; unknown type: 2978 [1/3%]). The average length of follow-up was 2.0 years, and there were 6762 expulsions with a crude incidence rate of 14.9 per 1000 person-years (95% confidence interval, 14.6–15.3). Adjusted hazards ratios (aHRs) showed the younger age groups having a higher risk of IUD expulsion and a trend toward lower aHRs with increasing age. Individuals with parity of 4 or more had the highest risk of IUD expulsion, and a parity of 2 was associated with the lowest risk on adjusted analysis. Adjusted analysis revealed a greater risk of IUD expulsion among individuals with higher BMI or heavy menstrual bleeding diagnosis compared with the comparator group. Multiple racial and ethnic groups including non-Hispanic Black, Hispanic Black, Hispanic White, Asian, or Pacific Islander were associated with a greater risk of IUD expulsion compared with non-Hispanic Whites when adjusting for covariates. When comparing aHRs by copper IUD or LNG-IUD; younger age was more strongly associated with expulsion among copper IUD users than LNG-IUD users, the risk for expulsion associated with obesity was significantly attenuated for copper IUD users compared with LNG-IUD users, and the risk of expulsion for those with heavy menstrual bleeding was partially attenuated by copper IUDs. Adjusted analysis revealed no association between dysmenorrhea and IUD expulsion. The results of this study show that, among the 6 risk factors investigated here, the risk of IUD expulsion was highest among individuals with a diagnosis of heavy menstrual bleeding, particularly in recent and past periods.

OBJECTIVE:The APEX-IUD (Association of Perforation and Expulsion of Intrauterine Devices) study evaluated the association of postpartum timing of intrauterine device (IUD) insertion, breastfeeding, heavy menstrual bleeding, and IUD type (levonorgestrel-releasing vs copper) with risks of uterine perforation and IUD expulsion in usual clinical practice. We summarize the clinically important findings to inform counseling and shared decision making.METHODS:APEX-IUD was a real-world (using U.S. health care data) retrospective cohort study of individuals aged 50 years and younger with IUD insertions between 2001 and 2018 and with electronic health record data. Cumulative incidences of uterine perforation and IUD expulsion were calculated. Adjusted hazard ratios (aHRs) and 95% CIs were estimated from proportional hazards models with control of confounding.RESULTS:Among the study population of 326,658, absolute risk of uterine perforation was low overall (cumulative incidence, 0.21% [95% CI 0.19-0.23%] at 1 year and 0.61% [95% CI 0.56-0.66% at 5 years]) but was elevated for IUDs inserted during time intervals within 1 year postpartum, particularly among those between 4 days and 6 weeks postpartum (aHR 6.71, 95% CI 4.80-9.38), relative to nonpostpartum insertions. Among postpartum insertions, IUD expulsion risk was greatest for insertions in the immediate postpartum period (0-3 days after delivery) compared with nonpostpartum (aHR 5.34, 95% CI 4.47-6.39). Postpartum individuals who were breastfeeding had a slightly elevated risk of perforation and lowered risk of expulsion than those not breastfeeding. Among nonpostpartum individuals, those with a heavy menstrual bleeding diagnosis were at greater risk of expulsion than those without (aHR 2.84, 95% CI 2.66-3.03); heavy menstrual bleeding also was associated with a slightly elevated perforation risk. There was a slightly elevated perforation risk and slightly lower expulsion risk associated with levonorgestrel-releasing IUDs compared with copper IUDs.CONCLUSION:Absolute risk of adverse outcomes with IUD insertion is low. Clinicians should be aware of the differences in risks of uterine perforation and expulsion associated with IUD insertion during specific postpartum time periods and with a heavy menstrual bleeding diagnosis. This information should be incorporated into counseling and decision making for patients considering IUD insertion.FUNDING SOURCE:Bayer AG.

