Telehealth for High-Risk Pregnancies in the Setting of the COVID-19 Pandemic.

As New York City became an international epicenter of the novel coronavirus disease 2019 (COVID-19) pandemic, telehealth was rapidly integrated into prenatal care at Columbia University Irving Medical Center, an academic hospital system in Manhattan. Goals of implementation were to consolidate in-person prenatal screening, surveillance, and examinations into fewer in-person visits while maintaining patient access to ongoing antenatal care and subspecialty consultations via telehealth virtual visits. The rationale for this change was to minimize patient travel and thus risk for COVID-19 exposure. Because a large portion of obstetric patients had underlying medical or fetal conditions placing them at increased risk for adverse outcomes, prenatal care telehealth regimens were tailored for increased surveillance and/or counseling. Based on the incorporation of telehealth into prenatal care for high-risk patients, specific recommendations are made for the following conditions, clinical scenarios, and services: (1) hypertensive disorders of pregnancy including preeclampsia, gestational hypertension, and chronic hypertension; (2) pregestational and gestational diabetes mellitus; (3) maternal cardiovascular disease; (4) maternal neurologic conditions; (5) history of preterm birth and poor obstetrical history including prior stillbirth; (6) fetal conditions such as intrauterine growth restriction, congenital anomalies, and multiple gestations including monochorionic placentation; (7) genetic counseling; (8) mental health services; (9) obstetric anesthesia consultations; and (10) postpartum care. While telehealth virtual visits do not fully replace in-person encounters during prenatal care, they do offer a means of reducing potential patient and provider exposure to COVID-19 while providing consolidated in-person testing and services. KEY POINTS: · Telehealth for prenatal care is feasible.. · Telehealth may reduce coronavirus exposure during prenatal care.. · Telehealth should be tailored for high risk prenatal patients..

Telehealth Uptake into Prenatal Care and Provider Attitudes during the COVID-19 Pandemic in New York City: A Quantitative and Qualitative Analysis.

OBJECTIVE: This study aimed to (1) determine to what degree prenatal care was able to be transitioned to telehealth at prenatal practices associated with two affiliated hospitals in New York City during the novel coronavirus disease 2019 (COVID-19) pandemic and (2) describe providers' experience with this transition. STUDY DESIGN: Trends in whether prenatal care visits were conducted in-person or via telehealth were analyzed by week for a 5-week period from March 9 to April 12 at Columbia University Irving Medical Center (CUIMC)-affiliated prenatal practices in New York City during the COVID-19 pandemic. Visits were analyzed for maternal-fetal medicine (MFM) and general obstetrical faculty practices, as well as a clinic system serving patients with public insurance. The proportion of visits that were telehealth was analyzed by visit type by week. A survey and semistructured interviews of providers were conducted evaluating resources and obstacles in the uptake of telehealth. RESULTS: During the study period, there were 4,248 visits, of which approximately one-third were performed by telehealth (n = 1,352, 31.8%). By the fifth week, 56.1% of generalist visits, 61.5% of MFM visits, and 41.5% of clinic visits were performed via telehealth. A total of 36 providers completed the survey and 11 were interviewed. Accessing technology and performing visits, documentation, and follow-up using the telehealth electronic medical record were all viewed favorably by providers. In transitioning to telehealth, operational challenges were more significant for health clinics than for MFM and generalist faculty practices with patients receiving public insurance experiencing greater difficulties and barriers to care. Additional resources on the patient and operational level were required to optimize attendance at in-person and video visits for clinic patients. CONCLUSION: Telehealth was rapidly implemented in the setting of the COVID-19 pandemic and was viewed favorably by providers. Limited barriers to care were observed for practices serving patients with commercial insurance. However, to optimize access for patients with Medicaid, additional patient-level and operational supports were required. KEY POINTS: · Telehealth uptake differed based on insurance.. · Medicaid patients may require increased assistance for telehealth.. · Quick adoption of telehealth is feasible..

A contemporary amniotic fluid volume chart for the United States: The NICHD Fetal Growth Studies-Singletons.

