Revisiting the evolution of the Hippocratic Oath in obstetrics and gynecology.

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.

Abnormal fetal heart rate patterns caused by pathophysiologic processes other than fetal acidemia.

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.

Remote patient monitoring for management of diabetes mellitus in pregnancy is associated with improved maternal and neonatal outcomes.

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.

A new index for obstetrics safety and quality of care: integrating cesarean delivery rates with maternal and neonatal outcomes.

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.

Use of cervical elastography at 18 to 22 weeks' gestation in the prediction of spontaneous preterm birth.

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.

Coronavirus disease 2019 infection and placental histopathology in women delivering at term.

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.

Identification of factors associated with delayed treatment of obstetric hypertensive emergencies.

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.

The two Achilles heels of surgical randomized controlled trials: differences in surgical skills and reporting of average performance.

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.

Term cesarean delivery in the first pregnancy is not associated with an increased risk for preterm delivery in the subsequent pregnancy.

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.

Cervical ripening agents in the second trimester of pregnancy in women with a scarred uterus: a systematic review and metaanalysis of observational studies.

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.

The use of cervical sonography to differentiate true from false labor in term patients presenting for labor check.

BACKGROUND: Cervical length by transvaginal ultrasound to predict preterm labor is widely used in clinical practice. Virtually no data exist on cervical length measurement to differentiate true from false labor in term patients who present for labor check. False-positive diagnosis of true labor at term may lead to unnecessary hospital admissions, obstetrical interventions, resource utilization, and cost. OBJECTIVE: We sought to determine if cervical length by transvaginal ultrasound can differentiate true from false labor in term patients presenting for labor check. STUDY DESIGN: This is a prospective observational study of women presenting to labor and delivery with labor symptoms at 37-42 weeks, singleton cephalic gestation, regular uterine contractions (≥4/20 min), intact membranes, and cervix ≤4 cm dilated and ≤80% effaced. Those patients with placenta previa and indications for immediate delivery were excluded. The shortest best cervical length of 3 collected images was used for analysis. Providers managing labor were blinded to the cervical length. True labor was defined as spontaneous rupture of membranes or spontaneous cervical dilation ≥4 cm and ≥80% effaced within 24 hours of cervical length measurement. In the absence of these outcomes, labor status was determined as false labor. Receiver operating characteristic curves were generated to assess the predictive ability of cervical length to differentiate true from false labor and were analyzed separately for primiparous and multiparous patients. The diagnostic accuracies of various cervical length cutoffs were determined. The relationship of cervical length and time to delivery was also analyzed including both use and nonuse of oxytocin. RESULTS: In all, 77 patients were included in the study; the prevalence of true labor was 58.4% (45/77). Patients who were in true labor had shorter cervical length as compared to those in false labor: median 1.3 cm (range 0.5-4.1) vs 2.4 cm (range 1.0-5.0), respectively (P < .001). The area under the receiver operating characteristic curve for primiparous patients was 0.88 (P < .001) and for multiparous patients was 0.76 (P < .01), both demonstrating good correlation. The area under the receiver operating characteristic curves were not significantly different between primiparous and multiparous (P = .23). The area under the receiver operating characteristic curve for primiparous and multiparous patients combined was 0.8 (P < .0001), indicating a good overall correlation between cervical length and its ability to differentiate true from false labor. Overall, a cervical length cutoff of ≤1.5 cm to predict true labor had the highest specificity (81%), positive predictive value (83%), and positive likelihood ratio (4.2). There were no differences in cervical length prediction between primiparous and multiparous patients. Cervical length was positively correlated with time to delivery, regardless of the use of oxytocin. CONCLUSION: In differentiating true from false labor in term patients who present for labor check, a cervical length of ≤1.5 cm was the most clinically optimal cutoff with the lowest false positive rate-due to its highest specificity-and highest positive predictive value and positive likelihood ratios. Its use to decide admission in patients at term with labor symptoms may prevent unnecessary admissions, obstetrical interventions, resource utilization, and cost.

Efficacy of midtrimester short cervix interventions is conditional on intraamniotic inflammation.

BACKGROUND: Midtrimester ultrasound is a valuable method for identifying asymptomatic women at risk for spontaneous preterm delivery (PTD). However, response to various treatments (cerclage, progestogen) has been variable in the clinical setting. It remains unclear how other biomarkers may be used to guide intervention strategies. OBJECTIVE: We applied an amniotic fluid inflammatory scoring system to determine if the degree of inflammation is associated with intervention efficacy in patients with midtrimester short cervix. STUDY DESIGN: Women carrying a singleton fetus between 16-24 weeks' gestation with a short cervix (≤25 mm) on transvaginal ultrasound underwent amniocentesis and were assigned to McDonald cerclage, no cerclage, or weekly 17-alpha hydroxyprogesterone caproate (17OHP-C). Our previously described inflammatory risk score (comprised of 14 inflammatory markers) was used to classify patients as high (score ≥8) or low (score <8) risk for inflammation. Gestational age at delivery was compared for each intervention and risk score status. Risk of delivering as a function of the remaining gestation was evaluated using modified Cox proportional hazards models with incorporation of methods to account for both left and right truncation bias. RESULTS: Ninety patients were included: 24 were in the nonintervention control group, 51 received cerclage, and 15 received 17OHP-C. Inflammation status at time of sampling influenced the efficacy of the treatment (P < .001). Compared to the nonintervention control group, in patients with low inflammation (score < 8), both cerclage (adjusted hazard ratio [HR], 2.86; 95% confidence interval [CI], 1.28-6.37) and 17OHP-C (HR, 3.11; 95% CI, 1.04-9.30) were associated with increased hazard of PTD. In contrast, in patients with high inflammation (score ≥8) both cerclage (HR, 0.22; 95% CI, 0.08-0.65) and 17OHP-C (HR, 0.20; 95% CI, 0.05-0.81) were associated with lower hazard of delivering preterm. CONCLUSION: Cerclage placement or administration of 17OHP-C therapy for midtrimester short cervix for PTD prevention appears beneficial only in the subset of patients with high inflammation. Knowledge of the amniotic fluid inflammatory status may aid in guiding the appropriate therapy for women presenting with midtrimester short cervix who are at increased risk of PTD.

