Rates Of Adverse Outcomes Research Articles

A comparison of Mersilene tape versus braided suture in transvaginal cervical cerclage: A retrospective case-control study.

Previous studies have indicated that there is an association between cervical cerclage and type of suture material. However, it is still unclear which suture material can provide the greatest benefit to patients who have undergone cerclage. This study investigated the effect of two different suture materials (Mersilene tape vs braided suture) used for transvaginal cervical cerclage placement on maternal outcomes of women with cervical insufficiency. In this retrospective case-control study, 170 women who underwent history-, ultrasound-, or physical examination-indicated transvaginal cervical cerclage were categorized according to suture materials used for cerclage: a total of 96 received Mersilene tape and 74 received braided suture. Study participants received a transvaginal cervical cerclage before 28 weeks and were followed up until delivery to assess pregnancy and neonatal outcomes. The primary outcome was gestational age at delivery. Secondary outcomes included preterm premature rupture of membranes (PPROM), premature rupture of membranes (PROM), chorioamnionitis, neonatal survival rate, and neonatal morbidity. Out of 170 eligible women, 74 (43.5%) received braided suture while 96 (56.5%) received Mersilene tape. Baseline characteristics were similar between the two groups. The group that received braided suture had a lower incidence of gestational age at delivery <37 weeks (29.2% vs 54.2%, P = 0.046), PPROM (9.5% vs 21.9%, P = 0.029) and PROM (17.6% vs 32.3%, P = 0.028) compared to the group that received Mersilene tape. However, there were no significant differences between the two groups in average gestational age at delivery, the rate of gestational age at delivery <24, <28, <32, and < 34 weeks, chorioamnionitis, and neonatal survival rate, as well as neonatal morbidity. Compared to Mersilene tape, the utilization of braided suture has been significantly associated with a reduction in the incidence of gestational age at delivery <37 weeks, as well as a decreased risk of PPROM and PROM. However, the use of braided sutures did not result in discernible differences in the rates of chorioamnionitis or adverse neonatal outcomes.

Optimal range of gestational weight gain for singleton pregnant women: a cohort study based on Chinese specific body mass index categories

BackgroundThe purpose was to explore the optimal proportion of GWG in Chinese singleton pregnant women according to Chinese specific body mass index (BMI) categories.MethodsA retrospective cohort study with 16,977 singleton pregnant women was conducted. Among the including subjects, 2/3 of which were randomly imported into the training set for calculating the optimal GWG ranges using the percentile method, the Odd Ratio (OR) method, and the combined risk curve method. And another third of the subjects were used to evaluate the GWG ranges obtained. The detection rate of adverse outcomes of pregnant women was used to evaluate the applicability of GWG obtained. The range corresponding to the lowest detection rate is the recommended GWG range in this study.ResultsAccording to the percentile method, the suitable GWG of pregnant women with underweight, normal weight, overweight or obesity before pregnancy were 12.0 ∼ 17.5 kg, 11.0 ∼ 17.0 kg, and 9.0 ∼ 15.5 kg, respectively. According to the OR method, the suitable GWG range were 11 ∼ 18 kg, 7 ∼ 11 kg, and 6 ∼ 8 kg, respectively. According to the combined risk curve method, the suitable GWG range were 11.2 ∼ 17.2 kg, 3.6 ∼ 11.5 kg, and − 5.2 ∼ 7.0 kg, respectively. When the GWG for different BMI categories were 11 ∼ 18 kg, 7 ∼ 11 kg, and 6 ∼ 8 kg, the pregnant women have the lowest detection rate of adverse maternal and infant outcomes.ConclusionsThe recommended GWG based on this study for underweight, normal, overweight or obese pregnant women were 11 ∼ 18 kg, 7 ∼ 11 kg, and 6 ∼ 8 kg, respectively.

Clinical differences between drug-induced type 1 Brugada pattern and syndrome.

Diagnosis of Brugada syndrome (BrS) may be established by exposing a Type 1 Brugada pattern using a sodium channel blocker. Data on the outcomes of different patient populations with drug-induced Type 1 Brugada pattern are limited. The present study reports on the characteristics and outcome of subjects with ajmaline induced Type 1 Brugada pattern. A multicenter retrospective study including all consecutive cases of ajmaline-induced Type 1 Brugada pattern from seven centers. A total of 260 patients (69.9% males, mean age 43.4 ± 13.5) were included. Additional characteristics included history of syncope (n = 56, 21.5%), family history of BrS (n = 58, 22.3%) or sudden cardiac death (n = 47, 18.1%) and ventricular fibrillation (n = 3, 1.2%). Patients were divided into those meeting current diagnostic criteria for drug-induced BrS (DIBrS) and compared to the drug-induced Brugada pattern (DIBrECG). Females were significantly overrepresented in the DIBrS group (n = 50, 40% vs. n = 29, 21.5%, p = .001). A significantly higher prevalence of type 2/3 Brugada ECG at baseline was found in the DIBrECG group (n = 108, 80.8% vs. n = 75, 60% in the DIBrS, p = .026). During a median follow up of three (IQR 1.50-5.32) years, a single event of significant arrhythmia occurred in the DIBrS group. Less than half of subjects with ajmaline-induced Brugada pattern met current criteria for BrS. These individuals had very low rate of adverse outcomes during a follow up of 3 years, irrespective of the indication for the test or eligibility for the BrS diagnosis.