BACKGROUND: Amniotic fluid is essential to normal fetal development and is estimated clinically with ultrasound scanning to identify pregnancies that are at risk for poor perinatal outcome. OBJECTIVE: Our goal was to develop a United States standard for amniotic fluid volume that is estimated by the amniotic fluid index and single deepest pocket. STUDY DESIGN: We performed a planned secondary analysis of a multicenter observational study of 2334 low-risk women with normal singleton gestations from 1 of 4 self-reported racial/ethnic groups. Eligible women had confirmed first-trimester dating criteria with health status, lifestyles, and medical and obstetric histories that were associated with normal fetal growth. Consenting women underwent serial (up to 5) sonographic evaluations of amniotic fluid between 15 and 40 weeks of gestation after being assigned randomly to 1 of 4 gestational age observation schedules. Twelve United States perinatal centers participated, and all sonograms were performed by credentialed sonographers who used identical, high-resolution equipment; caregivers were unaware of results but were notified for oligohydramnios. Women (n=597) who were subsequently found to have clinically significant antepartum complications were excluded. Racial/ethnic-specific nomograms for amniotic fluid index and single deepest pocket across gestation were developed with the use of linear mixed models with cubic splines; racial/ethnic differences were evaluated both with global and between-group tests. Median, 3rd, 5th, 10th, 90th, 95th and 97th percentile values were also estimated. We further considered the possible confounding effects of selected maternal characteristics and the estimated fetal weight at each sonogram. RESULTS: A total of 1719 pregnant women met inclusion criteria and had available data. These included 480 non-Hispanic white women, 418 non-Hispanic black women, 485 Hispanic women, and 336 Asian women. Both the amniotic fluid index and the single deepest pocket varied across gestation with maximal values at 26 and 33 weeks of gestation, respectively. Statistically significant differences were observed by maternal race/ethnicity. The between-group differences that were observed at 17-22 and 35-40 weeks of gestation remained statistically significant after adjustment for maternal characteristics and estimated fetal weight. These between-group racial/ethnic differences were most prominent after 35 weeks of gestation and at the extremes of dispersion (3rd and 97th percentiles). All 3rd and 97th percentile amniotic fluid index values were within the range of commonly used cutoffs to define oligohydramnios (≤5 cm) and polyhydramnios (≥25 cm). However, the 3rd percentile values ranged between 5.9 cm at 40 weeks of gestation and 10.1 cm at 25-27 weeks of gestation; the 97th percentile values ranged between 24.8 cm at 38 weeks of gestation and 15.7 cm at 15 weeks of gestation. CONCLUSION: Sonographic amniotic fluid volume estimates vary by racial/ethnic group, but the absolute differences appear to be small and may not be clinically significant. Selected maternal characteristics and estimated fetal weight did not affect the racial/ethnic differences. Between-group differences are maximal after 35 weeks of gestation and at the extremes of the upper and lower dispersion estimates. Given the observed variability in extreme (3rd and 97th percentile) dispersion values over the gestation, use of single cutoffs to define out-of-range measurements may not be appropriate clinically. These data might form a contemporary United States standard for amniotic fluid estimation that uses the amniotic fluid index and the single deepest pocket.

Term cesarean delivery in the first pregnancy is not associated with an increased risk for preterm delivery in the subsequent pregnancy.

