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1.
Am J Obstet Gynecol ; 230(5): 469.e1-469.e5, 2024 May.
Artículo en Inglés | MEDLINE | ID: mdl-38413328

RESUMEN

Hippocrates, an influential figure in ancient Greek medicine, is best known for his lasting contribution, the Hippocratic Oath, which includes a significant message about obstetrics and gynecology. Given the Oath's status as a widely regarded ethical code for medical practice, it requires critical evaluation. The message of the Oath, as it related to obstetrics and gynecology, is expressed in ancient Greek by the phrase "οὐδὲ γυναικὶ πεσσὸν φθόριον δώσω" which translates directly to "I will not give to any woman a harming pessary." The words fetus and abortion were not present in the original Greek text of the Oath. Yet, this message of the Hippocratic Oath has been interpreted often as a prohibition against abortion. In this article, we present a critical linguistic and historical analysis and argue against the notion that the Hippocratic Oath was prohibiting abortion. We provide evidence that the words "foetum" (fetus) and "abortu" (abortion) were inserted in the Latin translations of the Oath, which then carried on in subsequent English versions. The addition of the words "fetus" and "abortion" in the Latin translations significantly altered the Oath's original meaning. Unfortunately, these alterations in the translation of the Hippocratic Oath have been accepted over the years because of cultural, religious, and social reasons. We assert that because the original Hippocratic Oath did not contain language related to abortion, it should not be construed as prohibiting it. The interpretation of the Oath should be based on precise and rigorous translation and speculative interpretations should be avoided.


Asunto(s)
Ginecología , Juramento Hipocrático , Obstetricia , Obstetricia/historia , Obstetricia/ética , Humanos , Ginecología/historia , Ginecología/ética , Historia Antigua , Femenino , Embarazo , Aborto Inducido/ética , Aborto Inducido/historia
2.
Am J Obstet Gynecol ; 228(5S): S1144-S1157, 2023 05.
Artículo en Inglés | MEDLINE | ID: mdl-36964003

RESUMEN

Fetal acidemia is a common final pathway to fetal death, and in many cases, to fetal central nervous system injury. However, certain fetal pathophysiological processes are associated with significant category II or category III fetal heart rate changes before the development of or in the absence of fetal acidemia. The most frequent of these processes include fetal infection and/or inflammation, anemia, fetal congenital heart disease, and fetal central nervous system injury. In the presence of significant category II or category III fetal heart rate patterns, clinicians should consider the possibility of the aforementioned fetal processes depending on the clinical circumstances. The common characteristic of these pathophysiological processes is that their associated fetal heart rate patterns are linked to increased adverse neonatal outcomes despite the absence of acidemia at birth. Therefore, in these cases, the fetal heart rate patterns may provide more insight about the fetal condition and pathophysiology than the acid-base status at birth. In addition, as successful timing of intrapartum interventions on the basis of evolution of fetal heart rate patterns aims to prevent fetal acidemia, it may not be logical to continue to use the fetal acid-base status at birth as the gold standard outcome to determine the predictive ability of category II or III fetal heart rate patterns. A more reasonable approach may be to use the umbilical cord blood acid-base status at birth as the gold standard for determining the appropriateness of the timing of our interventions.


Asunto(s)
Acidosis , Enfermedades Fetales , Embarazo , Femenino , Recién Nacido , Humanos , Frecuencia Cardíaca Fetal/fisiología , Parto , Enfermedades Fetales/epidemiología , Atención Prenatal , Sangre Fetal
3.
Am J Obstet Gynecol ; 228(6): 726.e1-726.e11, 2023 06.
Artículo en Inglés | MEDLINE | ID: mdl-36841348

RESUMEN

BACKGROUND: Diabetes mellitus is a common medical complication of pregnancy, and its treatment is complex. Recent years have seen an increase in the application of mobile health tools and advanced technologies, such as remote patient monitoring, with the aim of improving care for diabetes mellitus in pregnancy. Previous studies of these technologies for the treatment of diabetes in pregnancy have been small and have not clearly shown clinical benefit with implementation. OBJECTIVE: Remote patient monitoring allows clinicians to monitor patients' health data (such as glucose values) in near real-time, between office visits, to make timely adjustments to care. Our objective was to determine if using remote patient monitoring for the management of diabetes in pregnancy leads to an improvement in maternal and neonatal outcomes. STUDY DESIGN: This was a retrospective cohort study of pregnant patients with diabetes mellitus managed by the maternal-fetal medicine practice at one academic institution between October 2019 and April 2021. This practice transitioned from paper-based blood glucose logs to remote patient monitoring in February 2020. Remote patient monitoring options included (1) device integration with Bluetooth glucometers that automatically uploaded measured glucose values to the patient's Epic MyChart application or (2) manual entry in which patients manually logged their glucose readings into their MyChart application. Values in the MyChart application directly transferred to the patient's electronic health record for review and management by clinicians. In total, 533 patients were studied. We compared 173 patients managed with paper logs to 360 patients managed with remote patient monitoring (176 device integration and 184 manual entry). Our primary outcomes were composite maternal morbidity (which included third- and fourth-degree lacerations, chorioamnionitis, postpartum hemorrhage requiring transfusion, postpartum hysterectomy, wound infection or separation, venous thromboembolism, and maternal admission to the intensive care unit) and composite neonatal morbidity (which included umbilical cord pH <7.00, 5 minute Apgar score <7, respiratory morbidity, hyperbilirubinemia, meconium aspiration, intraventricular hemorrhage, necrotizing enterocolitis, sepsis, pneumonia, seizures, hypoxic ischemic encephalopathy, shoulder dystocia, trauma, brain or body cooling, and neonatal intensive care unit admission). Secondary outcomes were measures of glycemic control and the individual components of the primary composite outcomes. We also performed a secondary analysis in which the patients who used the two different remote patient monitoring options (device integration vs manual entry) were compared. Chi-square, Fisher's exact, 2-sample t, and Mann-Whitney tests were used to compare the groups. A result was considered statistically significant at P<.05. RESULTS: Maternal baseline characteristics were not significantly different between the remote patient monitoring and paper groups aside from a slightly higher baseline rate of chronic hypertension in the remote patient monitoring group (6.1% vs 1.2%; P=.011). The primary outcomes of composite maternal and composite neonatal morbidity were not significantly different between the groups. However, remote patient monitoring patients submitted more glucose values (177 vs 146; P=.008), were more likely to achieve glycemic control in target range (79.2% vs 52.0%; P<.0001), and achieved the target range sooner (median, 3.3 vs 4.1 weeks; P=.025) than patients managed with paper logs. This was achieved without increasing in-person visits. Remote patient monitoring patients had lower rates of preeclampsia (5.8% vs 15.0%; P=.0006) and their infants had lower rates of neonatal hypoglycemia in the first 24 hours of life (29.8% vs 51.7%; P<.0001). CONCLUSION: Remote patient monitoring for the management of diabetes mellitus in pregnancy is superior to a traditional paper-based approach in achieving glycemic control and is associated with improved maternal and neonatal outcomes.