Effects of the COVID-19 pandemic on the rates of adverse birth outcomes and fetal mortality in Japan: an analysis of national data from 2010 to 2022

BackgroundAlthough the coronavirus disease 2019 (COVID-19) pandemic affected trends of multiple health outcomes in Japan, there is a paucity of studies investigating the effect of the pandemic on adverse birth outcomes and fetal mortality. This study aimed to investigate the effect of the onset of the pandemic on the trends in adverse birth outcomes and fetal mortality using national data in Japan.MethodsWe used the 2010–2022 birth and fetal mortality data from the Vital Statistics in Japan. We defined the starting time of the effect of the pandemic as April 2020, and the period from January 2010 to March 2020 and that from April 2020 to December 2022 were defined as the pre- and post- pandemic period, respectively. The rates of preterm birth, term low birth weight (TLBW), small-for-gestational-age (SGA), large-for-gestational-age (LGA), spontaneous fetal mortality, and artificial fetal mortality were used as outcomes. An interrupted time series analysis was conducted using monthly time series data of the outcomes to evaluate the effects of the pandemic. In addition, a modified Poisson regression model was used to evaluate the effects of the pandemic on these outcomes using individual-level data, and the adjusted risk ratio of the effect was calculated.ResultsThe adverse birth and fetal mortality outcomes showed a decreasing trend over the years, except for preterm birth and LGA birth rates, and SGA birth rates tended to reach their lowest values after the onset of the pandemic. The interrupted time series analysis revealed that the pandemic decreased preterm birth, TLBW, and SGA birth rates. In addition, the regression analysis revealed that the pandemic decreased the TLBW, SGA, and artificial fetal mortality rates.ConclusionsAnalyses performed using national data suggested that the pandemic decreased the TLBW and SGA rates in Japan.

Global and regional burden of vaccine-associated facial paralysis, 1967-2023: Findings from the WHO international pharmacovigilance database.

The scarce and conflicting data on vaccine-associated facial paralysis limit our understanding of vaccine safety on a global scale. Therefore, this study aims to evaluate the global burden of vaccine-associated facial paralysis and to identify the extent of its association with individual vaccines, thereby contributing to the development of a more effective vaccination program. We used data on vaccine-associated facial paralysis from 1967 to 2023 (total reports, n = 131 255 418 418) from the World Health Organization International Pharmacovigilance Database. Global reporting counts, reported odds ratios (ROR), and information components (ICs) were computed to elucidate the association between the 16 vaccines and the occurrence of vaccine-associated facial paralysis across 156 countries. We identified 26 197 reports (men, n = 10 507 [40.11%]) of vaccine-associated facial paralysis from 49 537 reports of all-cause facial paralysis. Vaccine-associated facial paralysis has been consistently reported; however, a pronounced increase in reported incidence has emerged after the onset of the coronavirus disease 2019 (COVID-19) pandemic, which is attributable to the COVID-19 mRNA vaccine. Most vaccines were associated with facial paralysis, with differing levels of association, except for tuberculosis vaccines. COVID-19 mRNA vaccines had the highest association with facial paralysis reports (ROR, 28.31 [95% confidence interval, 27.60-29.03]; IC, 3.37 [IC0.25, 3.35]), followed by encephalitis, influenza, hepatitis A, papillomavirus, hepatitis B, typhoid, varicella-zoster, meningococcal, Ad-5 vectored COVID-19, measles, mumps and rubella, diphtheria, tetanus toxoids, pertussis, polio, and Hemophilus influenza type b, pneumococcal, rotavirus diarrhea, and inactivated whole-virus COVID-19 vaccines. Concerning age- and sex-specific risks, vaccine-associated facial paralysis was more strongly associated with older age groups and males. The serious adverse outcome and death rate of vaccine-associated facial paralysis were extremely low (0.07% and 0.00%, respectively). An increase in vaccine-induced facial paralysis, primarily owing to COVID-19 mRNA vaccines, was observed with most vaccines, except tuberculosis vaccines. Given the higher association observed in the older and male groups with vaccine-associated facial paralysis, close monitoring of these demographics when administering vaccines that are significantly associated with adverse reactions is crucial.