BACKGROUND: Prior studies have reported an increased risk for preterm delivery following a term cesarean delivery. However, these studies did not adjust for high-risk conditions related to the first cesarean delivery and are known to recur. OBJECTIVE: The objective of the study was to determine whether there is an association between term cesarean delivery in the first pregnancy and subsequent spontaneous or indicated preterm delivery. STUDY DESIGN: This was a retrospective cohort study of women with the first 2 consecutive singleton deliveries (2007-2014) identified through a linked pregnancy database at a single institution. Women with a first pregnancy that resulted in cesarean delivery at term were compared with women whose first pregnancy resulted in a vaginal delivery at term. Exclusion criteria were known to recur medical or obstetrical complications during the first pregnancy. A propensity score analysis was performed by matching women who underwent a cesarean delivery with those who underwent a vaginal delivery in the first pregnancy. The association between cesarean delivery in the first pregnancy and preterm delivery in the second pregnancy in this matched set was examined using conditional logistic regression. The primary outcome was overall preterm delivery <37 weeks in the second pregnancy. Secondary outcomes included type of preterm delivery (spontaneous vs indicated), late preterm delivery (34-36 6/7 weeks), early preterm delivery (<34 weeks), and small-for-gestational-age birth. RESULTS: Of a total of 6456 linked pregnancies, 2284 deliveries were matched; 1142 were preceded by cesarean delivery and 1142 were preceded by vaginal delivery. The main indications for cesarean delivery in the first pregnancy were dystocia in 703 (61.5%), nonreassuring fetal status in 222 (19.4%), breech presentation in 100 (8.8%), and other in 84 (7.4%). The mean (SD) gestational ages at delivery for the second pregnancy was 38.8 (1.8) and 38.9 (1.7) weeks, respectively, for prior cesarean delivery and vaginal delivery. The risks of preterm delivery in the second pregnancy among women with a previous cesarean and vaginal delivery were 6.0% and 5.2%, respectively (adjusted odds ratio, 1.46, 95% confidence interval, [CI] 0.77-2.76). In an analysis stratified by the type of preterm delivery in the second pregnancy, no associations were seen between cesarean delivery in the first pregnancy and spontaneous preterm delivery (4.6% vs 3.9%; adjusted odds ratio, 1.40, 95% confidence interval, 0.59-3.32) or indicated preterm delivery (1.6% vs 1.4%; adjusted odds ratio, 1.21, 95% confidence interval, 0.60-2.46). Similarly, no significant differences were found in late preterm delivery (4.6% vs 4.1%; adjusted odds ratio, 1.13, 95% confidence interval, 0.55-2.29), early preterm delivery (1.6% vs 1.2%; adjusted odds ratio, 1.25, 95% confidence interval, 0.59-2.67), or neonates with birthweight less than the fifth percentile for gestational age (3.6% vs 2.2%; adjusted odds ratio, 1.26, 95% confidence interval, 0.52-3.06). CONCLUSION: After robust adjustment for confounders through a propensity score analysis related to the indication for the first cesarean delivery at term, cesarean delivery is not associated with an increase in preterm delivery, spontaneous or indicated, in the subsequent pregnancy.

Length of the second stage of labor and preterm delivery risk in the subsequent pregnancy.

BACKGROUND: Cervical injury is regarded as an important risk factor for preterm delivery. A prolonged second stage of labor may increase the risk of cervical injury that, in turn, may be associated with increased risk of spontaneous preterm delivery in the subsequent pregnancy. OBJECTIVE: We sought to evaluate whether the duration of the second stage of labor in a term primiparous singleton delivery is associated with an increased risk of singleton spontaneous preterm delivery (<37 weeks) in the second pregnancy. STUDY DESIGN: We carried out a retrospective cohort analysis of women with 2 consecutive pregnancies: a first term (≥37 weeks) delivery and second birth. Data were derived from a single institution's prospectively collected obstetrical database from January 2005 through January 2015. Duration of the second stage of labor was examined as a continuous variable, modeled based on nonparametric restricted cubic regression spline with 4 degrees of freedom. Second-stage duration was also examined as short (<30 minutes), normal (30-179 minutes), and prolonged, defined as ≥180 minutes. The association between the duration of the second stage of labor in the first term pregnancy and the risk for spontaneous preterm delivery in the second pregnancy was evaluated before and after adjusting for potential confounders based on the Cox proportional hazards regression model. Associations were expressed based on the adjusted hazard ratio and 95% confidence interval. RESULTS: In all, 6715 women met inclusion criteria. The hazard of spontaneous preterm delivery in the second pregnancy trended higher with both shorter and longer second-stage labors. The length of the second stage of labor in the first term delivery was categorized as short (<30 minutes) in 1749 (26.0%), normal (30-179 minutes) in 4551 (67.8%), and prolonged (≥180 minutes), in 415 (6.2%) women. Of these 6715 women with a first term delivery, 4.2% (n = 279) delivered spontaneously preterm in the second pregnancy. The risks of spontaneous preterm delivery among women with prolonged (≥180 minutes) second stage of labor and normal labor duration (30-179 minutes) were 5.4% (n = 22) and 3.5% (n = 158), respectively (adjusted hazard ratio, 1.81; 95% confidence interval, 1.15-2.84). This increased risk for prolonged second stage of labor was primarily seen among women who underwent a cesarean (hazard ratio, 3.38; 95% confidence interval, 1.09-10.49), but was imprecise among women who delivered vaginally (hazard ratio, 1.52; 95% confidence interval, 0.62-3.74). The risk of spontaneous preterm delivery among women with short second stage of labor (<30 minutes) in their first term pregnancy was 5.8% (n = 99; hazard ratio, 1.28; 95% confidence interval, 0.99-1.67). CONCLUSION: The risk of spontaneous preterm delivery in the second pregnancy was increased in women with a prolonged (≥180 minutes) second stage in the first term pregnancy. This risk was even greater among women who were delivered by cesarean in the first pregnancy.

