A randomized controlled trial comparing the efficacy of nifedipine and enalapril in the postpartum period.

BACKGROUND: Postpartum hypertension is a common medical complication of pregnancy and is associated with increased healthcare use, including unplanned interactions with the medical system and readmission, which can add significant stress to both a newly postpartum patient and the medical care delivery system. We currently do not know what the best antihypertensive treatment for postpartum hypertension is and tend to use antihypertensives commonly used during pregnancy. However, the mechanism of action of angiotensin-converting enzyme inhibitors may be well suited for the pathophysiology of hypertension in the postpartum period and may help to provide better control of hypertension and, in turn, decrease healthcare use. OBJECTIVE: This study aimed to determine if enalapril is superior to nifedipine in preventing prolonged hospitalizations, unplanned medical visits, and/or readmission among women with postpartum hypertension. STUDY DESIGN: We performed an open-label, randomized controlled trial (ClinicalTrials.gov registered: NCT04236258) in which patients ≥18 years with chronic hypertension, gestational hypertension, or preeclampsia were recruited to receive either 10 mg enalapril daily or 30 mg extended-release nifedipine daily as an initial antihypertensive agent in the period from delivery to 6 weeks postpartum. Recruitment occurred at a tertiary academic hospital from January 2020 to February 2021. Exclusion criteria included being on an antihypertensive when pregnancy started or requiring ≥2 daily antihypertensives during pregnancy. The antihypertensive regimen was managed by the participants' obstetrical provider after the initial randomization. The primary outcome was a composite of prolonged hospitalization, unplanned clinic visits, triage visits, and/or readmission. A total of 40 patients in each arm were needed to detect a decrease in the primary outcome rate from 70% to 40% (α=0.05; power 0.80). Analyses were performed based on the intention-to-treat principal, and each arm was oversampled because of the risk for participant dropout. RESULTS: A total of 47 patients were randomized to each arm. Aside from the mode of delivery and twin gestation, the maternal demographics were similar between the 2 groups. The primary outcome occurred in 31 of 47 patients (66%) randomized to the nifedipine group and in 30 of 47 (64%) randomized to the enalapril group (P=.83). There was no significant difference in the primary outcome after controlling for mode of delivery and twin gestation. More patients in the enalapril arm had a second antihypertensive added during their primary hospitalization (16 vs 6) and more patients in the nifedipine arm were still on their antihypertensive at 2 weeks postpartum (42 vs 36). There were no adverse events in either group. CONCLUSION: Enalapril was not superior to nifedipine when used as an initial antihypertensive in the immediate postpartum period in terms of decreasing healthcare use.

Intrapartum ultrasound measurement of angle of progression at the onset of the second stage of labor for prediction of spontaneous vaginal delivery in term singleton pregnancies: a systematic review and meta-analysis.

