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1.
JAMA Netw Open ; 7(7): e2416870, 2024 Jul 01.
Artículo en Inglés | MEDLINE | ID: mdl-38949814

RESUMEN

Importance: Compared with early cord clamping (ECC), umbilical cord milking (UCM) reduces delivery room cardiorespiratory support, hypoxic-ischemic encephalopathy, and therapeutic hypothermia in nonvigorous near-term and full-term infants. However, UCM postdischarge outcomes are not known. Objective: To determine the 2-year outcomes of children randomized to UCM or ECC at birth in the Milking in Nonvigorous Infants (MINVI) trial. Design, Setting, and Participants: A secondary analysis to evaluate longer-term outcomes of a cluster-randomized crossover trial was conducted from January 9, 2021, to September 25, 2023. The primary trial took place in 10 medical centers in the US, Canada, and Poland from January 5, 2019, to June 1, 2021, and hypothesized that UCM would reduce admission to the neonatal intensive care unit compared with ECC; follow-up concluded September 26, 2023. The population included near-term and full-term infants aged 35 to 42 weeks' gestation at birth who were nonvigorous; families provided consent to complete developmental screening questionnaires through age 2 years. Intervention: UCM and ECC. Main Outcomes and Measures: Ages and Stages Questionnaire, 3rd Edition (ASQ-3) and Modified Checklist for Autism in Toddlers, Revised/Follow-Up (M-CHAT-R/F) questionnaires at ages 22 to 26 months. Intention-to-treat analysis and per-protocol analyses were used. Results: Among 1730 newborns from the primary trial, long-term outcomes were evaluated in 971 children (81%) who had ASQ-3 scores available at 2 years or died before age 2 years and 927 children (77%) who had M-CHAT-R/F scores or died before age 2 years. Maternal and neonatal characteristics by treatment group were similar, with median birth gestational age of 39 (IQR, 38-40) weeks in both groups; 224 infants (45%) in the UCM group and 201 (43%) in the ECC group were female. The median ASQ-3 total scores were similar (UCM: 255 [IQR, 225-280] vs ECC: 255 [IQR, 230-280]; P = .87), with no significant differences in the ASQ-3 subdomains. Medium- to high-risk M-CHAT-R/F scores were also similar (UCM, 9% [45 of 486] vs ECC, 8% [37 of 441]; P = .86). Conclusions and Relevance: In this secondary analysis of a randomized clinical trial among late near-term and full-term infants who were nonvigorous at birth, ASQ-3 scores at age 2 years were not significantly different between the UCM and ECC groups. Combined with previously reported important short-term benefits, this follow-up study suggests UCM is a feasible, no-cost intervention without longer-term neurodevelopmental risks of cord milking in nonvigorous near-term and term newborns. Trial Registration: ClinicalTrials.gov Identifier: NCT03631940.


Asunto(s)
Clampeo del Cordón Umbilical , Humanos , Femenino , Recién Nacido , Masculino , Lactante , Clampeo del Cordón Umbilical/métodos , Estudios Cruzados , Cordón Umbilical , Hipoxia-Isquemia Encefálica/terapia , Preescolar
2.
J Matern Fetal Neonatal Med ; 37(1): 2367082, 2024 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-38873885

RESUMEN

OBJECTIVE: It is currently unknown whether adjunctive azithromycin prophylaxis at the time of non-elective cesarean has differential effects on neonatal outcomes in the context of prematurity. The objective of this study was to compare whether neonatal outcomes differ in term and preterm infants exposed to adjunctive azithromycin prophylaxis before non-elective cesarean delivery. STUDY DESIGN: A planned secondary analysis of a multi-center randomized controlled trial that enrolled women with singleton pregnancies ≥24 weeks gestation undergoing non-elective cesarean delivery (during labor or ≥4 h after membrane rupture). Women received standard antibiotic prophylaxis and were randomized to either adjunctive azithromycin (500 mg) or placebo. The primary composite outcome was neonatal death, suspected or confirmed neonatal sepsis, and serious neonatal morbidities (NEC, PVL, IVH, BPD). Secondary outcomes included NICU admission, neonatal readmission, culture positive infections and prevalence of resistant organisms. Odds ratios (OR) for the effect of azithromycin versus placebo were compared between gestational age strata (preterm [less than 37 weeks] versus term [37 weeks or greater]). Tests of interaction examined homogeneity of treatment effect with gestational age. RESULTS: The analysis includes 2,013 infants, 226 preterm (11.2%) and 1,787 term. Mean gestational ages were 34 and 39.5 weeks, respectively. Within term and preterm strata, maternal and delivery characteristics were similar between the azithromycin and placebo groups. There was no difference in the odds of composite neonatal outcome between those exposed to azithromycin versus placebo in preterm neonates (OR 0.82, 95% CI 0.48-1.41) and in term neonates (OR 1.06, 95% CI 0.77-1.46), with no difference between gestational age strata (p = 0.42). Analysis of secondary outcomes also revealed no differences in treatment effects within or between gestational age strata. CONCLUSION: Exposure to adjunctive azithromycin antibiotic prophylaxis for non-elective cesarean delivery does not increase neonatal morbidity or mortality in term or preterm infants. CLINICAL TRIAL REGISTRATION: https://clinicaltrials.gov, NCT01235546.