Characterization of Thermal and Mechanical Indices from Serial Ultrasound Exams and Associations with Neonatal Anthropometry: The NICHD Fetal Growth Studies.

OBJECTIVE: This article aims to determine if the number of maternal ultrasound scans where the highest thermal (TI) or mechanical (MI) indices recorded during obstetrical ultrasound exceed 1.0 were associated with neonatal anthropometric measurements. STUDY DESIGN: A prospective cohort of 2,334 nonobese low-risk pregnant women from 12 U.S. clinical sites underwent a total of six ultrasound scans, for which the highest TI and MI values were recorded. Neonatal anthropometric measurements were obtained within 12 to 24 hours of delivery. Multiple linear regression models adjusted for maternal race/ethnicity, body mass index, weight gain, and gestational age were used to examine associations between the number of maternal ultrasounds during gestation with a TI or MI exceeding 1.0 and the mean change in neonatal anthropometry. RESULTS: Ultrasounds with TI or MI >1.0 were not associated with birth weight, neonatal length, nor head, chest, and abdominal circumferences. TI >1.0 was negatively associated with neonatal mid-upper arm and mid-upper thigh circumferences. MI >1.0 was negatively associated with neonatal skinfold measurements of the anterior thigh and triceps, and neonatal circumferences of the mid-upper thigh and umbilicus. CONCLUSION: Prenatal ultrasound examinations in which TI or MI intermittently exceeded 1.0 did not identify a pattern of alterations of birth size.

Ultrasound Quality Assurance for Singletons in the National Institute of Child Health and Human Development Fetal Growth Studies.

OBJECTIVES: To report on the ultrasound quality assurance program for the National Institute of Child Health and Human Development Fetal Growth Studies and describe both its advantages and generalizability. METHODS: After training on an ultrasound system and software, research sonographers were expected to capture blank (unmeasured) images in triplicate for crown-rump length, biparietal diameter, head circumference, abdominal circumference, and femur length. A primary expert sonographer was designated and validated. A 5% sample (n = 740 of 14,785 scans) was randomly selected in 3 distinct rounds from within strata of maternal body mass index (round 1 only), gestational age, and research site. Unmeasured images were extracted from selected scans and measured with the ultrasound software by an expert sonographer. Correlations and coefficients of variation (CVs) were calculated, and the within-measurement standard deviation (ie, technical error of the measurement), was calculated. RESULTS: The reliability between the site sonographers and the expert was high, with correlations exceeding 0.99 for all dimensions in all rounds. The CV % values showed low variability, with the percentage differences being less than 2%, except for abdominal circumference in rounds 2 and 3, in which it averaged about 3%. Correlations remained high (>0.90) with increasing fetal size; there was a monotonic increase in technical errors of the measurement but without a corresponding increase in the CV %. CONCLUSIONS: Using rigorous procedures for training sonographers, coupled with quality assurance oversight, we determined that the measurements acquired longitudinally for singletons are both accurate and reliable for establishment of an ultrasound standard for fetal growth.

Nonspontaneous late preterm birth: etiology and outcomes.

