Healthcare provider experiences of deploying a continuous remote patient monitoring pilot program during the COVID-19 pandemic: a structured qualitative analysis.

Objective: To describe the healthcare provider (HCP) experience of launching a COVID-19 remote patient monitoring (CRPM) program during the global COVID-19 pandemic. Methods: We conducted qualitative, semi-structured interviews with eight HCPs involved in deploying the CRPM pilot program in the Military Health System (MHS) from June to December 2020. Interviews were audio recorded, transcribed, and analyzed thematically using an inductive approach. We then deductively mapped themes from interviews to the updated Consolidated Framework for Implementation Research (CFIR). Results: We identified the following main themes mapped to CFIR domains listed in parentheses: external and internal environments (outer and inner settings), processes around implementation (implementation process domain), the right people (individuals domain), and program characteristics (innovation domain). Participants believed that buy-in from leadership and HCPs was critical for successful program implementation. HCP participants showed qualities of clinical champions and believed in the CRPM program. Conclusion: The MHS deployed a successful remote patient monitoring pilot program during the global COVID-19 pandemic. HCPs found the CRPM program and the technology enabling the program to be acceptable, feasible, and usable. HCP participants exhibited characteristics of clinical champions. Leadership engagement was the most often-cited key factor for successful program implementation.

Financial and Clinical Impact of Virtual Care During the COVID-19 Pandemic: Difference-in-Differences Analysis.

BACKGROUND: Virtual care (VC) and remote patient monitoring programs were deployed widely during the COVID-19 pandemic. Deployments were heterogeneous and evolved as the pandemic progressed, complicating subsequent attempts to quantify their impact. The unique arrangement of the US Military Health System (MHS) enabled direct comparison between facilities that did and did not implement a standardized VC program. The VC program enrolled patients symptomatic for COVID-19 or at risk for severe disease. Patients' vital signs were continuously monitored at home with a wearable device (Current Health). A central team monitored vital signs and conducted daily or twice-daily reviews (the nurse-to-patient ratio was 1:30). OBJECTIVE: Our goal was to describe the operational model of a VC program for COVID-19, evaluate its financial impact, and detail its clinical outcomes. METHODS: This was a retrospective difference-in-differences (DiD) evaluation that compared 8 military treatment facilities (MTFs) with and 39 MTFs without a VC program. Tricare Prime beneficiaries diagnosed with COVID-19 (Medicare Severity Diagnosis Related Group 177 or International Classification of Diseases-10 codes U07.1/07.2) who were eligible for care within the MHS and aged 21 years and or older between December 2020 and December 2021 were included. Primary outcomes were length of stay and associated cost savings; secondary outcomes were escalation to physical care from home, 30-day readmissions after VC discharge, adherence to the wearable, and alarms per patient-day. RESULTS: A total of 1838 patients with COVID-19 were admitted to an MTF with a VC program of 3988 admitted to the MHS. Of these patients, 237 (13%) were enrolled in the VC program. The DiD analysis indicated that centers with the program had a 12% lower length of stay averaged across all COVID-19 patients, saving US $2047 per patient. The total cost of equipping, establishing, and staffing the VC program was estimated at US $3816 per day. Total net savings were estimated at US $2.3 million in the first year of the program across the MHS. The wearables were activated by 231 patients (97.5%) and were monitored through the Current Health platform for a total of 3474 (median 7.9, range 3.2-16.5) days. Wearable adherence was 85% (IQR 63%-94%). Patients triggered a median of 1.6 (IQR 0.7-5.2) vital sign alarms per patient per day; 203 (85.7%) were monitored at home and then directly discharged from VC; 27 (11.4%) were escalated to a physical hospital bed as part of their initial admission. There were no increases in 30-day readmissions or emergency department visits. CONCLUSIONS: Monitored patients were adherent to the wearable device and triggered a manageable number of alarms/day for the monitoring-team-to-patient ratio. Despite only enrolling 13% of COVID-19 patients at centers where it was available, the program offered substantial savings averaged across all patients in those centers without adversely affecting clinical outcomes.

Impact of an educational program and decision tool on choice of maternity hospital: the delivery decisions randomized clinical trial.