Asunto(s)
Diabetes Gestacional , Enfermedades del Recién Nacido , Síndrome de Aspiración de Meconio , Embarazo , Lactante , Femenino , Humanos , Recién Nacido , Estudios Retrospectivos , Diabetes Gestacional/tratamiento farmacológico , Glucemia , Enfermedades del Recién Nacido/terapia , Monitoreo Fisiológico , Resultado del Embarazo
4.
Am J Obstet Gynecol ; 226(4): 556.e1-556.e9, 2022 04.
Artículo en Inglés | MEDLINE | ID: mdl-34634261

RESUMEN

BACKGROUND: Cesarean delivery rates have been used as obstetrical quality indicators. However, these approaches do not consider the accompanying maternal and neonatal morbidities. A challenge in the field of obstetrics has been to establish a valid outcomes quality measure that encompasses preexisting high-risk maternal factors and associated maternal and neonatal morbidities and is universally acceptable to all stakeholders, including patients, healthcare providers, payers, and governmental agencies. OBJECTIVE: This study aimed to (1) establish a new single metric for obstetrical quality improvement among nulliparous patients with term singleton vertex-presenting fetus, integrating cesarean delivery rates adjusted for preexisting high-risk maternal factors with associated maternal and neonatal morbidities, and (2) determine whether obstetrician quality ranking by this new metric is different compared with the rating based on individual crude and/or risk-adjusted cesarean delivery rates. The single metric has been termed obstetrical safety and quality index. STUDY DESIGN: This was a cross-sectional study of all nulliparous patients with term singleton vertex-presenting fetuses delivered by 12 randomly chosen obstetricians in a single institution. A review of all records was performed, including a review of maternal high-risk factors and maternal and neonatal outcomes. Maternal and neonatal medical records were reviewed to determine crude and adjusted cesarean delivery rates by obstetricians and quantify maternal and neonatal complications. We estimated the obstetrician-specific crude cesarean delivery rates and rates adjusted for obstetrician-specific maternal and neonatal complications from logistic regression models. From this model, we derived the obstetrical safety and quality index for each obstetrician. The final ranking based on the obstetrical safety and quality index was compared with the initial ranking by crude cesarean delivery rates. Maternal and neonatal morbidities were analyzed as ≥1 and ≥2 maternal and/or neonatal complications. RESULTS: These 12 obstetricians delivered a total of 535 women; thus, 1070 (535 maternal and 535 neonatal) medical records were reviewed to determine crude and adjusted cesarean delivery rates by obstetricians and quantify maternal and neonatal complications. The ranking of crude cesarean delivery rates was not correlated (rho=0.05; 95% confidence interval, -0.54 to 0.60) to the final ranking based on the obstetrical safety and quality index. Of note, 8 of 12 obstetricians shifted their rank quartiles after adjustments for high-risk maternal conditions and maternal and neonatal outcomes. There was a strong correlation between the ranking based on ≥1 maternal and/or neonatal complication and ranking based on ≥2 maternal and/or neonatal complications (rho=0.63; 95% confidence interval, 0.08-0.88). CONCLUSION: Ranking based on crude cesarean delivery rates varied significantly after considering high-risk maternal conditions and associated maternal and neonatal outcomes. Therefore, the obstetrical safety and quality index, a single metric, was developed to identify ways to improve clinician practice standards within an institution. Use of this novel quality measure may help to change initiatives geared toward patient safety, balancing cesarean delivery rates with optimal maternal and neonatal outcomes. This metric could be used to compare obstetrical quality not only among individual obstetricians but also among hospitals that practice obstetrics.