OBJECTIVE: We sought to determine the proportion of evidence-based (EB), vs non-EB (NEB) iatrogenic late preterm birth, and to compare corresponding rates of neonatal intensive care unit (NICU) admission. STUDY DESIGN: We performed a retrospective cohort study. Cases were categorized as EB or NEB. NICU admission was compared between groups in both univariate and multivariate analysis. RESULTS: Of 2693 late preterm deliveries, 32.3% (872/2693) were iatrogenic; 56.7% were delivered for NEB indications. Women with NEB deliveries were older (30.0 vs 28.6 years, P = .001), and more likely to be pregnant with twins (18.8% vs 7.9%, P < .001), have private insurance (80.3% vs 59.0%, P < .001), or have a second complicating factor (27.5% vs 10.1%, P < .001). A total of 56% of EB deliveries resulted in NICU admissions. After controlling for confounders, early gestational age (34 vs 36 weeks: odds ratio, 19.34; 95% confidence interval, 4.28-87.5) and mode of delivery (cesarean: odds ratio, 1.88; 95% confidence interval, 1.15-3.05) were most strongly associated with NICU admission. CONCLUSION: Over half of nonspontaneous late preterm births were NEB. EB guidelines are needed.

Outcomes of Neonates Born to Mothers With Severe Acute Respiratory Syndrome Coronavirus 2 Infection at a Large Medical Center in New York City.

Importance: Limited data on vertical and perinatal transmission of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and health outcomes of neonates born to mothers with symptomatic or asymptomatic coronavirus disease 2019 (COVID-19) are available. Studies are needed to inform evidence-based infection prevention and control (IP&C) policies. Objective: To describe the outcomes of neonates born to mothers with perinatal SARS-CoV-2 infection and the IP&C practices associated with these outcomes. Design, Setting, and Participants: This retrospective cohort analysis reviewed the medical records for maternal and newborn data for all 101 neonates born to 100 mothers positive for or with suspected SARS-CoV-2 infection from March 13 to April 24, 2020. Testing for SARS-CoV-2 was performed using Cobas (Roche Diagnostics) or Xpert Xpress (Cepheid) assays. Newborns were admitted to well-baby nurseries (WBNs) (82 infants) and neonatal intensive care units (NICUs) (19 infants) in 2 affiliate hospitals at a large academic medical center in New York, New York. Newborns from the WBNs roomed-in with their mothers, who were required to wear masks. Direct breastfeeding after appropriate hygiene was encouraged. Exposures: Perinatal exposure to maternal asymptomatic/mild vs severe/critical COVID-19. Main Outcomes and Measures: The primary outcome was newborn SARS-CoV-2 testing results. Maternal COVID-19 status was classified as asymptomatic/mildly symptomatic vs severe/critical. Newborn characteristics and clinical courses were compared across maternal COVID-19 severity. Results: In total, 141 tests were obtained from 101 newborns (54 girls [53.5%]) on 0 to 25 days of life (DOL-0 to DOL-25) (median, DOL-1; interquartile range [IQR], DOL-1 to DOL-3). Two newborns had indeterminate test results, indicative of low viral load (2.0%; 95% CI, 0.2%-7.0%); 1 newborn never underwent retesting but remained well on follow-up, and the other had negative results on retesting. Maternal severe/critical COVID-19 was associated with newborns born approximately 1 week earlier (median gestational age, 37.9 [IQR, 37.1-38.4] vs 39.1 [IQR, 38.3-40.2] weeks; P = .02) and at increased risk of requiring phototherapy (3 of 10 [30.0%] vs 6 of 91 [7.0%]; P = .04) compared with newborns of mothers with asymptomatic/mild COVID-19. Fifty-five newborns were followed up in a new COVID-19 Newborn Follow-up Clinic at DOL-3 to DOL-10 and remained well. Twenty of these newborns plus 3 newborns followed up elsewhere had 32 nonroutine encounters documented at DOL-3 to DOL-25, and none had evidence of SARS-CoV-2 infection, including 6 with negative retesting results. Conclusions and Relevance: No clinical evidence of vertical transmission was identified in 101 newborns of mothers positive for or with suspected SARS-CoV-2 infection, despite most newborns rooming-in and direct breastfeeding practices.

