American journal of perinatology最新文献

ACOG publications on stillbirth or postpartum hemorrhage (PPH) do not consider stillbirth as a risk factor for postpartum hemorrhagic morbidity. This study aimed to ascertain the likelihood of composite maternal hemorrhagic outcome (CMHO) among individuals who delivered vaginally with livebirth versus a stillbirth.This was a retrospective cohort study of all parturients greater than 20 weeks gestation who delivered vaginally at a single level IV site within 24 months. Demographic differences and baseline PPH risks were analyzed. CMHO included any of the following: estimated blood loss ≥1,000 mL, use of uterotonics (beyond prophylactic oxytocin), Bakri balloon, surgical management of PPH, blood transfusion, hysterectomy, venous thromboembolism (VTE), admission to the intensive care unit (ICU), or maternal death. Statistical analysis included chi-squared, Kruskal-Wallis, and Poisson regression with robust error variance for risk ratios, adjusting for gestational age (GA), bleeding on admission, chorioamnionitis, and prior uterine surgery.Of 8,623 consecutive vaginal births ≥20 weeks gestation, 89 (1.9%) were stillbirths. Maternal age, marital status, GA at delivery, and PPH risk stratification at admission differed significantly. Bleeding at admission (p < 0.001), prior uterine surgery (p < 0.001), magnesium sulfate use (p = 0.006), chorioamnionitis (p < 0.001), platelet count <100 (p = 0.001), platelet count <50 (p < 0.001), and retained products of conception (p < 0.001) were different in the two groups. CMHO was significantly higher with a stillbirth delivery (32.6 vs. 16.8%; aRR: 1.56, 95% CI: 1.01-2.46). After adjustment, the components of the CMHO that differed significantly were estimated blood loss ≥1,000 mL and ICU admission. Tamponade, surgical intervention, VTE, hysterectomy, and maternal death did not differ between the two groups.Pregnancies with stillbirth, compared with livebirth, had an increased risk of hemorrhagic related morbidity. In addition to being useful in shared decision-making, our results can be nidus for intervention trials to decrease the hemorrhagic morbidity associated with stillbirth. · The risk of CMHO was significantly higher in the stillbirth group even after adjustment for potential confounders (32.6% vs. 16.8%).. · Stillbirth was associated with a significantly higher risk of blood loss of ≥1,000 mL.. · Stillbirth was also associated with higher likelihood of uterotonic use, transfusion, and admission to ICU..

Nipocalimab, a neonatal Fc receptor blocker, showed evidence of efficacy and safety in preventing or delaying fetal anemia in a phase 2 study of early-onset severe hemolytic disease of the fetus and newborn, demonstrating potential for treatment of other maternal immunoglobulin G alloantibody-mediated fetal diseases. The phase 3 FREESIA-3 study aims to evaluate the efficacy and safety of nipocalimab or intravenous immunoglobulin (IVIG) with prednisone in pregnancies with a previous occurrence of fetal and neonatal alloimmune thrombocytopenia (FNAIT) with or without intracranial hemorrhage or severe fetal/neonatal bleeding (high- or standard-risk, respectively).FREESIA-3 is a phase 3, open-label, randomized, multicenter study in pregnant individuals at risk for FNAIT. Participants are randomized 4:1 to receive either weekly 45 mg/kg intravenous nipocalimab or weekly IVIG with prednisone starting at 13 to 18 weeks of gestational age (standard-risk) or 12 weeks of gestational age (high-risk) until delivery. During treatment, pregnant participants will receive ultrasound monitoring every 2 weeks for fetal bleeding, growth, and development. Postnatal follow-up is 24 weeks for maternal participants and 104 weeks for neonates/infants.The primary endpoint is an adverse outcome of death or adjudicated severe bleeding in utero up to 1 week postbirth, or platelet count at birth of < 30 × 10⁹/L in a fetus/neonate. Secondary endpoints include fetal/neonatal death, neonatal platelet count at birth, nadir neonatal platelet count over 1 week postbirth, neonate requiring platelet transfusion(s), adjudicated fetal and neonatal bleeding up to 1 week postbirth, neonate receiving IVIG for thrombocytopenia, safety in maternal participants and neonates/infants, and immunogenicity of nipocalimab. Exploratory endpoints include patient- and caregiver-reported outcome assessments and nipocalimab pharmacokinetics and pharmacodynamics.FREESIA-3, an open-label, multicenter, randomized, phase 3 study, will evaluate the efficacy and safety of nipocalimab in both standard- and high-risk pregnancies for FNAIT. · FNAIT is a transplacental alloantibody-driven disease.. · Nipocalimab blocks IgG recycling, lowering IgG levels.. · Nipocalimab blocks IgG placental transfer to the fetus.. · Nipocalimab reduced adverse outcomes in EOS-HDFN.. · FREESIA-3 studies nipocalimab efficacy/safety in FNAIT..