Asunto(s)
Obstetricia , Cesárea/efectos adversos , Estudios Transversales , Femenino , Hospitales , Humanos , Recién Nacido , Embarazo , Mejoramiento de la Calidad
5.
Am J Obstet Gynecol ; 226(4): 475-486, 2022 04.
Artículo en Inglés | MEDLINE | ID: mdl-35369904

RESUMEN

Growth-restricted fetuses are at risk of hypoxemia, acidemia, and stillbirth because of progressive placental dysfunction. Current fetal well-being, neonatal risks following delivery, and the anticipated rate of fetal deterioration are the major management considerations in fetal growth restriction. Surveillance has to quantify the fetal risks accurately to determine the delivery threshold and identify the testing frequency most likely to capture future deterioration and prevent stillbirth. From the second trimester onward, the biophysical profile score correlates over 90% with the current fetal pH, and a normal score predicts a pH >7.25 with a 100% positive predictive value; an abnormal score on the other hand predicts current fetal acidemia with similar certainty. Between 30% and 70% of growth-restricted fetuses with a nonreactive heart rate require biophysical profile scoring to verify fetal well-being, and an abnormal score in 8% to 27% identifies the need for delivery, which is not suspected by Doppler findings. Future fetal well-being is not predicted by the biophysical profile score, which emphasizes the importance of umbilical artery Doppler and amniotic fluid volume to determine surveillance frequency. Studies with integrated surveillance strategies that combine frequent heart rate monitoring with biophysical profile scoring and Doppler report better outcomes and stillbirth rates of between 0% and 4%, compared with those between 8% and 11% with empirically determined surveillance frequency. The variations in clinical behavior and management challenges across gestational age are better addressed when biophysical profile scoring is integrated into the surveillance of fetal growth restriction. This review aims to provide guidance on biophysical profile scoring in the in- and outpatient management of fetal growth restriction.


Asunto(s)
Retardo del Crecimiento Fetal , Placenta , Líquido Amniótico , Femenino , Retardo del Crecimiento Fetal/diagnóstico por imagen , Humanos , Recién Nacido , Embarazo , Ultrasonografía , Arterias Umbilicales/diagnóstico por imagen
6.
Am J Obstet Gynecol ; 225(5): 525.e1-525.e9, 2021 11.
Artículo en Inglés | MEDLINE | ID: mdl-34051170

RESUMEN

BACKGROUND: Accurate identification of the women who will have spontaneous preterm birth continues to be a great challenge. The use of cervical elastography for prediction of preterm birth is promising, but several limitations exist. Newer cervical elastography technology has been developed that may prove useful in evaluation of risk of preterm birth. OBJECTIVE: This study aimed to develop standard cervical elastography nomograms for singleton pregnancies at 18 to 22 weeks' gestation using the E-Cervix ultrasound application, assess intraobserver reliability of the E-Cervix elastography parameters, and determine whether these cervical elastography measurements can be used in the prediction of spontaneous preterm birth. STUDY DESIGN: This was a prospective cohort study of pregnant women undergoing cervical length screening assessment via transvaginal ultrasound examination at 18 to 22 weeks' gestation. A semiautomatic, cervical elastography application (E-Cervix) was used during the transvaginal examination to calculate 5 quantitative parameters (internal os stiffness, external os stiffness, internal -to -external os stiffness ratio, hardness ratio, and elasticity contrast index) and create a standard nomogram for each one of them. The intraobserver reliability was calculated using Shrout-Fleiss reliability. Cervical elastography parameters were compared between those who delivered preterm (<37 weeks) spontaneously and those who delivered full term. A multivariable logistic regression model was performed to determine the ability of the cervical elastography parameters to predict spontaneous preterm birth. RESULTS: A total of 742 women were included, of which 49 (6.6%) had a spontaneous preterm delivery. A standard nomogram was created for each of the cervical elastography parameters from those who had a full-term birth in the index pregnancy (n=693). Intraobserver reliability was good or excellent (intraclass correlation, 0.757-0.887) for each of the cervical elastography parameters except external os stiffness which was poor (intraclass correlation, 0.441). In univariate analysis, none of the cervical elastography parameters were associated with a statistically significant increased risk of spontaneous preterm birth. In a multivariable model adjusting for history of preterm birth, gravidity, ethnicity, cervical cerclage, and vaginal progesterone use, increasing elasticity contrast index was significantly associated with an increased risk of spontaneous preterm birth (odds ratio, 1.15; 95% confidence interval, 1.02-1.30; P=.02). CONCLUSION: Cervical elastography parameters are reliably measured and are stable across 18 to 22 weeks' gestation. Based on our findings, the elasticity contrast index was associated with an increased risk of spontaneous preterm birth and may be a useful parameter for future research.


Asunto(s)
Medición de Longitud Cervical/métodos , Cuello del Útero/diagnóstico por imagen , Diagnóstico por Imagen de Elasticidad , Nacimiento Prematuro , Medición de Riesgo/métodos , Adulto , Estudios de Cohortes , Femenino , Edad Gestacional , Humanos , Nomogramas , Embarazo , Reproducibilidad de los Resultados
7.
Am J Obstet Gynecol ; 224(4): 382.e1-382.e18, 2021 04.
Artículo en Inglés | MEDLINE | ID: mdl-33091406

