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OBJECTIVE: UCS survival outcome disparities by race have been reported. We aimed to investigate social determinants of health (SDOH) and their relation to survival outcomes in women at two affiliated high-volume institutions serving a racially and economically diverse population. METHODS: Women diagnosed with stage I-IV UCS treated at St. Paul University Hospital, University of Texas Southwestern (UTSW) Zale Lipshy Pavilion-William P. Clements Jr. University Hospital, and Parkland Memorial Hospital between 1992 and 2022 were eligible. Patients were identified by the local tumor registries; a retrospective study was conducted. The Pearson chi-square test was utilized for categorical variables. OS and PFS were calculated using Kaplan-Meier estimates and compared with the log-rank test. Multivariate Cox models were used to identify independent prognostic factors. All statistical analyses were performed using SAS, version 9.4. RESULTS: Over half of the 218 patients with UCS were NHB. 35% of the patients had stage IV disease. Most HSP and NHB patients had a lower median household income* than Asian/Pacific Islander (API) or NHW (p < 0.001). Stage at diagnosis significantly affected OS (p < 0.001) but not PFS (p = 0.46) in univariate analyses. Accounting for age at diagnosis, insurance, income*, hospital, distance between hospital and home, months from diagnosis to first treatment, stage, and adjuvant therapy, race was significant for OS (p = 0.03) and PFS (p = 0.04). *Median household income by ZIP Code. CONCLUSIONS: Racial disparities were seen in median household income. Most SDOH independently analyzed in this study did not affect OS. The complex interaction between race and stage in UCS survival outcomes needs further investigation.
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Carcinosarcoma , Determinantes Sociales de la Salud , Neoplasias Uterinas , Humanos , Femenino , Carcinosarcoma/patología , Carcinosarcoma/terapia , Carcinosarcoma/mortalidad , Carcinosarcoma/etnología , Persona de Mediana Edad , Neoplasias Uterinas/patología , Neoplasias Uterinas/etnología , Neoplasias Uterinas/terapia , Neoplasias Uterinas/mortalidad , Estudios Retrospectivos , Anciano , Estadificación de Neoplasias , Adulto , Anciano de 80 o más Años , Supervivencia sin ProgresiónRESUMEN
BACKGROUND: Although cesarean delivery is the most common surgery performed in the United States, prescribing practices for analgesia vary. Strategies to manage postpartum pain have mostly focused on the immediate postpartum period when patients are still admitted to the hospital. At discharge, most providers prescribe a fixed number of opioid tablets. Most patients do not use all the opioids that they are prescribed at hospital discharge. This leads to an excess of opioids in the community, which can ultimately lead to misuse and diversion. OBJECTIVE: This study aimed to determine whether a transition from universal opioid prescribing to a personalized, patient-specific protocol decreases morphine milligram equivalents prescribed at hospital discharge after cesarean delivery while adequately controlling pain. STUDY DESIGN: This was a prospective cohort study of patients undergoing cesarean delivery before and after the implementation of a personalized opioid-prescribing practice at the time of hospital discharge. Each patient was prescribed scheduled ibuprofen and acetaminophen, with a prescription for oxycodone tablets equal to 5 times the morphine milligram equivalents used in the 24 hours before discharge, calculated via an electronic order set. The previous traditional cohorts were routinely prescribed 30 tablets of acetaminophen-codeine 300/30 mg. The primary outcome was morphine milligram equivalents prescribed at discharge. A hotline to address pain control issues after discharge was established, and calls, emergency department visits, and readmissions were examined. Statistical analyses was performed using chi-square and Wilcoxon rank-sum test, with a P value of <.05 considered statistically significant. RESULTS: Overall, 412 patients underwent cesarean delivery in the 6 weeks after initiation of the personalized prescribing protocol and were compared with 367 patients before the change. The median morphine milligram equivalents prescribed at discharge was lower with personalized prescribing (37.5 [interquartile range, 0-75] vs 135 [interquartile range, 135-135]; P<.001). Moreover, 176 patients (43%) were not prescribed opioids at discharge, which was a substantial change as all 367 patients in the traditional cohort received opioids at discharge (P<.001). Of note, 9 hotline phone calls were received; none required additional opioids after a 24-hour trial of scheduled ibuprofen, which none had taken before the call. In addition, 11 patients (2.7%) presented to the emergency department for pain evaluation, of which none required readmission or an outpatient prescription of opioids. CONCLUSION: A personalized protocol for opioid prescriptions after cesarean delivery decreased the total morphine milligram equivalents and the number of opioid tablets at discharge, without hospital readmissions or need for rescue opioid prescriptions after discharge. Opioids released into our community will be reduced by more than 90,000 tablets per year, without demonstrable adverse effect.
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Acetaminofén , Analgésicos Opioides , Embarazo , Femenino , Humanos , Estados Unidos , Analgésicos Opioides/uso terapéutico , Ibuprofeno/uso terapéutico , Estudios Prospectivos , Pacientes Ambulatorios , Registros Electrónicos de Salud , Dolor Postoperatorio/tratamiento farmacológico , Pautas de la Práctica en Medicina , Oxicodona , PrescripcionesRESUMEN
OBJECTIVE: This study aimed to examine the relationship of fetal station in the first stage of labor to labor curves and cesarean delivery rates among women presenting in spontaneous labor. STUDY DESIGN: Labor curves for patients with nonanomalous singletons who presented in spontaneous labor to our hospital's Obstetric Triage Unit with intact membranes from January 1, 2012, to August 31, 2016 were reviewed. Cervical exams and time of exam were obtained for each patient from presentation to triage until delivery. Station for each presentation and cervical dilation was estimated using a random effects model and the slope of cervical station change was calculated to estimate the change in dilation by hour. Perinatal outcomes, including cesarean delivery rates, were examined according to fetal station at initial presentation. Factors known to affect labor curves-epidural analgesia, infant birthweight, maternal habitus, and parity-were also examined. RESULTS: There were 8,123 patients presented in spontaneous labor with intact membranes. For patients presenting at 6-cm dilation, the rate of change of labor was significantly different when identified to have a station greater than 0 (+1 and more caudad) when compared with those with -1 and more cephalad station (both p < 0.001). This relationship persisted when analyzed according to epidural analgesia, birthweight, maternal habitus, and parity. The frequency of cesarean delivery was significantly higher for women presenting in spontaneous labor with negative fetal station (p < 0.05). When stratified across all dilation (3-9 cm), this trend remained significant (p < 0.001). CONCLUSION: In the first stage of labor, advanced fetal station was significantly associated with differing rates of labor progression, and positive fetal station was significantly less likely to result in cesarean delivery. Physical examination, including station, remains a critical element in labor management. KEY POINTS: · Fetal station is important in labor management.. · Fetal station at initial exam is related to time to delivery.. · Positive fetal station at initial exam is less likely to result in cesarean delivery..