This study aimed to compare temperature control during therapeutic hypothermia (TH) in neonates with moderate or severe hypoxic-ischemic encephalopathy (HIE) using manual cooling (MC) or a servo-controlled (SC) system.Retrospective cohort study including neonates with ≥ 35 weeks' gestation with moderate or severe HIE who were treated with TH between 2018 and 2020, using MC with ice packs or a SC system. Temperature curves and clinical outcomes were compared between the two methods of cooling. Data were summarized using descriptive statistics. Groups were compared with appropriate parametric or nonparametric tests. Temperature stability and rewarming variability were evaluated, and secondary outcomes were analyzed using risk ratios with 95% confidence intervals and logistic regression adjusted for encephalopathy severity.During the study period, 56 neonates with moderate or severe HIE were cooled, 31 (55.4%) with MC and 25 (44.6%) with a SC system. Baseline characteristics and time to target temperature were similar. SC achieved more stable hypothermia, with less variability (p = 0.014) and reduced time outside the therapeutic range (2.7 vs. 8.1%, p = 0.005). Extreme temperature deviations occurred only in the MC group. Rewarming rates were comparable, although variability was greater with MC. Clinical outcomes showed lower risk of hypotension (RR: 0.647, 95% CI: 0.409-1.02; p = 0.044), inotrope use (RR: 0.647, 95% CI: 0.409-1.02; p = 0.044), and abnormal magnetic resonance imaging (MRI) findings (12.0 vs. 46.2%; RR: 0.26, 95% CI: 0.08-0.81; p = 0.013) in the SC group. After adjusting for clinical encephalopathy severity, SC remained independently protective against abnormal MRI (aOR: 0.19; 95% CI: 0.04-0.865; p = 0.03) and hypotension (aOR: 0.27; 95% CI: 0.08-0.95; p = 0.04). Mortality occurred only in the MC group.While both methods were effective, the SC system offered more stable temperature control and may reduce complications during and after TH. · Temperature stability is critical for the effectiveness of TH.. · SC cooling provided more stable temperature control than MC.. · SC cooling and MC were feasible in a neonatal intensive care unit setting.. · SC cooling may reduce neurological complications during and after TH..

This study aimed to evaluate the feasibility of randomizing patients to weight-based low molecular weight heparin (LMWH) versus no pharmacologic thromboprophylaxis following cesarean delivery (CD).Single-center, open-label pilot randomized controlled trial of individuals aged 18+ undergoing CD at the University of Utah Health from November 2023 to June 2024. Those with a contraindication to anticoagulation, a plan for therapeutic anticoagulation, or considered at highest risk for postpartum venous thromboembolism (VTE; i.e., undergoing cesarean-hysterectomy, high-risk thrombophilia, personal history of thromboembolism) were excluded. Enrolled individuals were randomized in a 1:1 ratio utilizing block randomization with randomly varying block sizes to receive weight-based LMWH for 14 days or no pharmacologic thromboprophylaxis. The primary outcome was feasibility, defined as ≥35% enrollment of eligible individuals and retention of ≥85% of enrolled individuals through all study procedures. Secondary feasibility outcomes included the number of eligible patients per month, approach rate, enrollment rate, and retention rate. Additional outcomes included VTE, wound hematoma, patient-reported symptoms, or a bleeding complication within 6 weeks postpartum. Baseline characteristics were compared between those approached and enrolled and those not enrolled. The proportion meeting each of the outcomes was reported with 95% confidence intervals (CI).Over the 6-month study period, 694 patients were screened and found eligible for an average of 106 eligible patients per month. There were 611 patients approached (88%, 95% CI: 85.6-90.5), of which 64 enrolled (10.5%, 95% CI: 8-12.9), and 61 participants were retained through all study procedures (95.3%, 95% CI: 90-100). Thus, the overall primary outcome feasibility parameters were not met. Among the 64 individuals enrolled and randomized, the mean age was 31.0 years (standard deviation: 5.5 years), and the majority were non-Hispanic White (56%). Baseline characteristics were similar between those who were approached and enrolled compared with those not enrolled. There were no differences in additional clinical outcomes (VTE, wound hematoma, patient-reported symptoms, or bleeding complications) by prophylaxis group.In this pilot trial, individual patient randomization to weight-based LMWH or no pharmacologic thromboprophylaxis after CD was not feasible due to low enrollment rates. Future trials addressing postpartum thromboembolism prevention should consider alternative study designs. · Individual patient randomization to enoxaparin or no therapy after CD was not feasible.. · The approach rate, enrollment rate, and retention rate were 88, 11, and 95%, respectively, in this single-center pilot.. · Future prospective studies may need to consider alternative designs..