OBJECTIVE:To compare cesarean delivery rates and indications by race/ethnicity among nulliparous women with term, singleton, vertex presentation deliveries.METHODS:This is a retrospective cohort study of nulliparous women delivering term, singleton, vertex neonates at Kaiser Permanente Northern California from 1/1/2016 to 6/30/2017. Women with cesarean for elective, malpresentation, or previa were excluded. Multivariable logistic regression models adjusting for maternal, neonatal, and facility factors were used to assess the likelihood of cesarean by race/ethnicity. Further modeling was performed to examine odds of cesarean for the indications of failure to progress and fetal intolerance by race/ethnicity.RESULTS:The cohort of 16,587 racially/ethnically diverse women meeting inclusion and exclusion criteria consisted of 41.62% White, 27.73% Asian, 22.11% Hispanic, 5.32% Black, and 3.21% multiple race/other women. In adjusted logistic regression models, all race and ethnic categories had higher odds of cesarean deliveries in comparison to White women. Black women had the highest odds of cesarean delivery (adjusted OR [aOR] = 1.73, 95% CI: 1.45-2.06), followed by Asian (aOR = 1.59, 95% CI: 1.45-2.06), multiple race/other (aOR = 1.45, 95% CI: 1.17-1.80), and Hispanic (aOR = 1.43, 95% CI: 1.28-1.59) women. Compared with White women, Asian (aOR = 1.46, 95% CI: 1.22-1.74) and Hispanic (aOR = 1.25, 95% CI: 1.03-1.52) women had higher odds of failure to progress as the indication. Among women with failure to progress, Black (aOR = 0.50, 95% CI: 0.30-0.81), Hispanic (aOR = 0.68, 95% CI: 0.53-0.87), and Asian (aOR = 0.77, 95% CI: 0.61-0.96) women were less likely than White women to reach 10 cm dilation. Compared with White women, Black women were more likely to have cesarean delivery for fetal intolerance (aOR = 1.51, 95% CI: 1.10-2.07). Among women with fetal intolerance of labor, there were no significant differences by race/ethnicity for Apgar score or neonatal intensive care unit admission.CONCLUSIONS:Race/ethnicity was significantly associated with the odds of cesarean and indication. All other race/ethnicity groups had higher odds of cesarean compared with White women. Compared with White women, Black women had greater odds of fetal intolerance as an indication, while Hispanic and Asian women had greater odds of failure to progress. Maternal, neonate, and facility factors for cesarean delivery did not explain the observed disparities in cesarean delivery rates.

OBJECTIVE:To explore to what extent intrauterine device (IUD) expulsion is associated with demographic and clinical risk factors.METHODS:The APEX-IUD (Association of Perforation and Expulsion of IntraUterine Devices) study was a U.S. cohort study using electronic health records from three integrated health care systems (Kaiser Permanente Northern California, Southern California, and Washington) and a health care information exchange (Regenstrief Institute). These analyses included individuals aged 50 years or younger with IUD insertions from 2001 to 2018. Intrauterine device expulsion cumulative incidence and incidence rates were estimated. Using Cox regression models, hazard ratios with 95% CIs were estimated before and after adjustment for risk factors of interest (age, race and ethnicity, parity, body mass index [BMI], heavy menstrual bleeding, and dysmenorrhea) and potential confounders.RESULTS:In total, 228,834 individuals with IUD insertion and no delivery in the previous 52 weeks were identified (184,733 [80.7%] with levonorgestrel-releasing intrauterine system). Diagnosis of heavy menstrual bleeding-particularly a diagnosis in both recent and past periods-was the strongest risk factor for IUD expulsion. Categories with the highest risk of IUD expulsion within each risk factor included individuals diagnosed with overweight, obesity, and morbid obesity; those in younger age groups, especially among those aged 24 years or younger; and in those with parity of four or more. Non-Hispanic White individuals had the lowest incidence and risk, and after adjustment, Asian or Pacific Islander individuals had the highest risk. Dysmenorrhea was not independently associated with expulsion risk when adjusting for heavy menstrual bleeding.CONCLUSION:Most risk factors for expulsion identified in this study appear consistent with known physiologic factors that affect uterine anatomy and physiology (age, BMI, heavy menstrual bleeding, parity). The increased risk of IUD expulsion among individuals of color warrants further investigation. Intrauterine devices are an effective long-term contraceptive; expulsion is uncommon, but patients should be counseled accordingly.FUNDING SOURCE:Bayer AG.CLINICAL TRIAL REGISTRATION:EU PAS register, EUPAS33461.

ObjectiveTo investigate whether obstetric complications prior to systemic sclerosis (SSc) diagnosis are more common in SSc patients compared to the general obstetric population.MethodsA case–control study was performed at Kaiser Permanente Northern California to compare prior obstetric complications in adult women who later developed SSc (cases) with women from the general obstetric population who did not develop SSc (controls; matched 10:1 by age and year of delivery) from 2007 to 2016. Exposures included past hypertensive disorders of pregnancy (preeclampsia, eclampsia, gestational hypertension), premature rupture of membranes (PROM), intrauterine growth restriction (IUGR), maternal infections, neonatal intensive care unit (NICU) admission, and preterm birth. Fischer's exact tests were used to compare categorical variables. Conditional logistic regression models estimated the odds ratio (OR), and corresponding 95% confidence intervals (95% CIs) for the outcome SSc.ResultsSeventeen SSc cases and 170 non‐SSc controls were identified, with median maternal age at delivery 34 years (range 23–46 years) and median time from delivery to SSc diagnosis 2 years (range 0.2–7.3 years). Women with SSc were more likely to be Hispanic and Black. Prior obstetric complications appeared higher in women with an eventual SSc diagnosis compared to controls (70.6% versus 50%), including hypertensive disorders (17.7% versus 9.4%), PROM (11.8% versus 4.1%), IUGR (5.9% versus 1.8%), maternal infection (29.4% versus 14.1%), NICU admissions (23.5% versus 7.7%), and preterm delivery (29.4% versus 21.8%). Women with SSc had a higher odds of delivering infants requiring NICU admission (OR 4.7 [95% CI 1.2–18.8]).ConclusionWomen who eventually develop SSc had trends toward more complicated pregnancy histories before overt diagnosis.

