Prediction of COVID-19 Severity at Delivery after Asymptomatic or Mild COVID-19 during Pregnancy.

OBJECTIVE: This study aimed to develop a prediction model that estimates the probability that a pregnant person who has had asymptomatic or mild coronavirus disease 2019 (COVID-19) prior to delivery admission will progress in severity to moderate, severe, or critical COVID-19. STUDY DESIGN: This was a secondary analysis of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)-positive patients who delivered from March through December 2020 at hospitals across the United States. Those eligible for this analysis presented for delivery with a current or previous asymptomatic or mild SARS-CoV-2 infection. The primary outcome was moderate, severe, or critical COVID-19 during the delivery admission through 42 days postpartum. The prediction model was developed and internally validated using stratified cross-validation with stepwise backward elimination, incorporating only variables that were known on the day of hospital admission. RESULTS: Of the 2,818 patients included, 26 (0.9%; 95% confidence interval [CI], 0.6-1.3%) developed moderate-severe-critical COVID-19 during the study period. Variables in the prediction model were gestational age at delivery admission (adjusted odds ratio [aOR], 1.15; 95% CI, 1.08-1.22 per 1-week decrease), a hypertensive disorder in a prior pregnancy (aOR 3.05; 95% CI, 1.25-7.46), and systolic blood pressure at admission (aOR, 1.04; 95% CI, 1.02-1.05 per mm Hg increase). This model yielded an area under the receiver operating characteristic curve of 0.82 (95% CI, 0.72-0.91). CONCLUSION: Among individuals presenting for delivery who had asymptomatic-mild COVID-19, gestational age at delivery admission, a hypertensive disorder in a prior pregnancy, and systolic blood pressure at admission were predictive of delivering with moderate, severe, or critical COVID-19. This prediction model may be a useful tool to optimize resources for SARS-CoV-2-infected pregnant individuals admitted for delivery. KEY POINTS: · Three factors were associated with delivery with more severe COVID-19.. · The developed model yielded an area under the receiver operating characteristic curve of 0.82 and model fit was good.. · The model may be useful tool for SARS-CoV-2 infected pregnancies admitted for delivery..

Postpartum pharmacologic thromboprophylaxis and complications in a US cohort.

BACKGROUND: Venous thromboembolism accounts for approximately 9% of pregnancy-related deaths in the United States. National guidelines recommend postpartum risk stratification and pharmacologic prophylaxis in at-risk individuals. Knowledge on modern rates of postpartum pharmacologic thromboprophylaxis and its associated risks is limited. OBJECTIVE: This study aimed to describe the rate of, and factors associated with, initiation of postpartum pharmacologic prophylaxis for venous thromboembolism, and to assess associated adverse outcomes. STUDY DESIGN: This was a secondary analysis of a multicenter cohort of individuals delivering on randomly selected days at 17 US hospitals (2019-2020). Medical records were reviewed by trained and certified personnel. Those with an antepartum diagnosis of venous thromboembolism, receiving antepartum anticoagulation, or known SARS-CoV-2 infection were excluded. The primary outcome was use of postpartum pharmacologic thromboprophylaxis. Secondary outcomes included bleeding complications, surgical site infection, hospital readmission, and venous thromboembolism through 6 weeks postpartum. The rate of thromboprophylaxis administration was assessed by mode of delivery, institution, and continuance to the outpatient setting. Multivariable regression models were developed using k-fold cross-validation with stepwise backward elimination to evaluate factors associated with thromboprophylaxis administration. Univariable and multivariable logistic models with propensity score covariate adjustment were performed to assess the association between thromboprophylaxis administration and adverse outcomes. RESULTS: Of 21,114 individuals in the analytical cohort, 11.9% (95% confidence interval, 11.4%-12.3%) received postpartum pharmacologic thromboprophylaxis; the frequency of receipt was 29.8% (95% confidence interval, 28.7%-30.9%) following cesarean and 3.5% (95% confidence interval, 3.2%-3.8%) following vaginal delivery. Institutional rates of prophylaxis varied from 0.21% to 34.8%. Most individuals (83.3%) received thromboprophylaxis only as inpatients. In adjusted analysis, cesarean delivery (adjusted odds ratio, 19.17; 95% confidence interval, 16.70-22.00), hysterectomy (adjusted odds ratio, 15.70; 95% confidence interval, 4.35-56.65), and obesity (adjusted odds ratio, 3.45; 95% confidence interval, 3.02-3.95) were the strongest factors associated with thromboprophylaxis administration. Thromboprophylaxis administration was not associated with surgical site infection (0.9% vs 0.6%; odds ratio, 1.48; 95% confidence interval, 0.80-2.74), bleeding complications (0.2% vs 0.1%; odds ratio, 2.60; 95% confidence interval, 0.99-6.80), or postpartum readmission (0.9% vs 0.3%; adjusted odds ratio, 1.38; 95% confidence interval, 0.68-2.81). The overall rate of venous thromboembolism was 0.06% (95% confidence interval, 0.03%-0.10%) and was higher in those receiving prophylaxis (0.2%) compared with those not receiving prophylaxis (0.04%). CONCLUSION: Approximately 1 in 10 patients received postpartum pharmacologic thromboprophylaxis in this US cohort. Rates of prophylaxis varied widely by institution. Cesarean delivery, hysterectomy, and obesity were predominant factors associated with postpartum thromboprophylaxis administration.