This study aimed to determine whether immediate postnatal heart rate (HR) assessment during delayed cord clamping (DCC) influences the clinical decision-making of neonatal resuscitation providers.The decision to perform or defer DCC primarily relies on subjective parameters, potentially leading to variations in subsequent steps of the resuscitation algorithm. In this study, HR, a numerical parameter, was introduced during DCC. Ten subjects completed a total of 60 short scenarios simulating DCC for a 27-week preterm manikin. Each subject experienced two consecutive sets (control vs. test) of three scenarios with predefined HR ranges (<60, 60-99, and ≥ 100/minute) presented in random order. In control scenarios, subjects participated in the DCC procedure per usual practice. In test scenarios, they manually measured HR during DCC. Objective variables and subjective questionnaire responses were collected.The mean DCC duration significantly increased for HR 60 to 99/minute (45.4 vs. 55.3 seconds, p = 0.035) and HR ≥ 100/minute (37.1 vs. 63.7 seconds, p = 0.011) scenarios in the test group compared with the control. For the HR < 60/minute scenario, mean DCC duration and time to ECG attachment tended to be shorter in the test group (45.4 vs. 34.6 and 89.7 vs. 56.3 seconds, respectively). In this HR range, initiation of respiratory support occurred significantly earlier in the test group (mean 72.7 vs. 47.6 seconds, p = 0.020). According to the questionnaire, 2 (20%) subjects believed tone and respiratory effort were sufficient for DCC decision-making. Seven (70%) subjects perceived that HR assessment during DCC had a "strong" or "very strong" impact on the decision to delay or proceed with cord clamping, with confidence levels rising from a median of 3 to 4 on a 5-point Likert scale.Assessing immediate postnatal HR during DCC appears to impact clinical decision-making for providers, implying the potential for enhancing uniformity of decisions among healthcare professionals surrounding DCC. · The decision to perform or defer DCC primarily relies on subjective parameters.. · HR assessment during DCC appears to impact clinical decision-making for providers.. · Assessing HR during DCC may potentially enhance uniformity of decisions among HCPs..

Postpartum hemorrhage (PPH) remains a leading cause of maternal morbidity and mortality, with cesarean delivery posing a heightened risk. While interventions such as prophylactic tranexamic acid and balloon tamponade have limitations-especially when the cervix is not dilated-vacuum-assisted uterine tamponade may offer a novel intraoperative approach. This prospective pilot study evaluated the feasibility of the Daisy catheter, a cervical drain device developed by Raydiant Oximetry, Inc., designed to evacuate blood and promote uterine contraction through continuous negative-pressure suction.We enrolled ten pregnant individuals scheduled for cesarean delivery at a tertiary care center, all of whom had at least one PPH risk factor. Following fetal and placental delivery, the Daisy catheter was inserted trans-hysterotomically, advanced through the cervix, and connected to wall suction (-90 to -100 mm Hg) for 2 hours. Quantitative blood loss, perioperative hemoglobin change, ultrasound findings, and adverse events were recorded.Device placement succeeded in 9 of 10 cases; one failure was due to an undiagnosed cervical cerclage. Eight participants completed the full suction protocol. Mean hemoglobin decline from preoperative baseline to postoperative day 1 was 1.36 ± 0.47 g/dL, significantly lower than the 1.9 ± 1.1 g/dL observed in a historical cohort from 31 U.S. hospitals (p = 0.019). Ultrasound at 2 hours postpartum confirmed correct device placement, absence of intrauterine clot, and no evidence of trauma. Device removal was uncomplicated, and no adverse events were reported.These preliminary findings suggest that intraoperative use of the Daisy device is feasible, well-tolerated, and may reduce blood loss after cesarean delivery. Larger, randomized trials are warranted to evaluate its impact on transfusion rates, reoperation, and overall maternal outcomes, particularly in settings where alternative tamponade methods are limited. The ClinicalTrials.gov identifier is NCT06219538. · Vacuum tamponade used during cesarean delivery.. · Daisy device showed safe, feasible deployment.. · Hemoglobin drop was lower than the historical average..