BACKGROUND: Intrauterine devices are effective instruments for contraception, and 1 levonorgestrel-releasing device is also indicated for the treatment of heavy menstrual bleeding (menorrhagia). OBJECTIVE: To compare the incidence of intrauterine device expulsion and uterine perforation in women with and without a diagnosis of menorrhagia within the first 12 months before device insertion STUDY DESIGN: This was a retrospective cohort study conducted in 3 integrated healthcare systems (Kaiser Permanente Northern California, Southern California, and Washington) and a healthcare information exchange (Regenstrief Institute) in the United States using electronic health records. Nonpostpartum women aged <= 50 years with intrauterine device (eg, levonorgestrel or copper) insertions from 2001 to 2018 and without a delivery in the previous 12 months were studied in this analysis. Recent menorrhagia diagnosis (ie, recorded <= 12 months before insertion) was ascertained from the International Classification of Diseases, Ninth and Tenth Revision, Clinical Modification codes. The study outcomes, viz, device expulsion and device-related uterine perforation (complete or partial), were ascertained from electronic medical records and validated in the data sources. The cumulative incidence and crude incidence rates with 95% confidence intervals were estimated. Cox proportional hazards models estimated the crude and adjusted hazard ratios using propensity score overlap weighting (13-16 variables) and 95% confidence intervals. RESULTS: Among 228,834 nonpostpartum women, the mean age was 33.1 years, 44.4% of them were White, and 31,600 (13.8%) had a recent menorrhagia diagnosis. Most women had a levonorgestrel-releasing device (96.4% of those with and 78.2% of those without a menorrhagia diagnosis). Women with a menorrhagia diagnosis were likely to be older, obese, and have dysmenorrhea or fibroids. Women with a menorrhagia diagnosis had a higher intrauterine deviceeexpulsion rate (40.01 vs 10.92 per 1000 personyears) than those without, especially evident in the first few months after insertion. Women with a menorrhagia diagnosis had a higher cumulative incidence (95% confidence interval) of expulsion (7.00% [6.70-7.32] at 1 year and 12.03% [11.52-12.55] at 5 years) vs those without (1.77% [1.70-1.84] at 1 year and 3.69% [3.56-3.83] at 5 years). The risk of expulsion was increased for women with a menorrhagia diagnosis vs for those without (adjusted hazard ratio, 2.84 [95% confidence interval, 2.66-3.03]). The perforation rate was low overall (<1/1000 person-years) but higher in women with a diagnosis of menorrhagia vs in those without (0.98 vs 0.63 per 1000 person-years). The cumulative incidence (95% confidence interval) of uterine perforation was slightly higher for women with a menorrhagia diagnosis (0.09% [0.06-0.14] at 1 year and 0.39% [0.29-0.53] at 5 years) than those without it (0.07% [0.06-0.08] at 1 year and 0.28% [0.24-0.33] at 5 years). The risk of perforation was slightly increased in women with a menorrhagia diagnosis vs in those without (adjusted hazard ratio, 1.53; 95% confidence interval, 1.10-2.13). CONCLUSION: The risk of expulsion is significantly higher in women with a recent diagnosis of menorrhagia. Patient education and counseling regarding the potential expulsion risk is recommended at insertion. The absolute risk of perforation for women with a recent diagnosis of menorrhagia is very low. The increased expulsion and perforation rates observed are likely because of causal factors of menorrhagia.