OBJECTIVE: This study aimed to investigate the diagnostic performance of transperineal ultrasound-measured angles of progression at the onset of the second stage of labor for the prediction of spontaneous vaginal delivery in singleton term pregnancies with cephalic presentation. DATA SOURCES: We performed a predefined systematic search in PubMed, Embase, Scopus, Web of Science, and Google Scholar from inception to February 5, 2021. STUDY ELIGIBILITY CRITERIA: Prospective cohort studies that evaluated the diagnostic performance of transperineal ultrasound-measured angles of progression (index test) at the onset of the second stage of labor (ie, when complete cervical dilation is diagnosed) for the prediction of spontaneous vaginal delivery (reference standard) were eligible for inclusion. Eligible studies were limited to those published as full-text articles in the English language and those that included only parturients with a singleton healthy fetus at term with cephalic presentation. STUDY APPRAISAL AND SYNTHESIS METHODS: Study quality was assessed using the Quality Assessment of Diagnostic Accuracy Studies 2 tool. Summary receiver operating characteristic curves, pooled sensitivities and specificities, area under the curve, and summary likelihood ratios were calculated using the Stata software. Subgroup analyses were done based on angle of progression ranges of 108° to 119°, 120° to 140°, and 141° to 153°. RESULTS: A total of 8 studies reporting on 887 pregnancies were included. Summary estimates of the sensitivity and specificity of transperineal ultrasound-measured angle of progression at the onset of the second stage of labor for predicting spontaneous vaginal delivery were 94% (95% confidence interval, 88%-97%) and 47% (95% confidence interval, 18%-78%), respectively, for an angle of progression of 108° to 119°, 81% (95% confidence interval, 70%-89%) and 73% (95% confidence interval, 57%-85%), respectively, for an angle of progression of 120° to 140°, and 66% (95% confidence interval, 56%-74%) and 82% (95% confidence interval, 66%-92%), respectively, for an angle of progression of 141° to 153°. Likelihood ratio syntheses gave overall positive likelihood ratios of 1.8 (95% confidence interval, 1-3.3), 3 (95% confidence interval, 2-4.7), and 3.7 (95% confidence interval, 1.7-8.1) and negative likelihood ratios of 0.13 (95% confidence interval, 0.07-0.22), 0.26 (95% confidence interval, 0.18-0.38), and 0.42 (95% confidence interval, 0.29-0.60) for angle of progression ranges of 108° to 119°, 120° to 140°, and 141° to 153°, respectively. CONCLUSION: Angle of progression measured by transperineal ultrasound at the onset of the second stage of labor may predict spontaneous vaginal delivery in singleton, term, cephalic presenting pregnancies and has the potential to be used along with physical examinations and other clinical factors in the management of labor and delivery.

Psychiatric Conditions During Pregnancy and Postpartum in a Universally Insured American Population.

BACKGROUND: Mental health conditions are common and can have significant effects during the perinatal period. Our objective was to determine the incidences and predictors of psychiatric conditions during pregnancy and postpartum among universally insured American women. MATERIAL AND METHODS: This was an Institutional Review Board (IRB)-approved protocol using a retrospective cohort of 104,866 deliveries covered by TRICARE from 2005 to 2014. We used TRICARE claims data to identify pregnant women without current psychiatric conditions who developed new psychiatric condition(s) during pregnancy or postpartum compared with those who did not, as identified by International Classification of Diseases (ICD)-9 CM codes. Predictors of psychiatric conditions during pregnancy or postpartum were determined using stepwise logistic regression models. RESULTS: A total of 104,866 women met the inclusion criteria; of these, 35% (n = 36,192) were diagnosed with a new psychiatric condition during pregnancy or within 1 year of delivery, 15% (n = 15,636) with a psychiatric condition during pregnancy, and 20% (n = 20,556) with a psychiatric condition within 1 year of delivery. We demonstrated that the African-American race (odds ratio [OR] 1.16, 95% CI 1.10-1.22), active duty status (OR 1.20, 95% CI 1.14-1.25), and severe maternal morbidity during delivery (OR 1.18, 95% CI 1.02-1.35) were significantly associated with the occurrence of a psychiatric condition within 1 year of delivery. For Asian women, there was a 28% higher odds of developing a psychiatric disorder during pregnancy (adjusted OR 1.28, 95% CI 1.17-1.40) compared with White women. Active duty women were twice as likely to be diagnosed with post-traumatic stress disorder (adjusted OR 2.31, 95% CI 1.83-2.90). CONCLUSION: In a universally insured population, the incidences of psychiatric conditions in pregnancy and within a year of delivery were similar to the American population. Additionally, the development of psychiatric conditions in pregnancy and within a year of delivery may be associated with race, active duty status, and complicated births.

Association between hospital-level cesarean delivery rates and severe maternal morbidity and unexpected newborn complications.