RESUMEN

BACKGROUND: There is a paucity of data describing the effects of coronavirus disease 2019 on placental pathology, especially in asymptomatic patients. Although the pathophysiology of coronavirus disease 2019 is not completely understood, there is emerging evidence that it causes a severe systemic inflammatory response and results in a hypercoagulable state with widespread microthrombi. We hypothesized that it is plausible that a similar disease process may occur in the fetal-maternal unit. OBJECTIVE: This study aimed to determine whether coronavirus disease 2019 in term patients admitted to labor and delivery, including women without coronavirus disease 2019 symptomatology, is associated with increased placental injury compared with a cohort of coronavirus disease 2019-negative controls. STUDY DESIGN: This was a retrospective cohort study performed at NYU Winthrop Hospital between March 31, 2020, and June 17, 2020. During the study period, all women admitted to labor and delivery were routinely tested for severe acute respiratory syndrome coronavirus 2 regardless of symptomatology. The placental histopathologic findings of patients with coronavirus disease 2019 (n=77) who delivered a singleton gestation at term were compared with a control group of term patients without coronavirus disease 2019 (n=56). Controls were excluded if they had obstetrical or medical complications including fetal growth restriction, oligohydramnios, hypertension, diabetes, coagulopathy, or thrombophilia. Multivariable logistic regression models were performed for variables that were significant (P<.05) in univariable analyses. A subgroup analysis was also performed comparing asymptomatic coronavirus disease 2019 cases with negative controls. RESULTS: In univariable analyses, coronavirus disease 2019 cases were more likely to have evidence of fetal vascular malperfusion, that is, presence of avascular villi and mural fibrin deposition (32.5% [25/77] vs 3.6% [2/56], P<.0001) and villitis of unknown etiology (20.8% [16/77] vs 7.1% [4/56], P=.030). These findings persisted in a subgroup analysis of asymptomatic coronavirus disease 2019 cases compared with coronavirus disease 2019-negative controls. In a multivariable model adjusting for maternal age, race and ethnicity, mode of delivery, preeclampsia, fetal growth restriction, and oligohydramnios, the frequency of fetal vascular malperfusion abnormalities remained significantly higher in the coronavirus disease 2019 group (odds ratio, 12.63; 95% confidence interval, 2.40-66.40). Although the frequency of villitis of unknown etiology was more than double in coronavirus disease 2019 cases compared with controls, this did not reach statistical significance in a similar multivariable model (odds ratio, 2.11; 95% confidence interval, 0.50-8.97). All neonates of mothers with coronavirus disease 2019 tested negative for severe acute respiratory syndrome coronavirus 2 by polymerase chain reaction. CONCLUSION: Despite the fact that all neonates born to mothers with coronavirus disease 2019 were negative for severe acute respiratory syndrome coronavirus 2 by polymerase chain reaction, we found that coronavirus disease 2019 in term patients admitted to labor and delivery is associated with increased rates of placental histopathologic abnormalities, particularly fetal vascular malperfusion and villitis of unknown etiology. These findings seem to occur even among asymptomatic term patients.


Asunto(s)
COVID-19/patología , Placenta/patología , Complicaciones Infecciosas del Embarazo/patología , SARS-CoV-2 , Adulto , Femenino , Feto/irrigación sanguínea , Humanos , Recién Nacido , Modelos Logísticos , Enfermedades Placentarias/patología , Embarazo , Estudios Retrospectivos
8.
Am J Obstet Gynecol ; 222(5): 499.e1-499.e6, 2020 05.
Artículo en Inglés | MEDLINE | ID: mdl-31794723

RESUMEN

BACKGROUND: While elevated second-trimester maternal serum alpha fetoprotein has been associated with adverse pregnancy outcomes, the utility of first-trimester maternal serum alpha fetoprotein in predicting these outcomes is limited. Some laboratories have been including maternal serum alpha fetoprotein as part of the first-trimester analyte screening for aneuploidy and preeclampsia, offering its potential utility in predicting pregnancy outcomes. OBJECTIVE: Our primary objective was to determine the association between elevated first-trimester maternal serum alpha fetoprotein and preeclampsia as well as ischemic placental disease (a composite of preeclampsia, fetal growth restriction, and/or placental abruption). Secondary outcomes included early-onset preeclampsia requiring delivery at <34 weeks gestation, fetal growth restriction, placental abruption, preterm delivery, fetal demise, and spontaneous abortion. STUDY DESIGN: An institutional review board-approved multisite retrospective cohort study was performed including all patients with first-trimester maternal serum alpha fetoprotein as part of routine first-trimester aneuploidy screening from April 2015 through January 2017. Pregnancies with multiple gestations, known structural or chromosomal abnormalities, known malignancy, and incomplete delivery records were excluded. Delivery records were reviewed for baseline characteristics and adverse pregnancy outcomes. The optimal cutoff point for first-trimester maternal serum alpha fetoprotein to predict these outcomes was assessed, and an elevated maternal serum alpha fetoprotein was considered >2.0 multiple of the median. A Fisher exact test and odds ratios were used to determine the association between elevated first-trimester maternal serum alpha fetoprotein and adverse pregnancy outcomes. Spearman correlation coefficient assessed the relationship between first- and second-trimester maternal serum alpha fetoprotein. RESULTS: Of 1478 patients with first-trimester maternal serum alpha fetoprotein, 1280 had complete records available for review (86.6%). There was no association demonstrated between elevated first-trimester maternal serum alpha fetoprotein (>2.0 multiple of the median) and the primary outcome, overall preeclampsia (5.8% vs 4.6%, odds ratio, 1.29, 95% confidence interval, 0.58-2.91). However, there was an increased incidence of ischemic placental disease, 15.8% vs 7.7% (odds ratio, 2.26, 95% confidence interval, 1.33-3.87) in those with an elevated alpha fetoprotein. Also, elevated first-trimester maternal serum alpha fetoprotein was associated with a higher incidence of fetal growth restriction (7.5% vs 2.3%, odds ratio, 3.40, 95% confidence interval, 1.56-7.42) and preterm birth (18.3% vs 10.3%, odds ratio, 1.95, 95% confidence interval, 1.18-3.21). Also, a positive correlation between first- and second-trimester maternal serum alpha fetoprotein was demonstrated (rho = 0.46, P < .0001). CONCLUSION: Elevated first-trimester maternal serum alpha fetoprotein is associated with ischemic placental disease, fetal growth restriction, and preterm birth. This suggests that elevated maternal serum alpha fetoprotein may help to identify high risk pregnancies as early as the first trimester of pregnancy. Future studies are necessary to determine whether the addition of first-trimester maternal serum alpha fetoprotein to existing algorithms can improve the early detection of ischemic placental disease.