COVID-19 Admission Rates and Changes in Care Quality in US Hospitals

Unprecedented increases in hospital occupancy rates during COVID-19 surges in 2020 caused concern over hospital care quality for patients without COVID-19. To examine changes in hospital nonsurgical care quality for patients without COVID-19 during periods of high and low COVID-19 admissions. This cross-sectional study used data from the 2019 and 2020 Agency for Healthcare Research and Quality's Healthcare Cost and Utilization Project State Inpatient Databases. Data were obtained for all nonfederal, acute care hospitals in 36 states with admissions in 2019 and 2020, and patients without a diagnosis of COVID-19 or pneumonia who were at risk for selected quality indicators were included. The data analysis was performed between January 1, 2023, and March 15, 2024. Each hospital and week in 2020 was categorized based on the number of COVID-19 admissions per 100 beds: less than 1.0, 1.0 to 4.9, 5.0 to 9.9, 10.0 to 14.9, and 15.0 or greater. The main outcomes were rates of adverse outcomes for selected quality indicators, including pressure ulcers and in-hospital mortality for acute myocardial infarction, heart failure, acute stroke, gastrointestinal hemorrhage, hip fracture, and percutaneous coronary intervention. Changes in 2020 compared with 2019 were calculated for each level of the weekly COVID-19 admission rate, adjusting for case-mix and hospital-month fixed effects. Changes during weeks with high COVID-19 admissions (≥15 per 100 beds) were compared with changes during weeks with low COVID-19 admissions (<1 per 100 beds). The analysis included 19 111 629 discharges (50.3% female; mean [SD] age, 63.0 [18.0] years) from 3283 hospitals in 36 states. In weeks 18 to 48 of 2020, 35 851 hospital-weeks (36.7%) had low COVID-19 admission rates, and 8094 (8.3%) had high rates. Quality indicators for patients without COVID-19 significantly worsened in 2020 during weeks with high vs low COVID-19 admissions. Pressure ulcer rates increased by 0.09 per 1000 admissions (95% CI, 0.01-0.17 per 1000 admissions; relative change, 24.3%), heart failure mortality increased by 0.40 per 100 admissions (95% CI, 0.18-0.63 per 100 admissions; relative change, 21.1%), hip fracture mortality increased by 0.40 per 100 admissions (95% CI, 0.04-0.77 per 100 admissions; relative change, 29.4%), and a weighted mean of mortality for the selected indicators increased by 0.30 per 100 admissions (95% CI, 0.14-0.45 per 100 admissions; relative change, 10.6%). In this cross-sectional study, COVID-19 surges were associated with declines in hospital quality, highlighting the importance of identifying and implementing strategies to maintain care quality during periods of high hospital use.

#2888 Measured glomerular filtration rate and risk of adverse outcomes in 6059 patients from the Stockholm CREAtinine Measurements (SCREAM) project

Abstract Background and Aims Evidence on the risks of adverse outcomes associated with glomerular filtration rate (GFR) has been limited to estimated GFR (eGFR), due to limited availability of large-scale data with measured GFR (mGFR). These studies either used creatinine (eGFRcr), cystatin C (eGFRcys), or both (eGFRcr-cys), which can be influenced by the non-GFR determinants of creatinine and cystatin C. Here, we aimed to (1) quantify associations between mGFR and the risk of all-cause mortality and kidney failure with replacement therapy (KFRT) and (2) investigate which filtration marker most closely resembled these associations. Method We included 6059 adults referred for single-point plasma iohexol clearance between 2011-2021 in Stockholm, Sweden (SCREAM project), and who had simultaneous measures of creatinine and cystatin C. eGFR was calculated with the CKD-EPI 2012 (eGFRcys) and 2021 (eGFRcr and eGFRcr-cys) equations. Hazard ratios were estimated using Cox regression, adjusting for age, sex, medical history, medications and urinary albumin-to-creatinine ratio (UACR). Results Mean age was 59 years, 40% were women, median mGFR was 66 ml/min/1.73 m2 and median UACR was 1.1 mg/mmol. During median 3.8 years of follow-up, 1961 individuals died and 425 progressed to KFRT. Associations between mGFR and mortality increased linearly for values &amp;lt;90 ml/min/1.73 m2 and were not statistically significant between 90-120 ml/min/1.73 m2 (Figure). Compared with mGFR of 90 ml/min/1.73 m2, hazard ratios for mortality were 1.5 (95% CI 1.3-1.6), 1.7 (1.5-1.8), 2.0 (1.8-2.1) and 2.4 (2.0-2.7) for 60, 45, 30 and 15 ml/min/1.732, respectively (Table). eGFRcr-cys most closely resembled the mortality risk relationships of mGFR. Conversely, eGFRcr had a strong U-shaped pattern with underestimation of risks &amp;lt;90 ml/min/1.73 m2 and overestimation of risks between 90-120 ml/min/1.73 m2; for eGFRcys this pattern was reversed. Associations between mGFR and KFRT were also linear (Figure). Compared with mGFR of 60 ml/min/1.73 m2, hazard ratios for KFRT were 2.1 (1.4-3.0), 6.2 (4.5-8.5), and 32.1 (23.4-44.0) for 45, 30 and 15 ml/min/1.732, respectively (Table). Both mGFR and estimating equations displayed similar monotonic risk associations. Conclusion In the largest study on mGFR and outcomes to date, lower mGFR was linearly associated with an increase in the risks of mortality and KFRT. eGFRcr-cys closely resembled the relationship between mGFR and mortality, whereas eGFRcr under-estimated mortality risk and had a U-shaped association. All estimating equations had similar associations with KFRT risk.