Asunto(s)
Antibacterianos , Profilaxis Antibiótica , Azitromicina , Cesárea , Recien Nacido Prematuro , Humanos , Azitromicina/uso terapéutico , Azitromicina/administración & dosificación , Femenino , Profilaxis Antibiótica/métodos , Recién Nacido , Embarazo , Cesárea/estadística & datos numéricos , Antibacterianos/uso terapéutico , Antibacterianos/administración & dosificación , Adulto , Edad Gestacional , Nacimiento a Término , Enfermedades del Recién Nacido/prevención & control , Enfermedades del Recién Nacido/epidemiología
3.
J Perinatol ; 44(3): 415-418, 2024 Mar.
Artículo en Inglés | MEDLINE | ID: mdl-38129598

RESUMEN

OBJECTIVES: To determine parental perspectives in a trial with waived consent. STUDY DESIGN: Anonymous survey of birth parents with term infants who were randomized using a waiver of consent, administered after infant discharge. RESULTS: 121 (11%) survey responses were collected. Of the 121 responding parents 111 (92%) reported that this form of consent was acceptable and 116 (96%) reported feeling comfortable having another child participate in a similar study. 110 (91%) respondents reported that they both understood the information provided in the consent process and had enough time to consider participation. Four percent had a negative opinion on the study's effect on their child's health. CONCLUSIONS: Most responding parents reported both acceptability of this study design in the neonatal period and that the study had a positive effect on their child's health. Future work should investigate additional ways to involve parents and elicit feedback on varied methods of pediatric consent.


Asunto(s)
Consentimiento Informado , Padres , Lactante , Recién Nacido , Niño , Humanos , Encuestas y Cuestionarios , Emociones , Proyectos de Investigación
4.
Res Sq ; 2023 Oct 30.
Artículo en Inglés | MEDLINE | ID: mdl-37961362

RESUMEN

Objectives: To determine parental perspectives in a trial with waived consent. Study Design: Biological parents of non-vigorous term infants randomized using a waiver of consent for a delivery room intervention completed an anonymous survey after discharge. Results: 121 survey responses were collected. Most responding parents reported that this form of consent was acceptable (92%) and that they would feel comfortable having another child participate in a similar study (96%). The majority (> 90%) also reported that the information provided after randomization was clear to understand future data collection procedures. Four percent had a negative opinion on the study's effect on their child's health. Conclusions: The majority of responding parents reported both acceptability of this study design in the neonatal period and that the study had a positive effect on their child's health. Future work should investigate additional ways to involve parents and elicit feedback on varied methods of pediatric consent.

5.
Pediatrics ; 152(6)2023 Dec 01.
Artículo en Inglés | MEDLINE | ID: mdl-37941523

RESUMEN

OBJECTIVES: To determine whether rate of severe intraventricular hemorrhage (IVH) or death among preterm infants receiving placental transfusion with UCM is noninferior to delayed cord clamping (DCC). METHODS: Noninferiority randomized controlled trial comparing UCM versus DCC in preterm infants born 28 to 32 weeks recruited between June 2017 through September 2022 from 19 university and private medical centers in 4 countries. The primary outcome was Grade III/IV IVH or death evaluated at a 1% noninferiority margin. RESULTS: Among 1019 infants (UCM n = 511 and DCC n = 508), all completed the trial from birth through initial hospitalization (mean gestational age 31 weeks, 44% female). For the primary outcome, 7 of 511 (1.4%) infants randomized to UCM developed severe IVH or died compared to 7 of 508 (1.4%) infants randomized to DCC (rate difference 0.01%, 95% confidence interval: (-1.4% to 1.4%), P = .99). CONCLUSIONS: In this randomized controlled trial of UCM versus DCC among preterm infants born between 28 and 32 weeks' gestation, there was no difference in the rates of severe IVH or death. UCM may be a safe alternative to DCC in premature infants born at 28 to 32 weeks who require resuscitation.


Asunto(s)
Recien Nacido Prematuro , Clampeo del Cordón Umbilical , Recién Nacido , Humanos , Femenino , Lactante , Embarazo , Masculino , Cordón Umbilical/cirugía , Placenta , Edad Gestacional , Hemorragia Cerebral/etiología , Constricción
6.
Am J Perinatol ; 2023 Nov 21.
Artículo en Inglés | MEDLINE | ID: mdl-37989208