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OBJECTIVE: Newborn hypothermia has been implicated in neonatal morbidity without randomized evidence that it compromises the infant. Our objective was to determine if a difference in operating room temperature at cesarean birth impacts neonatal morbidity. STUDY DESIGN: Women undergoing cesarean delivery of a liveborn infant without major malformations were included. The institutional preexisting operating room temperature of 20°C (67°F) was compared with an experimental group of 24°C (75°F) by cluster randomization assigned on a weekly basis. Newborn hypothermia was defined as axillary temperature on arrival to the nursery of less than 36.5°C (<97.7°F). The primary outcome was a composite of neonatal morbidity including respiratory support, sepsis, hypoglycemia, and neonatal death. RESULTS: Between November 2016 and May 2018, 5,221 women had cesarean deliveries at Parkland Hospital with 2,817 randomized to the standard care group and 2,404 to the experimental group. The rate of neonatal composite morbidity did not differ between the groups: standard care 398 (14%) versus experimental 378 (16%), p = 0.11. This was despite a significant decrease in the rate of neonatal hypothermia: standard care 1,195 (43%) versus experimental 414 (18%), p < 0.001. There was no difference in the composite outcome for preterm infants (<37 wk) between the groups: standard care 194 (49%) versus experimental 185 (54%), p = 0.25. CONCLUSION: An 8°F increase in operating room temperature was significantly associated with a reduced rate of neonatal hypothermia, although this decrease was not associated with a significant improvement in neonatal morbidity. However, the increase in operating room temperature was met with resistance from obstetricians and operating room personnel. This trial is registered (registration no.: NCT03008577).
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OBJECTIVE: The nomenclature has evolved from low implantation to cesarean scar pregnancy (CSP) and criteria are recommended for identification and management. Management guidelines include pregnancy termination due to life-threatening complications. This article applies ultrasound (US) parameters recommended by the Society for Maternal Fetal Medicine (SMFM) in women who were expectantly managed. STUDY DESIGN: Pregnancies were identified between March 1, 2013 and December 31, 2020. Inclusion criteria were women with CSP or low implantation identified on US. Studies were reviewed for niche, smallest myometrial thickness (SMT), and location of basalis blinded to clinical data. Clinical outcomes, pregnancy outcome, need for intervention, hysterectomy, transfusion, pathologic findings, and morbidities were obtained by chart review. RESULTS: Of 101 pregnancies with low implantation, 43 met the SMFM criteria at < 10 weeks and 28 at 10 to 14 weeks. At < 10 weeks, SMFM criteria identified 45out of 76 women; of these 13 required hysterectomy; there were 6 who required hysterectomy but did not meet the SMFM criteria. At 10 to < 14 weeks, SMFM criteria identified 28 out of 42 women; of these 15 required hysterectomy. US parameters yielded significant differences in women requiring hysterectomy, at < 10 weeks and 10 to < 14 weeks' gestational age epochs, but the sensitivity, specificity, positive (PPV), and negative predictive values (NPV) of these US parameters have limitations in identifying invasion to determine management. Of the 101 pregnancies, 46 (46%) failed < 20 weeks, 16 (35%) required medical/surgical management including 6 hysterectomies, and 30 (65%) required no intervention. There were 55 pregnancies (55%) that progressed beyond 20 weeks. Of these, 16 required hysterectomy (29%) while 39 (71%) did not. In the overall cohort of 101, 22 (21.8%) required hysterectomy and an additional16 (15.8%) required some type of intervention, while 66.7% required no intervention. CONCLUSION: SMFM US criteria for CSP have limitations for discerning clinical management due to lack of discriminatory threshold. KEY POINTS: · The SMFM US criteria for CSP at <10 or <14 weeks have limitations for clinical management.. · The sensitivity and specificity of the ultrasound findings limit the utility for management. · The SMT of <1 mm is more discriminating than <3 mm for hysterectomy..
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OBJECTIVE: Given the rising rates of maternal morbidity and mortality in the United States and the contribution of mental illness, especially among individuals living in underresourced communities, the objective was to evaluate the prevalence of unmet health-related social needs and their impact on perinatal mental health outcomes. STUDY DESIGN: This was a prospective observational study of postpartum patients residing within regions with increased rates of poor perinatal outcomes and sociodemographic disparities. Patients were enrolled in a multidisciplinary public health initiative "extending Maternal Care After Pregnancy (eMCAP)" between October 1, 2020 and October 31, 2021. Unmet health-related social needs were assessed at delivery. Symptoms of postpartum depression and anxiety were evaluated at 1 month postpartum utilizing the Edinburgh Postnatal Depression Scale (EPDS) and Generalized Anxiety Disorder-7 (GAD7) screening tools, respectively. Mean EPDS and GAD7 scores and odds of screening positive (scoring ≥ 10) were compared among individuals with and without unmet health-related social needs with p < 0.05 considered significant. RESULTS: Of participants enrolled in eMCAP, 603 completed at least one EPDS or GAD7 at 1 month. Most had at least one social need, most commonly dependence on social programs for food (n = 413/603; 68%). Individuals lacking transportation to medical (odds ratio [OR]: 4.0, 95% confidence interval [CI]: 1.2-13.32) and nonmedical appointments (OR: 4.17, 95% CI: 1.08-16.03) had significantly higher odds of screening positive on EPDS while participants lacking transportation to medical appointments (OR: 2.73, 95% CI: 0.97-7.70) had significantly higher odds of screening positive on GAD7. CONCLUSION: Among postpartum individuals in underserved communities, social needs correlate with higher depression and anxiety screening scores. This highlights the need to address social needs to improve maternal mental health. KEY POINTS: · Social needs are prevalent among underserved patients.. · Needs can be assessed in a structured or freeform manner.. · Unmet needs correlate with poor mental health outcomes.. · Similar needs correlate with depression and anxiety..