This study aimed to describe neuromonitoring findings and short-term outcomes after the implementation of a digital health strategy comprising continuous, real-time, tele-based video-aEEG/EEG monitoring in a publicly funded NICU in Brazil.Prospective, observational cohort study conducted between July 2017 and June 2021, analyzing neuromonitoring data of high-risk newborns and correlating it with clinical and imaging outcomes.A total of 116 newborns, with a median gestational age of 37 weeks (interquartile range [IQR]: 32^2/7-39^2/7) and a median birth weight of 2,800 g (IQR: 1,472-3,305), were enrolled with more than 8,000 hours of monitoring. The main indication was suspected seizure (n = 49, 42.2%). A total of 43 (37.1%) neonates presented pathological background activity, and sleep-wake cycle (SWC) was absent in 68 (58.6%). Seizures were identified in 36 (31.0%) neonates, predominantly within the first 12 hours of life (n = 14, 38.9%), electrographic-only (n = 29, 80.6%), and repetitive (n = 24, 66.7%). A total of 47 (40.5%) neonates received antiseizure medications, with phenobarbital being the most frequently used (46; 97.9%). Only one patient (2.1%) was discharged receiving antiseizure medication. Cranial ultrasound (cUS) was performed in 94 (81.0%) infants, with abnormal findings in 34 (36.2%) infants. Pathological background activity, absence of SWC, and seizures were significantly associated with severe abnormalities on cUS, and increased risk of death before discharge.The implementation of a digital health strategy incorporating real-time and continuous video-aEEG/EEG monitoring demonstrated potential to improve diagnostic accuracy for electrographic seizures, optimize antiseizure medication stewardship, and inform early neuroprotective interventions. · Brain monitoring improves seizure diagnosis.. · aEEG/EEG supported antiseizure medication discontinuation.. · Abnormal aEEG/EEG findings are associated with poor outcomes.. · Remote aEEG/EEG monitoring is feasible in LMIC..

Induction of labor (IOL) and hospitalist coverage are becoming more common. While hospitalist coverage has been associated with improved maternal outcomes and lower cesarean delivery rates, its impact on IOL remains unclear. The objective of this study was to compare the induction time to vaginal delivery across three obstetric coverage models: hospitalists, faculty generalists, and private practice generalists.This single-site retrospective cohort study analyzed singleton, term (≥39 weeks), vertex patients undergoing IOL at NYU Langone Hospital-Long Island from January 1, 2022, to September 30, 2022. Hospitalists at this institution managed high-risk obstetric patients, including those under maternal-fetal medicine care, resident clinic, and unregistered patients who presented to labor and delivery, along with serving as labor and delivery safety officer on the labor floor. Faculty and private practice generalists managed their respective groups. Outcomes included induction time to vaginal delivery, mode of delivery, induction methods, and maternal and neonatal complications. Statistical analyses included chi-square, ANOVA, and multivariable linear regression. A p-value of < 0.05 was statistically significant.Among 403 patients, 92 (22.8%) were managed by hospitalists, 115 (28.5%) by faculty, and 196 (48.6%) by private generalists. Median (IQR) induction-to-delivery times were similar across groups: hospitalists 20.5 (15.3-27.5) hours, faculty 23.4 (16.5-31.1) hours, and private 19.7 (14.1-25.6) hours (p = 0.004). However, when limited to vaginal deliveries, no significant difference was observed in induction-to-vaginal-delivery time (p = 0.17). Private generalists had the shortest induction-to-cesarean time and time to membrane rupture leading to cesarean. There were no differences in intrapartum or postpartum complications. Hospitalists had more NICU admissions after vaginal delivery, mostly unrelated to labor.Induction-to-vaginal delivery times and complication rates were similar across coverage models, but differences in NICU admissions and cesarean delivery times highlight care variations. Collaboration and evidence-based standardized induction protocols may optimize outcomes across coverage models. · Induction to vaginal delivery time can be similar across obstetric groups.. · Labor and delivery units with high induction rates may benefit from hospitalists.. · An evidence-based induction protocol may optimize maternal and fetal outcomes..