RESUMEN

OBJECTIVE: Delayed cord clamping (DCC) is recommended for all neonates; however, adapting such practice can be slow or unsustainable, especially among preterm neonates. During DCC neonates are exposed to a cool environment, raising concerns for neonatal hypothermia. Moderate hypothermia may induce morbidities that counteract the potential benefits of DCC. A quality improvement project on a thermoregulation-focused DCC protocol was implemented for neonates less than 34 weeks' gestational age (GA). The aim was to increase the compliance rate of DCC while maintaining normothermia. STUDY DESIGN: The DCC protocol was implemented on October 1, 2020 in a large Level III neonatal intensive care unit. The thermoregulation measures included increasing delivery room temperature and using heat conservation supplies (sterile polyethylene suit, warm towels, and thermal pads). Baseline characteristics, the compliance rate of DCC, and admission temperatures were compared 4 months' preimplementation and 26 months' postimplementation RESULTS: The rate of DCC increased from 20% (11/54) in preimplementation to 57% (240/425) in postimplementation (p < 0.001). The balancing measure of admission normothermia remained unchanged. In a postimplementation subgroup analysis, the DCC cohort had less tendency to experience admission moderate hypothermia (<36°C; 9.2 vs. 14.1%, p = 0.11). The DCC cohort had more favorable secondary outcomes including higher admission hematocrit, less blood transfusions, less intraventricular hemorrhage, and lower mortality. Improving the process measure of accurate documentation could help to identify implementation barriers. CONCLUSION: Performing DCC in preterm neonates was feasible and beneficial without increasing admission hypothermia. KEY POINTS: · Thermoregulation-focused DCC protocol was implemented to increase DCC while maintaining normothermia.. · DCC rate increased from 20 to 57% while admission normothermia rate remained the same.. · DCC practice on preterm neonates is safe and feasible while maintaining normothermia..

7.
J Midwifery Womens Health ; 68(4): 458-465, 2023.
Artículo en Inglés | MEDLINE | ID: mdl-37114662

RESUMEN

INTRODUCTION: Planned home or birth center births sometimes require emergency transfers to a hospital. Poor communication among members of the birth care team during a transfer can lead to unfavorable outcomes for the birthing person and newborn. To improve the quality of birth transfers in Utah, the Utah Women and Newborns Quality Collaborative partnered with the LIFT Simulation Design Lab to develop and pilot an interprofessional birth transfer simulation training. METHODS: We engaged community stakeholders to identify learning objectives and co-design the simulation trainings using principles of participatory design. We conducted 5 simulation trainings featuring birth transfers during a postpartum hemorrhage. The LIFT Lab evaluated the trainings to determine if they were feasible, acceptable, and effective. Measures included a post-training form asking participants to evaluate the quality of the training and a 9-question pre- and post-training survey measuring changes in participants' self-efficacy regarding components of birth transfer. The changes were assessed for significance using a paired t test. RESULTS: A total of 102 participants attended the 5 trainings; all health care provider groups were well represented. Most participants felt the simulations were similar to real situations and would benefit others in their professions. All participants said the trainings were a good use of their time. Following the training, participants had significantly higher levels of self-efficacy regarding their ability to manage birth transfers. DISCUSSION: Birth transfer simulation trainings are an acceptable, feasible, and effective method for training interprofessional birth care teams.


Asunto(s)
Hemorragia Posparto , Entrenamiento Simulado , Recién Nacido , Embarazo , Humanos , Femenino , Relaciones Interprofesionales , Grupo de Atención al Paciente
8.
J Midwifery Womens Health ; 68(3): 353-363, 2023.
Artículo en Inglés | MEDLINE | ID: mdl-37073545

RESUMEN

INTRODUCTION: This study seeks to understand the experiences of Utah midwives and doulas caring for patients during the recent coronavirus disease 2019 (COVID-19) pandemic. Specifically, the goal of the study was to describe the perceived impact on the community birth system and explore differences in the access and use of personal protective equipment (PPE) between in- and out-of-hospital births. METHODS: This study used a cross-sectional, descriptive study design. A 26-item survey developed by the research team was sent via email to Utah birth workers, including nurse-midwives, community midwives, and doulas. Quantitative data were collected during December 2020 and January 2021. Descriptive statistics were used in the analysis. RESULTS: Of the 409 birth workers who were sent a link to the survey, 120 (30%) responded: 38 (32%) CNMs, 30 (25%) direct-entry or community midwives, and 52 (43%) doulas. The majority (79%) reported changes to clinical practice during the COVID-19 pandemic. Community midwives (71%) who responded indicated practice volume increased. Survey participants reported an increased patient preference for home births (53%) and birth center births (43%). Among those with one or more patient transfers to the hospital, 61% experienced a change in the process. One participant reported that it took 43 minutes longer to transfer to the hospital. Community midwives and doulas reported poor access to a regular source of PPE. DISCUSSION: Survey participants reported changes to planned birth locations during the COVID-19 pandemic. When necessary, transfers to hospitals were reported to be slower. Community midwives and doulas reported having insufficient access to PPE and reported limited knowledge about COVID-19 testing resources and resources for educating patients on COVID-19. This study adds an important perspective to the existing literature on COVID-19 by indicating that policymakers should include community birth partners in community planning for natural disasters and future pandemics.