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OBJECTIVE: Circumvallate placenta has a suggested association with adverse pregnancy outcomes (antenatal bleeding, placental abruption, preterm birth, emergency cesarean, small for gestational age infants, and stillbirth). The aim was to determine if prenatal diagnosis of circumvallate placenta is associated with these adverse pregnancy outcomes. STUDY DESIGN: Pregnancies with a singleton gestation prenatally diagnosed with circumvallate placenta between January 1, 2012 and March 31, 2021 were identified. Adverse pregnancy outcomes were obtained. Rates of adverse pregnancy outcomes were compared among those with prenatally diagnosed circumvallate placentas to those without this prenatal diagnosis with a 4:1 control matched group. Pregnancies with known fetal anomalies or other placental abnormalities were excluded. Statistical analyses included Student's t-test and Χ 2 with p < 0.05 considered significant. RESULTS: Prenatal ultrasound findings of circumvallate placenta were seen in 179 pregnant people (0.20% of all anatomic US studies and 0.17% of all deliveries). Diagnosis was made at a mean gestational age of 19.8 ± 2.4 weeks. Adverse pregnancy outcomes were similar between groups. CONCLUSION: Prenatal ultrasound findings of circumvallate placenta do not correlate with adverse pregnancy outcomes. Given overall good prognosis, prenatal diagnosis of circumvallate placenta may not warrant additional surveillance during pregnancy. KEY POINTS: · The risk of prenatally diagnosed circumvallate placenta was previously unclear.. · Prenatally diagnosed circumvallate placenta is not associated with adverse pregnancy outcomes.. · No change in management may be necessary with prenatally diagnosed circumvallate placenta..
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BACKGROUND: Although there is a well-known association between fetal bradycardia and maternal eclampsia, the characteristics of fetal heart rate tracings after an eclamptic seizure have not previously been thoroughly described. Fetal heart rate changes are thought to be related to maternal lactic acidemia caused by vasospasm and uterine hyperactivity leading to placental hypoperfusion and fetal hypoxia. The decision to intervene in the case of an abnormal fetal heart rate tracing after an eclamptic seizure is often difficult; however, maternal resuscitation should be the primary focus. OBJECTIVE: This study aimed to quantify and characterize fetal heart rate changes associated with a maternal eclamptic seizure. Moreover, we sought to document subsequent obstetrical management following these seizures complicated by fetal heart rate decelerations. STUDY DESIGN: This was a retrospective study of fetal heart rate tracings associated with eclampsia during a 13-year period at a single institution. Eclampsia was diagnosed following the 2013 Executive Summary of the American College of Obstetricians and Gynecologists criteria. Tracings were independently reviewed and classified by 3 physicians using the National Institute of Child Health and Human Development Criteria. Hospital records were reviewed to ascertain obstetrical management after the eclamptic seizure. RESULTS: A total of 107 women were diagnosed with eclampsia from January 2009 to December 2021. Of these women, 31 experienced 34 intrapartum seizures during which time electronic fetal heart rate monitoring was ongoing. During the 34 seizures, fetal heart rate decelerations were documented in 79% of cases. The mean duration of bradycardia was 5.80±2.98 minutes with a range of 2 to 15 minutes. Fetal heart decelerations occurred, on average, 2.7±1.6 minutes after the onset of the eclamptic seizure. In half of the fetuses with fetal heart rate changes, fetal tachycardia followed, and in 48% of cases, there was minimal variability noted. As a result of the fetal heart rate tracings and clinical findings, 4 women underwent an emergent cesarean delivery, including 2 that were diagnosed with placental abruption. In this cohort, there were 4 cases of abruption. The mean duration from the seizure to delivery was 299±353 minutes. The mean neonatal cord pH was 7.20±0.11 with a mean base excess of -8.6±4.4 mmol/L. There was no perinatal death. CONCLUSION: After an eclamptic seizure, 79% of fetuses demonstrated prolonged decelerations, and half of the fetuses developed fetal tachycardia after recovery from the episode of bradycardia. Despite these periods of fetal heart rate decelerations associated with eclampsia, prioritization of maternal support and stabilization resulted in a favorable perinatal outcome without immediate operative intervention in more than two-thirds of cases.
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Eclampsia , Frecuencia Cardíaca Fetal , Bradicardia/epidemiología , Bradicardia/etiología , Niño , Eclampsia/epidemiología , Femenino , Monitoreo Fetal , Frecuencia Cardíaca , Frecuencia Cardíaca Fetal/fisiología , Humanos , Recién Nacido , Placenta , Embarazo , Estudios Retrospectivos , Convulsiones/etiologíaRESUMEN
BACKGROUND: Severe hypertension remains one of the leading preventable causes of maternal mortality in the United States. Timeliness to response to severe hypertension in pregnancy is a crucial quality indicator tracked by state and national organizations. We hypothesized that the implementation of the Maternal-Fetal Triage Index, a validated acuity tool, would improve care performance in women with severe hypertension in an urban, inner-city hospital setting. OBJECTIVE: This study aimed to assess the impact of the Maternal-Fetal Triage Index on the management of women presenting with severe preeclampsia diagnosed by severe hypertension as measured by time to provider assessment, administration of magnesium sulfate, and immediate administration of acute antihypertensives. STUDY DESIGN: This was a prospective, observational study of pregnant women presenting to the labor and delivery triage unit with severe preeclampsia diagnosed by severe hypertension giving birth at a large urban inner-city academic facility before (epoch 1: January 1, 2019, to December 31, 2019) and after (epoch 2: March 1, 2021, to September 31, 2021) the implementation of the Maternal-Fetal Triage Index. Baseline outcomes of time to assessment, time to magnesium sulfate prophylaxis, and time to antihypertensive medication administration before the implementation of the Maternal-Fetal Triage Index were assessed. The Maternal-Fetal Triage Index tool was implemented on March 1, 2021, following standardized education in 2020 for all triage nurses, unit technicians, healthcare unit coordinators, and healthcare providers. Time to assessment, administration of magnesium sulfate prophylaxis, and time to antihypertensive administration after the implementation of the Maternal-Fetal Triage Index were compared with measures before the implementation of the Maternal-Fetal Triage Index. Statistical analysis included Wilcoxon rank-sum test with P<.05 considered significant when comparing epoch 1 with epoch 2. RESULTS: A total of 370 patients were admitted with severe hypertension in 2019 before the use of the Maternal-Fetal Triage Index, and 254 patients were admitted with severe hypertension in 2021 after the implementation of the Maternal-Fetal Triage Index. There was no difference between epochs across baseline characteristics, including age, race and ethnicity, parity, and body mass index. After the Maternal-Fetal Triage Index was implemented, the time to provider assessment was significantly improved, from a median time of 44 minutes (interquartile range, 0-65) in epoch 1 to 17 minutes (interquartile range, 0-39) in epoch 2 (P<.001). Furthermore, the time from arrival to magnesium sulfate prophylaxis was significantly faster with a median time of 161 minutes (interquartile range, 109-256) in epoch 1 vs 127 minutes (interquartile range, 85-258) in epoch 2 (P=.001). Moreover, there was a decrease in the time from arrival to antihypertensive medication administration for severe blood pressures after the implementation of the Maternal-Fetal Triage Index (101 minutes [interquartile range, 61-177] vs 66 minutes [interquartile range, 35-203]; P<.001). CONCLUSION: The implementation of the Maternal-Fetal Triage Index at a large urban inner-city hospital was associated with improved timeliness of assessment and treatment of women with severe hypertension. The Maternal-Fetal Triage Index is a viable tool to improve the efficiency in triage units, specifically in the management of severe hypertension.