BACKGROUND: Although there are many indications for a cesarean delivery, the "optimal" cesarean delivery rate is unknown. Neonatal and maternal morbidity have largely not been considered in the generation of hospital-level cesarean delivery rate targets. OBJECTIVE: We sought to examine if the widely adopted and reported markers of maternal and neonatal morbidity were associated with hospital cesarean delivery rates to provide context for potential comparison and consideration for defining cesarean delivery rate targets. We hypothesized that hospitals with higher cesarean delivery rates would have increased rates of severe maternal morbidity, though we were less certain of the associations of the cesarean delivery rates with unexpected newborn complications. STUDY DESIGN: This is a cross-sectional, ecological study using data from the 2016 Nationwide Readmission Database of hospitals with at least 100 deliveries per year. The exposure of interest was hospital cesarean delivery rate. The outcomes were (1) severe maternal morbidity with and without transfusion-in accordance with the Centers for Disease Control and Prevention's definition, and (2) neonatal morbidity-defined using The Joint Commission's Perinatal Quality metric of moderate and severe unexpected newborn complications among term, singleton, and nonanomalous neonates. Before assuming a single linear relationship to model the associations between morbidity and cesarean delivery rates, the Joinpoint Regression Analysis program was used to examine for potential splines in the relationships with both severe maternal morbidity (with and without transfusion) and severe and moderate unexpected newborn complications. Poisson regression model was then used to determine the association between morbidity and cesarean delivery rates. RESULTS: The analysis included 831,111 deliveries from 621 hospitals. The mean cesarean delivery rate was 30.5%. The median severe maternal morbidity rate was 1.40 per 100 deliveries (interquartile range, 0.71-2.21 per 1000 deliveries). Excluding transfusion, the median severe maternal morbidity rate was 0.47 per 100 deliveries (interquartile range, 0.22-0.73 per 100 deliveries). The median rate of severe and moderate unexpected newborn complications was 1.01 per 100 low-risk newborns (interquartile range, 0.64-1.69 per 100 low-risk newborns) and 1.79 per 1000 low-risk newborns (interquartile range, 0.94-2.93 per 100 low-risk newborns), respectively. In the unadjusted analysis, every percentage point increase in a hospital's cesarean delivery rate was associated with a 3.4% (95% confidence interval, 2.3%-4.4%) and a 2.3% (95% confidence interval, 1.0%-3.5%) increase in severe maternal morbidity including and excluding transfusion, respectively. After adjustment for the case mix and hospital factors, only the relationship with severe maternal morbidity including transfusion remained significant: 3.3% (95% confidence interval, 1.7%-4.9%) increase in severe maternal morbidity per 1 percentage point increase in the cesarean delivery rate. There was no observed association between cesarean delivery rates and unexpected newborn complications CONCLUSION: Severe maternal morbidity and unexpected newborn complications occur in fewer than 5 in 100 births. Findings from this analysis of hospitals with cesarean delivery rates ranging from 6.8%-56.3% suggest that those with lower cesarean delivery rates have lower severe maternal morbidity (which includes transfusion) and similar unexpected newborn complications compared with hospitals with higher cesarean delivery rates. This work may provide a helpful context to providers, hospitals, and policymakers who are measuring and reporting outcomes. Regarding neonatal morbidity in particular, the Joint Commission manual notes that the unexpected newborn complication metric was specifically designed to be compared against maternal-focused metrics such as cesarean delivery rates. More work is needed to define and identify appropriate measures of maternal and neonatal morbidity for these types of comparisons.

Blood gas measures as predictors for neonatal encephalopathy severity.

OBJECTIVE: To correlate arterial umbilical cord gas (aUCG) and infant blood gas with severity of neurological injury. STUDY DESIGN: Retrospective single-site study of infants evaluated for therapeutic hypothermia. Clinical neurological examination and a validated MRI scoring system were used to assess injury severity. RESULTS: Sixty-eight infants were included. aUCG base deficit (BD) and lactate correlated with infant blood gas counterparts (r = 0.43 and r = 0.56, respectively). aUCG and infant pH did not correlate. Infant blood gas lactate (RADJ2 = 0.40), infant BD (RADJ2 = 0.26), infant pH (RADJ2 = 0.17), aUCG base deficit (RADJ2 = 0.08), and aUCG lactate (RADJ2 = 0.11) were associated with clinical neurological examination severity. aUCG and infant blood gas measures were not correlated with MRI score. CONCLUSION: Metabolic measures from initial infant blood gases were most associated with the clinical neurological examination severity and can be used to evaluate hypoxic-ischemic cerebral injury risk.