Asunto(s)
COVID-19 , Doulas , Partería , Embarazo , Femenino , Humanos , COVID-19/epidemiología , Utah/epidemiología , Prueba de COVID-19 , Pandemias , Estudios Transversales
9.
Am J Perinatol ; 40(5): 532-538, 2023 04.
Artículo en Inglés | MEDLINE | ID: mdl-34044454

RESUMEN

OBJECTIVE: In the antenatal late preterm steroids (ALPS) trial betamethasone significantly decreased short-term neonatal respiratory morbidity but increased the risk of neonatal hypoglycemia, diagnosed only categorically (<40 mg/dL). We sought to better characterize the nature, duration, and treatment for hypoglycemia. STUDY DESIGN: Secondary analysis of infants from ALPS, a multicenter trial randomizing women at risk for late preterm delivery to betamethasone or placebo. This study was a reabstraction of all available charts from the parent trial, all of which were requested. Unreviewed charts included those lost to follow-up or from sites not participating in the reabstraction. Duration of hypoglycemia (<40 mg/dL), lowest value and treatment, if any, were assessed by group. Measures of association and regression models were used where appropriate. RESULTS: Of 2,831 randomized, 2,609 (92.2%) were included. There were 387 (29.3%) and 223 (17.3%) with hypoglycemia in the betamethasone and placebo groups, respectively (relative risk [RR]: 1.69, 95% confidence interval [CI]: 1.46-1.96). Hypoglycemia generally occurred in the first 24 hours in both groups: 374/385 (97.1%) in the betamethasone group and 214/222 (96.4%) in the placebo group (p = 0.63). Of 387 neonates with hypoglycemia in the betamethasone group, 132 (34.1%) received treatment, while 73/223 (32.7%) received treatment in placebo group (p = 0.73). The lowest recorded blood sugar was similar between groups. Most hypoglycemia resolved by 24 hours in both (93.0 vs. 89.3% in the betamethasone and placebo groups, respectively, p = 0.18). Among infants with hypoglycemia in the first 24 hours, the time to resolution was shorter in the betamethasone group (2.80 [interquartile range: 2.03-7.03) vs. 3.74 (interquartile range: 2.15-15.08) hours; p = 0.002]. Persistence for >72 hours was rare and similar in both groups, nine (2.4%, betamethasone) and four (1.9%, placebo, p = 0.18). CONCLUSION: In this cohort, hypoglycemia was transient and most received no treatment, with a quicker resolution in the betamethasone group. Prolonged hypoglycemia was uncommon irrespective of steroid exposure. KEY POINTS: · Hypoglycemia was transient and approximately two-thirds received no treatment.. · Neonates in the ALPS trial who received betamethasone had a shorter time to resolution than those with hypoglycemia in the placebo group.. · Prolonged hypoglycemia occurred in approximately 2 out of 100 late preterm newborns, irrespective of antenatal steroid exposure..


Asunto(s)
Hipoglucemia , Nacimiento Prematuro , Síndrome de Dificultad Respiratoria del Recién Nacido , Lactante , Recién Nacido , Femenino , Embarazo , Humanos , Nacimiento Prematuro/prevención & control , Estudios de Cohortes , Síndrome de Dificultad Respiratoria del Recién Nacido/prevención & control , Síndrome de Dificultad Respiratoria del Recién Nacido/tratamiento farmacológico , Betametasona/efectos adversos , Hipoglucemia/inducido químicamente
10.
Am J Obstet Gynecol ; 228(2): 217.e1-217.e14, 2023 02.
Artículo en Inglés | MEDLINE | ID: mdl-35970202