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Hipertensión Inducida en el Embarazo , Preeclampsia , Antihipertensivos/uso terapéutico , Femenino , Humanos , Hipertensión Inducida en el Embarazo/diagnóstico , Hipertensión Inducida en el Embarazo/tratamiento farmacológico , Sulfato de Magnesio/uso terapéutico , Preeclampsia/diagnóstico , Preeclampsia/tratamiento farmacológico , Preeclampsia/prevención & control , Embarazo , Estudios Prospectivos , TriajeRESUMEN
OBJECTIVE: Acute kidney injury (AKI)-complicating pregnancy is used as a marker of severe maternal morbidity (SMM) and frequently associated with obstetric hypertensive disorders. We examined AKI in pregnancies complicated by late-onset preeclampsia with severe features (SPE) using the Kidney Disease: Improving Global Outcomes (KDIGO) criteria. We compared outcomes of pregnancies with and without AKI and stratified by stage of disease. We further differentiated renal dysfunction at the time of admission and compared outcomes to those who developed AKI after admission. STUDY DESIGN: This was a retrospective cohort study of women with care established before 20 weeks and diagnosed with preeclampsia with severe features with delivery at ≥34 weeks. Women with chronic hypertension or suspected underlying renal dysfunction were excluded. KDIGO criteria were applied to stratify staging of renal disease. Demographics and perinatal outcomes were compared using Chi-square analysis and Wilcoxon's rank-sum test with p < 0.05 considered significant. RESULTS: From January 2015 through December 2019, a total of 3,515 women meeting study criteria were delivered. Of these, 517 (15%) women met KDIGO criteria for AKI at delivery with 248 (48%) having AKI at the time of admission and the remaining 269 (52%) after admission. Stratified by severity, 412 (80%) had stage 1 disease, 89 (17%) had stage II, and 16 (3%) had stage III. Women with AKI had higher rates of cesarean delivery (risk ratio [RR] = 1.3; 95% confidence interval [CI]: 1.17-1.44), postpartum hemorrhage (RR = 1.46; 95% CI: 1.29-1.66), and longer lengths of stay. Other associated outcomes included NICU admission (RR = 1.72; 95% CI: 1.19-2.48), 5-minute Apgar score ≤ 3 (RR = 5.11; 95% CI: 1.98-13.18), and infant length of stay. CONCLUSION: Of women with late preterm SPE, 15% were found to have AKI by KDIGO criteria. The majority (80%) of AKI was stage I disease, and approximately half of the cases were present by the time of admission. KEY POINTS: · AKI was found in 15% of our cohort with 80% stage I disease.. · Half of the cases of AKI were present on admission.. · Few adverse perinatal outcomes are associated with AKI..
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Preterm birth is a substantial public health concern. In 2019, the US preterm birth rate was 10.23%, which is the fifth straight year of increase in this rate. Moreover, preterm birth accounts for approximately 1 in 6 infant deaths, and surviving children often suffer developmental delay or long-term neurologic impairment. Although the burden of preterm birth is clear, identifying strategies to reduce preterm birth has been challenging. On October 29, 2019, a US Food and Drug Administration advisory committee voted 9 vs 7 to withdraw interim accelerated approval of 17-alpha hydroxyprogesterone caproate for preventing recurrent preterm birth because the called for a confirmatory trial, known as the Prevention of Preterm Birth in Women With a Previous Singleton Spontaneous Preterm Delivery trial, was not confirmatory. The Prevention of Preterm Birth in Women With a Previous Singleton Spontaneous Preterm Delivery trial included subjects enrolled in the United States and Canada to ensure that at least 10% of patients would be from North America; however, this trial took 9 years to complete and did not demonstrate significant treatment effects in the 2 primary outcomes of interest. Delivery before 35 weeks' gestation occurred in 122 of 1130 women (11%) given 17-alpha hydroxyprogesterone caproate compared with 66 of 578 women (11.5%) given placebo (relative risk, 0.95; 95% confidence interval, 0.71-1.26; P=.72). Similarly, the coprimary outcome neonatal composite index occurred in 61 of 1093 women (5.6%) given 17-alpha hydroxyprogesterone caproate compared with 28 of 559 women (5.0%) given placebo (relative risk, 1.12; 95% confidence interval, 0.68-1.61; P=.73). There was also a lack of efficacy for 17-alpha hydroxyprogesterone caproate treatment in the analysis of a variety of secondary outcomes. Like the Maternal-Fetal Medicine Units Network trial, the Prevention of Preterm Birth in Women With a Previous Singleton Spontaneous Preterm Delivery trial was also flawed. Importantly, the Maternal-Fetal Medicine Unit Network trial was the sole justification for treating women in the United States with 17-alpha hydroxyprogesterone caproate for nearly 2 decades. Currently, despite more than half a century, 17-alpha hydroxyprogesterone caproate still has not been found to be clearly effective. In this context, how does the advising physician dependent on scientific evidence advise a patient that 17-alpha hydroxyprogesterone caproate is effective when the evidence to support this advice has repeatedly been found to be inadequate? This clinical opinion is a critical appraisal of the 2 randomized trials examining the efficacy of 17-alpha hydroxyprogesterone caproate to prevent recurrent preterm birth and a chronicle of events in the regulatory process of drug approval to help answer this question. With this examination, these events illustrate the complexity of pharmaceutical regulations in the era of accelerated Food and Drug Administration approval and characterize the financial impact and influence in medicine. In this report, we also emphasize the value of observational studies in contemporary practice and identify other examples in medicine where accelerated Food and Drug Administration approval has been withdrawn. Importantly, the themes of the 17-alpha hydroxyprogesterone caproate story are not limited to obstetrics. It can also serve as a microcosm of issues within the US healthcare system, which ultimately contributes to the high cost of healthcare. In our opinion, the answer to the question is clear-the facts speak for themselves-and we believe 17-alpha hydroxyprogesterone caproate should not be endorsed for use to prevent recurrent preterm birth in the United States.