Severe placental abruption: clinical definition and associations with maternal complications.

BACKGROUND: Placental abruption traditionally is defined as the premature separation of the implanted placenta before the delivery of the fetus. The existing clinical criteria of severity rely exclusively on fetal (fetal distress or fetal death) and maternal complications without consideration of neonatal or preterm delivery-related complications. However, two-thirds of abruption cases are accompanied by fetal or neonatal complications, including preterm delivery. A clinically meaningful classification for abruption therefore should include not only maternal complications but also adverse fetal and neonatal outcomes that include intrauterine growth restriction and preterm delivery. OBJECTIVES: The purpose of this study was to define severe placental abruption and to compare serious maternal morbidity profiles of such cases with all other cases of abruption (ie, mild abruption) and nonabruption cases. STUDY DESIGN: We performed a retrospective cohort analysis using the Premier database of hospitalizations that resulted in singleton births in the United States between 2006 and 2012 (n = 27,796,465). Severe abruption was defined as abruption accompanied by at least 1 of the following events: maternal (disseminated intravascular coagulation, hypovolemic shock, blood transfusion, hysterectomy, renal failure, or in-hospital death), fetal (nonreassuring fetal status, intrauterine growth restriction, or fetal death), or neonatal (neonatal death, preterm delivery or small for gestational age) complications. Abruption cases that did not qualify as being severe were classified as mild abruption cases. The morbidity profile included amniotic fluid embolism, pulmonary edema, acute respiratory or heart failure, acute myocardial infarction, cardiomyopathy, puerperal cerebrovascular disorders, or coma. Associations were expressed as rate ratios with 95% confidence intervals that were derived from fitting log-linear Poisson regression models. RESULTS: The overall prevalence rate of abruption was 9.6 per 1000, of which two-thirds of cases were classified as being severe (6.5 per 1000). Serious maternal complications occurred in 15.4, 33.3, and 141.7 per 10,000 among nonabruption cases and mild and severe abruption cases, respectively. In comparison with no abruption, the rate ratio for serious maternal complications were 1.52 (95% confidence interval, 1.35-1.72) and 4.29 (95% confidence interval, 4.11-4.47) in women with mild and severe placental abruption, respectively. Rate ratios for the individual complications were 2- to 7-fold higher among severe abruption cases. Furthermore, the rate ratios for serious maternal complications among severe abruption cases compared with mild abruption cases was 3.47 (95% confidence interval, 3.05-3.95). This association was considerably stronger for virtually all maternal complications among cases with severe abruption compared with mild abruption. Annual rates of mild and severe abruption were fairly constant during the study period. Although the maternal complication rate among non-abruption births was stable from 2006-2012, the rate of complications among mild abruption cases dropped from 2006-2008 and then leveled off thereafter. In contrast, the rate of serious complications among severe abruption cases remained fairly stable from 2006-2010 and increased sharply thereafter. CONCLUSIONS: Severe abruption was associated with a distinctively higher morbidity risk profile compared with the other 2 groups. The clinical characteristics and morbidity profile of mild abruption were more similar to those of women without an abruption. These findings suggest that the definition of severe placental abruption based on the proposed specific criteria is clinically relevant and may facilitate epidemiologic and genetic research.

Effectiveness and short-term safety of modified sodium hyaluronic acid-carboxymethylcellulose at cesarean delivery: a randomized trial.

BACKGROUND: The rising cesarean birth rate has drawn attention to risks associated with repeat cesarean birth. Prevention of adhesions with adhesion barriers has been promoted as a way to decrease operative difficulty. However, robust data demonstrating effectiveness of such interventions are lacking. OBJECTIVE: We report data from a multicenter trial designed to evaluate the short-term safety and effectiveness of a modified sodium hyaluronic acid (HA)-carboxymethylcellulose (CMC) absorbable adhesion barrier for reduction of adhesions following cesarean delivery. STUDY DESIGN: Patients who underwent primary or repeat cesarean delivery were included in this multicenter, single-blinded (patient), randomized controlled trial. Patients were randomized into either HA-CMC (N = 380) or no treatment (N = 373). No other modifications to their treatment were part of the protocol. Short-term safety data were collected following randomization. The location and density of adhesions (primary outcome) were assessed at their subsequent delivery using a validated tool, which can also be used to derive an adhesion score that ranges from 0-12. RESULTS: No differences in baseline characteristics, postoperative course, or incidence of complications between the groups following randomization were noted. Eighty patients from the HA-CMC group and 92 controls returned for subsequent deliveries. Adhesions in any location were reported in 75.6% of the HA-CMC group and 75.9% of the controls (P = .99). There was no significant difference in the median adhesion score; 2 (range 0-10) for the HA-CMC group vs 2 (range 0-8) for the control group (P = .65). One third of the HA-CMC patients met the definition for severe adhesions (adhesion score >4) compared to 15.5% in the control group (P = .052). There were no significant differences in the time from incision to delivery (P = .56). Uterine dehiscence in the next pregnancy was reported in 2 patients in HA-CMC group vs 1 in the control group (P = .60). CONCLUSION: Although we did not identify any short-term safety concerns, HA-CMC adhesion barrier applied at cesarean delivery did not reduce adhesion formation at the subsequent cesarean delivery.