Redesigning antenatal care: Prospective use of an implementation framework to establish a population-based multidisciplinary first-trimester screening, assessment and prevention service.

Australian rates of adverse obstetric outcomes have improved little despite guidelines recommending history-based screening and intervention. The first trimester provides a unique opportunity to predict and prevent complications, yet population-based screening has failed to be translated into broad clinical practice. This study aimed to redesign antenatal care within an Australian public healthcare centre to align with evidence-based maternity care, including population-based first-trimester screening with early initiation of preventative strategies in high-risk pregnancies. A five-phase action-process model, sharing key elements with implementation science theory, was used to explore barriers to change in antenatal care, co-design a novel service with consumers and establish a population-based antenatal pathway commencing with a multidisciplinary first-trimester screening, assessment and planning visit. The case for change and associated barriers were defined from the perspective of antenatal care stakeholders. Key needs of each group were established, and solutions were created using co-design methodology, allowing the team to create a novel approach to antenatal care which directly addressed identified barriers. Implementation of the service was associated with a fall in the median gestation at first specialist maternity care provider visit from 20 to 13 weeks. This study confirms the feasibility of establishing a comprehensive first-trimester screening program within a public Australian healthcare setting and highlights a co-design process which places individualised assessment at the forefront of antenatal care. This framework may be applicable to most public maternity settings in Australia, with expansion aimed at providing equity of care, including in rural and remote settings.

The reduced function allele SLCO1B1 c.521T>C is of no practical relevance for the renal graft function over the first post-transplant year in patients treated with mycophenolic acid.

It is unclear whether renal transplant recipients treated with mycophenolic acid (MPA) who carry the reduced-function allele at polymorphism SLCO1B1 c.521T>C differ from their wild-type peers regarding renal outcomes and tolerability. We aimed to estimate the effect of this polymorphism on the graft function (estimated glomerular filtration rate, eGFR) over the first 12 post-transplant months in patients on MPA-based maintenance immunosuppression. In a 12-month observational cohort study, consecutive adult patients were repeatedly assessed for eGFR. The SLCO1B1 c.521C>T variant allele carriers (exposed) and wild-type subjects (controls) were balanced on a range of demographic, medical, and genetic variables at baseline, and eGFR trajectory was estimated with further adjustment for time-varying covariates. A subset of patients were assessed for exposure to MPA 5-7 days after the transplantation. The adjusted eGFR slopes from day 1 to day 28 (daily), and from day 28 to day 365 (monthly) were practically identical in exposed (n = 86) and control (n = 168) patients [geometric means ratios (GMR) = 0.99, 95% confidence interval (CI) = 0.92-1.06 and GMR = 0.98, 0.94-1.01, respectively]. The rates of adverse renal outcomes and possible MPA-related adverse effects were low, and similar in exposed and controls [rate ratios (RR) = 0.94, 0.49-1.84 and RR = 1.08, 0.74-1.58, respectively]. The pharmacokinetic analysis did not signal meaningful differences regarding exposure to MPA, overall (exposed n = 23, control n = 45), if cotreated with cyclosporine (n = 17 vs. n = 26) or with tacrolimus (n = 8 vs. n = 17). In patients treated with MPA, variant allele SLCO1B1 c.521T>C appears of no practical relevance regarding the 12-month renal graft function, MPA safety and exposure to MPA at early steady-state.

Glucagon-like-peptide-1 receptor agonists versus dipeptidyl peptidase-4 inhibitors and cardiovascular outcomes in diabetes in relation to achieved glycemic control. A Danish nationwide study.

To compare the cardiovascular preventive effect associated with glucagon-like-peptide-1 receptor agonists (GLP-1 RA) versus dipeptidyl peptidase-4 inhibitors (DPP-4i) according to the achieved target level of glycated hemoglobin (HbA1c). We used retrospective Danish registries to include type 2 diabetes patients already in metformin treatment initiating GLP-1 RA or DPP-4i between 2007 and 2021. Patients were included 6 months after GLP-1 RA or DPP-4i initiation. The last available HbA1c measurement before inclusion was collected. The achieved HbA1c level was categorized according to a target level below or above 53 mmol/mol (7%). The primary outcome was a composite of nonfatal myocardial infarction, nonfatal stroke, and all-cause death. We used a multivariable Cox proportional hazard model to estimate the effect of HbA1c levels on the outcome among GLP-1 RA users compared to DPP-4i users. The study included 13 634 GLP-1 RA users (median age 56.9, interquartile range [IQR]: 48.5-65.5; 53% males) and 39 839 DPP-4i users (median age 63.4, IQR: 54.6-71.8; 61% males). The number of GLP-1 RA and DPP-4i users according to achieved HbA1c levels were as follows: HbA1c ≤ 53 mmol/mol (≤7.0%): 3026 (22%) versus 4824 (12%); HbA1c > 53 mmol/mol (>7.0%): 6577 (48%) versus 17 508 (44%); missing HbA1c: 4031 (30%) versus 17 507 (44%). During a median follow-up of 5 years (IQR: 2.6-5.0), 954 GLP-1 RA users experienced the primary outcome compared to 7093 DPP-4i users. The 5-year risk (95% confidence interval [CI]) of the outcome associated with GLP1-RA versus DPP-4i according to HbA1c categories was as follows: HbA1c ≤ 53 mmol/mol: 10.3% (8.2-12.3) versus 24.3% (22.7-25.8); HbA1c > 53 mmol/mol: 16.0% (14.3-17.6) versus 21.1% (20.3-21.9); missing HbA1c: 17.1% (15.7-18.5) versus 25.6% (24.9-26.3). The preventive effect associated with GLP-1 RA versus DPP-4i was significantly enhanced when achieving lower HbA1c levels: HbA1c ≤ 53 mmol/mol: 0.65 (0.52-0.80); HbA1c > 53 mmol/mol: 0.92 (0.83-1.03); missing HbA1c: 0.92 (0.84-1.02) (p value for interaction <.001). GLP-1 RA use was associated with a lower rate of major adverse cardiovascular outcomes. The association was stronger in patients achieving the target glycemic level and weaker in patients not achieving the target glycemic level, suggestive of an interaction between achieved HbA1c level and GLP-1 RA.