IMPORTANCE Intrauterine device (IUD) expulsion increases the risk of unintended pregnancy; how timing of postpartum IUD insertion and breastfeeding are associated with risk of expulsion is relevant to the benefit-risk profile. OBJECTIVE To evaluate the association of postpartum timing of IUD insertion and breastfeeding status with incidence and risk of IUD expulsion. DESIGN, SETTING, AND PARTICIPANTS The Association of Perforation and Expulsion of Intrauterine Devices (APEX-IUD) cohort study includedwomen aged 50 years or younger with an IUD insertion between 2001 and 2018. The breastfeeding analysis focused on a subcohort of women at 52 or fewer weeks post partum with known breastfeeding status. The study was conducted using data from electronic health records (EHRs) at 4 research sites with access to EHR: 3 Kaiser Permanente sites (Northern California, Southern California, Washington) and the Regenstrief Institute (Indiana). Data analysis was conducted from June to November 2019. EXPOSURES Timing of IUD insertion post partum was categorized into discrete time periods: 0 to 3 days, 4 days to 6 or fewer weeks, more than 6 weeks to 14 or fewer weeks, more than 14 weeks to 52 or fewer weeks, and non-post partum (>52 weeks or no evidence of delivery). Breastfeeding status at the time of insertion was determined from clinical records, diagnostic codes, or questionnaires from well-baby visits. MAIN OUTCOMES AND MEASURES Incidence rates and adjusted hazard ratios (aHRs) were estimated using propensity scores to adjust for confounding. RESULTS The full cohort included 326 658 women (mean [SD] age, 32.0 [8.3] years; 38 911 [11.9%] Asian or Pacific Islander; 696 [0.2%] Hispanic Black; 56 180 [17.2%] Hispanic other; 42 501 [13.0%] Hispanic White; 28 323 [8.7%] non-Hispanic Black; 137 102 [42.0%] non-Hispanic White), and the subcohort included 94 817 women. Most IUDs were levonorgestrel-releasing (259 234 [ 79.4%]). There were 8943 expulsions. The 5-year cumulative incidence of IUD expulsion was highest for insertions 0 to 3 days post partum (10.73%; 95% CI, 9.12%-12.61%) and lowest for insertions more than 6 weeks to 14 or fewer weeks post partum (3.18%; 95% CI, 2.95%-3.42%). Adjusted HRs using women with non-post partum IUD insertion as the referent were 5.34 (95% CI, 4.47-6.39) for those with postpartum insertion at 0 to 3 days; 1.22 (95% CI, 1.05-1.41) for those with postpartum insertion at 4 days to 6 or fewer weeks; 1.06 (95% CI, 0.95-1.18) for those with postpartum insertion at more than 6 to 14 or fewerweeks; and 1.43 (95% CI, 1.29-1.60) for those with postpartum insertion at more than 14 to 52 or fewer weeks. In the subcohort, 5-year cumulative incidence was 3.49% (95% CI, 3.25%-3.73%) for breastfeeding women and 4.57%(95% CI, 4.22%-4.95%) for nonbreastfeeding women; the adjusted HR for breastfeeding vs not breastfeeding was 0.71 (95% CI, 0.64-0.78). CONCLUSIONS AND RELEVANCE In this study of real-world data, IUD expulsion was rare but more common with immediate postpartum insertion. Breastfeeding was associated with lower expulsion risk.

Objective To estimate the risk of mesh complications in women with and without subsequent pelvic and abdominal radiation therapy (RT). Methods We identified women within a large health care organization who underwent mesh-augmented surgery for pelvic floor disorders between 2008 and 2014 and subsequently received RT prior to 2018. We compared them to a randomly selected group of women who underwent similar mesh-augmented pelvic reconstructive surgery without RT in a 1:4 ratio. Mesh complications were identified through chart review corroborated with the ninth and tenth revisions of the International Classification of Diseases and Current Procedural Terminology codes for mesh complications. Mesh complications between groups were compared using survival analysis and Cox proportional hazards models. Results We identified 36 women with RT and compared them with 144 women without RT. Indications for mesh implantation and concomitant vaginal procedures were similar between the groups. The majority of mesh implants (94.4%) were midurethral slings. Twelve mesh complications (6.7%) were identified, with similar rates in the RT (8.3%) and no-RT (6.2%) groups (P = 0.65). The risk of mesh complications did not differ between groups when compared using the Cox proportional hazards model, controlling for age, body mass index, diabetes, menopausal status, and smoking (hazard ratio, 1.19; 95% confidence interval, 0.802-1.787). Conclusions There was no difference in the occurrence of mesh-related complications between women with and without RT. Abdominopelvic RT may not substantially increase the risk of mesh complications following placement of a synthetic sling for stress urinary incontinence. The need for future RT may only be a minor factor in counseling patients on the risks of mesh implants for pelvic floor disorders.

BACKGROUND: Intrauterine devices are effective and safe, long-acting reversible contraceptives, but the risk of uterine perforation occurs with an estimated incidence of 1 to 2 per 1000 insertions. The European Active Surveillance Study for Intrauterine Devices, a European prospective observational study that enrolled 61,448 participants (2006-2012), found that women breastfeeding at the time of device insertion or with the device inserted at <= 36 weeks after delivery had a higher risk of uterine perforation. The Association of Uterine Perforation and Expulsion of Intrauterine Device (APEX-IUD) study was a Food and Drug Administration-mandated study designed to reflect current United States clinical practice. The aims of the APEX-IUD study were to evaluate the risk of intrauterine device-related uterine perforation and device expulsion among women who were breastfeeding or within 12 months after delivery at insertion. OBJECTIVE: We aimed to describe the APEX-IUD study design, methodology, and analytical plan and present population characteristics, size of risk factor groups, and duration of follow-up. STUDY DESIGN: APEX-IUD study was a retrospective cohort study conducted in 4 organizations with access to electronic health records: Kaiser Permanente Northern California, Kaiser Permanente Southern California, Kaiser Permanente Washington, and Regenstrief Institute in Indiana. Variables were identified through structured data (eg, diagnostic, procedural, medication codes) and unstructured data (eg, clinical notes) via natural language processing. Outcomes include uterine perforation and device expulsion; potential risk factors were breastfeeding at insertion, postpartum timing of insertion, device type, and menorrhagia diagnosis in the year before insertion. Covariates include demographic characteristics, clinical characteristics, and procedure-related variables, such as difficult insertion. The first potential date of inclusion for eligible women varies by research site (from January 1, 2001 to January 1, 2010). Follow-up begins at insertion and ends at first occurrence of an outcome of interest, a censoring event (device removal or reinsertion, pregnancy, hysterectomy, sterilization, device expiration, death, disenrollment, last clinical encounter), or end of the study period (June 30, 2018). Comparisons of levels of exposure variables were made using Cox regression models with confounding adjusted by propensity score weighting using overlap weights. RESULTS: The study population includes 326,658 women with at least 1 device insertion during the study period (Kaiser Permanente Northern California, 161,442; Kaiser Permanente Southern California, 123,214; Kaiser Permanente Washington, 20,526; Regenstrief Institute, 21,476). The median duration of continuous enrollment was 90 (site medians 74-177) months. The mean age was 32 years, and the population was racially and ethnically diverse across the 4 sites. The mean body mass index was 28.5 kg/m(2), and of the women included in the study, 10.0% had menorrhagia <= 12 months before insertion, 5.3% had uterine fibroids, and 10% were recent smokers; furthermore, among these women, 79.4% had levonorgestrel-releasing devices, and 19.5% had copper devices. Across sites, 97,824 women had an intrauterine device insertion at <= 52 weeks after delivery, of which 94,817 women (97%) had breastfeeding status at insertion determined; in addition, 228,834 women had intrauterine device insertion at >52 weeks after delivery or no evidence of a delivery in their health record. CONCLUSION: Combining retrospective data from multiple sites allowed for a large and diverse study population. Collaboration with clinicians in the study design and validation of outcomes ensured that the APEX-IUD study results reflect current United States clinical practice. Results from this study will provide valuable information based on real-world evidence about risk factors for intrauterine devices perforation and expulsion for clinicians.