Electronic Reminder to Transition Care After Hypertensive Disorders of Pregnancy: A Randomized Controlled Trial.

OBJECTIVE: Scalable interventions are needed to improve preventive care for those with increased cardiovascular disease (CVD) risk identified during pregnancy. We hypothesized that an automated reminder message for clinicians (nudge) would increase counseling at the postpartum visit on patient transitions of care. METHODS: We conducted a single-center, randomized controlled trial including birthing people with a hypertensive disorder of pregnancy evaluating a nudge compared with usual care. The nudge, including counseling phrases and patient-specific information on hypertensive diagnosis, was sent to the obstetric clinician through the electronic medical record up to 7 days before the postpartum visit. The primary outcome was documentation of counseling on transitions of care to primary care or cardiology. Secondary outcomes were documentation of CVD risk, use of counseling phrases, and preventive care visit within 6 months. A sample size of 94 per group (n=188) was planned to compare the nudge intervention with usual care; given the anticipated loss to follow-up, the sample size was increased to 222. Intention-to-treat analyses were performed, with P <.05 considered significant. RESULTS: From February to June 2021, 392 patients were screened, and 222 were randomized and analyzed. Of these, 205 (92.3%) attended a postpartum visit. Groups were similar, but more women in the usual care group had diabetes (16.1% vs 6.7%, P =.03). After adjustment for diabetes, patients in the nudge group were more likely to have documented counseling on transitions of care (38.8% vs 26.2%, adjusted relative risk [aRR] 1.53, 95% CI 1.02-2.31), CVD risk (21.4% vs 8.4%, aRR 2.57, 95% CI 1.20-5.49), and use of aspirin in a future pregnancy (14.3% vs 1.9%, aRR 7.49, 95% CI 1.66-33.93). Counseling phrases were used more often in the nudge group (11.2% vs 0.9%, aRR 12.27, 95% CI 1.50-100.28). Preventive care visit attendance did not differ by group (22.1% vs 24.6%, aRR 0.91, 95% CI 0.57-1.47). CONCLUSION: A timely electronic reminder to obstetric clinicians improved counseling about transitions of care after hypertensive disorders of pregnancy but did not result in increased preventive care visit attendance. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov , NCT04660032.

The Temporal Relationship Between the Coronavirus Disease 2019 (COVID-19) Pandemic and Preterm Birth.

OBJECTIVE: To evaluate whether preterm birth rates changed in relation to the onset of the coronavirus disease 2019 (COVID-19) pandemic and whether any change depended on socioeconomic status. METHODS: This is an observational cohort study of pregnant individuals with a singleton gestation who delivered in the years 2019 and 2020 at 1 of 16 U.S. hospitals of the Maternal-Fetal Medicine Units Network. The frequency of preterm birth for those who delivered before the onset of the COVID-19 pandemic (ie, in 2019) was compared with that of those who delivered after its onset (ie, in 2020). Interaction analyses were performed for people of different individual- and community-level socioeconomic characteristics (ie, race and ethnicity, insurance status, Social Vulnerability Index (SVI) of a person's residence). RESULTS: During 2019 and 2020, 18,526 individuals met inclusion criteria. The chance of preterm birth before the COVID-19 pandemic was similar to that after the onset of the pandemic (11.7% vs 12.5%, adjusted relative risk 0.94, 95% CI 0.86-1.03). In interaction analyses, race and ethnicity, insurance status, and the SVI did not modify the association between the epoch and the chance of preterm birth before 37 weeks of gestation (all interaction P >.05). CONCLUSION: There was no statistically significant difference in preterm birth rates in relation to the COVID-19 pandemic onset. This lack of association was largely independent of socioeconomic indicators such as race and ethnicity, insurance status, or SVI of the residential community in which an individual lived.

Association Between Giving Birth During the Early Coronavirus Disease 2019 (COVID-19) Pandemic and Serious Maternal Morbidity.