A randomized comparative-effectiveness study of two enhanced prenatal care models for low-income pregnant people: Engaging Mothers & Babies; Reimagining Antenatal Care for Everyone (EMBRACE)

BackgroundImproving perinatal mental health and care experiences and preventing adverse maternal and infant outcomes are essential prenatal care components, yet existing services often miss the mark, particularly for low-income populations. An enhanced group prenatal care program, “Glow! Group Prenatal Care and Support,” was developed in California's Central Valley in response to poor perinatal mental health, disrespectful care experiences, and high rates of adverse birth outcomes among families with low incomes. MethodsEngaging Mothers & Babies; Reimagining Antenatal Care for Everyone (EMBRACE) is a pragmatic, two-arm, randomized, comparative-effectiveness study designed to assess depression (primary outcome), the experience of care (secondary outcome), and preterm birth (exploratory outcome) among Medi-Cal (California's Medicaid program)-eligible pregnant and birthing people, comparing those assigned to Glow! Group Prenatal Care and Support (Glow/GC) with those assigned to enhanced, individual prenatal care through the California Department of Public Health's Comprehensive Perinatal Services Program (CPSP/IC). Participating clinical practices offer the two comparators, alternating between comparators every 6 weeks, with the starting comparator randomized at the practice level. Participant-reported outcomes are assessed through interviewer-administered surveys at study entry, during the participant's third trimester, and at 3 months postpartum; preterm birth and other clinical outcomes are abstracted from labor and delivery records. Patient care experiences are further assessed in qualitative interviews. The protocol complies with the Standard Protocol Items for Randomized Trials. ConclusionsThis comparative-effectiveness study will be used to determine which of two forms of enhanced prenatal care is more effective, informing future decisions regarding their use.Trial Registration: ClinicalTrials.gov: NCT04154423.

Active but not quiescent lupus nephritis during pregnancy is associated with a higher rate of adverse obstetric outcomes: Analysis of a prospective cohort.

To compare the maternal-fetal/neonatal outcome in patients with systemic lupus erythematosus (SLE) with and without lupus nephritis (LN) in remission or with active disease. A prospective cohort of pregnant patients with SLE (ACR 1997 criteria) was studied from January 2009 to December 2021. Demographic, clinical, biochemical, and immunological variables as well as the usual maternal-fetal/neonatal complications were recorded. We compared four groups according to the status of SLE during pregnancy: patients with quiescent SLE without lupus nephritis, patients with active SLE without lupus nephritis, patients with quiescent lupus nephritis, and patients with active lupus nephritis. Statistical analysis included descriptive statistics, bivariate analysis, and Cox regression analysis. A total of 439 pregnancies were studied, with a median age of 28 ± 6, SLE duration of 60 months (interquartile range 36-120). A higher frequency of maternal and fetal/neonatal complications was observed in patients with active SLE with or without lupus nephritis. Multivariate analysis showed that active LN was a risk factor for gestational hypertension (hazard ratios [HR] 1.95; 95% confidence intervals [CI]: 1.01-6.39), premature rupture of membranes (HR 3.56; 95% CI: 1.79-16.05) and more frequent cesarean section (HR 1.82; 95% CI: 1.13-2.94). LN is associated with a higher frequency of maternal complications, especially in those patients with active disease during pregnancy, and those maternal complications had an impact on poor fetal/neonatal outcomes. Strict control and timely care of LN could improve the obstetric prognosis.