BACKGROUND: Reducing cesarean rates is a public health priority. To help pregnant people select hospitals with lower cesarean rates, numerous organizations publish publically hospital cesarean rate data. Few pregnant people use these data when deciding where to deliver. We sought to determine whether making cesarean rate data more accessible and understandable increases the likelihood of pregnant people selecting low-cesarean rate hospitals. METHODS: We conducted a 1:1 randomized controlled trial in 2019-2021 among users of a fertility and pregnancy mobile application. Eligible participants were trying to conceive for fewer than five months or were 28-104 days into their pregnancies. Of 189,456 participants approached and enrolled, 120,621 participants met entry criteria and were included in analyses. The intervention group was offered an educational program explaining the importance of hospital cesarean rates and an interactive tool presenting hospital cesarean rates as 1-to-5-star ratings. Control group users were offered an educational program about hospital choice and a hospital choice tool without cesarean rate data. The primary outcome was the star rating of the hospital selected by each patient during pregnancy. Secondary outcomes were the importance of cesarean rates in choosing a hospital and delivery method (post-hoc secondary outcome). RESULTS: Of 120,621 participants (mean [SD] age, 27.8 [7.9]), 12,284 (10.2%) reported their choice of hospital during pregnancy, with similar reporting rates in the intervention and control groups. Intervention group participants selected hospitals with higher star ratings (2.52 vs 2.16; difference, 0.37 [95% CI, 0.32 to 0.43] p < 0.001) and were more likely to believe that the hospitals they chose would impact their chances of having cesarean deliveries (38.5% vs 33.1%, p < 0.001) but did not assign higher priority to cesarean delivery rates when choosing their hospitals (76.2% vs 74.3%, p = 0.05). There was no difference in self-reported cesarean rates between the intervention and control groups (31.4% vs 31.4%, p = 0.98). CONCLUSION: People offered an educational program and interactive tool to compare hospital cesarean rates were more likely to use cesarean data in selecting a hospital and selected hospitals with lower cesarean rates but were not less likely to have a cesarean. CLINICAL TRIAL REGISTRATION: Registered December 9, 2016 at clinicaltrials.gov, First enrollment November 2019. ID NCT02987803, https://clinicaltrials.gov/ct2/show/NCT02987803.

Deployment of an End-to-End Remote, Digitalized Clinical Study Protocol in COVID-19: Process Evaluation.

BACKGROUND: The SARS-CoV-2 (COVID-19) pandemic may accelerate the adoption of digital, decentralized clinical trials. Conceptual recommendations for digitalized and remote clinical studies and technology are available to enable digitalization. Fully remote studies may break down some of the participation barriers in traditional trials. However, they add logistical complexity and offer fewer opportunities to intervene following a technical failure or adverse event. OBJECTIVE: Our group designed an end-to-end digitalized clinical study protocol, using the Food and Drug Administration (FDA)-cleared Current Health (CH) remote monitoring platform to collect symptoms and continuous physiological data of individuals recently infected with COVID-19 in the community. The purpose of this work is to provide a detailed example of an end-to-end digitalized protocol implementation based on conceptual recommendations by describing the study setup in detail, evaluating its performance, and identifying points of success and failure. METHODS: Primary recruitment was via social media and word of mouth. Informed consent was obtained during a virtual appointment, and the CH-monitoring kit was shipped directly to the participants. The wearable continuously recorded pulse rate (PR), respiratory rate (RR), oxygen saturation (SpO2), skin temperature, and step count, while a tablet administered symptom surveys. Data were transmitted in real time to the CH cloud-based platform and displayed in the web-based dashboard, with alerts to the study team if the wearable was not charged or worn. The study duration was up to 30 days. The time to recruit, screen, consent, set up equipment, and collect data was quantified, and advertising engagement was tracked with a web analytics service. RESULTS: Of 13 different study advertisements, 5 (38.5%) were live on social media at any one time. In total, 38 eligibility forms were completed, and 19 (50%) respondents met the eligibility criteria. Of these, 9 (47.4%) were contactable and 8 (88.9%) provided informed consent. Deployment times ranged from 22 to 110 hours, and participants set up the equipment and started transmitting vital signs within 7.6 (IQR 6.3-10) hours of delivery. The mean wearable adherence was 70% (SD 19%), and the mean daily survey adherence was 88% (SD 21%) for the 8 participants. Vital signs were in normal ranges during study participation, and symptoms decreased over time. CONCLUSIONS: Evaluation of clinical study implementation is important to capture what works and what might need to be modified. A well-calibrated approach to online advertising and enrollment can remove barriers to recruitment and lower costs but remains the most challenging part of research. Equipment was effectively and promptly shipped to participants and removed the risk of illness transmission associated with in-person encounters during a pandemic. Wearable technology incorporating continuous, clinical-grade monitoring offered an unprecedented level of detail and ecological validity. However, study planning, relationship building, and troubleshooting are more complex in the remote setting. The relevance of a study to potential participants remains key to its success.