STUDY OBJECTIVE:There is growing advocacy for use of long-acting reversible contraception among sexually active adolescents. Our primary aims were to evaluate the etonogestrel subdermal contraceptive implant (SCI) insertion trends among adolescents, as well as SCI retention at 1, 2, and 3 years, indications for removal, and to identify pregnancies that occurred during SCI use. DESIGN, SETTING, PARTICIPANTS, INTERVENTIONS, AND MAIN OUTCOME MEASURES: A retrospective cohort study was conducted of adolescents aged 13-19 years with SCI insertions in 2008-2014 within a large integrated health care system. Demographic and clinical characteristics included age, race/ethnicity, body mass index, gravidity, parity, insertions, reinsertions, indications for removal, and pregnancy. Electronic medical record review was conducted on a randomized sample of 540 adolescents with insertions during 2008-2011 for the retention objective to validate electronically extracted variables. Analyses included descriptive statistics, survival analysis with Kaplan-Meier estimates for implant retention and Cochran-Armitage trend test for insertions according to year during 2008-2014.RESULTS:Most adolescent SCI users were non-Hispanic white (43%), or Hispanic (34.2%) and 16 years or older (84.2%) at the time of insertion. Overall, 1-, 2-, and 3-year retention rates were 78.6%, 59.4%, and 26.2%, respectively, with retention at 44.3% at 2 years 9 months (indicative of removal of method for near expiration of 3-year device). The insertion rate trend showed statistically significant increases annually, from 0.14% in 2008 to 0.91% in 2014; P < .0001. No pregnancies were documented during implant use. The most common indication for SCI removal was device expiration.CONCLUSION:SCI insertions increased annually among adolescents, with more than a sixfold increase over the 6-year study period, and more than half of the SCIs were retained through 2 years of use. The most common indication of SCI removal was completion of Food and Drug Administration-approved duration.

OBJECTIVE: To evaluate preterm birth rate and pregnancy outcomes in women with and without congenital uterine anomalies. STUDY DESIGN: We performed a retrospective observational matched-cohort study of 674 nulliparous women with and without uterine anomalies delivering a live birth in Kaiser Permanente Northern California between 2009-2016. Women with uterine anomalies (n=337) (didelphys, septate, bicornuate, unicornuate) were compared to 337 women without uterine anomalies. Primary outcome was preterm birth (PTB). Secondary outcomes were preterm premature rupture of membranes (PPROM), small for gestational age (SGA), cesarean delivery, and postpartum hemorrhage. RESULTS: The incidence of PTB < 37 weeks and PTB < 34 weeks in women with uterine anomalies was 23.7% and 8%, respectively. As compared to women without uterine anomalies, women with a uterine anomaly had an increased risk of PTB < 37 weeks (odds ratio [OR] 4.1; 95% confidence interval [CI] 2.5-6.6; p<0.01), PTB < 34 weeks (OR 4.8; 95% CI 2.0-11.8; p<0.01), PPROM (OR 4.7; 95% CI 2.3-9.4; p<0.01), cesarean delivery (OR 3.0; 95% CI 2.2-4.2; p<0.01), and malpresentation (OR 9.0; 95% CI 5.4-15.1; p<0.01). There was a low incidence of PTB < 28 weeks in both groups (1.8% cases vs. 0.3% controls; p=0.1). Compared to women without uterine anomalies, women with a uterine anomaly showed a tendency towards increased risk of postpartum hemorrhage (OR 2.8; 95% CI 0.9-8.9; p=0.07) and SGA (OR 1.5; 95% CI 1.0-2.4; p=0.06). There were no hysterectomies. The diagnosis of uterine anomaly was confirmed in 69% of the subjects by cesarean, MRI, or laparoscopy; 2D ultrasound alone was used to make the diagnosis in 25% of subjects. CONCLUSION: Women with a uterine anomaly are at increased risk of preterm birth and adverse pregnancy outcomes, but most women deliver at term. This is the largest study to date of pregnancy outcomes in women with uterine anomalies with most anomalies confirmed by a reliable method of diagnosis.