RESUMEN

BACKGROUND: Delayed cord clamping and umbilical cord milking provide placental transfusion to vigorous newborns. Delayed cord clamping in nonvigorous newborns may not be provided owing to a perceived need for immediate resuscitation. Umbilical cord milking is an alternative, as it can be performed more quickly than delayed cord clamping and may confer similar benefits. OBJECTIVE: We hypothesized that umbilical cord milking would reduce admission to the neonatal intensive care unit compared with early cord clamping in nonvigorous newborns born between 35 and 42 weeks' gestation. STUDY DESIGN: This was a pragmatic cluster-randomized crossover trial of infants born at 35 to 42 weeks' gestation in 10 medical centers in 3 countries between January 2019 and May 2021. The centers were randomized to umbilical cord milking or early cord clamping for approximately 1 year and then crossed over for an additional year or until the required number of consented subjects was reached. Waiver of consent as obtained in all centers to implement the intervention. Infants were eligible if nonvigorous at birth (poor tone, pale color, or lack of breathing in the first 15 seconds after birth) and were assigned to umbilical cord milking or early cord clamping according to their birth hospital randomization assignment. The baseline characteristics and outcomes were collected following deferred informed consent. The primary outcome was admission to the neonatal intensive care unit for predefined criteria. The main safety outcome was hypoxic-ischemic encephalopathy. Data were analyzed by the intention-to-treat concept. RESULTS: Among 16,234 screened newborns, 1780 were eligible (905 umbilical cord milking, 875 early cord clamping), and 1730 had primary outcome data for analysis (97% of eligible; 872 umbilical cord milking, 858 early cord clamping) either via informed consent (606 umbilical cord milking, 601 early cord clamping) or waiver of informed consent (266 umbilical cord milking, 257 early cord clamping). The difference in the frequency of neonatal intensive care unit admission using predefined criteria between the umbilical cord milking (23%) and early cord clamping (28%) groups did not reach statistical significance (modeled odds ratio, 0.69; 95% confidence interval, 0.41-1.14). Umbilical cord milking was associated with predefined secondary outcomes, including higher hemoglobin (modeled mean difference between umbilical cord milking and early cord clamping groups 0.68 g/dL, 95% confidence interval, 0.31-1.05), lower odds of abnormal 1-minute Apgar scores (Apgar ≤3, 30% vs 34%, crude odds ratio, 0.72; 95% confidence interval, 0.56-0.92); cardiorespiratory support at delivery (61% vs 71%, modeled odds ratio, 0.57; 95% confidence interval, 0.33-0.99), and therapeutic hypothermia (3% vs 4%, crude odds ratio, 0.57; 95% confidence interval, 0.33-0.99). Moderate-to-severe hypoxic-ischemic encephalopathy was significantly less common with umbilical cord milking (1% vs 3%, crude odds ratio, 0.48; 95% confidence interval, 0.24-0.96). No significant differences were observed for normal saline bolus, phototherapy, abnormal 5-minute Apgar scores (Apgar ≤6, 15.7% vs 18.8%, crude odds ratio, 0.81; 95% confidence interval, 0.62-1.06), or a serious adverse event composite of death before discharge. CONCLUSION: Among nonvigorous infants born at 35 to 42 weeks' gestation, umbilical cord milking did not reduce neonatal intensive care unit admission for predefined criteria. However, infants in the umbilical cord milking arm had higher hemoglobin, received less delivery room cardiorespiratory support, had a lower incidence of moderate-to-severe hypoxic-ischemic encephalopathy, and received less therapeutic hypothermia. These data may provide the first randomized controlled trial evidence that umbilical cord milking in nonvigorous infants is feasible, safe and, superior to early cord clamping.


Asunto(s)
Enfermedades del Recién Nacido , Clampeo del Cordón Umbilical , Cordón Umbilical , Femenino , Humanos , Recién Nacido , Embarazo , Transfusión Sanguínea , Constricción , Estudios Cruzados , Hemoglobinas , Hipoxia-Isquemia Encefálica/etiología , Recien Nacido Prematuro , Placenta , Cordón Umbilical/cirugía , Clampeo del Cordón Umbilical/métodos , Enfermedades del Prematuro/cirugía , Enfermedades del Prematuro/terapia , Enfermedades del Recién Nacido/cirugía , Enfermedades del Recién Nacido/terapia
12.
Obstet Gynecol ; 139(6): 1043-1049, 2022 06 01.
Artículo en Inglés | MEDLINE | ID: mdl-35675601

RESUMEN

OBJECTIVE: To estimate the association between timing of administration of adjunctive azithromycin for prophylaxis at unscheduled cesarean delivery and maternal infection and neonatal morbidity. METHODS: We conducted a secondary analysis of a randomized trial of adjunctive azithromycin prophylaxis in patients with singleton gestations who were undergoing unscheduled cesarean delivery. The primary exposure was the timing of initiation of the study drug (after skin incision or 0-30 minutes, more than 30-60 minutes, or more than 60 minutes before skin incision). The primary outcome was a composite of endometritis, wound infection, and other maternal infections occurring up to 6 weeks after cesarean delivery. Secondary outcomes included composite neonatal morbidity, neonatal intensive care unit admission for longer than 72 hours, and neonatal sepsis. The association of azithromycin with outcomes was compared within each antibiotic timing group and presented as risk ratios (RRs) with 95% CIs. A Breslow-Day homogeneity test was applied to assess differences in association by antibiotic timing. RESULTS: Of 2,013 participants, antibiotics were initiated after skin incision (median 3 minutes, range 0-229 minutes) in 269 (13.4%), 0-30 minutes before skin incision in 1,378 (68.5%), more than 30-60 minutes before skin incision in 270 (13.4%), and more than 60 minutes before skin incision (median 85 minutes, range 61-218 minutes) in 96 (4.8%). The RRs (95% CIs) of the infectious composite outcome for azithromycin compared with placebo were significantly lower for groups that initiated azithromycin after skin incision or within 1 hour before skin incision (after skin incision: RR 0.31, 95% CI 0.13-0.76; 0-30 minutes before: RR 0.62, 95% CI 0.44-0.89; more than 30-60 minutes before: 0.31, 95% CI 0.13-0.66). Risks were not significantly different in patients who received azithromycin more than 60 minutes before skin incision (RR 0.59, 95% CI 0.10-3.36). Results were similar when endometritis and wound infections were analyzed separately. Neonatal outcomes were not significantly different for azithromycin compared with placebo across all timing groups. CONCLUSION: Adjunctive azithromycin administration up to 60 minutes before or at a median of 3 minutes after skin incision was associated with reduced risks of maternal composite postoperative infection in unscheduled cesarean deliveries. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT01235546.