Participant Experiences of a COVID-19 Virtual Clinical Study Using the Current Health Remote Monitoring Platform: Case Study and Qualitative Analysis.

BACKGROUND: During the COVID-19 pandemic, individuals with a positive viral test were enrolled in a study, within 48 hours, to remotely monitor their vital signs to characterize disease progression and recovery. A virtual trial design was adopted to reduce risks to participants and the research community in a study titled Risk Stratification and Early Alerting Regarding COVID-19 Hospitalization (RiskSEARCH). The Food and Drug Administration-cleared Current Health platform with a wearable device is a continuous remote patient monitoring technology that supports hospital-at-home care and is used as a data collection tool. Enrolled participants wore the Current Health wearable device continuously for up to 30 days and took a daily symptom survey via a tablet that was provided. A qualitative substudy was conducted in parallel to better understand virtual trial implementation, including barriers and facilitators for participants. OBJECTIVE: This study aimed to understand the barriers and facilitators of the user experience of interacting with a virtual care platform and research team, while participating in a fully virtual study using qualitative and quantitative data. METHODS: Semistructured interviews were conducted to understand participants' experience of participating in a virtual study during a global pandemic. The schedule included their experience of enrollment and their interactions with equipment and study staff. A total of 3 RiskSEARCH participants were interviewed over telephone, and transcriptions were inductively coded and analyzed using thematic analysis. Themes were mapped onto the Theoretical Domains Framework (TDF) to identify and describe the factors that influenced study adherence. Quantitative metrics, including adherence to wearable and scheduled tasks collected as part of the RiskSEARCH main study, were paired with the interviews to present an overall picture of participation. RESULTS: All participants exceeded our definition of a fully adherent participant and reported that participation was feasible and had a low burden. The symptoms progressively resolved during the trial. Inductive thematic analysis identified 13 main themes from the interview data, which were deductively mapped onto 11 of the 14 TDF domains, highlighting barriers and facilitators for each. CONCLUSIONS: Participants in the RiskSEARCH substudy showed high levels of adherence and engagement throughout participation. Although participants experienced some challenges in setting up and maintaining the Current Health kit (eg, charging devices), they reported feeling that the requirements of participation were both reasonable and realistic. We demonstrated that the TDF can be used for inductive thematic analysis. We anticipate expanding this work in future virtual studies and trials to identify barriers and enabling factors for implementation.

Assessment of Remote Vital Sign Monitoring and Alarms in a Real-World Healthcare at Home Dataset.

The importance of vital sign monitoring to detect deterioration increases during healthcare at home. Continuous monitoring with wearables increases assessment frequency but may create information overload for clinicians. The goal of this work was to demonstrate the impact of vital sign observation frequency and alarm settings on alarms in a real-world dataset. Vital signs were collected from 76 patients admitted to healthcare at home programs using the Current Health (CH) platform; its wearable continuously measured respiratory rate (RR), pulse rate (PR), and oxygen saturation (SpO2). Total alarms, alarm rate, patient rate, and detection time were calculated for three alarm rulesets to detect changes in SpO2, PR, and RR under four vital sign observation frequencies and four window sizes for the alarm algorithms' median filter. Total alarms ranged from 65 to 3113. The alarm rate and early detection increased with the observation frequency for all alarm rulesets. Median filter windows reduced alarms triggered by normal fluctuations in vital signs without compromising the granularity of time between assessments. Frequent assessments enabled with continuous monitoring support early intervention but need to pair with settings that balance sensitivity, specificity, clinical risk, and provider capacity to respond when a patient is home to minimize clinician burden.