Foster Care and Health in Medicaid-Enrolled Children Experiencing Parental Opioid Use Disorder

The burden of the US opioid crisis has fallen heavily on children, a vulnerable population increasingly exposed to parental opioid use disorder (POUD) in utero or during childhood. A paucity of studies have investigated foster care involvement among those experiencing parental opioid use during childhood and the associated health and health care outcomes. To examine the health and health care outcomes of children experiencing POUD with and without foster care involvement. This population-based cohort study used nationwide Medicaid claims data from January 1, 2014, to December 31, 2020. Participants included Medicaid-enrolled children experiencing parental opioid use-related disorder during ages 4 to 18 years. Data were analyzed between January 2023 and February 2024. Person-years with (exposed) and without (nonexposed) foster care involvement, identified using Medicaid eligibility, procedure, and diagnostic codes. The main outcomes included physical and mental health conditions, developmental disorders, substance use, and health care utilization. The Pearson χ2 test, the t test, and linear regression were used to compare outcomes in person-years with (exposed) and without (nonexposed) foster care involvement. An event study design was used to examine health care utilization patterns before and after foster care involvement. In a longitudinal sample of 8 939 666 person-years from 1 985 180 Medicaid-enrolled children, 49% of children were females and 51% were males. Their mean (SD) age was 10 (4.2) years. The prevalence of foster care involvement was 3% (276 456 person-years), increasing from 1.5% in 2014 to 4.7% in 2020. Compared with those without foster care involvement (8 663 210 person-years), foster care involvement was associated with a higher prevalence of developmental delays (12% vs 7%), depression (10% vs 4%), trauma and stress (35% vs 7%), and substance use-related disorders (4% vs 1%; P < .001 for all). Foster children had higher rates of health care utilization across a wide array of preventive services, including well-child visits (64% vs 44%) and immunizations (41% vs 31%; P < .001 for all). Health care utilization increased sharply in the first year entering foster care but decreased as children exited care. In this cohort study of Medicaid-enrolled children experiencing parental opioid use-related disorder, foster care involvement increased significantly between 2014 and 2020. Involvement was associated with increased rates of adverse health outcomes and health care utilization. These findings underscore the importance of policies that support children and families affected by opioid use disorder, as well as the systems that serve them.

Abstract PO1-01-12: A retrospective cohort study on the effect of adding adjuvant ovarian function suppression to endocrine therapy in premenopausal women with T1-T2 tumor hormone-positive breast cancer on survival and disease recurrence

Abstract Background: Breast cancer is the most common diagnosed cancer in women and is the leading cause of cancer death. Young women diagnosed with breast cancer are at higher rates of adverse outcomes in terms of survival and recurrence. Hormone sensitive breast cancer is the commonest subtype of breast cancer in this group. To date, the standard adjuvant treatment is endocrine therapy for both pre and post-menopausal women. Recent published studies have recommended adding ovarian function therapy to premenopausal women who are at high risk of recurrence. In this study we evaluated the impact of adding adjuvant ovarian function suppression for premenopausal women with small (T1 and T2) hormone receptor positive node negative breast cancer who did not receive any form of chemotherapy on overall survival and disease-free recurrence. Methods: We performed a retrospective study where we evaluated the electronic medical records of 4431 premenopausal women diagnosed with breast cancer in Asan Medical Center in Seoul, South Korea. All the analyzed patients were operated from the period of January 2006 till December 2019. The inclusion criteria were age of 55 and below, T1 and T2 tumors with N0 disease who received selective estrogen receptor modulators (SERM - Tamoxifen) and didn’t receive neo or adjuvant chemotherapy. We compared patients who received SERM (Tam Only) only to patients who received SERM and ovarian function suppression (Tam + OFS) medications. The primary endpoint was overall survival (OS), and the secondary endpoint was mortality and disease-free survival (DFS). We used chi-square test for categorical variables and t-test for continuous variables. The p-value was set as p&amp;lt; 0.05 as statistically significant. Kaplan Meier curve and log rank test were used to analyze the data for overall survival, disease-free survival and mortality. We performed an additional subgroup analysis adjusted to age, tumor size, Ki67%, progesterone receptor, HER2 status and type of operation. Results: There was equal distribution of cases between tamoxifen only group and tamoxifen + OFS group (2121 versus 2310 respectively). The median age in each group was 45 years of age. Tumor size of ≤0.5cm was the commonest in the tamoxifen only group whereas tamoxifen + OFS group had majority of cases with tumor size of 1 - 2cm. Both groups had a Ki-67% of 10-20%. Histologic grade of 2 and nuclear grade of 2 were most commonly representative in the comparing groups. Invasive ductal carcinoma was the most common histological subtype (93-94%) and invasive lobular carcinoma accounted for 5-6% of cases. Regarding immunohistochemistry results, 91-93% of patients were progesterone receptor positive and 68-73% were HER2 negative. The majority underwent breast conserving surgery compared to mastectomy. We have also looked at the pattern of prescribing OFS treatment in the Tamoxifen + OFS group regarding the length of treatment. Nearly 80% of patients received OFS treatment for a period of 1-2 years whereas only 5.2% received &amp;lt; 1 year and 1.8% &amp;gt;2years. After adjusting to age, tumor size, Ki67%, PR receptor and HER2 status, the result was only significant for higher risk of DFS in the TAM + OFS group in Ki67 &amp;lt; 20%. The OFS+TAM had more DFS and mortality events compared to TAM only group. However, the only significant result was the overall survival favoring tamoxifen only group with a p-value of 0.039 and HR of 1.05-7.99. Conclusion: Adding ovarian function suppression to tamoxifen in premenopausal hormone positive node negative T1-T2 tumors didn’t show any benefit in terms of disease-free interval and overall survival. Further studies are advised to assess the benefit of adding ovarian function suppression to this group of patients Table 1: baseline characteristics of Table 2: Disease Free Survival Subgroup Analysis Citation Format: Sarah Al Safi, Hee Jeong Kim, Seonok Kim, Sae Byul Lee, Jisun Kim, Tae-Kyung Yoo, Il-Yong Chung, Beom Seok Ko, Byung Ho Son. A retrospective cohort study on the effect of adding adjuvant ovarian function suppression to endocrine therapy in premenopausal women with T1-T2 tumor hormone-positive breast cancer on survival and disease recurrence [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO1-01-12.