Asunto(s)
Azitromicina , Endometritis , Antibacterianos/uso terapéutico , Profilaxis Antibiótica/métodos , Azitromicina/uso terapéutico , Endometritis/prevención & control , Femenino , Humanos , Recién Nacido , Embarazo , Infección de la Herida Quirúrgica/prevención & control
13.
Hypertension ; 79(7): 1515-1524, 2022 07.
Artículo en Inglés | MEDLINE | ID: mdl-35545947

RESUMEN

BACKGROUND: The ability to diagnose preeclampsia clinically is suboptimal. Our objective was to validate a novel multianalyte assay and characterize its performance, when intended for use as an aid to rule-out preeclampsia. METHODS: Prospective, multicenter cohort study of pregnant individuals presenting between 280/7 and 366/7 weeks' with preeclampsia-associated signs and symptoms. Individuals not diagnosed with preeclampsia after baseline evaluation were enrolled in the study cohort, with those who later developed preeclampsia, classified as cases and compared with a negative control group who did not develop preeclampsia. Individuals with assay values at time of enrollment ≥0.0325, determined using a previously developed algorithm, considered at risk. The primary analysis was the time to develop preeclampsia assessed using a multivariate Cox regression model. RESULTS: One thousand thirty-six pregnant individuals were enrolled in the study cohort with an incidence of preeclampsia of 30.3% (27.6%-33.2%). The time to develop preeclampsia was shorter for those with an at-risk compared with negative assay result (log-rank P<0.0001; adjusted hazard ratio of 4.81 [3.69-6.27, P<0.0001]). The performance metrics for the assay to rule-out preeclampsia within 7 days of enrollment showed a sensitivity 76.4% (67.5%-83.5%), negative predictive value 95.0% (92.8%-96.6%), and negative likelihood ratio 0.46 (0.32-0.65). Assay performance improved if delivery occurred <37 weeks and for individuals enrolled between 28 and 35 weeks. CONCLUSIONS: We confirmed that a novel multianalyte assay was associated with the time to develop preeclampsia and has a moderate sensitivity and negative likelihood ratio but high negative predictive value when assessed as an aid to rule out preeclampsia within 7 days of enrollment. REGISTRATION: The study was registered on Clinicaltrials.gov (Identifier NCT02780414).


Asunto(s)
Preeclampsia , Biomarcadores , Estudios de Cohortes , Femenino , Humanos , Preeclampsia/diagnóstico , Preeclampsia/epidemiología , Valor Predictivo de las Pruebas , Embarazo , Estudios Prospectivos
14.
Am J Perinatol ; 39(10): 1042-1047, 2022 07.
Artículo en Inglés | MEDLINE | ID: mdl-35253125

RESUMEN

OBJECTIVE: Despite legislation and hospital policies (present in some institutions) mandating a minimum length of stay in an effort to decrease the frequency of hospital readmissions, the effectiveness of this approach remains uncertain.We hypothesized that following cesarean delivery (CD), the rates of maternal readmission or unscheduled health care visits are lower in patients discharged on postoperative day (POD) 3 or ≥4 as compared with those discharged earlier on POD 2. METHODS: This is a secondary analysis of a multicenter randomized trial comparing adjunctive azithromycin for unscheduled CD to prevent infection. Groups were compared based on the duration of hospitalization measured in days from delivery (POD 0) to day of discharge and categorized as POD 2, 3, and ≥4. The primary outcome was the composite of any maternal postpartum readmission, unscheduled clinic, or emergency room (ER) visit, within 6 weeks of delivery. Secondary outcomes included components of the primary outcome and neonatal readmissions. We excluded women with hypertensive disorders of pregnancy and infections diagnosed prior to POD 2. RESULTS: A total of 1,391 patients were included. The rate of the primary outcome of any readmission increased with POD at discharge: 5.9% for POD 2, 9.4% for POD 3, and 10.9% for POD ≥4 group (trend for p = 0.03). The primary outcome increased with later discharge (POD ≥4 when compared with POD 2). Among components of the composite, ER and unscheduled clinic visits, but not maternal readmissions, increased with the timing of discharge for patients discharged on POD ≥4 when compared with POD 2. Using logistic regression, discharge on POD 3 and on POD ≥4 was significantly associated with the composite (adjusted odds ratios [aOR] 2.6, 95% confidence interval [CI] [1.3-5.3]; aOR 2.9, 95% CI [1.3-6.4], respectively) compared with POD 2. CONCLUSION: The risk of maternal readmission composite following uncomplicated but unscheduled CD was not lower in patients discharged home on POD 3 or ≥4 compared with patients discharged earlier (POD 2). KEY POINTS: · Risk of maternal readmission is higher in patients discharged on POD 3 or 4 compared with POD 2.. · No significant differences by the timing of discharge were observed for any neonatal readmissions.. · Timing of discharge should include an individualized approach with the option of discharge by POD 2..