Delivery Outcomes During the COVID-19 Pandemic as Reported in a Pregnancy Mobile App: Retrospective Cohort Study.

BACKGROUND: The COVID-19 pandemic has presented obstacles for providers and patients in the maternal health care setting, causing changes to many pregnant women's birth plans, as well as abrupt changes in hospital labor and delivery policies and procedures. Few data exist on the effects of the COVID-19 pandemic on the maternal health care landscape at the national level in the United States. OBJECTIVE: The aim of this study is to assess the incidence of key obstetrics outcomes (preterm delivery, Cesarean sections, and home births) and length of hospital stay during the COVID-19 pandemic as compared to the 6 months prior. METHODS: We conducted a retrospective cohort study of women aged 18-44 years in the United States who delivered between October 1, 2019, and September 30, 2020, had singleton deliveries, and completed a birth report in the Ovia Pregnancy mobile app. Women were assigned to the prepandemic cohort if they delivered between October 2019 and March 2020, and the pandemic cohort if they delivered between April and September 2020. Gestational age at delivery, delivery method, delivery facility type, and length of hospital stay were compared. RESULTS: A total of 304,023 birth reports were collected, with 152,832 (50.26%) in the prepandemic cohort and 151,191 (49.73%) in the pandemic cohort. Compared to the prepandemic cohort, principal findings indicate a 5.67% decrease in preterm delivery rates in the pandemic cohort (P<.001; odds ratio [OR] 0.94, 95% CI 0.91-0.96), a 30.0% increase in home birth rates (P<.001; OR 1.3, 95% CI 1.23-1.4), and a 7.81% decrease in the average hospital length of stay postdelivery (mean 2.48 days, SD 1.35). There were no overall changes in Cesarean section rates between cohorts, but differences were observed between age, race, and ethnicity subgroups. CONCLUSIONS: Results suggest a need for continuous monitoring of maternal health trends as the COVID-19 pandemic progresses and underline the important role of digital data collection, particularly during the pandemic.

Time to conception and the menstrual cycle: an observational study of fertility app users who conceived.

The objective of this research was to evaluate the association between menstrual cycle characteristics (cycle length, cycle-length variability, and their interaction) and the amount of time it takes women to conceive using a robust multiple linear regression. Participants downloaded Ovia Fertility in 2015 indicated that they had just started trying to conceive, and reported conception within 12 months (n = 45,360, adjusted model n = 8835). The average time to conception among women in the adjusted model was 3.94 months (n = 8835). Women with normal cycle lengths (27-29 days) conceived more quickly than women with cycle lengths of 25-26 days (+0.41 months; p < 0.001), 30-31 days (+0.27 months; p < 0.01), 32-33 days (+0.44 months; p < 0.001), and 34+ days (+0.75 months; p < 0.001). Women with regular cycle-length variability (<9 days between cycles) conceived more quickly than women with irregular variability (+0.72 months; p < 0.001). Results of the interaction analysis indicated that, among women with regular cycle-length variability, those with normal cycle length had shorter time to conception than women with either short or long cycle length. The interaction between cycle length and cycle-length variability provided enhanced insights into the amount of time it takes to conceive, compared to either indicator alone.

Patient Experience of Obstetric Care During the COVID-19 Pandemic: Preliminary Results From a Recurring National Survey.

The experience of pregnant and postpartum patients continues to evolve during the COVID-19 pandemic. Limited clinical data and the unknown nature of the virus' impact and transmission routes have forced constant changes to traditional care delivery. Dependence on telehealth technology such as telephonic and videoconferencing has surged, and patients' willingness to visit traditional health care facilities has plummeted. We set out to create an ongoing surveillance system to monitor changes to prenatal and obstetric care and the patient experience during the COVID-19 pandemic.

Findings from a mobile application-based cohort are consistent with established knowledge of the menstrual cycle, fertile window, and conception.