BACKGROUND/OBJECTIVES Hispanics have lower advance directive (AD) completion than non‐Hispanic Whites. Few studies have assessed the role of language preference in end‐of‐life planning. We investigated whether language preference and needing an interpreter affected AD completion among older adults in an integrated health system. DESIGN Retrospective cohort investigation of electronic medical records. SETTING Northern California integrated health system. PARTICIPANTS A total of 620,948 Hispanic and non‐Hispanic White patients, aged 55 years and older, between January 1, 2013, and December 31, 2017. MEASUREMENTS Descriptive statistics and bivariate analysis were performed to compare AD completion among non‐Hispanic Whites, Hispanics, and Hispanic subgroups by language preference (English speaking, Spanish speaking, and needed interpreter). We conducted multivariable logistic regression to determine the relationship between language preference and having an AD while controlling for demographic, clinical, and utilization factors. RESULTS We found 20.3% of non‐Hispanic Whites (n = 512,577) and 10.9% of Hispanics (n = 108,371) had completed an AD. Among Hispanics, after controlling for demographic, clinical, and utilization factors, compared with Spanish speakers requiring an interpreter, English speakers had nearly two‐fold increased odds of completing an AD (adjusted odds ratio (aOR) = 2.6; 95% confidence interval (CI) = 2.4–2.9), whereas Spanish speakers not requiring an interpreter had 20% increased odds (aOR = 1.2; 95% CI = 1.1–1.3). Additional predictors of successful AD completion were being female, being older, having more comorbidities, having more hospital and emergency department visits, and having higher socioeconomic status. There were no differences associated with primary care provider characteristics. CONCLUSION These findings indicate the need for a tailored outreach to Hispanics, particularly among those subgroups who require the need of an interpreter, to reduce AD completion disparities.

To assess whether a Spanish-language text messaging program helps Latinos with diabetes better manage their disease. Spanish-speaking Latinos with type 2 diabetes and HbA1c ≥ 8% (N = 38) were recruited January 1, 2016–May 31, 2016, at a large integrated healthcare delivery system. Participants received 1–3 Spanish-language text messages about diabetes self-care per day for 3 months with an optional 3-month extension. The Wilcoxon signed-rank test for paired data was used to compare pre-post intervention HbA1c. The Wilcoxon-Mann-Whitney nonparametric test was used to compare changes in HbA1c across groups. After 3 months, the median HbA1c reduction overall was 1.4 percentage points (IQR: 0.5–3.3, p < 0.01). Latinos having pre-intervention HbA1c > 10.0% had a greater reduction in median HbA1c (3.8, IQR: 0.5–5.3) compared with those having pre-intervention HbA1c ≤ 10.0% (0.9, IQR: 0.1–1.9, p < 0.05). This reduction in median HbA1c persisted after 6 months (1.3, IQR: 0.2–2.9, p < 0.01). A Spanish-language text messaging program was an effective way to improve glycemic control for Latinos with type 2 diabetes. Culturally and linguistically tailored text messaging programs for managing diabetes should be considered.

Objective The objective of this study is to evaluate racial/ethnic differences in disease manifestations and survival in a US cohort of patients with systemic sclerosis (SSc), with a focus on Asian patients. Methods A retrospective cohort study was conducted among Kaiser Permanente Northern California adults with an incident SSc diagnosis by a rheumatologist from 2007 to 2016, confirmed by a chart review to fulfill 2013 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classification criteria. Self‐reported race/ethnicity was categorized as non‐Hispanic white, Asian, Hispanic, and black. Disease manifestations and survival were compared, using white patients as the reference. Results A total of 609 patients with incident SSc were identified: 89% were women, and 81% had limited cutaneous SSc, with a mean age at diagnosis of 55.4 ± 14.8 years. The racial/ethnic distribution was 51% non‐Hispanic white (n = 310), 25% Hispanic (n = 154), 16% Asian (n = 96), and 8% black (n = 49). Compared with white patients, black patients had a greater prevalence of diffuse disease (14.5% vs. 44.9%; P < 0.001), and Asians had higher rates of anti‐U1‐RNP antibodies (32.1% vs. 11.9%; P = 0.005). Nine‐year overall survival rates following SSc diagnosis were lower in Asian (52.3%), black (52.2%), and Hispanic patients (68.2%) compared with white patients (75.8%). Pulmonary hypertension and infections were the leading causes of death in Asian patients. Asian race was associated with higher mortality on univariable (hazard ratio [HR] 1.83 [95% confidence interval (CI) 1.08‐2.99]; P = 0.020) and multivariable analyses (HR 1.80 [95% CI 0.99‐3.16]; P = 0.047) when adjusting for age, sex, body mass index, cutaneous subtype, smoking status, interstitial lung disease, pulmonary hypertension, renal crisis, and malabsorption syndrome. Conclusion Asian patients with SSc in this US cohort had increased mortality compared with white patients. These patients warrant close monitoring for disease progression.