OBJECTIVE: To evaluate whether delivering during the early the coronavirus disease 2019 (COVID-19) pandemic was associated with increased risk of maternal death or serious morbidity from common obstetric complications compared with a historical control period. METHODS: This was a multicenter retrospective cohort study with manual medical-record abstraction performed by centrally trained and certified research personnel at 17 U.S. hospitals. Individuals who gave birth on randomly selected dates in 2019 (before the pandemic) and 2020 (during the pandemic) were compared. Hospital, health care system, and community risk-mitigation strategies for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in response to the early COVID-19 pandemic are described. The primary outcome was a composite of maternal death or serious morbidity from common obstetric complications, including hypertensive disorders of pregnancy (eclampsia, end organ dysfunction, or need for acute antihypertensive therapy), postpartum hemorrhage (operative intervention or receipt of 4 or more units blood products), and infections other than SARS-CoV-2 (sepsis, pelvic abscess, prolonged intravenous antibiotics, bacteremia, deep surgical site infection). The major secondary outcome was cesarean birth. RESULTS: Overall, 12,133 patients giving birth during and 9,709 before the pandemic were included. Hospital, health care system, and community SARS-CoV-2 mitigation strategies were employed at all sites for a portion of 2020, with a peak in modifications from March to June 2020. Of patients delivering during the pandemic, 3% had a positive SARS-CoV-2 test result during pregnancy through 42 days postpartum. Giving birth during the pandemic was not associated with a change in the frequency of the primary composite outcome (9.3% vs 8.9%, adjusted relative risk [aRR] 1.02, 95% CI 0.93-1.11) or cesarean birth (32.4% vs 31.3%, aRR 1.02, 95% CI 0.97-1.07). No maternal deaths were observed. CONCLUSION: Despite substantial hospital, health care, and community modifications, giving birth during the early COVID-19 pandemic was not associated with higher rates of serious maternal morbidity from common obstetric complications. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT04519502.

Implementation of an Enhanced Recovery after Surgery Pathway to Reduce Inpatient Opioid Consumption after Cesarean Delivery.

OBJECTIVE: Opioid prescription after cesarean delivery is excessive and can lead to chronic opioid use disorder. We assessed the impact of an enhanced recovery after surgery (ERAS) pathway on inpatient opioid consumption after cesarean delivery. STUDY DESIGN: An ERAS pathway was implemented as a quality improvement initiative in December 2019. Preintervention (PRE) data were collected from March to May 2019 to assess baseline opioid consumption. Postintervention (POST) data were collected from January to March 2020. The primary outcome was inpatient postoperative opioid consumption in morphine milligram equivalents (MME). Secondary outcomes included the consumption of any opioids, postpartum length of stay, and opioid prescription at discharge. RESULTS: A total of 92 women were in the PRE group and 91 were in the POST group. Inpatient opioid consumption decreased by 87.3% from PRE to POST, from 124.7 (interquartile range [IQR]: 10-181.6) MME to 15.8 (IQR: 0-75) MME (p < 0.001). There was no difference in median postpartum length of stay (3.4 days PRE vs. 3.3 days POST; p = 0.12). The proportion of women who did not consume any opioids increased by 75.4% from PRE to POST (p = 0.02). The proportion of women discharged with an opioid prescription decreased by 25.6% from PRE to POST (p = 0.007), despite no formal change to prescribing practices. After adjustment for differences in race/ethnicity and gravidity, there was still a reduction in total inpatient opioid consumption (p < 0.001) and an increase in the proportion of women not consuming any opioids (adjusted relative risk (RR): 2.14, 95% confidence interval [CI]: 1.18-3.87), but the difference in rate of prescription of opioids at discharge was no longer statistically significant (adjusted RR: 0.70, 95% CI: 0.48-1.02). CONCLUSION: Adoption of an ERAS pathway for cesarean delivery resulted in a marked reduction in inpatient opioid consumption. Such a pathway can be implemented across institutions and may be a powerful tool in combating the opioid epidemic. KEY POINTS: · ERAS after cesarean reduces inpatient opioid consumption.. · ERAS after cesarean increases the proportion of women not consuming any opioids.. · This pathway can be feasibly adopted elsewhere..

First- or second-trimester SARS-CoV-2 infection and subsequent pregnancy outcomes.