Asunto(s)
Desprendimiento Prematuro de la Placenta , Enfermedades Placentarias , Preeclampsia , Nacimiento Prematuro , Aneuploidia , Femenino , Retardo del Crecimiento Fetal , Humanos , Recién Nacido , Placenta , Embarazo , Resultado del Embarazo , Primer Trimestre del Embarazo , Segundo Trimestre del Embarazo , Estudios Retrospectivos , alfa-Fetoproteínas
9.
Am J Obstet Gynecol ; 223(2): 250.e1-250.e11, 2020 08.
Artículo en Inglés | MEDLINE | ID: mdl-32067968

RESUMEN

BACKGROUND: Obstetric hypertensive emergency is defined as having systolic blood pressure ≥160 mm Hg or diastolic blood pressure ≥110 mm Hg, confirmed 15 minutes apart. The American College of Obstetricians and Gynecologists recommends that acute-onset, severe hypertension be treated with first line-therapy (intravenous labetalol, intravenous hydralazine or oral nifedipine) within 60 minutes to reduce risk of maternal morbidity and death. OBJECTIVE: Our objective was to identify barriers that lead to delayed treatment of obstetric hypertensive emergency. STUDY DESIGN: A retrospective cohort study was performed that compared women who were treated appropriately within 60 minutes vs those with delay in first-line therapy. We identified 604 patients with discharge diagnoses of chronic hypertension, gestational hypertension, or preeclampsia using International Classification of Diseases-10 codes and obstetric antihypertensive usage in a pharmacy database at 1 academic institution from January 2017 through June 2018. Of these, 267 women (44.2%) experienced obstetric hypertensive emergency in the intrapartum period or within 2 days of delivery; the results from 213 women were used for analysis. We evaluated maternal characteristics, presenting symptoms and circumstances, timing of hypertensive emergency, gestational age at presentation, and administered medications. Chi square, Fisher's exact, Wilcoxon rank-sum, and sample t-tests were used to compare the 2 groups. Univariable logistic regression was applied to determine predictors of delayed treatment. Multivariable regression model was also performed; C-statistic and Hosmer and Lemeshow goodness-of-fit test were used to assess the model fit. A result was considered statistically significant at P<.05. RESULTS: Of the 213 women, 110 (51.6%) had delayed treatment vs 103 (48.4%) who were treated within 60 minutes. Patients who had delayed treatment were 3.2 times more likely to have an initial blood pressure in the nonsevere range vs those who had timely treatment (odds ratio, 3.24; 95% confidence interval, 1.85-5.68). Timeliness of treatment was associated with presence or absence of preeclampsia symptoms; patients without preeclampsia symptoms were 2.7 times more likely to have delayed treatment (odds ratio, 2.68; 95% confidence interval, 1.50-4.80). Patients with hypertensive emergencies that occurred overnight between 10 pm and 6 am were 2.7 times more likely to have delayed treatment vs those emergencies that occurred between 6 am and 10 pm (odds ratio, 2.72; 95% confidence interval, 1.27-5.83). Delayed treatment also had an association with race, with white patients being 1.8 times more likely to have delayed treatment (odds ratio, 1.79; 95% confidence interval, 1.04-3.08). Patients who were treated at <60 minutes had a lower gestational age at presentation vs those with delayed treatment (34.6±5 vs 36.6±4 weeks, respectively; P<.001). For every 1-week increase in gestational age at presentation, there was a 9% increase in the likelihood of delayed treatment (odds ratio, 1.11; 95% confidence interval, 1.04-1.19). Another factor that was associated with delay of treatment was having a complaint of labor symptoms, which made patients 2.2 times as likely to experience treatment delay (odds ratio, 2.17; 95% confidence interval, 1.07-4.41). CONCLUSION: Initial blood pressure in the nonsevere range, absence of preeclampsia symptoms, presentation overnight, white race, having complaint of labor symptoms, and increasing gestational age at presentation are barriers that lead to a delay in the treatment of obstetric hypertensive emergency. Quality improvement initiatives that target these barriers should be instituted to improve timely treatment.


