Comparison of maternal and neonatal outcome before and after the availability of a rapid assay for fetal fibronectin at a tertiary level maternity hospital

Spontaneous preterm birth prior to 37 weeks gestation is a leading cause of neonatal morbidity and mortality. The preterm birth rate in the United States remains higher than in many other westernized countries. The etiology of preterm birth, identification of women at risk, and effective interventions for preterm birth prevention remain public health, research, and clinical challenges. Fetal fibronectin (FFN), a specific biomarker, seen in cervical and vaginal secretions with disruption of the decidual interface, predicts risk for preterm delivery. The purpose of this retrospective cohort study was to examine whether the availability of clinical FFN testing had an impact on preterm birth, NICU admissions, or use of hospital services. The study compared cohorts seen for assessment of preterm labor symptoms in the six months prior (n=372) to and after (n=390) availability of testing ; 215 tests were performed on 183 subjects. Test use increased significantly during the time of test availability, (trend, p < 0.001) however, overall test utilization rate remained below 50%. The study failed to demonstrate a reduction in preterm delivery, NICU admission, or hospital admissions. Lack of major significant study findings are likely attributable to insufficient power due to limited test utilization, prolonged implementation time, and lack of procedural policies, which reduced the potential impact of testing on patient care. The test negative predictive value (100%) for delivery within 14 days was consistent with previous findings, however, this did not lead to the reduced hospital admissions seen in previous studies. Findings suggest that implementation of FFN testing in clinical settings takes time and requires more rigorous policies for use to replicate previous research findings. Current practice combines FFN testing with cervical length and consideration of other risk factors, especially a history of preterm birth, to improve diagnostic precision. Use of predictive algorithms using the best evidence and predictive factors for subpopulations may lead to improved diagnostic precision in the futur

Maternal bleeding complications following early versus delayed umbilical cord clamping in multiple pregnancies

Abstract Background In 2015, the American Academy of Pediatrics recommended delayed umbilical cord clamping for at least 30–60 s for all infants. However, there is limited data regarding the maternal safety of delayed cord clamping in multiple pregnancies. We aimed to compare the maternal bleeding complications following early cord clamping (ECC) versus of delayed cord clamping (DCC) in multiple pregnancies. Methods A retrospective cohort study of pregnant women with multiples who delivered live-born infants at Sharp Healthcare Hospitals in San Diego, CA, USA during January 1st, 2016 – September 30th, 2017. Bleeding complications of 295 women who underwent ECC (less than 30 s) were compared with 154 women who underwent DCC (more than 30 s). ECC or DCC was performed according to individual obstetrician discretion. Results Four hundred forty-nine women with multiple pregnancies (N = 910 infants) were included in the study. 252 (85.4%) women underwent cesarean section in ECC group vs. 99 (64.3%) in DCC group. 58 (19.7%) women delivered monochorionic twins in ECC group vs. 32 (20.8%) women in DCC group. There was no increase in maternal estimate blood loss when DCC was performed comparing to ECC. There were no differences in operative time, post-delivery decrease in hematocrits, rates of postpartum hemorrhage, bleeding complications, maternal blood transfusions and therapeutic hysterectomy between the two groups. Conclusions No differences in maternal bleeding complications were found with DCC in multiple pregnancies compared to ECC. Delayed cord clamping can be done safely in multiple pregnancies without any increased maternal risk

Acceptability of Bedside Resuscitation With Intact Umbilical Cord to Clinicians and Patients’ Families in the United States

BackgroundWhile delayed umbilical cord clamping in preterm infants has shown to improve long-term neurological outcomes, infants who are thought to need resuscitation do not receive delayed cord clamping even though they may benefit the most. A mobile resuscitation platform allows infants to be resuscitated at the mother’s bedside with the cord intact. The newborn is supplied with placental blood during the resuscitation in view of the mother. The objective of the study is to assess the usability and acceptability of mobile resuscitation platform, LifeStart trolley, among the infants’ parents and perinatal providers.MethodsA resuscitation platform was present during every delivery that required advanced neonatal providers for high-risk deliveries. Perinatal providers and parents of the infants were given a questionnaire shortly after the delivery.Results60 neonatal subjects were placed on the trolley. The majority of deliveries were high risk for meconium-stained amniotic fluid (43%), and non-reassuring fetal heart rate (45%). About 50% of neonatal providers felt that there were some concerns regarding access to the baby. No parents were uncomfortable with the bedside neonatal interventions, and most parents perceived that communication was improved because of the proximity to the care team.ConclusionBedside resuscitation with umbilical cord intact through the use of a mobile resuscitation trolley is feasible, safe, and effective, but about half of the perinatal providers expressed concerns. Logistical issues such as improved space management and/or delivery setup should be considered in centers planning to perform neonatal resuscitation with an intact cord

Cardiac and cerebral hemodynamics with umbilical cord milking compared with early cord clamping: A randomized cluster crossover trial.