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Caproato de 17 alfa-Hidroxiprogesterona/uso terapéutico , Aprobación de Drogas , Medicina Basada en la Evidencia , Nacimiento Prematuro/prevención & control , Progestinas/uso terapéutico , United States Food and Drug Administration , Control de Medicamentos y Narcóticos , Femenino , Humanos , Estudios Observacionales como Asunto , Embarazo , Ensayos Clínicos Controlados Aleatorios como Asunto , Recurrencia , Estados UnidosRESUMEN
BACKGROUND: Expedited partner therapy for Chlamydia trachomatis has had mixed efficacy in different populations, but limited data exist on the efficacy of the therapy in a pregnant population. OBJECTIVE: This study aimed to evaluate the real-world effectiveness of establishing a prenatal expedited partner therapy program in eradicating chlamydia before delivery and to examine the maternal and neonatal outcomes between women who received expedited partner therapy for chlamydia and women who received standard partner referral testing and treatment during pregnancy. STUDY DESIGN: An expedited partner therapy program was implemented on August 21, 2019, at a public hospital in a county with high chlamydia prevalence. Pregnant women were provided with single-dose packets of azithromycin to treat partners following a diagnosis of chlamydia infection. We prospectively observed pregnant women treated in the expedited partner therapy program who delivered at our institution in the same year and compared the outcomes with a historic cohort from the previous year that had traditional partner referral testing and treatment. We excluded women with concurrent gonorrhea, HIV, syphilis, or current intimate partner violence. The primary outcome was chlamydia reinfection or no-cure rates at repeat testing in 4 to 6 weeks following treatment or at the 36-week prenatal care screening. Secondary outcomes included obstetrical, maternal, and neonatal outcomes, including premature rupture of membranes, chorioamnionitis, endometritis, neonatal intensive care unit admission, neonatal sepsis, pneumonia, and conjunctivitis. RESULTS: The rate of chlamydia infection was 3.6% over a 2-year period in our delivered population. In the year following the implementation of the expedited partner therapy, compared with 419 women (mean±standard deviation, 23.4±5.5 years) who were diagnosed with chlamydia infection in the previous year, 471 women (mean±standard deviation age, 23.8±5.3 years) who delivered at our institution were diagnosed with chlamydia infection. There was no difference in race, parity, prenatal care attendance, or concomitant sexually transmitted infections. Compared with the pre-expedited partner therapy group, the rate of reinfection in the post-expedited partner therapy group was not statistically different (60/471 [13%] vs 61/419 [15%]; odds ratio, 0.86 [95% confidence interval 0.58-1.26]). In a per-protocol analysis, 72 women (17%) in the pre-expedited partner therapy group and 389 women (83%) in post-expedited partner therapy group received expedited partner therapy; reinfection was not statistically different between groups (P=.47). There was no difference in secondary outcomes, although a trend toward improved rates of endometritis was noted in the post-expedited partner therapy group (odds ratio, 0.13; 95% confidence interval, 0.02-1.02). CONCLUSION: The implementation of a prenatal expedited partner therapy program did not affect the rate of chlamydia reinfection before delivery. Treatment of chlamydia in an inner-city population has multiple factors that lead to successful treatment. Future efforts to reduce sexually transmitted infection and chlamydia reinfection rates in an at-risk population should include exploring patient education and safe sex practices beyond expedited partner therapy alone during pregnancy.
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Antibacterianos/uso terapéutico , Azitromicina/uso terapéutico , Infecciones por Chlamydia/tratamiento farmacológico , Infecciones por Chlamydia/prevención & control , Complicaciones Infecciosas del Embarazo/prevención & control , Parejas Sexuales , Adulto , Estudios de Cohortes , Femenino , Humanos , Masculino , Embarazo , Atención Prenatal , Reinfección/epidemiología , Reinfección/prevención & control , Estudios Retrospectivos , Adulto JovenRESUMEN
BACKGROUND: Although simulation is now widely used to improve teamwork and communication, data demonstrating improvement in clinical outcomes are limited. OBJECTIVE: This study aimed to examine the clinical performance and outcomes associated with postpartum hemorrhage because of uterine atony following the implementation of a multidisciplinary simulation program. STUDY DESIGN: This was a prospective observational study of response to postpartum hemorrhage because of uterine atony in an academic medical center before (epoch 1: July 2017-June 2018) and after (epoch 2: July 2019-June 2020) implementing a multidisciplinary simulation program. A total of 22 postpartum hemorrhage simulations were performed from July 2018 to June 2019 involving more than 300 nursing, obstetrical, and anesthesia providers. The simulation program focused on managing postpartum hemorrhage events and improving teamwork and communication of the multidisciplinary teams. To evaluate the clinical effectiveness of the simulation program, the primary outcome was response to postpartum hemorrhage defined as the time from the administration of uterotonic medications to transfusion of the first unit of blood in the first 12 hours following delivery, comparing epoch 2 to epoch 1 following the implementation of a simulation program. Statistical analysis included the use of the Pearson chi-square test, Wilcoxon rank-sum test, Hodges-Lehmann statistic for differences, and bootstrap methods with a P value of <.05 considered significant. RESULTS: Between July 1, 2017, and June 30, 2018, there were 12,305 patients who delivered, of which 495 patients (4%) required transfusion. Between July 1, 2019, and June 30, 2020, there were 12,414 patients who delivered, of which 480 patients (4%) required transfusion. When isolating cases of postpartum hemorrhage because of uterine atony in both transfused groups, there were 157 women in the presimulation group (epoch 1) and 165 women in the postsimulation group (epoch 2), respectively. There was no difference in age, race, parity, or perinatal outcomes between the 2 epochs. Women in epoch 2 began receiving blood products significantly earlier in the first 12 hours following delivery compared with women in epoch 1 (51 [range, 28-125] minutes vs 102 [range, 32-320] minutes; P=.005). In addition, there was a significantly decreased variation in the time from the administration of uterotonic medications to transfusion of blood in epoch 2 (P=.035). Furthermore, women in epoch 2 had significantly lower estimated blood loss than women in epoch 1 (1250 [range, 1000-1750] mL vs 1500 [range, 1000-2000] mL; P=.032). CONCLUSION: The implementation of a multidisciplinary simulation program at a large academic center focusing on the management of postpartum hemorrhage was associated with an improved clinical response. Specifically, there were significantly faster times from the administration of uterotonic medications to transfusion of blood, decreased variance in the time from the administration of uterotonic medications to transfusion of blood, and lower estimated blood loss following the implementation of a simulation program. Because delay in treatment is a major cause of preventable maternal death in obstetrical hemorrhage, the results in our study provided clinical evidence that a simulation program may improve patient outcomes in such emergencies.