OBJECTIVE: To investigate the validity of self-reported fertility data generated by a mobile application-based cohort in comparison with data collected by traditional clinical methodologies. DESIGN: Data were collected from July 2013 to July 2018 through a mobile application designed to track fertility. Bayesian hierarchical models were used to assess day-specific pregnancy probabilities. Descriptive statistics were used to estimate differences in day of ovulation and lengths of menstrual phases and to assess changes in the cervix and ovulation-related symptoms drawing closer to the day of ovulation. SETTING: Not applicable. PATIENT(S): Data consisted of 225,596 menstrual cycles from 98,903 women. INTERVENTION(S): None. MAIN OUTCOME MEASURE(S): Day-specific probabilities of pregnancy, variability in lengths of the follicular and luteal phases, trends in prevalence of symptoms and cervix changes across the fertile window. RESULT(S): Analyses were consistent with established clinical knowledge. Probability of conception was highest during the 5 days before and day of ovulation, with the highest probability occurring the day before ovulation. The average cycle length was 29.6 days, and average lengths of the follicular and luteal phases were 15.8 and 13.7 days, respectively. Closer to day of ovulation, women were more likely to report changes in the cervix corresponding to fluid consistency, feel, position, and openness and symptoms associated with ovulation, including pelvic pain, tender breasts, increased sex drive, and cramps. CONCLUSION(S): Components of the menstrual cycle and fertile window, when re-evaluated with a mobile application-based cohort, were found to be consistent with established clinical knowledge, suggesting an agreement between traditional and modern data collection methodologies.

Conflict of interest related to clinical practice is underreported: The case of noninvasive prenatal testing.

Authors of policy statements from the American College of Obstetricians and Gynecologists and from the Society for Maternal-Fetal Medicine do not acknowledge the potential for their clinical income to influence their opinions, or the positions of the societies they represent. These policy statements were published in Obstetrics and Gynecology and the American Journal of Obstetrics and Gynecology, again, without acknowledgment of the potential for conflict of interest. The case of noninvasive prenatal testing, which has threatened the role of maternal-fetal medicine in the practice of prenatal screening and diagnosis, and has significantly reduced the demand for invasive prenatal diagnosis, illustrates the importance of identifying this potential conflict.

Evaluation of the fetal QT interval using non-invasive fetal ECG technology.

Non-invasive fetal electrocardiography (NI-FECG) is a promising alternative continuous fetal monitoring method that has the potential to allow morphological analysis of the FECG. However, there are a number of challenges associated with the evaluation of morphological parameters from the NI-FECG, including low signal to noise ratio of the NI-FECG and methodological challenges for getting reference annotations and evaluating the accuracy of segmentation algorithms. This work aims to validate the measurement of the fetal QT interval in term laboring women using a NI-FECG electrocardiogram monitor. Fetal electrocardiogram data were recorded from 22 laboring women at term using the NI-FECG and an invasive fetal scalp electrode simultaneously. A total of 105 one-minute epochs were selected for analysis. Three pediatric electrophysiologists independently annotated individual waveforms and averaged waveforms from each epoch. The intervals measured on the averaged cycles taken from the NI-FECG and the fetal scalp electrode showed a close agreement; the root mean square error between all corresponding averaged NI-FECG and fetal scalp electrode beats was 13.6 ms, which is lower than the lowest adult root mean square error of 16.1 ms observed in related adult QT studies. These results provide evidence that NI-FECG technology enables accurate extraction of the fetal QT interval.

More chorionic villi obtained at a single center compared to previously published reports.

UNLABELLED: Abstract Objective: The chorionic villus sampling (CVS) technique is not standardized between institutions and can vary greatly between operators. Our goal was to (1) compare the amount of villi obtained by the transabdominal (TA) and transcervical (TC) CVS; (2) compare our single center yield of villi to previously published reports. METHODS: Women undergoing CVS in a singleton pregnancy between 2009 and 2011 were retrospectively identified at a single center. TA CVS was performed using a 20 gauge spinal needle. TC CVS was performed using a 1.4-mm suction catheter. Milligrams of villi and blood from all TA (n=97) and TC (n=36) CVS were obtained. STATA software was used to perform statistical analysis. RESULTS: The median amount of tissue obtained during a TC CVS [50 mg ; range (5-200 mg)] was higher than the median amount obtained from TA CVS [36 mg; range (8-140 mg)]; p=0.002. There was more blood contamination in the samples obtained using the TC approach (median=10 mg; range 5-40 mg) than in the samples from the TA approach (median=5 mg; range 0-27 mg); p<0.0001. The amount of villi obtained from our institution was significantly higher than has been previously reported [TC (p=0.0001) and TA (p<0.0001)]. CONCLUSIONS: TC CVS produced significantly more villi than the TA approach. However, both techniques generated enough villi for direct testing. This information may be useful when multiple genetic tests are being requested. Regardless of route of sampling, the volume of villi obtained was higher at our institution than previously reported. More information regarding amount of villi obtained and relationship to pregnancy complications is needed.