Symptoms and Critical Illness Among Obstetric Patients With Coronavirus Disease 2019 (COVID-19) Infection.

OBJECTIVE: To characterize symptoms and disease severity among pregnant women with coronavirus disease 2019 (COVID-19) infection, along with laboratory findings, imaging, and clinical outcomes. METHODS: Pregnant women with COVID-19 infection were identified at two affiliated hospitals in New York City from March 13 to April 19, 2020, for this case series study. Women were diagnosed with COVID-19 infection based on either universal testing on admission or testing because of COVID-19-related symptoms. Disease was classified as either 1) asymptomatic or mild or 2) moderate or severe based on dyspnea, tachypnea, or hypoxia. Clinical and demographic risk factors for moderate or severe disease were analyzed and calculated as odds ratios (ORs) with 95% CIs. Laboratory findings and associated symptoms were compared between those with mild or asymptomatic and moderate or severe disease. The clinical courses and associated complications of women hospitalized with moderate and severe disease are described. RESULTS: Of 158 pregnant women with COVID-19 infection, 124 (78%) had mild or asymptomatic disease and 34 (22%) had moderate or severe disease. Of 15 hospitalized women with moderate or severe disease, 10 received respiratory support with supplemental oxygen and one required intubation. Women with moderate or severe disease had a higher likelihood of having an underlying medical comorbidity (50% vs 27%, OR 2.76, 95% CI 1.26-6.02). Asthma was more common among those with moderate or severe disease (24% vs 8%, OR 3.51, 95% CI 1.26-9.75). Women with moderate or severe disease were significantly more likely to have leukopenia and elevated aspartate transaminase and ferritin. Women with moderate or severe disease were at significantly higher risk for cough and chest pain and pressure. Nine women received ICU or step-down-level care, including four for 9 days or longer. Two women underwent preterm delivery because their clinical status deteriorated. CONCLUSION: One in five pregnant women who contracted COVID-19 infection developed moderate or severe disease, including a small proportion with prolonged critical illness who received ICU or step-down-level care.

Performing a fetal anatomy scan at the time of first-trimester screening.

Over the past decade, prenatal diagnosis has shifted rapidly from the second trimester into the first trimester. Although the nuchal-translucency scan may detect a small proportion of fetal structural malformations, fetal anatomy is not routinely assessed until the fetal anatomical survey is performed in the second trimester between 18 and 22 weeks. The recent development of high-frequency transvaginal ultrasound transducers has led to vastly improved ultrasound resolution and improved visualization of fetal anatomy earlier in gestation. Several pilot studies of a first-trimester anatomic survey have reported detection rates comparable with those achieved in the routine second-trimester anatomic survey. As advanced ultrasound technology becomes more available, there is an urgent need to evaluate the diagnostic ability of a first-trimester anatomic survey and to determine the role of a first-trimester anatomic survey in the current screening paradigm.

Pregnancy in renal transplant recipients.

Women with renal disease face increasing infertility and high-risk pregnancy as they approach end-stage renal disease due to uremia. Renal transplantation has provided these patients the ability to return to a better quality of life, and for a number of women who are of child bearing age with renal disease, it has restored their fertility and provided the opportunity to have children. But, although fertility is restored, pregnancy in these women still harbors risk to the mother, graft, and fetus. Selected patients who have stable graft function can have successful pregnancies under the supervision of a multidisciplinary team involving maternal fetal medicine specialists and transplant nephrologists. Careful observation and management are required to optimize outcome for mother and fetus.

Immunosuppressant therapy in pregnant organ transplant recipients.

