Pre and Post-Lockdown Cesarean Deliveries and Perinatal Quality Indicators During the COVID-19 Pandemic.

We examined statewide perinatal quality indicators: nulliparous singleton term vertex cesarean births (NTSV) or low risk cesarean births, and non-medically indicated early term delivery (NMETD) rates during COVID-19 pandemic pre-lockdown (1/1/2019 to 3/23/2020) and post-lockdown (after 3/23/2020). Interrupted time-series analyses were used to examine the effects of the COVID-19 pandemic on these indicators. We observed a statistically significant increase in NTSV cesarean rates, 4.4% (95%CI: 1.3,7.4) immediately after lockdown, and a decrease in NMETD rate, 1.6% (95%CI: -2.5,-0.7). We observed an increase (0.3%; 95%CI: 0.0,0.6) in the slope (i.e., trend change) of NTSV rates post-lockdown and a decrease (-0.2%; 95%CI: -0.3,-0.1) in the slope of NMETD rates. Results suggest that the COVID-19 pandemic had an immediate effect on perinatal quality indicators in Delaware, with gradual return to pre-pandemic rates as the pandemic continued. In addition to emergency preparedness planning, hospital monitoring of perinatal quality indicators might improve obstetrical care during public health emergencies.

Shoulder dystocia and composite adverse outcomes for the maternal-neonatal dyad.

BACKGROUND: Although the neonatal morbidity associated with shoulder dystocia are well known, the maternal morbidity caused by this obstetrical emergency is infrequently reported. OBJECTIVE: This study aimed to assess the composite adverse maternal and neonatal outcomes among vaginal deliveries (at 34 weeks or later) with and without shoulder dystocia. STUDY DESIGN: This is a secondary analysis of the Consortium of Safe Labor, an observational obstetrical cohort of all vaginal deliveries occurring at 19 hospitals (from 2002-2008) and for which data on the occurrence of shoulder dystocia were available. The composite adverse maternal outcome included third- or fourth-degree perineal laceration, postpartum hemorrhage (>500 cc blood loss for a vaginal delivery and >1000 cc blood loss for cesarean delivery), blood transfusion, chorioamnionitis, endometritis, thromboembolism, admission to intensive care unit, or maternal death. The composite adverse neonatal outcome included an Apgar score of <7 at 5 minutes, a birth injury, neonatal seizure, hypoxic ischemic encephalopathy, or neonatal death. A multivariable Poisson regression was used to estimate the adjusted relative risks with 95% confidence intervals. The area under the receiver operating characteristic curve was constructed to determine if clinical factors would identify shoulder dystocia. RESULTS: Of the 228,438 women in the overall cohort, 130,008 (59.6%) met the inclusion criteria, and among them, shoulder dystocia was documented in 2159 (1.7%) cases. The rate of composite maternal morbidity was significantly higher among deliveries with shoulder dystocia (14.7%) than without (8.6%; adjusted relative risk, 1.71; 95% confidence interval, 1.64-2.01). The most common maternal morbidity with shoulder dystocia was a third- or fourth-degree laceration (adjusted relative risk, 2.82; 95% confidence interval, 2.39-3.31). The risk of composite neonatal morbidity with shoulder dystocia (12.2%) was also significantly higher than without shoulder dystocia (2.4%) (adjusted relative risk, 5.18; 95% confidence interval, 4.60-5.84). The most common neonatal morbidity was birth injury (adjusted relative risk, 5.39; 95% confidence interval, 4.71-6.17). The area under the curve for maternal characteristics to identify shoulder dystocia was 0.66 and it was 0.67 for intrapartum factors. CONCLUSION: Although shoulder dystocia is unpredictable, the associated morbidity affects both mothers and newborns. The focus should be on concurrently averting the composite morbidity for the maternal-neonatal dyad with shoulder dystocia.

Prospective evaluation of the efficacy of immunoassays in the diagnosis of rupture of the membranes.