Asunto(s)
Antihipertensivos/uso terapéutico , Urgencias Médicas , Etnicidad/estadística & datos numéricos , Hipertensión Inducida en el Embarazo/tratamiento farmacológico , Tiempo de Tratamiento/estadística & datos numéricos , Administración Intravenosa , Administración Oral , Adulto , Negro o Afroamericano , Atención Posterior/estadística & datos numéricos , Enfermedad Crónica , Femenino , Edad Gestacional , Hispánicos o Latinos , Humanos , Hidralazina/uso terapéutico , Hipertensión/tratamiento farmacológico , Hipertensión/fisiopatología , Hipertensión Inducida en el Embarazo/fisiopatología , Labetalol/uso terapéutico , Trabajo de Parto , Nifedipino/uso terapéutico , Preeclampsia/tratamiento farmacológico , Preeclampsia/fisiopatología , Embarazo , Complicaciones Cardiovasculares del Embarazo/tratamiento farmacológico , Complicaciones Cardiovasculares del Embarazo/fisiopatología , Estudios Retrospectivos , Factores de Riesgo , Índice de Severidad de la Enfermedad , Población Blanca
10.
Am J Obstet Gynecol ; 221(3): 230-232, 2019 09.
Artículo en Inglés | MEDLINE | ID: mdl-31121141

RESUMEN

Randomized controlled trials of surgery are fundamentally different from randomized controlled trials of medications because it is difficult to blind or mask a surgical procedure or perform "sham" operations. An additional challenge is the variation in skills and surgical proficiency of participating centers and surgeons. Addressing heterogeneity in surgical proficiency remains of paramount importance, especially when randomized controlled trials involve a new or complex procedure such as minimally invasive radical surgery. In the presence of such heterogeneity, it is very cumbersome to evaluate objectively and monitor surgical skills so that most trials simply report associations that are averaged across surgeons and hospitals/centers. Such reporting is not transparent because the rates of complications and adverse outcomes are reported only as averages, and these averages may not apply to the individual participating surgeons or centers. These factors, coupled with the inherent nongeneralizability of findings from such randomized controlled trials, because of the strict inclusion and exclusion criteria for enrollment, may lead to conclusions that no longer apply to real life for individual surgeons or centers. Case in point is a recently published noninferiority randomized controlled trial that reported that minimally invasive radical hysterectomy was associated with lower rates of disease-free survival (86% vs 96.5% at 4.5 years) and overall survival (93.8% vs 99% at 3 years) than open abdominal radical hysterectomy in patients with cervical cancer. However, randomized controlled trials that involve 2 competing complex or new procedures may be affected by tremendous confounding because of variations in surgical proficiency and also nonstandardization for other confounding factors such as patient selection categories (ie, stage of cancer) and adjuvant postoperative therapies that may affect long-term survival. The purpose of this Viewpoint is not to provide an exhaustive review of the trial's shortcomings but to use it as an illustration to focus on 2 challenging areas that most randomized controlled trials of a new complex surgical procedure suffer from: (1) unadjusting or not correcting for surgical skill variability and (2) nontransparent reporting of averaged results. We provide suggestions to overcome these deficiencies through robust methods and statistical approaches.


Asunto(s)
Competencia Clínica , Ensayos Clínicos Controlados Aleatorios como Asunto , Proyectos de Investigación , Procedimientos Quirúrgicos Ginecológicos , Humanos
12.
Am J Obstet Gynecol ; 221(1): 61.e1-61.e7, 2019 07.
Artículo en Inglés | MEDLINE | ID: mdl-30802437

RESUMEN

BACKGROUND: Prior studies have reported an increased risk for preterm delivery following a term cesarean delivery. However, these studies did not adjust for high-risk conditions related to the first cesarean delivery and are known to recur. OBJECTIVE: The objective of the study was to determine whether there is an association between term cesarean delivery in the first pregnancy and subsequent spontaneous or indicated preterm delivery. STUDY DESIGN: This was a retrospective cohort study of women with the first 2 consecutive singleton deliveries (2007-2014) identified through a linked pregnancy database at a single institution. Women with a first pregnancy that resulted in cesarean delivery at term were compared with women whose first pregnancy resulted in a vaginal delivery at term. Exclusion criteria were known to recur medical or obstetrical complications during the first pregnancy. A propensity score analysis was performed by matching women who underwent a cesarean delivery with those who underwent a vaginal delivery in the first pregnancy. The association between cesarean delivery in the first pregnancy and preterm delivery in the second pregnancy in this matched set was examined using conditional logistic regression. The primary outcome was overall preterm delivery <37 weeks in the second pregnancy. Secondary outcomes included type of preterm delivery (spontaneous vs indicated), late preterm delivery (34-36 6/7 weeks), early preterm delivery (<34 weeks), and small-for-gestational-age birth. RESULTS: Of a total of 6456 linked pregnancies, 2284 deliveries were matched; 1142 were preceded by cesarean delivery and 1142 were preceded by vaginal delivery. The main indications for cesarean delivery in the first pregnancy were dystocia in 703 (61.5%), nonreassuring fetal status in 222 (19.4%), breech presentation in 100 (8.8%), and other in 84 (7.4%). The mean (SD) gestational ages at delivery for the second pregnancy was 38.8 (1.8) and 38.9 (1.7) weeks, respectively, for prior cesarean delivery and vaginal delivery. The risks of preterm delivery in the second pregnancy among women with a previous cesarean and vaginal delivery were 6.0% and 5.2%, respectively (adjusted odds ratio, 1.46, 95% confidence interval, [CI] 0.77-2.76). In an analysis stratified by the type of preterm delivery in the second pregnancy, no associations were seen between cesarean delivery in the first pregnancy and spontaneous preterm delivery (4.6% vs 3.9%; adjusted odds ratio, 1.40, 95% confidence interval, 0.59-3.32) or indicated preterm delivery (1.6% vs 1.4%; adjusted odds ratio, 1.21, 95% confidence interval, 0.60-2.46). Similarly, no significant differences were found in late preterm delivery (4.6% vs 4.1%; adjusted odds ratio, 1.13, 95% confidence interval, 0.55-2.29), early preterm delivery (1.6% vs 1.2%; adjusted odds ratio, 1.25, 95% confidence interval, 0.59-2.67), or neonates with birthweight less than the fifth percentile for gestational age (3.6% vs 2.2%; adjusted odds ratio, 1.26, 95% confidence interval, 0.52-3.06). CONCLUSION: After robust adjustment for confounders through a propensity score analysis related to the indication for the first cesarean delivery at term, cesarean delivery is not associated with an increase in preterm delivery, spontaneous or indicated, in the subsequent pregnancy.