Asunto(s)
Alta del Paciente , Readmisión del Paciente , Azitromicina , Cesárea , Femenino , Humanos , Recién Nacido , Modelos Logísticos , Embarazo , Estudios Retrospectivos
15.
Am J Perinatol ; 39(5): 539-545, 2022 04.
Artículo en Inglés | MEDLINE | ID: mdl-33003227

RESUMEN

OBJECTIVE: This study was aimed to evaluate the relationship between cesarean skin incision length and wound complications. STUDY DESIGN: Planned secondary analysis of a multicenter double-blind randomized trial of adjunctive azithromycin versus placebo (in addition to standard cefazolin) in women ≥24 weeks undergoing cesarean delivery during labor or ≥4 hours after membrane rupture. Skin incision length (cm) was measured just prior to skin closure. The primary outcome was a composite of wound complications (wound infection, separation, seroma, hematoma, or dehiscence) up to 6 weeks of postpartum. Individual components of the composite were examined as secondary outcomes. Outcomes were compared between groups defined by the lowest (≤25th), middle (25-75th) and highest (>75th) incision length quartiles. Logistic regression was used to adjust for potential confounding variables. RESULTS: Of the 2,013 women enrolled in the primary trial, 1,916 had recorded incision lengths and were included in this secondary analysis. The overall rate of composite wound complications was 7.8%. Median incision length was 15.0 cm (interquartile range: 14.0-16.5) with the lowest quartile defined as ≤14, middle as >14 to ≤16.5, and highest as >16.5 cm. Mean BMI, parity, use of staples, and duration of surgery differed significantly between the three incision length groups. In unadjusted analysis, the longest incision lengths were associated with an increased risk of the wound composite and wound infections (odds ratio [OR] = 2.27, 95% confidence interval [CI]: 1.43-3.60 and OR = 2.30, 95% CI: 1.27-4.15, respectively) compared with the shortest incision lengths. However, after multivariable adjustments, these associations were nullified. Additional analyses considering incision length as a continuous variable and using 10th/90th percentile cut-offs still did not suggest any associations with outcomes. CONCLUSION: Increasing skin incision length is not independently associated with an increased risk of postoperative wound complications. KEY POINTS: · After multivariable adjustments, skin incision length was not independently associated with an increased risk of postoperative wound complications.. · A reasonable incision length needed to safely perform the procedure should be used..


Asunto(s)
Complicaciones Posoperatorias , Infección de la Herida Quirúrgica , Cesárea/efectos adversos , Cesárea/métodos , Femenino , Humanos , Complicaciones Posoperatorias/epidemiología , Complicaciones Posoperatorias/etiología , Embarazo , Seroma/epidemiología , Seroma/etiología , Dehiscencia de la Herida Operatoria/epidemiología , Dehiscencia de la Herida Operatoria/etiología , Infección de la Herida Quirúrgica/epidemiología , Infección de la Herida Quirúrgica/etiología , Suturas/efectos adversos
16.
J Interpers Violence ; 37(19-20): NP18960-NP18987, 2022 10.
Artículo en Inglés | MEDLINE | ID: mdl-34715764

RESUMEN

There is little research on virtual service models like chat and text services in agencies that work with survivors of intimate partner violence (IPV) and sexual assault (SA). This study fills a gap in the research by exploring how chat and text services are provided in one IPV and SA-focused community organization. We analyzed chat and text transcripts (n = 392) from a large multiservice, multivictimization focused agency, and conducted interviews with 11 advocates providing chat and text services through the agency hotline. Staff interviews were analyzed using grounded theory and transcripts were analyzed using content analysis. Results indicate chat/text services provide a space for connection, resource provision, education, and access to resource gain in a timely, concise, and survivor-centered way. The five major goals for chat/text advocacy models include the following: (1) rapid access to support and connection; (2) identification of options and needs for each service user; (3) increased access to resources and supports; (4) expanded understanding of violence, abuse, and harm; and (5) improvement of survivor safety. The research team identified 15 general advocacy skills and 4 chat and text specific skills used by chat/text advocates to reach program goals. Findings highlight the utility of chat/text services for increasing access to support services for survivors of violence, particularly adolescents, emerging adults, those living with an abusive individual, and during times of emergency. Future research should continue to explore the promising practice modality of chat/text services for providing advocacy to underserved and hard-to-reach populations.


Asunto(s)
Violencia de Pareja , Sobrevivientes , Adolescente , Adulto , Humanos
17.
Obstet Gynecol ; 138(5): 788-794, 2021 11 01.
Artículo en Inglés | MEDLINE | ID: mdl-34619726