OBJECTIVE: A large, randomized cluster cross-over trial (N = 1730) comparing intact umbilical cord milking (UCM) to early cord clamping (ECC) in non-vigorous near-term/term newborns demonstrated a reduction in cardiorespiratory interventions at birth and less moderate to severe hypoxic ischemic encephalopathy. We evaluated changes in cerebral tissue oxygenation (StO2), pulse oximetry (SpO2), pulse rate and fraction of inspired oxygen (FiO2) during the first 10 min of life in a subset of infants enrolled in the parent trial. STUDY DESIGN: Infants enrolled in the Milking in Non-Vigorous Infants trial that had StO2 monitoring at birth were included in the sub-study conducted at 3 hospitals the US and Canada. A near-infrared spectroscopy sensor, pulse oximeter and electrocardiogram electrodes were placed. Pulse rate, StO2, SpO2, and FiO2 were collected for the first 10 min after birth. Longitudinal models were used to compare effects of UCM and ECC. RESULTS: Thirty-four infants had StO2 data. Fifteen of these infants received UCM and 19 had ECC. Infants receiving UCM had similar heart rates, SpO2, and StO2 values, but were exposed to less FiO2 over the first 10 min of life than infants with ECC (0.26 ± 0.12 vs. 0.81 ± 0.05 at 10 min). CONCLUSION: Non-vigorous term/near term infants who received UCM at birth required lower FiO2 after delivery when compared to infants who umbilical cords were clamped soon after birth while achieving similar peripheral and cerebral oxygenation. Cord milking may be a potential option for placental transfusion in non-vigorous near term/term infants when delayed cord clamping cannot be performed

Infrared Tympanic Thermometry for Neonatal Temperature Assessment

Objective To investigate the accuracy and precision of infrared tympanic thermometer use with neonates by comparing with axillary and rectal measurements. Design: Descriptive, comparative study. Setting Newborn nursery of a tertiary‐level perinatal center. Subjects Thirty‐four full‐term newborns. Instruments Infrared thermometers were used to collect tympanic temperatures. An electronic thermometer was used to collect axillary and rectal temperatures. Results There was no significant difference between tympanic and axillary temperatures. The range of variation (95% CI) was ± 0.7–.9°C. The mean difference between tympanic and rectal measurements was 0.4°C. The range of variation was ± 0.7–0.75°C. Right ear measurements produced the best approximation of axillary temperature, and protected ear measurements produced the best approximation of rectal temperature. The protected ear was 0.2–0.3°C higher than the exposed ear. Conclusions There was more variation between tympanic versus axillary and tympanic versus rectal measurements than between axillary and rectal measurements. Tympanic thermometry may be useful for rapid screening of neonatal temperature, but its usefulness for monitoring unstable neonates remains in question

Umbilical cord milking in non-vigorous infants: A cluster-randomized crossover trial

BACKGROUND: Delayed cord clamping (DCC) and umbilical cord milking (UCM) provide placental transfusion to vigorous newborns. Delayed cord clamping in non-vigorous newborns may not be provided due to perceived need for immediate resuscitation. UCM is an alternative since it can be performed more quickly than DCC and may confer similar benefits. OBJECTIVE: We hypothesized that UCM would reduce admission to the neonatal intensive care unit (NICU) compared with early cord clamping (ECC) in non-vigorous newborns born between 35-42 weeks\u27 gestation. STUDY DESIGN: A pragmatic cluster-randomized crossover trial of infants born at 35-42 weeks\u27 gestation from 10 medical centers in 3 countries between January 2019 and May 2021. Centers were randomized to UCM or ECC for approximately one 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 non-vigorous at birth (poor tone, pale color, or lack of breathing in the first 15 seconds after birth) and were assigned to UCM or ECC according to their birth hospital randomization assignment. Baseline characteristics and outcomes were collected following deferred informed consent. The primary outcome was admission to the NICU for predefined criteria. The main safety outcome was hypoxic-ischemic encephalopathy (HIE). Data were analyzed by intention to treat. RESULTS: Among 16,234 screened newborns, 1780 were eligible (905 UCM, 875 ECC) and 1730 had primary outcome data for analysis (97% of eligible; 872 UCM, 858 ECC) via either informed consent (606 UCM, 601 ECC) or waiver of informed consent (266 UCM, 257 ECC). The difference in the frequency of NICU admission using predefined criteria between the UCM (23%) and ECC (28%) groups did not reach statistical significance (modeled OR 0.69, 95% CI 0.41-1.14). UCM was associated with predefined secondary outcomes including a higher hemoglobin (modeled mean difference between UCM and ECC groups 0.68 g/dL, 95% CI 0.31-1.05), lower odds of abnormal 1-minute Apgar scores (Apgar ≤3, 30% vs 34%, crude OR 0.72, 95%CI 0.56-0.92); cardiorespiratory support at delivery (61% vs 71%, modeled OR 0.57, 95% CI 0.33-0.99) and therapeutic hypothermia (3% vs 4%, crude OR 0.57, 95% CI 0.33-0.99). Moderate-severe HIE was significantly less common with UCM (1% vs 3%, crude OR 0.48, 95% CI 0.24-0.96). No significant difference was observed for normal saline bolus, phototherapy, abnormal 5-minute Apgar scores (Apgar ≤6, 15.7% vs 18.8%, crude OR 0.81, 95% CI 0.62-1.06), or a serious adverse event composite of death before discharge. CONCLUSIONS: Among non-vigorous infants born at 35-42 weeks\u27 gestation, UCM did not reduce NICU admission for predefined criteria. However, infants in the UCM arm had higher hemoglobin, received less delivery room cardiorespiratory support, had a lower incidence of moderate to severe HIE and received less therapeutic hypothermia. These data may provide the first randomized controlled trial evidence that UCM in non-vigorous infants is feasible, safe and superior to ECC

Umbilical cord milking in nonvigorous infants: a cluster-randomized crossover trial.

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\u27 gestation. STUDY DESIGN: This was a pragmatic cluster-randomized crossover trial of infants born at 35 to 42 weeks\u27 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\u27 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