Asunto(s)
Cesárea/estadística & datos numéricos , Edad Gestacional , Nacimiento Prematuro/epidemiología , Nacimiento a Término , Adulto , Presentación de Nalgas , Estudios de Cohortes , Parto Obstétrico , Distocia , Femenino , Sufrimiento Fetal , Número de Embarazos , Humanos , Recién Nacido , Recién Nacido Pequeño para la Edad Gestacional , Modelos Logísticos , Oportunidad Relativa , Embarazo , Puntaje de Propensión , Estudios Retrospectivos , Factores de Riesgo , Adulto Joven
15.
Am J Obstet Gynecol ; 219(2): 191.e1-191.e6, 2018 08.
Artículo en Inglés | MEDLINE | ID: mdl-29750952

RESUMEN

BACKGROUND: During labor, maintenance of maternal euglycemia is critical to decrease the risk of neonatal hypoglycemia and associated morbidities. When continuous intravenous insulin infusion is needed, standardized insulin dosing charts have been used for titration of insulin to maintain glucose in target range. The GlucoStabilizer software program (Indiana University Health Inc, Indianapolis, IN) is a software-guided insulin dosing system that calculates the dose of intravenous insulin that is needed based on metabolic parameters, target glucose concentration, and an individual's response to insulin. Although this tool has been validated and shown to reduce both hypoglycemia and errors in critical care settings, the utility of this software has not been examined in obstetrics. OBJECTIVE: The purpose of this study was to determine whether the use of intravenous insulin dosing software in women with pregestational or gestational diabetes mellitus that requires intrapartum insulin infusion can improve the rate of glucose concentration in target range (70-100 mg/dL; 3.9-5.5 mmol/L) at the time delivery. STUDY DESIGN: We performed a retrospective cohort study comparing laboring patients with diabetes mellitus that required insulin infusion who were dosed by standard insulin dosing chart vs the GlucoStabilizer software program from January 2012 to December 2017. The GlucoStabilizer software program, which was implemented in May 2016, replaced the standard intravenous insulin dosing chart. Inclusion criteria were women with pregestational or gestational diabetes mellitus who were treated with an intravenous insulin infusion intrapartum for at least 2 hours. Maternal characteristics, glucose values in labor, and neonatal outcomes were extracted from delivery and neonatal records. The primary outcome was the percentage of women who achieved the target glucose range (defined as a blood glucose between 70-100 mg/dL; 3.9-5.5 mmol/L) before delivery. Parametric and nonparametric statistics were used to compare both groups; a probability value of <.05 was considered statistically significant. RESULTS: We identified 22 patients who were dosed by a standard insulin dosing chart and 11 patients who were dosed by the GlucoStabilizer software program during intrapartum management. The GlucoStabilizer software program was superior in achieving glucose values in target range at delivery (81.8% vs 9.1%; P<.001) compared with standard insulin dosing without increasing maternal hypoglycemia (0% vs 4.3%; P=.99). Patients whose insulin dosing was managed by the GlucoStabilizer software program also had lower mean capillary blood glucose values compared with the standard insulin infusion (102.9±5.9 mg/dL [5.7±0.33 mmol/L] vs 121.7±5.9 mg/dL [6.8±0.33 mmol/L]; P=.02). Before the initiation of the infusion, both groups demonstrated mean capillary blood glucose values outside of target range (122.6±8.8 mg/dL [6.7±0.49 mmol/L] for the GlucoStabilizer software program vs 131.9±10.1 mg/dL [7.3±0.56 mmol/L] for standard insulin treatment group; P=not significant). There were no significant differences in baseline maternal characteristics between the groups or neonatal outcomes. CONCLUSION: This study is the first to demonstrate that the use of software-guided intravenous insulin dosing in obstetrics can improve intrapartum glycemic management without increasing hypoglycemia in women with both pregestational and gestational diabetes mellitus that is treated with an insulin infusion.