BACKGROUND:Breast cancer risk has been extensively studied in women with genetic predisposition, that is, mutations in breast cancer genes 1 and 2. Although there are guidelines for performing bilateral salpingo-oophorectomies in individuals with specific genetic risks, oophorectomies are also performed in many women considered to be at average risk of developing breast cancer. The risk of breast cancer in women with average risk who undergo hysterectomy with bilateral salpingo-oophorectomy for benign indications is less clear.OBJECTIVE:This study aimed to estimate breast cancer risk after hysterectomy with and without concomitant bilateral salpingo-oophorectomy for benign indications.STUDY DESIGN:From 2001 to 2015, women aged 18 years and older from Kaiser Permanente Northern California who underwent hysterectomy alone and hysterectomy with bilateral salpingo-oophorectomy were identified using the International Classification of Diseases, Ninth Revision, procedure and Current Procedural Terminology codes. Women with a breast cancer gene mutation and previous history of breast cancer or gynecologic cancer were excluded. Descriptive and bivariate analyses were used to describe and compare demographic and clinical characteristics. Breast cancer incidence rates were calculated per 100,000 person-years. Survival analysis and Cox proportional hazard models were conducted to compare the risk of developing breast cancer.RESULTS:Of 49,215 women who underwent hysterectomy, 19,826 had hysterectomy with bilateral salpingo-oophorectomy. Whites, Hispanics, blacks, Asians, and other or unknown comprised 51.2%, 20.3%, 12.7%, 10.4%, and 5.3% of the study population, respectively. The average age of women with hysterectomy alone was 45.5 years compared with 50.8 years for those who had hysterectomy with bilateral salpingo-oophorectomy. During the study period, 915 women received a diagnosis of breast cancer. Age-specific breast cancer incidence rates were higher in women older than 60 years with oophorectomy than hysterectomy alone (471.2 [95% confidence interval, 386.2-556.2] vs 463.0 [95% confidence interval, 349.6-576.5], respectively). After controlling for age, race, income, and Charlson Comorbidity Index, women with bilateral salpingo-oophorectomy had a 14% lower risk of breast cancer than women with hysterectomy alone (hazard ratio, 0.86; 95% confidence interval, 0.75-0.98). All-cause mortality was higher with oophorectomy than hysterectomy alone (64.4% vs 35.6%, P<.0001, respectively).CONCLUSION:Women with concurrent bilateral salpingo-oophorectomy for benign indications had a lower risk of breast cancer than those who had hysterectomy alone. However, all-cause mortality was higher in women with oophorectomy. Perimenopausal patients undergoing hysterectomy for benign indications should be counseled on the risks and benefits of oophorectomy at the time of surgery.

Objective:The Centers for Disease Control and Prevention 2010 guidelines recommend group B streptococcus (GBS) screening at 35-37-week gestation to identify women with positive cultures who should receive intrapartum antibiotics and notes that the predictive value of a negative culture declines after 5 weeks. However, despite the lack of evidence, current guidelines do not recommend rescreening for those screened between 35 and 37 weeks. Our objectives were to investigate the rate of conversion from negative to positive results in women rescreened after appropriate screening at 35-37-week gestation and to examine the impact of rescreening on the use of intrapartum antibiotics. Additionally, we examined cases of early-onset group B streptococcal sepsis (early-onset GBS) in term neonates. Methods:We performed a retrospective cohort study of women delivering liveborn infants 1 January, 2010-31 December, 2014 in Kaiser Permanente Northern California. Data were obtained from database extraction and chart review. Results:We identified 135,585 women with GBS screening at 35-37-week gestation; 4511 (3.3%) women were rescreened. Of the 3860 (85.6%) initially screened negative, 218 (5.6%) converted to positive. Fewer women in the discordant negative to positive group received GBS prophylaxis prior to delivery compared with women with a single positive culture (65.9 versus 92.3%,p < .001). In the discordant negative to positive group, results were available at the time of delivery in 133 of 217 subjects (61.3%). There were 18 cases of early-onset GBS at term (0.10 per 1000 livebirths); the majority of cases occurred among women with negative screening. Conclusion:Our results provide support for the current CDC recommendation against rescreening near term for those women already screened at 35-37-week gestation given the low rate of conversion from negative to positive, and the extremely low rate of early-onset GBS in the screened population.