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Transfusión Sanguínea/métodos , Obstetricia/educación , Oxitócicos/uso terapéutico , Hemorragia Posparto/terapia , Entrenamiento Simulado/métodos , Tiempo de Tratamiento/estadística & datos numéricos , Inercia Uterina/terapia , Adulto , Femenino , Humanos , Embarazo , Estudios Prospectivos , Resultado del Tratamiento , Adulto JovenRESUMEN
OBJECTIVES: The placenta accreta spectrum (PAS) incidence has risen substantially over the past century, paralleling a rise in cesarean delivery (CD) rates. Prenatal diagnosis of PAS improves maternal outcomes. The Placenta Accreta Index (PAI) is a standardized approach to prenatal diagnosis of PAS incorporating clinical risk and ultrasound (US) findings suggestive of placental invasion. We sought to validate the PAI for prediction of PAS in pregnancies with prior CD. METHODS: This work was a retrospective cohort study of pregnancies with 1 or more prior CDs that received a US diagnosis of placenta previa or low-lying placenta in the third trimester. Images of third-trimester US with a complete placental evaluation were read by 2 blinded physicians, and the PAI was applied. Surgical outcomes and pathologic findings were reviewed. Placenta accreta spectrum was diagnosed if clinical evidence of invasion was seen at time of delivery or if any placental invasion was identified histologically. International Federation of Gynecology and Obstetrics criteria were used. RESULTS: A total of 194 women met inclusion criteria. Cesarean hysterectomy was performed in 92 (47%), CD in 97 (50%), and vaginal delivery in 5 (3%). Of those who underwent hysterectomy, PAS was histologically confirmed in 79 (85%) pregnancies. Of the remaining 13 who underwent hysterectomy, all met International Federation of Gynecology and Obstetrics grade 1 clinical criteria for PAS. With a threshold of greater than 4, the PAI has a sensitivity of 87%, specificity of 77%, positive predictive value of 72%, and negative predictive value of 90% for PAS diagnosis. CONCLUSIONS: Contemporaneous application of the PAI, a standardized approach to US diagnosis, is useful in the prenatal prediction of PAS.
Asunto(s)
Placenta Accreta , Placenta Previa , Femenino , Humanos , Placenta/diagnóstico por imagen , Placenta Accreta/diagnóstico por imagen , Placenta Previa/diagnóstico por imagen , Embarazo , Estudios Retrospectivos , Ultrasonografía PrenatalRESUMEN
OBJECTIVE: This study aimed to evaluate the rate and impact of episiotomy on maternal and newborn outcomes before and after restricted use of episiotomy. STUDY DESIGN: This population-based observational study used an obstetric database of all deliveries since 1990 that has been maintained with quality checks. Inclusion criteria were vaginal deliveries at ≥37 weeks. Exclusion criteria included fetal malformations, multifetal gestations, or fetal deaths known on arrival to Labor and Delivery. The primary outcomes of interest were episiotomy, perineal lacerations, and newborn outcomes. To evaluate the impact of restrictive episiotomy, data from 1990 to 1997 (35% overall episiotomy rate) were compared with data from 2010 to 2017 (2.5% overall episiotomy rate). Univariable analysis of maternal and infant outcomes were performed comparing the two-time epochs with the Pearson's Chi-squared test. RESULTS: Overall, 268,415 women met inclusion criteria and 49,089 (18.2%) had an episiotomy. The rate of episiotomy decreased from 37% of deliveries in 1990 to 2% in 2017. A total of 82,082 deliveries occurred in the 1990 to 1997 epoch and 57,183 in 2010 to 2017. Indicated use of episiotomy was associated with a significant decrease in third and fourth degree lacerations. Immediate newborn condition (5-minute Apgar's score ≤3 and umbilical artery pH <7.1) and neonatal outcomes (intraventricular hemorrhage [IVH] grade 3/4, positive culture sepsis, neonatal seizures, and neonatal demise) were not significantly different. CONCLUSION: Selective, indicated use of episiotomy compared with routine was associated with lower rates of third/fourth-degree lacerations with no change in neonatal outcomes. The common obstetric practice of routinely performing episiotomy, presumably to prevent perineal trauma, proved untrue when analyzed over almost three decades. KEY POINTS: · Episiotomy use decreased overtime at our institution.. · Decreased episiotomy use was associated with significant improvement in maternal outcomes.. · Neonatal outcomes were unchanged suggesting no deleterious effects with restricted episiotomy..