Provider Attitudes on Regionalization of Maternity Care: A National Survey.

OBJECTIVES: To explore provider perspectives surrounding national guidelines proposing regionalization of maternal care. METHODS: An 18-item survey focused on provider attitudes and practices surrounding regionalized maternity care was administered to a national sample of practicing obstetricians. We classified respondants reporting less than 500 annual deliveries at their hospital as low-volume providers and those practicing at hospitals performing 500 or more annual deliveries as high-volume providers. We compared responses according to hospital delivery volume using univariate analysis. RESULTS: Of the 497 physicians surveyed, 278 people responded (56%) with 229 currently practicing obstetrics. The median annual delivery volume amongst respondents was 200 (interquartile range 100-1900) with 146 (63.7%) practicing in low-volume delivery centers. The need for medical or surgical expertise was the most commonly reported indication for maternal transfer (19.7%) and independent of practice setting. Ninety-six percent of providers agreed with the concept of regionalization, but respondents in high-volume centers reported higher familiarity with the levels of maternal care paradigm compared to their low-volume counterparts (81.9% v. 62.3%, p < 0.01). Financial factors (60.3%), geography (48.9%), and access to care (43.2%) were the most cited major barriers to regionalization. High-volume providers endorsed geography as a major barrier more often than low-volume providers (57.8% v. 43.8%, p = 0.04). CONCLUSIONS FOR PRACTICE: Obstetricians may agree with the concept of regionalized maternity care but also identify significant barriers to its implementation. Early and frequent engagement of providers reflecting the diversity of delivery centers in a region is a simple but necessary step in any attempts to designate levels of maternal care.

The interrater reliability and agreement of a 0 to 10 uterine tone score in cesarean delivery.

BACKGROUND: Postpartum hemorrhage is a leading source of maternal morbidity and mortality worldwide with uterine atony identified as the underlying cause in up to 80% of cases. Several measures have been utilized to report uterine tone. The most commonly reported measure is a 0 to 10 numeric rating scale, but this scale has not been tested for reliability or agreement between different raters. OBJECTIVE: The primary purpose of this study was to evaluate the interrater reliability and agreement of the 0 to 10 visual numeric rating scale of uterine tone during cesarean delivery. A secondary purpose was to obtain estimates of scale responsiveness and minimal clinically important difference. STUDY DESIGN: Between August and November of 2018, obstetricians used a 0 to 10 numeric rating score to independently rate uterine tone at 3 and 10 minutes after cesarean delivery by palpation of the uterus. Of note, "0" represented "no tone" and "10" represented excellent tone. Each obstetrician independently and blinded to the other's score pointed to a numeric rating scale held by the anesthesiologist through a clear sterile drape. Intraclass correlation coefficients and Bland-Altman analysis were used to assess interrater reliability and agreement, respectively. Standardized response mean and standard error of measurement were used to obtain estimates of responsiveness and minimal clinically important difference, respectively. RESULTS: A total of 82 and 84 pairs of scores were collected at 3 and 10 minutes, respectively, from pairs of 62 unique obstetricians. The mean±standard deviation difference in scores between rater 1 and rater 2 was 0.4±1.4 at 3 minutes and 0.1±1.1 at 10 minutes. Intraclass correlation coefficients for a future single rater (intraclass correlation coefficient [1, 1]) at 3 and 10 minutes were 0.67 (95% confidence interval, 0.53-0.77) and 0.61 (95% confidence interval, 0.46-0.73), and for the average between 2 future raters (intraclass correlation coefficient [1, 2]), they were 0.80 (95% confidence interval, 0.71-0.87) and 0.76 (95% confidence interval, 0.63-0.84), indicating good and excellent reliability, respectively. Bland-Altman analysis estimated 95% limit of agreement between raters of -2.4 (95% confidence interval, -3.0 to -1.9) to 3.1 (95% confidence interval, 2.6-3.7) at 3 minutes and -2.1 (95% confidence interval, -2.5 to -1.7) to 2.4 (95% confidence interval, 2.0-2.8) at 10 minutes, consistent with good interrater agreement at both time points. The standardized response mean from 3 to 10 minutes after delivery was 1.1 (n=81). Standard error of measurement was 1.0 (95% confidence interval, 0.9-1.1) at 3 minutes and 0.8 (95% confidence interval, 0.7-0.9) at 10 minutes. CONCLUSION: The 0 to 10 numeric rating scale for uterine tone demonstrated good to excellent interrater reliability with 1 and 2 raters, respectively, and good interrater agreement. The scale was responsive to within-parturient change in tone, and preliminary estimates of the minimal clinically important difference were obtained. The 0 to 10 numeric rating scale for uterine tone may be a reliable, standardized tool for future research in reporting degree of uterotonic contraction during cesarean delivery.