Low-Lying Placenta and Pregnancy Outcomes in a Large National Cohort [ID 2683532

INTRODUCTION: We sought to understand the association of low-lying placenta and adverse pregnancy outcomes among those undergoing cesarean delivery. METHODS: This was a retrospective cohort study of persons undergoing cesarean delivery using the National Inpatient Sample from 2017 to 2019 through HCUP/AHRQ. Patients with placenta previa were excluded. Rates of adverse maternal outcomes were compared between patients undergoing cesaeran delivery with ICD-10 codes of low-lying placenta and those without. The outcomes included were preterm delivery, hemorrhage, hysterectomy, placenta accreta spectrum (PAS), sepsis, shock, disseminated intravascular coagulation (DIC), and transfusion. Groups were compared using ANOVA, chi-squared analysis, logistic and linear regressions to control for confounders. RESULTS: Over 700,000 participants underwent cesarean delivery. 2,664 (0.4%) had low-lying placenta. Affected patients were older, more likely to be anemic, privately insured, undergoing primary cesarean, and deliver at a large/urban teaching hospital. Those with low-lying placenta were more likely to deliver preterm (31.9% versus 14.3%), hemorrhage (27.8% versus 3.8%), undergo hysterectomy (2.0% versus 0.2%), have PAS (2.4% versus 0.2%), receive transfusion (5.4% versus 2.0%) (all P&lt;.001), and experience sepsis, shock, and DIC (all P&lt;.05). Many of these findings persisted after controlling for confounders—preterm delivery (adjusted odds ratio [aOR] 3.07; 95% CI, 2.81–3.35), hemorrhage (aOR 8.87; 95% CI, 8.10–9.73), hysterectomy (aOR 9.42; 95% CI, 7.11–12.47), PAS (aOR 13.41; 95% CI, 10.34–17.39), transfusion (aOR 2.56; 95% CI, 2.14–3.06), and shock (aOR 2.55; 95% CI, 1.44–4.52). CONCLUSION: Low-lying placenta at time of cesarean is associated with adverse outcomes and should be considered in counseling and delivery planning.

Listening to Black Women's Perspectives of Birth Centers and Midwifery Care: Advocacy, Protection, and Empowerment.

Black women in Texas experience high rates of adverse maternal outcomes that have been linked to health inequities and structural racism in the maternal care system. Birth centers and midwifery care are highlighted in the literature as contributing to improved perinatal care experiences and decreased adverse outcomes for Black women. However, compared with White women, Black women underuse birth centers and midwifery care. Black women's perceptions in Texas of birth center and midwifery care are underrepresented in research. Thus, this study aimed to highlight the views of Black women residing in Texas on birth centers and midwifery care to identify their needs and explore ways to increasing access to perinatal care. Semistructured interviews were conducted with 10 pregnant and postpartum Black women residing in Texas. Questions focused on the women's access, knowledge, and use of birth centers and midwifery care in the context of their lived maternal care experiences. Interview transcripts were reviewed and analyzed using inductive, qualitative content analysis. The Black women interviewed all shared experiences of discrimination and bias while receiving obstetric care that affected their interest in and overall perceptions of birth center and midwifery care. Participants also discussed financial and institutional barriers that impacted their ease of access to birth center and midwifery care services. Additionally, participants highlighted the need for culturally sensitive and respectful perinatalhealth care. The Black women interviewed in this study emphasized the prevalence of racism and discrimination in perinatal health care encounters, a reflection consistent with current literature. Black women also expressed a desire to use birth centers and midwifery care but identified the barriers in Texas that impede access. Study findings highlight the need to address barriers to promote equitable perinatal health care access for Black women.