Asunto(s)
Diabetes Gestacional/tratamiento farmacológico , Cálculo de Dosificación de Drogas , Hipoglucemiantes/administración & dosificación , Insulina/administración & dosificación , Trabajo de Parto , Embarazo en Diabéticas/tratamiento farmacológico , Programas Informáticos , Adulto , Glucemia/metabolismo , Estudios de Casos y Controles , Estudios de Cohortes , Diabetes Mellitus Tipo 1/tratamiento farmacológico , Diabetes Mellitus Tipo 1/metabolismo , Diabetes Mellitus Tipo 2/tratamiento farmacológico , Diabetes Mellitus Tipo 2/metabolismo , Diabetes Gestacional/metabolismo , Femenino , Humanos , Infusiones Intravenosas , Embarazo , Embarazo en Diabéticas/metabolismo , Estudios Retrospectivos
17.
J Minim Invasive Gynecol ; 24(1): 36-40, 2017 01 01.
Artículo en Inglés | MEDLINE | ID: mdl-27810437

RESUMEN

STUDY OBJECTIVE: To compare operative time in women stratified by body mass index (BMI) undergoing robotic-assisted sacrocolpopexy (RASC). Secondary objectives included characterizing perioperative characteristics and reoperation rates. DESIGN: Retrospective cohort study (Canadian Task Force classification II-2). SETTING: University-affiliated teaching hospital. PATIENTS: One hundred seventy-nine consecutive patients who underwent RASC by a single surgeon from 2009 through 2013. INTERVENTIONS: RASC. MEASUREMENTS AND MAIN RESULTS: Of 179 patients, 61 (34%) were normal weight (BMI < 25 kg/m2), 72 (40%) were overweight (BMI 25-30 kg/m2), and 46 (26%) were obese (BMI ≥ 30 kg/m2). Overweight patients were significantly older, more parous, more frequently postmenopausal, and more frequently underwent concomitant salpingo-oophorectomy. Median operative times were 202, 206, and 216 minutes in the normal-weight, overweight, and obese groups, respectively (p = .53). CONCLUSION: Obese women undergoing RASC have similar operative time and procedural characteristics as normal-weight and overweight patients. Longer term outcomes are needed to ensure comparable surgical and anatomic success.


Asunto(s)
Procedimientos Quirúrgicos Ginecológicos , Obesidad/complicaciones , Procedimientos Quirúrgicos Robotizados , Estudios de Cohortes , Femenino , Humanos , Persona de Mediana Edad , Tempo Operativo , Reoperación , Estudios Retrospectivos
20.
Am J Obstet Gynecol ; 215(2): 177-94, 2016 Aug.
Artículo en Inglés | MEDLINE | ID: mdl-27018469

RESUMEN

OBJECTIVE: The aim of this systematic review and metaanalysis was to determine the efficacy and safety of cervical ripening agents in the second trimester of pregnancy in patients with previous cesarean delivery. STUDY DESIGN: Data sources were PubMed, EMBASE, CINAHL, LILACS, Google Scholar, and clinicaltrials.gov (1983 through 2015). Eligibility criteria were cohort or cross-sectional studies that reported on efficacy and safety of cervical ripening agents in patients with previous cesarean delivery. Efficacy was determined based on the proportion of patients achieving vaginal delivery and vaginal delivery within 24 hours following administration of a cervical ripening agent. Safety was assessed by the risk of uterine rupture and complications such as retained placental products, blood transfusion requirement, and endometritis, when available, as secondary outcomes. Of the 176 studies identified, 38 met the inclusion criteria. Of these, 17 studies were descriptive and 21 studies compared the efficacy and safety of cervical ripening agents between patients with previous cesarean and those with no previous cesarean. From included studies, we abstracted data on cervical ripening agents and estimated the pooled risk differences and risk ratios with 95% confidence intervals. To account for between-study heterogeneity, we estimated risk ratios based on underlying random effects analyses. Publication bias was assessed via funnel plots and across-study heterogeneity was assessed based on the I(2) measure. RESULTS: The most commonly used agent was PGE1. In descriptive studies, PGE1 was associated with a vaginal delivery rate of 96.8%, of which 76.3% occurred within 24 hours, uterine rupture in 0.8%, retained placenta in 10.8%, and endometritis in 3.9% in patients with ≥1 cesarean. In comparative studies, the use of PGE1, PGE2, and mechanical methods (laminaria and dilation and curettage) were equally efficacious in achieving vaginal delivery between patients with and without prior cesarean (risk ratio, 0.99, and 95% confidence interval, 0.98-1.00; risk ratio, 1.00, and 95% confidence interval, 0.98-1.02; and risk ratio, 1.00, and 95% confidence interval, 0.98-1.01; respectively). In patients with history of ≥1 cesarean the use of PGE1 was associated with higher risk of uterine rupture (risk ratio, 6.57; 95% confidence interval, 2.21-19.52) and retained placenta (risk ratio, 1.21; 95% confidence interval, 1.03-1.43) compared to women without a prior cesarean. However, the risk of uterine rupture among women with history of only 1 cesarean (0.47%) was not statistically significant (risk ratio, 2.36; 95% confidence interval, 0.39-14.32), whereas among those with history of ≥2 cesareans (2.5%) was increased as compared to those with no previous cesarean (0.08%) (risk ratio, 17.55; 95% confidence interval, 3.00-102.8). Funnel plots did not demonstrate any clear evidence of publication bias. Across-study heterogeneity ranged from 0-81%. CONCLUSION: This systematic review and metaanalysis provides evidence that PGE1, PGE2, and mechanical methods are efficacious for achieving vaginal delivery in women with previous cesarean delivery. The use of prostaglandin PGE1 in the second trimester was not associated with significantly increased risk for uterine rupture among women with only 1 cesarean; however, this risk was substantially increased among women with ≥2 cesareans although the absolute risk appeared to be relatively small.


Asunto(s)
Alprostadil/uso terapéutico , Maduración Cervical/efectos de los fármacos , Cesárea , Trabajo de Parto Inducido/métodos , Segundo Trimestre del Embarazo , Administración Intravaginal , Femenino , Humanos , Embarazo
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