Six versus twelve hours of single-balloon catheter placement with oxytocin administration for labor induction: a randomized controlled trial.

BACKGROUND: Induction of labor is common in the United States. Multiple previous studies have tried to outline a faster time to delivery to improve maternal and fetal outcomes. OBJECTIVE: This study aimed to evaluate whether women who undergo induction of labor with a single-balloon catheter and oxytocin have a shorter time to delivery with planned removal of the catheter at 6 vs 12 hours. STUDY DESIGN: In this randomized controlled trial, induction of labor was performed using a combination of single-balloon catheter and oxytocin. Term women, both nulliparous and multiparous, aged 18 to 50 years old with cephalic singletons were included if they were undergoing induction of labor with a Bishop score of <6 and cervical dilation of <2 cm. Women were randomized to planned removal of the single-balloon catheter at 6 hours vs 12 hours. The primary outcome was time from catheter insertion to delivery. We were powered to show a 4-hour time difference with a sample size of 89 women per group (n=178). Planned sensitivity analyses were performed to account for cesarean delivery in labor. RESULTS: From February 2019 to June 2020, 237 women were screened, 178 women were randomized, and 177 women were included in the final analysis (89 women in the 6-hour group and 88 women in the 12-hour group). Insertion to delivery time was significantly shorter in the 6-hour group (19.2 vs 24.3 hours; P=.04), and the proportion of women delivered by 24 hours was significantly greater in the 6-hour group (67.4% vs 47.4%; P<.01). There was no difference in the Bishop score at removal of the catheter or secondary maternal or neonatal outcomes. In a Cox proportional-hazards model censoring for cesarean delivery, the 6-hour group had a significantly shorter insertion to delivery time (hazard ratio, 0.67; P=.02). CONCLUSION: Induction of labor with a single-balloon catheter and oxytocin with planned removal of the catheter at 6 hours rather than 12 hours results in a shorter time from insertion to delivery without increasing the rate of cesarean delivery. Decreasing the length of time a single-balloon catheter is in place should be considered in clinical protocols.

Patient characteristics associated with SARS-CoV-2 infection in parturients admitted for labour and delivery in Massachusetts during the spring 2020 surge: A prospective cohort study.