Pregnancy Outcomes in Patients with Prosthetic Heart Valves in Saudi Arabia

Background: Pregnancies in women with heart prostheses are high-risk pregnancies with increased maternal and fetal adverse outcomes. Advances in prosthetic heart valve design and anticoagulation have improved these outcomes over the past decades. Objectives: To study the pregnancy outcomes in pregnancies with heart prostheses and to compare these outcomes between mechanical and biosynthetic heart prostheses in Saudi patients. Methods: In this single centered retrospective study conducted at King Saud Medical City (KSUMC) between January 2011 and February 2020, we have reviewed all pregnant women’s heart prostheses. Fetal and maternal data were obtained, and outcomes were compared between pregnancies with mechanical heart prostheses and bioprostheses. Results: A total of 111 pregnancies were reviewed. A total of 51.4% of pregnancies had bioprostheses, 48.6% had mechanical prostheses, and 64.0% of participants were obese. The majority of the participants had a parity in the range of 2-9 (N=107, 96.4%). The most frequent type of rheumatic heart disease was mitral regurgitation (N=49, 44.1%), followed by mitral stenosis (N=32, 28.8%). There was no maternal mortality and no structural valve failure. There was a high rate of hospital admission in both groups, up to 55% of pregnancies. The rates of abortion, postpartum hemorrhage and transfusions were higher than those in general pregnancies; however, there was no difference in maternal and fetal complications between the two types of prostheses, i.e., bioprostheses and mechanical. Conclusion: Although women with prosthetic heart valves have higher rates of adverse outcomes, they generally tolerate pregnancy well. There was no difference in adverse outcomes between bioprosthetic and mechanical prostheses

Danish Diabetes Birth Registry 2: a study protocol of a national prospective cohort study to monitor outcomes of pregnancies of women with pre-existing diabetes

IntroductionDespite technological developments and intensified care, pregnancies in women with pre-existing diabetes are still considered high-risk pregnancies. The rate of adverse outcomes in pregnancies affected by diabetes in Denmark is...

Placental Histopathological Lesions and Adverse Neonatal Outcomes in Patients with Inflammatory Bowel Diseases- A retrospective Cohort Study.

Inflammatory bowel diseases (IBD) are significantly associated with adverse pregnancy and neonatal outcomes, though the pathomechanism is yet unknown. To investigate the relationship between IBD and adverse pregnancy outcomes by comparing neonatal outcomes and placental histopathology in two matched groups of patients with and without IBD. In this retrospective study, data of all patients who gave birth between 2008-2021 and were diagnosed with IBD were reviewed and compared to a control group matching two control cases for every IBD case. Neonatal outcomes and placental pathology were compared between the groups. Compared to the control group (n=76), the placentas of patients with IBD (n=36) were characterized by significantly lower placental weight (p < 0.001), and higher rates of maternal vascular malperfusion lesions (MVM, p < 0.001) and maternal and fetal inflammatory response lesions (p < 0.001). Neonates of patients with IBD were more frequently small for gestational age (SGA) (p=0.01), with increased rates of need for phototherapy (p = 0.03), respiratory morbidity and NICU admission (p < 0.001 for both outcomes). Multivariate logistic regression analyses adjusting for possible confounders (including maternal age, gestational age, chronic hypertension, smoking, and thrombophilia) confirmed the independent association between IBD and composite MVM lesions (aOR 4.31, p < 0.001), maternal inflammatory responses (aOR 40.22, p < 0.001) and SGA infants (aOR 4.31, p = 0.013). IBD is associated with increased rates of placental histopathological lesions and adverse pregnancy outcomes, including SGA infants. These novel findings imply the role of placental malperfusion and inflammatory processes in pregnancy complications of IBD patients, which should be followed accordingly. Approval of local ethics committee # WOMC-0219-20.

Moderating Effects of Informal Care on the Relationship Between ADL Limitations and Adverse Outcomes in Stroke Survivors.

Stroke survivors with limitations in activities of daily living (ADL) have a greater risk of experiencing falls, hospitalizations, or physical function decline. We examined how informal caregiving received in hours per week by stroke survivors moderated the relationship between ADL limitations and adverse outcomes. In this retrospective cohort, community-dwelling participants were extracted from the National Health and Aging Trends Study (2011-2020; n=277) and included if they had at least 1 formal or informal caregiver and reported an incident stroke in the prior year. Participants reported the amount of informal caregiving received in the month prior (low [<5.8], moderate [5.8-27.1], and high [27.2-350.4] hours per week) and their number of ADL limitations (ranging from 0 to 7). Participants were surveyed 1 year later to determine the number of adverse outcomes (ie, falls, hospitalizations, and physical function decline) experienced over the year. Poisson regression coefficients were converted to average marginal effects and estimated the moderating effects of informal caregiving hours per week on the relationship between ADL limitations and adverse outcomes. Stroke survivors were 69.7% White, 54.5% female, with an average age of 80.5 (SD, 7.6) years and 1.2 adverse outcomes at 2 years after the incident stroke. The relationships between informal caregiving hours and adverse outcomes and between ADL limitations and adverse outcomes were positive. The interaction between informal caregiving hours per week and ADL limitations indicated that those who received the lowest amount of informal caregiving had a rate of 0.12 more adverse outcomes per ADL (average marginal effect, 0.12 [95% CI, 0.005-0.23]; P=0.041) than those who received the highest amounts. Informal caregiving hours moderated the relationship between ADL limitations and adverse outcomes in this sample of community-based stroke survivors. Higher amounts relative to lower amounts of informal caregiving hours per week may be protective by decreasing the rate of adverse outcomes per ADL limitation.