RESUMEN
OBJECTIVE: Although intrahepatic cholestasis of pregnancy (ICP) remains poorly understood, there are several perinatal complications associated with this condition. This study aimed to examine perinatal outcomes of women with ICP, evaluate outcomes according to severity of disease, and monitor time to symptom improvement following diagnosis. STUDY DESIGN: It involves a prospective, observational study of women with ICP at a single institution. Women with new-onset pruritus without rash were referred to a high-risk obstetrics clinic and evaluated with fasting total bile acids (TBA). Laboratory-confirmed ICP was defined as fasting TBA ≥10 µmol/L. Following diagnosis, a standardized protocol was utilized, including treatment with ursodeoxycholic acid (UDCA). Perinatal outcomes were compared amongst those with and without ICP, and to the general population. Women with ICP were further analyzed based on maximum TBA: 10 to 39, 40 to 99, and ≥100 µmol/L. A Kaplan-Meier survival curve was used to analyze time to symptom improvement. RESULTS: A total of 404 patients were evaluated and 212 (52%) were diagnosed with ICP. The mean gestational age at diagnosis was 34.1 ± 3.3 weeks. When comparing those with ICP to those not confirmed, and to the general population, there were no differences in age, parity, mode of delivery, preeclampsia, or stillbirth (p > 0.05). Preterm birth was significantly associated with ICP (p < 0.01). This relationship was significant across increasing severity of TBA (p < 0.01) and persisted when examining rates of spontaneous preterm birth (p < 0.01). All women with fasting TBA ≥40 µmol/L delivered preterm due to premature rupture of membranes or spontaneous labor. Time to symptom improvement after diagnosis was over 2 weeks on average; however, this time increased with worsening severity of disease. CONCLUSION: Despite treatment with UDCA, women with ICP are at increased risk for spontaneous preterm birth, and this risk significantly increased with severity of disease. Although not significant, a trend exists between increasing time to symptom improvement and worsening severity of disease. KEY POINTS: · Preterm birth is significantly increased in patients diagnosed with intrahepatic cholestasis of pregnancy.. · The risk of preterm birth in women with ICP increases across increasing strata of disease.. · Following initiation of treatment in patients with ICP, symptom improvement takes more than 2 weeks..
Asunto(s)
Colestasis Intrahepática/epidemiología , Complicaciones del Embarazo/epidemiología , Nacimiento Prematuro/epidemiología , Mortinato/epidemiología , Adolescente , Adulto , Ácidos y Sales Biliares , Femenino , Edad Gestacional , Humanos , Recién Nacido , Modelos Logísticos , Embarazo , Resultado del Embarazo/epidemiología , Estudios Prospectivos , Texas/epidemiología , Adulto JovenRESUMEN
BACKGROUND: Because nearly one-third of births in the United States are now achieved by cesarean delivery, comprising more than 1.27 million women each year, national organizations have recently published revised guidelines for the management of labor. These new guidelines stipulate that labor arrest should not be diagnosed unless ≥6 cm cervical dilatation has been reached or labor has been stimulated for at ≥6 hours. OBJECTIVE: To determine the cervical dilatation and hours of labor stimulation prior to cesarean delivery for arrest of dilatation. MATERIALS AND METHODS: Between January 1, 1999, andDecember 31, 2000, a prospective observational study of all primary cesarean deliveries was conducted at 13 university centers comprising the Eunice Kennedy Shriver National Institute for Child Health and Human Development, Maternal-Fetal Medicine Units Network. This secondary analysis includes all live-born, singleton, nonanomalous, cephalic gestations delivered by primary cesarean delivery at ≥37 weeks. A cesarean delivery was considered to have been performed for arrest of dilatation if the indication for the procedure was failure to progress, cephalopelvic disproportion, or failed induction. Augmentation was defined as stimulation after spontaneous labor had been previously diagnosed. Analysis included both the latent and active phases of labor. The active phase of labor was diagnosed when cervical dilatation was ≥4 cm in the presence of uterine contractions. RESULTS: A total of 13,269 primary cesarean deliveries were available for analysis, 8,546 (65%) of which were performed for inadequate progress of labor with cervical dilatation recorded at the time of cesarean delivery. Of these cesarean deliveries for labor arrest, a total of 719 (8%) were performed in the latent phase of labor and 7827 (92%) were performed when cervical dilatation was ≥4 cm (active phase). Approximately two-thirds (n = =5876; 69%) received intrauterine pressure monitoring. A total of 5636 women (66% of those reaching the active phase of labor) had reached ≥6 cm cervical dilatation before cesarean delivery was performed. Moreover, 7440 (95%) of the 7827 women in active labor had ≥6 cm dilatation or had received labor stimulation ≥6 hours prior to cesarean delivery for arrest of dilatation. CONCLUSION: Women undergoing primary cesarean delivery for arrest of dilatation 15 years before the recommendations of the Obstetrics Care Consensus had received bona fide efforts to achieve adequate labor consistent with the recommendations of the Consensus. Because 95% of these women had ≥6 cm dilatation or had received labor stimulation ≥6 hours prior to cesarean delivery for arrest of dilatation, these new recommendations are unlikely to change the cesarean delivery rates.
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Cesárea/estadística & datos numéricos , Complicaciones del Trabajo de Parto/cirugía , Pautas de la Práctica en Medicina/estadística & datos numéricos , Adolescente , Adulto , Desproporción Cefalopelviana/cirugía , Femenino , Humanos , Primer Periodo del Trabajo de Parto , Trabajo de Parto Inducido/estadística & datos numéricos , Complicaciones del Trabajo de Parto/diagnóstico , Guías de Práctica Clínica como Asunto , Embarazo , Estudios Prospectivos , Adulto JovenRESUMEN
There has been a recent significant evolution in suggested practices for the management of labor because of the increased national cesarean delivery rate. One of the most significant changes was promulgated by the 2014 Obstetric Care Consensus entitled, "Safe Prevention of Primary Cesarean Delivery," which recommended reconsideration of the upper limits of the length of labor in the second stage as well as the first stage. We previously published a 2016 Clinical Opinion challenging the second-stage practice change. Over the past 2 years, there have been at least 5 reports as well as 2 national organization statements supporting revised management of second-stage labor. We now revisit the second-stage issue because we believe that it is important to carefully clarify the current status resulting from consensus statements as well as the evolving current status of scientific evidence. We structured this Clinical Opinion using questions in an effort to chronicle the story of how obstetric precepts on second-stage labor in use for more than 50 years were being replaced. How did we get here? What is the current evidence? What can be learned from this experience? Should American obstetrics now "fall back" to pre-existing obstetric precepts for the management of second-stage labor after having "sprung forward" an additional hour-namely, lengthening the duration of acceptable second-stage labor to 4 hours as recommended by the Obstetric Care Consensus? We believe that the data published since our 2016 Clinical Opinion buttress our original position that prolongation of the second stage beyond historical precepts is unsafe.