BACKGROUND: While studies from large cities affected by coronavirus disease 2019 (COVID-19) have reported on the prevalence of SARS-CoV-2 in the context of universal testing during admission for delivery, the patient demographic, social and clinical factors associated with SARS-CoV-2 infection in pregnant women are not fully understood. OBJECTIVE: To evaluate the epidemiological factors associated with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection in women admitted for labour and delivery, in the context of universal screening at four Boston-area hospitals. METHODS: In this prospective cohort study, we reviewed the health records of all women admitted for labour and delivery at four hospitals from the largest health system in Massachusetts between 19 April 2020 and 27 June 2020. We calculated the risk of SARS-CoV-2 infection, including asymptomatic infection. We calculated associations between SARS-CoV-2 infection and demographic and clinical characteristics. RESULTS: A total of 93 patients (3.2%, 95% confidence interval 2.5, 3.8) tested positive for SARS-CoV-2 infection on admission for labour and delivery out of 2945 patients included in the analysis; 80 (86.0%) of the patients who tested positive were asymptomatic at the time of testing. Factors associated with SARS-CoV-2 infection included the following: younger age, obesity, African American or Hispanic race/ethnicity, residence in heavily affected communities (as measured in cases reported per capita), presence of a household member with known SARS-CoV-2 infection, non-health care essential worker occupation and MassHealth or Medicaid insurance compared to commercial insurance. 93.8% of patients testing positive for SARS-CoV-2 on admission had one or more identifiable factors associated with disease acquisition. CONCLUSIONS: In this large sample of deliveries during the height of the surge in infections during the spring of 2020, SARS-CoV-2 infection was largely concentrated in patients with distinct demographic characteristics, those largely from disadvantaged communities. Racial disparities seen in pregnancy persist with respect to SARS-CoV-2 infection.

Changes in Delivery Timing for High-Risk Pregnancies in the United States.

OBJECTIVE: This study was aimed to assess whether the "39-week" rule is being extended to high-risk pregnancies and if so whether this has led to changes in neonatal morbidity or stillbirth. STUDY DESIGN: Birth certificate data between 2010 and 2014 from 23 states (55% of births in the United States) were used. Pregnancies were classified as high risk if they had any one of the following: maternal age greater than or equal to 40 years, prepregnancy body mass index (BMI) greater than or equal to 40 kg/m2, chronic (prepregnancy) hypertension, or diabetes (pregestational or gestational). Delivery timing changes for all pregnancies at term (37 weeks or greater) were compared with changes in the high-risk population. Neonatal morbidities (neonatal intensive care unit [NICU] admission, need for assisted ventilation, 5-minute Apgar score, and macrosomia), maternal morbidities (intensive care unit [ICU] admission, cesarean delivery, operative vaginal delivery, chorioamnionitis, and severe perineal laceration), and stillbirth rates were compared across time periods. Multivariate logistic regression was used to analyze whether gestational age-specific morbidity changes were due to shifts in delivery timing. RESULTS: For the overall population, there was a shift in delivery timing between 2010 and 2014, a 2.5% decrease in 38-week deliveries, and a 2.3% increase in 39-week deliveries (p < 0.01). This gestational age shift was identical in the high-risk population (2.7% decrease in 38-week deliveries and 2.9% increase in 39-week deliveries). For the high-risk population, NICU admission increased from 5.4 to 6.3% in 2014 (p < 0.01) and assisted ventilation rates declined from 3.8 to 2.9% (p < 0.01). These changes, however, were independent of changes in delivery timing. There was no increase in the rate of stillbirth (0.23% in 2010 and 0.23% in 2014; p = 0.50). CONCLUSION: There was a significant shift in delivery timing for high-risk pregnancies in the United States between 2010 and 2014. This shift, however, did not result in statistically significant changes in either neonatal morbidity or stillbirth. KEY POINTS: · From 2010 to 2014, term deliveries for high-risk pregnancies shifted towards 39 weeks.. · The shift towards 39 weeks in high-risk pregnancies was not accompanied by any improvement in neonatal morbidity.. · The shift towards 39 weeks in high-risk pregnancies did not result in an increase in the stillbirth rate..

Placental MRI: Effect of maternal position and uterine contractions on placental BOLD MRI measurements.