Background:Guidelines recommend screening all patients with newly diagnosed colorectal cancer (CRC) for Lynch syndrome (LS). However, the efficiency of universal LS screening in elderly populations has not been well studied.Objective:To compare the performance of age-restricted and universal LS screening using reflex mismatch repair (MMR) immunohistochemistry (IHC) of CRC tumors.Design:Retrospective cohort study.Setting:A large, diverse, community-based health care system.Participants:3891 persons with newly diagnosed CRC who had LS screening between 2011 and 2016.Measurements:Diagnostic yield of different LS screening strategies.Results:Sixty-three LS cases (diagnostic yield, 1.62%) were identified by universal screening, with only 5 (7.9%) detected after age 70 years and 1 (1.6%) detected after age 80 years. When all patients with CRC who had universal screening were used as the denominator, 58 LS cases (diagnostic yield, 1.49% [95% CI, 1.13% to 1.92%]) were identified in patients with CRC diagnosed at or before age 70 years, 60 LS cases (diagnostic yield, 1.54% [CI, 1.18% to 1.98%]) were identified in those with CRC diagnosed at or before age 75 years, and 62 LS cases (diagnostic yield, 1.59% [CI, 1.22% to 2.04%]) were identified in those with CRC diagnosed at or before age 80 years. Using 75 years as the upper age limit for screening missed 3 of 63 (4.8%) LS cases but resulted in 1053 (27.1%) fewer cases requiring tumor MMR IHC. Using 80 years as the upper age limit missed 1 of 63 (1.6%) LS cases and resulted in 668 (17.2%) fewer cases requiring tumor MMR IHC.Limitation:Persons who were eligible for but did not complete germline analysis were excluded from calculations of performance characteristics.Conclusion:The incremental diagnostic yield decreased substantially after age 70 to 75 years. Stopping reflex CRC screening for LS after age 80 years may be reasonable because of very low efficiency, particularly in resource-limited settings, but this merits further investigation. Studies evaluating the effect of diagnosing LS in elderly persons on their family members are needed.Primary Funding Source:Kaiser Permanente Northern California Division of Research.

Objective: To validate algorithms identifying uterine perforations and intrauterine device (IUD) expulsions and to ascertain availability of breastfeeding status at the time of IUD insertion. Study design and setting: Four health care systems with electronic health records (EHRs) participated: Kaiser Permanente Northern California (KPNC), Kaiser Permanente Southern California (KPSC), Kaiser Permanente Washington (KPWA), and Regenstrief Institute (RI). The study included women <= 50 years of age with an IUD insertion. Site-specific algorithms using structured and unstructured data were developed and a sample validated by EHR review. Positive predictive values (PPVs) of the algorithms were calculated. Breastfeeding status was assessed in a random sample of 125 women at each research site with IUD placement within 52 weeks postpartum. Results: The study population included 282,028 women with 325,582 IUD insertions. The PPVs for uterine perforation were KPNC 77%, KPSC 81%, KPWA 82%, and RI 47%; PPVs for IUD expulsion were KPNC 77%, KPSC 87%, KPWA 68%, and RI 37%. Across all research sites, breastfeeding status at the time of IUD insertion was determined for 94% of those sampled. Conclusions: Algorithms with a high PPV for uterine perforation and IUD expulsion were developed at 3 of the 4 research sites. Breastfeeding status at the time of IUD insertion could be determined at all research sites. Our findings suggest that a study to evaluate the associations of breastfeeding and postpartum IUD insertions with risk of uterine perforation and IUD expulsion can be successfully conducted retrospectively; however, automated application of algorithms must be supplemented with chart review for some outcomes at one research site due to low PPV.

An asthma medication ratio (AMR) ≥0.5 is associated with decreased healthcare utilization improving patient-centered outcomes in persistent asthma. There is limited literature on outcomes after restricting short acting beta-agonist (SABA) refills. We hypothesized that a multidisciplinary SABA-Reduction Program (SABA-RP), which included limitations on refills, would significantly increase the percentage of patients fulfilling an AMR of ≥0.5, the number of asthma controller medications (CM) divided by the total of asthma medications (CM plus SABA). A retrospective observational study of 1,084 patients, ages 18-65, with asthma fulfilling Health Effectiveness Data and Information Set (HEDIS) criteria was performed using data from Kaiser Permanente, Northern California (KPNC) in San Francisco. The SABA-RP consisted of both group and individual intensive asthma education of primary providers, patient outreach, and pharmacists changing SABA refills to zero. The program began April 1, 2015, and the study looked at one year prior and one year post-SABA-RP. Analysis included descriptive statistics, paired and unpaired t-tests, and multivariable logistic regression. 71% of patients met an AMR goal ≥0.5 prior to implementation of the SABA-RP, while 84% met the goal after implementation (p<0.01). There was no statistically significant association between ED/hospitalizations and meeting the AMR goal. Multivariable logistic regression showed younger, male, or Black/Hispanic subjects had significantly lower odds of meeting the AMR goal post-SABA-RP. Multidisciplinary change through implementation of a SABA-RP was associated with a higher number of patients fulfilling an AMR goal ≥0.5 in this large retrospective cohort study at KPNC.