Fetal MRI: A Technical Update with Educational Aspirations.

Fetal magnetic resonance imaging (MRI) examinations have become well-established procedures at many institutions and can serve as useful adjuncts to ultrasound (US) exams when diagnostic doubts remain after US. Due to fetal motion, however, fetal MRI exams are challenging and require the MR scanner to be used in a somewhat different mode than that employed for more routine clinical studies. Herein we review the techniques most commonly used, and those that are available, for fetal MRI with an emphasis on the physics of the techniques and how to deploy them to improve success rates for fetal MRI exams. By far the most common technique employed is single-shot T2-weighted imaging due to its excellent tissue contrast and relative immunity to fetal motion. Despite the significant challenges involved, however, many of the other techniques commonly employed in conventional neuro- and body MRI such as T1 and T2*-weighted imaging, diffusion and perfusion weighted imaging, as well as spectroscopic methods remain of interest for fetal MR applications. An effort to understand the strengths and limitations of these basic methods within the context of fetal MRI is made in order to optimize their use and facilitate implementation of technical improvements for the further development of fetal MR imaging, both in acquisition and post-processing strategies.

Postnatal outcome of fetuses with the prenatal diagnosis of gastroschisis.

OBJECTIVES: The purpose of this study was to assess the postnatal outcome and complications that arise in infants with the prenatal diagnosis of gastroschisis. METHODS: Prenatal sonograms with the diagnosis of gastroschisis were identified. Maternal age, indication for sonography, gestational age at diagnosis, other sonographic abnormalities, and postnatal outcome were recorded. RESULTS: Ninety-eight fetuses at 14.3 to 36 weeks' gestation had the diagnosis of gastroschisis on sonography. In 14 cases (14%), other fetal anomalies were identified, including hydronephrosis, hydrocephalus, coarctation of the aorta, and a limb anomaly. Bowel dilatation developed in 72 of 84 cases (86%) followed prenatally with sonography, and bowel wall thickening developed in 40 of 73 cases (55%). On postnatal follow-up, 57 of 68 infants (84%) had postnatal complications, many with multisystem complications, including 6 deaths, 40 with bowel-related complications, 30 with infectious complications, and 32 with anomalies involving other systems (genitourinary, cardiac, and central nervous system). The postnatal outcome did not correlate with the presence of bowel dilatation or bowel wall thickening on prenatal sonography. Only 11 infants (16.2%) had a completely uncomplicated postsurgical course. Hospital stays in survivors (n = 92) ranged from 8 to 307 days (mean, 53 days). CONCLUSIONS: Although reported survival rates are good for gastroschisis, the postoperative hospital stay is often lengthy, and complications are very common, especially those related to the gastrointestinal tract. Associated anomalies were more common in our study than previously reported.

Accuracy of sonography to predict estimated weight in fetuses with gastroschisis.

OBJECTIVES: The purpose of this study was to determine whether sonographic formulas for estimating fetal weight are as accurate for fetuses affected with gastroschisis as they are for healthy fetuses. We hypothesized that because the most commonly used Hadlock formulas rely on the abdominal circumference as a biometric variable, estimates of birth weight are less reliable in fetuses with gastroschisis than in healthy fetuses. METHODS: We performed a chart review of all fetuses with a prenatal diagnosis of gastroschisis at 3 tertiary care institutions from 1990 to 2008. Charts were reviewed for clinical and sonographic data. The estimated fetal weight at the prenatal sonogram closest to delivery was compared to the birth weight. Published Hadlock formulas using 4 biometric parameters were used to calculate the estimated fetal weight. Data analysis was performed using the Student t test and χ(2) test for continuous and categorical variables, respectively. RESULTS: One hundred eleven patients with gastroschisis were identified. Sixty-six patients had a prenatal sonogram with a calculated estimated fetal weight within 7 days of delivery; 88 patients had a sonogram within 14 days. The mean birth weights ± SD were 2292 ± 559 and 2477 ± 531 g in the 0- to 7- and 8- to 14-day groups, respectively. Sonographic biometric measurements underestimated the birth weight by an average of 5.6%. Intrauterine growth restriction was predicted in 72% of all pregnancies but was only present in 52%. CONCLUSIONS: Our study shows a systematic error of birth weight underestimation when using the Hadlock formulas in fetuses affected with gastroschisis.