Transplant recipients are becoming pregnant with increasing frequency, and successful pregnancy outcomes have now been reported for women with all types of solid organ transplants. To prevent rejection of the transplanted organ, these patients are maintained on a life-long immunosuppressive regimen that must also be continued through pregnancy. Controlled human studies of the safety of these drugs have not been conducted, and knowledge regarding the pharmacokinetics of these medications in pregnancy is limited. Significant experience and safety data regarding the use of some of the more common immunosuppressants in pregnancy have, however, been accumulated from large case series and national registries. These observational studies suggest that successful pregnancy outcomes are possible in female organ transplant recipients, although sporadic adverse outcomes have been reported after immunosuppressant use in pregnancy. In this chapter, we will outline the information available regarding the use of immunosuppressive medications in pregnant transplant recipients as well as general concepts regarding fetal exposure to immunosuppressants.

Estimating Gestational Age From Ultrasound Fetal Biometrics.

OBJECTIVE: To compare the accuracy of a new formula with one developed in 1984 (and still in common use) and to develop and compare racial and ethnic-specific and racial and ethnic-neutral formulas. METHODS: The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Fetal Growth Studies-Singletons was a prospective cohort study that recruited women in four self-reported racial-ethnic groups-non-Hispanic black, Hispanic, non-Hispanic white, and Asian-with singleton gestations from 12 U.S. centers (2009-2013). Women with a certain last menstrual period confirmed by first-trimester ultrasonogram had longitudinal fetal measurements by credentialed study ultrasonographers blinded to the gestational age at their five follow-up visits. Regression analyses were performed with linear mixed models to develop gestational age estimating formulas. Repeated cross-validation was used for validation. The estimation error was defined as the mean squared difference between the estimated and observed gestational age and was used to compare the formulas' accuracy. RESULTS: The new formula estimated the gestational age (±2 SD) within ±7 days from 14 to 20 weeks of gestation, ±10 days from 21 to 27 weeks of gestation, and ±17 days from 28 to 40 weeks of gestation. The new formula performed significantly better than a formula developed in 1984 with an estimation error of 10.4 compared with 11.2 days from 21 to 27 weeks of gestation and 17.0 compared with 19.8 days at 28-40 weeks of gestation, respectively. Racial and ethnic-specific formulas did not outperform the racial and ethnic-neutral formula. CONCLUSION: The NICHD gestational age estimation formula is associated with smaller errors than a well-established historical formula. Racial and ethnic-specific formulas are not superior to a racial-ethnic-neutral one.

First trimester Down syndrome screening: public health implications.

Down syndrome (DS) screening has been an integral part of routine prenatal screening for the last three decades. Recent efforts have been directed at developing additional non-invasive prenatal screening techniques that could not only improve sensitivity of prenatal screening, but also be employed in the first trimester to offer earlier diagnostic and interventional opportunities. Nuchal translucency has proven to be an effective and cost-effective screening test that, when combined with serum markers (hCG and pregnancy-associated plasma protein [PAPP-A]) in the first and/or second trimester, broadens the diagnostic possibilities and improves the diagnostic capabilities of current prenatal DS screening methods. Despite the potential benefits, significant operational issues regarding access to and availability of such testing may limit its widespread application and necessitates the maintenance of both non-sonographic and second trimester screening methods. The implementation of first trimester DS testing requires the development and maintenance of nationally standardized quality control systems to ensure the reliability of serum and ultrasound measurements and the accurate assessment of risk. Future efforts to improve prenatal screening should continue to emphasize the need for improved access to all aspects of prenatal care, stress the importance of provider education and the necessity for extensive patient counseling, and reinforce the role of patient education and choice.

Implementation of a national nuchal translucency education and quality monitoring program.

In 2004, leaders in first-trimester aneuploidy screening and a multidisciplinary group of experts established the Nuchal Translucency Quality Review Program, a national program to standardize education, credentialing, and quality monitoring of nuchal translucency. Since its inception, the program has credentialed more than 6,600 physician and ultrasonographer participants and collected more than 2.4 million nuchal translucency measurements. Ongoing quality monitoring is conducted through statistical analysis comparing the distribution and standard deviation of participants' nuchal translucency measurements against those obtained from a standard referent curve. Results of these analyses are distributed to participants quarterly and are used to track each participant's performance and to trigger performance improvement activities or mandatory remediation. This program could serve as a template for future education and credentialing programs that include partnerships with academic leaders, national professional organizations, and industry.