This study aimed to evaluate the role of early effective antibiotic therapy in preventing secondary meningitis as a sequelae of bacterial bloodstream infections (BSI).In this multicenter cohort study, we identified blood cultures that were positive for Group B Streptococcus (GBS), Staphylococcus aureus, Escherichia coli, and other non-E. coli gram-negative bacteria that had a corresponding cerebrospinal fluid sample collected ≤7 days after the positive blood culture among infants discharged from a neonatal intensive care unit managed by the Pediatrix Medical Group 2002 to 2020. The odds of secondary meningitis for early effective antibiotic therapy versus delayed antibiotic therapy were compared using an adjusted logistic regression model. The odds of secondary meningitis following GBS BSI were compared for infections treated with empirical vancomycin versus β-lactam antibiotic.Secondary meningitis was identified in 11% of 5,967 BSI. Early effective antibiotic therapy was not associated with a reduced odds of secondary meningitis for GBS (adjusted odds ratio [aOR]: 1.17; 95% confidence interval [CI]: 0.82-1.66) or E. coli (aOR: 1.06; 95% CI: 0.82-1.38); however, was associated with decreased odds for non-E. coli gram-negative bacteria (aOR: 0.69; 95% CI: 0.49-0.98) and S. aureus (aOR: 0.51; 95% CI: 0.34-0.74). GBS BSIs were more often complicated by meningitis when vancomycin was used empirically compared with β-lactam antibiotic (aOR: 2.01; 95% CI: 1.28-3.14).Early effective antibiotic therapy for BSI in infants did not reduce the odds of secondary meningitis caused by GBS or E. coli; however, early effective antibiotic therapy did reduce episodes due to non-E. coli gram-negative bacteria and S. aureus. · Early effective antibiotic therapy in the setting of non-E. coli gram-negative bacteria and S. aureus BSI was associated with reduced odds of secondary meningitis.. · Early effective antibiotic therapy for BSI in infants was not found to reduce the odds of secondary meningitis caused by GBS or E. coli.. · GBS BSIs were more commonly complicated by meningitis when vancomycin was used empirically compared with a β-lactam antibiotic..

Extracorporeal membrane oxygenation (ECMO) is an important rescue strategy for neonates with severe cardiorespiratory failure, yet its role in the management of hypoxic-ischemic encephalopathy (HIE) remains subject to debate. Historically, clinicians have been reluctant to offer ECMO to infants with significant neurological injury because of concerns related to poor neurodevelopmental outcomes and elevated risk of complications such as hemorrhage and stroke. Over the past two decades, however, accumulating evidence has suggested that many neonates with HIE not only tolerate ECMO well but may also achieve meaningful survival and functional recovery. In this state-of-the-art narrative review, we surveyed and synthesized observational studies, retrospective cohorts, and case series published since 2000 that evaluated ECMO in neonates with HIE. While randomized controlled trials dedicated exclusively to this population remain scarce, the available data indicate that ECMO can be safely implemented alongside standard therapies-including therapeutic hypothermia-without uniformly prohibitive rates of bleeding or adverse neurodevelopment. Although small sample sizes and single-center experiences limit the strength of these conclusions, survival rates in combined TH-ECMO cohorts are often reported above 80 to 90%, with a substantial proportion of survivors demonstrating acceptable early neurodevelopmental outcomes. Overall, the growing clinical acceptance of ECMO in HIE highlights the need for careful, individualized assessment of benefits and risks, as well as transparent discussions with families. Future multicenter collaborations focusing on robust longitudinal follow-up and evidence-based protocols will be essential to guide best practices and optimize outcomes for this high-risk neonatal population.