First-trimester cystic hygroma: relationship of nuchal translucency thickness and outcomes.

OBJECTIVE: To estimate the relationship between nuchal translucency thickness and abnormal karyotype, major congenital anomaly, perinatal loss, and composite abnormal outcome in fetuses with first-trimester nuchal cystic hygroma. METHODS: We performed a retrospective cohort study of first-trimester fetuses with ultrasound-diagnosed nuchal cystic hygroma collected over a 10-year period. RESULTS: There were 944 first-trimester fetuses with nuchal cystic hygroma. A karyotype abnormality occurred in 54.9% (400 of 729) of fetuses. A major congenital anomaly occurred in 28.8% (61 of 212) of fetuses with a normal karyotype. Perinatal loss occurred in 39% (115 of 295) of fetuses not electively terminated. Overall, an abnormal outcome occurred in 86.6% (543 of 627) of fetuses. After adjusting for potential confounders, every 1-mm increase in nuchal translucency thickness increased the odds of an abnormal karyotype by 44% (adjusted odds ratio [OR] 1.44, 95% confidence interval [CI] 1.29-1.60, P<.001), the odds of major congenital anomaly by 26% (adjusted OR 1.26, 95% CI, 1.08-1.47, P=.003), the odds of perinatal loss by 47% (adjusted OR 1.47, 95% CI 1.07-2.02, P=.019), and the odds of a composite abnormal outcome by 77% (adjusted OR 1.77, 95% CI 1.15-2.74, P=.01). CONCLUSION: First-trimester nuchal cystic hygroma is associated with high rates of karyotype abnormality, major congenital anomaly, perinatal loss, and abnormal outcome. As the thickness of the nuchal translucency increases, the odds of abnormal karyotype, major congenital anomaly, perinatal loss, and abnormal outcome increase.

Measurement of fetal heart rate variability on an electronic monitor using a prototype electronic ruler.

OBJECTIVE: To develop a prototype electronic ruler for assessment of fetal heart rate (FHR) variability on an electronic monitor and test its reliability and accuracy. STUDY DESIGN: A prototype electronic ruler was designed and developed for assessment of FHR variability on electronic monitors. The electronic ruler consisted of horizontal bands that were sized and colored to embed the four FHR variability categories. The reliability and accuracy of using the electronic ruler to assess FHR variability was studied with expert clinicians. RESULTS: Intrarater and interrater reliability was moderate for both the electronic ruler and paper strips. The amplitude measurement accuracy of expert variability assessment compared with a gold standard was significantly improved (p < 0.001) with the electronic ruler versus paper strips. The accuracy of subjects' FHR variability category responses compared with the gold standard revealed no significant difference (p = 0.50) using either display type. CONCLUSION: Performance of the electronic ruler was equivalent to paper strips, which may aid assessment of variability on electronic monitors as paper strips become less prevalent.

A GBS culture collected shortly after GBS prophylaxis may be inaccurate.

OBJECTIVE: To determine whether a vaginal-rectal culture obtained after antibiotic therapy has begun accurately detects pre-existing colonization with group B streptococcus (GBS). METHODS: A prospective cohort study of women presenting at in labor who were known to be colonized with GBS were recruited. A GBS culture was obtained prior to administration of intravenous penicillin prophylaxis and repeated 2 hours following the first dose of penicillin. The two results were compared. RESULTS: Eighty subjects were recruited. Complete results were obtained for 61 (76 %) subjects. Of these, 47 (77 %) had a GBS positive on initial culture. Persistence of GBS 2 hours after antibiotic exposure was seen in 30/47 (64 %). Conversion from GBS positive to GBS negative status was seen in 17/47 (36%). CONCLUSIONS: A vaginal-rectal culture for GBS performed after antibiotic prophylaxis has commenced may not accurately reflect a patient's GBS colonization status.