RESUMEN

OBJECTIVE: To evaluate patient safety, resource utilization, and transfusion-related cost after a policy change from universal type and screen to selective type and screen on admission to labor and delivery. METHODS: Between October 2017 and September 2019, we performed a single-center implementation study focusing on risk-based type and screen instead of universal type and screen. Implementation of our policy was October 2018 and compared 1 year preimplementation with 1 year postimplementation. Patients were risk-stratified in alignment with California Maternal Quality Care Collaborative recommendations. Under the new policy, the blood bank holds a blood sample for processing (hold clot) on patients at low- and medium-risk of hemorrhage. Type and screen and crossmatch are obtained on high-risk patients or with a prior positive antibody screen. We collected patient outcomes, safety and cost data, and compliance and resource utilization metrics. Cost included direct costs of transfusion-related testing in the labor and delivery unit during the study period, from a health system perspective. RESULTS: In 1 year postimplementation, there were no differences in emergency-release transfusion events (4 vs 3, P>.99). There were fewer emergency-release red blood cell (RBC) units transfused (9 vs 24, P=.002) and O-negative RBC units transfused (8 vs 18, P=.016) postimplementation compared with preimplementation. Hysterectomies (0.05% vs 0.1%, P=.44) and intensive care unit admissions (0.45% vs 0.51%, P=.43) were not different postimplementation compared with preimplementation. Postimplementation, mean monthly type and screen-related costs (ABO typing, antibody screen, and antibody workup costs) were lower, $9,753 compared with $20,676 in the preimplementation year, P<.001. CONCLUSION: Implementation of selective type and screen policy in the labor and delivery unit was associated with projected annual savings of $181,000 in an institution with 4,000 deliveries per year, without evidence of increased maternal morbidity.


Asunto(s)
Transfusión Sanguínea/economía , Transfusión Sanguínea/métodos , Trabajo de Parto , Seguridad del Paciente , Adulto , Bancos de Sangre , Tipificación y Pruebas Cruzadas Sanguíneas/economía , Tipificación y Pruebas Cruzadas Sanguíneas/métodos , Costos y Análisis de Costo , Femenino , Hemorragia/epidemiología , Hospitalización/estadística & datos numéricos , Humanos , Histerectomía/estadística & datos numéricos , Unidades de Cuidados Intensivos/estadística & datos numéricos , Políticas , Embarazo , Adulto Joven
18.
Hepatol Commun ; 5(2): 323-333, 2021 02.
Artículo en Inglés | MEDLINE | ID: mdl-33553978

RESUMEN

Acquired hepatocerebral degeneration refers to a neurological syndrome consisting of various movement disorders and cognitive impairment in advanced liver cirrhosis or portosystemic shunt. Neurological signs and symptoms may be attributed to the accumulation of toxic substances in the brain. The most common neurological presentation of this is parkinsonism. Our prospective study aimed to investigate the prevalence of parkinsonism in patients with cirrhosis who were evaluated for liver transplant and to identify any correlation between findings on brain magnetic resonance imaging (MRI) and severity of parkinsonism. Of the 120 enrolled participants with liver cirrhosis, 62 (52%) exhibited signs of parkinsonism and all had MRI basal ganglia hyperintensity. Eighteen patients from this group were transplanted and showed statistically significant improvements in their Unified Parkinson's Disease Rating Scale (UPDRS) scores. Conclusion: The data suggest the reversibility of the neurological impairment seen in cirrhosis, and therefore the effectiveness of transplantation in improving parkinsonian symptoms. There was no correlation between severity of MRI findings and clinical motor UPDRS part III. Laboratory findings showed no correlation among the abnormal levels, MRI brain signal abnormality, or UPDRS scores.


Asunto(s)
Encéfalo/patología , Cirrosis Hepática/complicaciones , Trastornos Parkinsonianos/diagnóstico , Trastornos Parkinsonianos/epidemiología , Adulto , Anciano , Femenino , Humanos , Cirrosis Hepática/cirugía , Trasplante de Hígado/estadística & datos numéricos , Imagen por Resonancia Magnética , Masculino , Massachusetts/epidemiología , Persona de Mediana Edad , Trastornos Parkinsonianos/patología , Prevalencia , Estudios Prospectivos , Índice de Severidad de la Enfermedad , Adulto Joven
20.
J Perinatol ; 41(2): 286-294, 2021 02.
Artículo en Inglés | MEDLINE | ID: mdl-32978526

RESUMEN

OBJECTIVE: To test associations between grades 3 or 4 (severe) intraventricular hemorrhage (IVH) and single nucleotide polymorphisms (SNPs) associated with coagulation, inflammation, angiogenesis, and organ development in an exploratory study. STUDY DESIGN: Extremely low-birthweight (ELBW) infants enrolled in the Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network's (NRN) Cytokines Study were included if they had cranial ultrasound (CUS) and genotyping data available in the NRN Anonymized DNA Repository and Database. Associations between SNPs and IVH severity were tested with multivariable logistic regression analysis. RESULT: One hundred thirty-nine infants with severe IVH and 687 infants with grade 1 or 0 IVH were included. One thousand two hundred seventy-nine SNPs were genotyped. Thirteen were preliminarily associated with severe IVH including five related to central nervous system (CNS) neuronal and neurovascular development. CONCLUSION: Genetic variants for CNS neuronal and neurovascular development may be associated with severe IVH in premature infants.


Asunto(s)
Recien Nacido con Peso al Nacer Extremadamente Bajo , Enfermedades del Prematuro , Peso al Nacer , Hemorragia Cerebral/diagnóstico por imagen , Hemorragia Cerebral/genética , Niño , Humanos , Lactante , Recién Nacido , Recien Nacido Prematuro , Enfermedades del Prematuro/genética
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