Objective: To assess efficacy of immunoassays to diagnose spontaneous rupture of membranes (SROM).Study design: We performed a prospective, observational analysis comparing two immunoassays designed to diagnose SROM (rupture of membranes (ROM) Plus® and Amnisure®) to standard clinical assessment for SROM and 48 h follow-up. Subjects had a singleton pregnancy ≥15 weeks' and suspected SROM. Sterile speculum exam (SSE) for nitrazine, ferning and pooling was performed. Immunoassays were run by independent providers blinded to results of SSE. The primary outcome was a final diagnosis of SROM at 48 h after initial evaluation.Results: Three hundred twenty-four subjects were enrolled (121 (37.3%) with SROM and 203 (62.7%) without SROM). Both ROM Plus® and Amnisure® had sensitivities and specificities >91% for the primary outcome. McNemar's test revealed no significant difference between immunoassay test sensitivities and specificities.Conclusion: Both the ROM Plus® and Amnisure® immunoassays may be used to accurately diagnose SROM. Performance of the two immunoassays was statistically equivalent.

Sealing the left atrial appendage: ready for prime time?

Atrial fibrillation (AF) is the most common sustained arrhythmia and a leading cause of stroke. Warfarin reduces the incidence of thromboemboli and is recommended for most patients with AF. However, oral anticoagulation is contraindicated or not tolerated by a significant percentage of patients with AF. Occlusion of the left atrial appendage, the major source of emboli in atrial fibrillation, has been shown to be a potential alternative to warfarin in patients with AF who have contraindications to anticoagulation. In this article, we describe the current percutaneous left atrial appendage occlusion devices, their safety in recent trials, and their potential role in stroke prevention in AF.

Creation and characterization of a renin knockout rat.

The renin-angiotensin system plays an important role in the control of blood pressure (BP) and renal function. To illuminate the importance of renin in the context of a disease background in vivo, we used zinc-finger nucleases (ZFNs) designed to target the renin gene and create a renin knockout in the SS/JrHsdMcwi (SS) rat. ZFN against renin caused a 10-bp deletion in exon 5, resulting in a frameshift mutation. Plasma renin activity was undetectable in the Ren-/- rat, and renin protein was absent from the juxtaglomerular cells in the kidney. Body weight was lower in the Ren-/- rats (than in the Ren+/- or wild-type littermates), and conscious BP on low-salt diet (0.4% NaCl) was 58 ± 2 mm Hg in the Ren-/- male rats versus 117 mm Hg in the Ren+/- littermates, a reduction of almost 50 mm Hg. Blood urea nitrogen (BUN) and plasma creatinine levels were elevated in the Ren-/- strain (BUN 112 ± 7 versus 23 ± 2 mg/dL and creatinine 0.53 ± 0.02 versus 0.26 ± 0.02 mg/dL), and kidney morphology was abnormal with a rudimentary inner renal medulla, cortical interstitial fibrosis, thickening of arterial walls, and abnormally shaped glomeruli. The development of the first rat knockout in the renin-angiotensin system demonstrates the efficacy of the ZFN technology for creating knockout rats for cardiovascular disease on any genetic background and emphasizes the role of renin in BP regulation and kidney function even in the low-renin SS rat.

Oxytocin regimen for labor augmentation, labor progression, and perinatal outcomes.

OBJECTIVE: To examine the effects and safety of high-dose (compared with low-dose) oxytocin regimen for labor augmentation on perinatal outcomes. METHODS: Data from the Consortium on Safe Labor were used. A total of 15,054 women from six hospitals were eligible for the analysis. Women were grouped based on their oxytocin starting dose and incremental dosing of 1, 2, and 4 milliunits/min. Duration of labor and a number of maternal and neonatal outcomes were compared among these three groups stratified by parity. Multivariable logistic regression and generalized linear mixed model were used to adjust for potential confounders. RESULTS: Oxytocin regimen did not affect the rate of cesarean delivery or other perinatal outcomes. Compared with 1 milliunit/min, the regimens starting with 2 milliunits/min and 4 milliunits/min reduced the duration of first stage by 0.8 hours (95% confidence interval 0.5-1.1) and 1.3 hours (1.0-1.7), respectively, in nulliparous women. No effect was observed on the second stage of labor. Similar patterns were observed in multiparous women. High-dose regimen was associated with a reduced risk of meconium stain, chorioamnionitis, and newborn fever in multiparous women. CONCLUSION: High-dose oxytocin regimen (starting dose at 4 milliunits/min and increment of 4 millliunits/min) is associated with a shorter duration of first-stage of labor for all parities without increasing the cesarean delivery rate or adversely affecting perinatal outcomes. LEVEL OF EVIDENCE: II.