INTRODUCTION: Before using blood-oxygen-level-dependent magnetic resonance imaging (BOLD MRI) during maternal hyperoxia as a method to detect individual placental dysfunction, it is necessary to understand spatiotemporal variations that represent normal placental function. We investigated the effect of maternal position and Braxton-Hicks contractions on estimates obtained from BOLD MRI of the placenta during maternal hyperoxia. METHODS: For 24 uncomplicated singleton pregnancies (gestational age 27-36 weeks), two separate BOLD MRI datasets were acquired, one in the supine and one in the left lateral maternal position. The maternal oxygenation was adjusted as 5 min of room air (21% O2), followed by 5 min of 100% FiO2. After datasets were corrected for signal non-uniformities and motion, global and regional BOLD signal changes in R2* and voxel-wise Time-To-Plateau (TTP) in the placenta were measured. The overall placental and uterine volume changes were determined across time to detect contractions. RESULTS: In mothers without contractions, increases in global placental R2* in the supine position were larger compared to the left lateral position with maternal hyperoxia. Maternal position did not alter global TTP but did result in regional changes in TTP. 57% of the subjects had Braxton-Hicks contractions and 58% of these had global placental R2* decreases during the contraction. CONCLUSION: Both maternal position and Braxton-Hicks contractions significantly affect global and regional changes in placental R2* and regional TTP. This suggests that both factors must be taken into account in analyses when comparing placental BOLD signals over time within and between individuals.

Cephalic Elevation Device for Second-Stage Cesarean Delivery: A Randomized Controlled Trial.

OBJECTIVE: A cephalic elevation device is an inflatable device that elevates the fetal head. We sought to evaluate whether such a device reduces time to delivery after hysterotomy and lowers morbidity in cesarean deliveries during the second stage of labor. METHODS: We conducted a double-blind randomized controlled trial among nulliparous, term women aged 18-50 years with vertex singleton pregnancies. Women were eligible if they were to undergo cesarean delivery in the second stage of labor. All participating women had the cephalic elevation device inserted by the delivering provider and were randomly allocated to inflation or noninflation of the device. Inflation was performed in a blinded fashion. The primary outcome was time from hysterotomy to delivery. A sample size of 30 per group (N=60 participants) was planned to detect a 50% decrease in time to delivery after hysterotomy with cephalic elevation device inflation. RESULTS: From January 2018 through July 2019, 60 women who underwent cesarean delivery in the second stage were randomized. Analysis was by intention to treat. Women in the inflation group were older (33 vs 30.5 years), but the groups were otherwise similar. In both groups, most women had a low-transverse hysterotomy (93%). The median time from hysterotomy to delivery was significantly shorter in the inflation group (31 vs 54 seconds; P<.01). There was no significant difference in neonatal outcomes. CONCLUSION: Use of the cephalic elevation device during second-stage cesarean delivery led to a 23-second reduction time from hysterotomy to delivery. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT03342508. FUNDING SOURCE: The cephalic elevation devices used in this study were donated by Safe Obstetrics Systems.

Introduction of a Novel System for Quantitating Blood Loss After Vaginal Delivery: A Retrospective Interrupted Time Series Analysis With Concurrent Control Group.

BACKGROUND: Postpartum hemorrhage (PPH) is a leading cause of maternal mortality worldwide. While volumetric and gravimetric blood loss measurement techniques have been shown to increase PPH detection compared to visual estimation of blood loss (vBL), a combination of these methods has not been evaluated. The primary aim of this study was to compare the change in odds of PPH detection after vaginal delivery (VD; the intervention series) versus cesarean delivery (CD; the control series) before versus after implementation of a device (Triton L&D, Gauss Surgical, Inc, Los Altos, CA) that combines gravimetric and volumetric estimation of blood loss (tBL). METHODS: After institutional review board (IRB) approval, patients were identified who had a VD or CD at our institution 3 months before and 3 months after the implementation of a tBL device for VD. The levels and trends in odds of PPH detection (the primary outcome, defined as blood loss ≥500 mL for VD and ≥1000 mL for CD) were compared within and between delivery methods before and after implementation of the device. Secondary outcomes were blood loss ≥1000 mL, total blood loss, secondary uterotonic use, and a composite outcome related to PPH management (transfusion, vasopressor administration, and/or surgical procedures). A post hoc subgroup analysis compared nadir hematocrit, hematocrit reduction ≥10%, and difference between vBL or tBL and calculated blood loss (cBL) between VDs before and after introduction of the device. All outcome comparisons were performed using segmented regression with inverse probability of treatment weighting. RESULTS: The weighted odds ratio (wOR) of PPH detection post- versus preimplementation of the device was 2.74 (95% confidence interval [CI], 1.39-5.41; P = .004) for VDs versus 1.43 (95% CI, 0.72-2.85; P = .304) for CDs (P for interaction .190). No difference was detected in the secondary outcomes for VDs between time periods. In the subgroup of VD patients who had postdelivery hematocrits measured, the mean difference between vBL or tBL and cBL was smaller in the tBL (mean ± standard deviation [SD]: -237 ± 522 mL) versus vBL group (-600 ± 596 mL; weighted difference in means [95% CI]: 349 mL [13-684]; P = .042). CONCLUSIONS: In this interrupted time series analysis, the odds of PPH detection after VD increased after implementation of the tBL device. However, a statistical difference was not detected between the increase in PPH detection post- versus preimplementation of the device in VDs versus CDs.