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Analgesia Epidural , Cesárea/métodos , Parto Obstétrico/métodos , Segundo Periodo del Trabajo de Parto , Paridad , Analgesia Obstétrica , Consenso , Distocia/terapia , Medicina Basada en la Evidencia , Femenino , Humanos , Obstetricia , Guías de Práctica Clínica como Asunto , Embarazo , Factores de TiempoRESUMEN
BACKGROUND: In 2014, the Eunice Kennedy Shriver National Institute of Child Health and Human Development Fetal Imaging Workshop consensus recommended that sonograms be offered routinely to all pregnant women. In the absence of another indication, this examination is recommended at 18-22 weeks of gestation. Studies of anomaly detection often focus on pregnancies at risk for anomalies and on the yield of detailed sonography, topics less applicable to counseling low-risk pregnancies about the benefits and limitations of standard sonography. The clinical utility of follow-up sonogram in low-risk pregnancies for the purpose of fetal anomaly detection has not been established. OBJECTIVE: The objective of the study was to evaluate the utility of follow-up standard sonography for anomaly detection among low-risk pregnancies in a nonreferred population. STUDY DESIGN: We performed a retrospective cohort study of singleton pregnancies that underwent standard sonography at 18-21 6/7 weeks of gestation from October 2011 through March 2018 with subsequent delivery of a live-born infant at our hospital. Pregnancies with indications for detailed sonography in our system were excluded to evaluate fetal anomalies first identified with standard sonography. Anomalies were categorized according to the European Registration of Congenital Anomalies and Twins (EUROCAT) system, with confirmation based on neonatal evaluation. Among those with no anomaly detected initially, we evaluated the rate of subsequent detection according to number of follow-up sonograms, gestational age at sonography, organ system(s) affected, and anomaly severity. Statistical analyses were performed using χ2 and a Mantel-Haenszel test. RESULTS: Standard sonography was performed in 40,335 pregnancies at 18-21 6/7 weeks, and 11,770 (29%) had at least 1 follow-up sonogram, with a second follow-up sonogram in 3520 (9%). Major abnormalities were confirmed in 387 infants (1%), with 248 (64%) detected initially and 28 (7%) and 5 (1%) detected on the first and second follow-up sonograms. Detection of residual anomalies on follow-up sonograms was significantly lower than detection on the initial standard examination: 64% on initial examination, 45% for first follow-up, and 45% for second follow-up (P < .01). A larger number of follow-up examinations were required per anomalous fetus detected: 163 examinations per anomalous fetus detected initially, 420 per fetus detected at the first follow-up examination, and 705 per fetus detected at the second follow-up sonogram (P < .01). The number of follow-up examinations to detect each additional anomalous fetus was not affected by gestational age (P = .7). Survival to hospital discharge was significantly lower for fetuses with anomalies detected on initial (88%) than for fetuses with anomalies undetected until delivery (90 of 91, 99%; P < .002). CONCLUSION: In a low-risk, nonreferred cohort with fetal anomaly prevalence of 1%, follow-up sonography resulted in detection of 45% of fetal anomalies that had not been identified during the initial standard sonogram. Significantly more follow-up sonograms were required to detect each additional anomalous fetus.
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Anomalías Congénitas/diagnóstico por imagen , Edad Gestacional , Guías de Práctica Clínica como Asunto , Ultrasonografía Prenatal/métodos , Anomalías Múltiples/diagnóstico por imagen , Adulto , Enfermedades del Desarrollo Óseo/congénito , Enfermedades del Desarrollo Óseo/diagnóstico por imagen , Estudios de Cohortes , Anomalías Craneofaciales/diagnóstico por imagen , Anomalías del Sistema Digestivo/diagnóstico por imagen , Femenino , Cardiopatías Congénitas/diagnóstico por imagen , Humanos , Recién Nacido , Malformaciones del Sistema Nervioso/diagnóstico por imagen , Embarazo , Segundo Trimestre del Embarazo , Anomalías del Sistema Respiratorio/diagnóstico por imagen , Estudios Retrospectivos , Ultrasonografía Prenatal/normas , Anomalías Urogenitales/diagnóstico por imagenRESUMEN
OBJECTIVES: To evaluate fetal anomaly detection in pregnancies with pregestational diabetes, according to the gestational age at the time of specialized sonography, use of follow-up sonography, maternal body mass index, and organ system(s) involved. METHODS: Women with pregestational diabetes who received prenatal care and delivered a live-born or stillborn neonate at our hospital from October 2011 through April 2017 were ascertained. We included all pregnancies with at least 1 confirmed structural anomaly (EUROCAT classification) who had detailed sonography at 18 weeks' gestation or later. We analyzed detection of anomalous fetuses at the initial detailed sonogram and, if no abnormality was identified, during any follow-up sonograms. Statistical analyses were performed with the χ2 test and Mantel-Haenszel χ2 test for trend. RESULTS: Seventy-two anomalous neonates (72 of 1060 [6.8%]) were born. Overall detection was 55 of 72 (76%); 49 of 72 (68%) were detected at the initial detailed sonogram, compared to 6 of 15 (40%) of follow-up examinations (P = .04). Recognition at the initial or follow-up examination was not dependent on gestational age or body mass index category (all P > .05). Of individual organ system anomalies, 67 of 89 (75%) were identified. Detection exceeded 85% for central nervous system, genitourinary, and musculoskeletal abnormalities and 43% for craniofacial anomalies. Sixty-five percent of cardiac anomalies were detected, and 14 of 17 (82%) requiring specialized care in the immediate neonatal period were recognized. CONCLUSIONS: Approximately three-fourths of anomalous fetuses were identified, with greater detection at the initial detailed examination. Fetuses with central nervous system, genitourinary, musculoskeletal abnormalities and those with cardiac anomalies requiring specialized cardiac care were more likely to come to attention.