Preliminary evaluation of dynamic glucose enhanced MRI of the human placenta during glucose tolerance test.

BACKGROUND: To investigate dynamic glucose enhanced (DGE) chemical exchange saturation transfer (CEST) MRI as a means to non-invasively image glucose transport in the human placenta. METHODS: Continuous wave (CW) CEST MRI was performed at 3.0 Tesla. The glucose contrast enhancement (GCE) was calculated based on the magnetization transfer asymmetry (MTRasym), and the DGE was calculated with the positive side of Z-spectra in reference to the first time point. The glucose CEST (GlucoCEST) was optimized using a glucose solution phantom. Glucose solution perfused ex vivo placenta tissue was used to demonstrate GlucoCEST MRI effect. The vascular density of ex vivo placental tissue was evaluated with yellow dye after MRI scans. Finally, we preliminarily demonstrated GlucoCEST MRI in five pregnant subjects who received a glucose tolerance test. For human studies, the dynamic R2* change was captured with T2*-weighted echo planar imaging (EPI). RESULTS: The GCE effect peaks at a saturation B1 field of about 2 µT, and the GlucoCEST effect increases linearly with the glucose concentration between 4-20 mM. In ex vivo tissue, the GlucoCEST MRI was sensitive to the glucose perfusate and the placenta vascular density. Although the in vivo GCE baseline was sensitive to field inhomogeneity and motion artifacts, the temporal evolution of the GlucoCEST effect showed a consistent and positive response after oral glucose tolerance drink. CONCLUSIONS: Despite the challenges of placental motion and field inhomogeneity, our study demonstrated the feasibility of DGE placenta MRI at 3.0 Tesla.

Placental MRI: Developing Accurate Quantitative Measures of Oxygenation.

The Human Placenta Project has focused attention on the need for noninvasive magnetic resonance imaging (MRI)-based techniques to diagnose and monitor placental function throughout pregnancy. The hope is that the management of placenta-related pathologies would be improved if physicians had more direct, real-time measures of placental health to guide clinical decision making. As oxygen alters signal intensity on MRI and oxygen transport is a key function of the placenta, many of the MRI methods under development are focused on quantifying oxygen transport or oxygen content of the placenta. For example, measurements from blood oxygen level-dependent imaging of the placenta during maternal hyperoxia correspond to outcomes in twin pregnancies, suggesting that some aspects of placental oxygen transport can be monitored by MRI. Additional methods are being developed to accurately quantify baseline placental oxygenation by MRI relaxometry. However, direct validation of placental MRI methods is challenging and therefore animal studies and ex vivo studies of human placentas are needed. Here we provide an overview of the current state of the art of oxygen transport and quantification with MRI. We suggest that as these techniques are being developed, increased focus be placed on ensuring they are robust and reliable across individuals and standardized to enable predictive diagnostic models to be generated from the data. The field is still several years away from establishing the clinical benefit of monitoring placental function in real time with MRI, but the promise of individual personalized diagnosis and monitoring of placental disease in real time continues to motivate this effort.