BACKGROUND: SARS-CoV-2 infection during pregnancy is associated with adverse pregnancy outcomes, including fetal death and preterm birth. It is not known whether that risk occurs only during the time of acute infection or whether the risk persists later in pregnancy. OBJECTIVE: This study aimed to evaluate whether the risk of SARS-CoV-2 infection during pregnancy persists after an acute maternal illness. STUDY DESIGN: A retrospective cohort study of pregnant patients with and without SARS-CoV-2 infection delivering at 17 hospitals in the United States between March 2020 and December 2020. Patients experiencing a SARS-CoV-2-positive test at or before 28 weeks of gestation with a subsequent delivery hospitalization were compared with those without a positive SAR-CoV-2 test at the same hospitals with randomly selected delivery days during the same period. Deliveries occurring at <20 weeks of gestation in both groups were excluded. The study outcomes included fetal or neonatal death, preterm birth at <37 weeks of gestation and <34 weeks of gestation, hypertensive disorders of pregnancy (HDP), any major congenital malformation, and size for gestational age of <5th or <10th percentiles at birth based on published standards. HDP that were collected included HDP and preeclampsia with severe features, both overall and with delivery at <37 weeks of gestation. RESULTS: Of 2326 patients who tested positive for SARS-CoV-2 during pregnancy and were at least 20 weeks of gestation at delivery from March 2020 to December 2020, 402 patients (delivering 414 fetuses or neonates) were SARS-CoV-2 positive before 28 weeks of gestation and before their admission for delivery; they were compared with 11,705 patients without a positive SARS-CoV-2 test. In adjusted analyses, those with SARS-CoV-2 before 28 weeks of gestation had a subsequent increased risk of fetal or neonatal death (2.9% vs 1.5%; adjusted relative risk, 1.97; 95% confidence interval, 1.01-3.85), preterm birth at <37 weeks of gestation (19.6% vs 13.8%; adjusted relative risk, 1.29; 95% confidence interval, 1.02-1.63), and HDP with delivery at <37 weeks of gestation (7.2% vs 4.1%; adjusted relative risk, 1.74; 95% confidence interval, 1.19-2.55). There was no difference in the rates of preterm birth at <34 weeks of gestation, any major congenital malformation, and size for gestational age of <5th or <10th percentiles. In addition, there was no significant difference in the rate of gestational hypertension overall or preeclampsia with severe features. CONCLUSION: There was a modest increase in the risk of adverse pregnancy outcomes after SARS-CoV-2 infection.

Association of SARS-CoV-2 Infection With Serious Maternal Morbidity and Mortality From Obstetric Complications.

Importance: It remains unknown whether SARS-CoV-2 infection specifically increases the risk of serious obstetric morbidity. Objective: To evaluate the association of SARS-CoV-2 infection with serious maternal morbidity or mortality from common obstetric complications. Design, Setting, and Participants: Retrospective cohort study of 14 104 pregnant and postpartum patients delivered between March 1, 2020, and December 31, 2020 (with final follow-up to February 11, 2021), at 17 US hospitals participating in the Eunice Kennedy Shriver National Institute of Child Health and Human Development's Gestational Research Assessments of COVID-19 (GRAVID) Study. All patients with SARS-CoV-2 were included and compared with those without a positive SARS-CoV-2 test result who delivered on randomly selected dates over the same period. Exposures: SARS-CoV-2 infection was based on a positive nucleic acid or antigen test result. Secondary analyses further stratified those with SARS-CoV-2 infection by disease severity. Main Outcomes and Measures: The primary outcome was a composite of maternal death or serious morbidity related to hypertensive disorders of pregnancy, postpartum hemorrhage, or infection other than SARS-CoV-2. The main secondary outcome was cesarean birth. Results: Of the 14 104 included patients (mean age, 29.7 years), 2352 patients had SARS-CoV-2 infection and 11 752 did not have a positive SARS-CoV-2 test result. Compared with those without a positive SARS-CoV-2 test result, SARS-CoV-2 infection was significantly associated with the primary outcome (13.4% vs 9.2%; difference, 4.2% [95% CI, 2.8%-5.6%]; adjusted relative risk [aRR], 1.41 [95% CI, 1.23-1.61]). All 5 maternal deaths were in the SARS-CoV-2 group. SARS-CoV-2 infection was not significantly associated with cesarean birth (34.7% vs 32.4%; aRR, 1.05 [95% CI, 0.99-1.11]). Compared with those without a positive SARS-CoV-2 test result, moderate or higher COVID-19 severity (n = 586) was significantly associated with the primary outcome (26.1% vs 9.2%; difference, 16.9% [95% CI, 13.3%-20.4%]; aRR, 2.06 [95% CI, 1.73-2.46]) and the major secondary outcome of cesarean birth (45.4% vs 32.4%; difference, 12.8% [95% CI, 8.7%-16.8%]; aRR, 1.17 [95% CI, 1.07-1.28]), but mild or asymptomatic infection (n = 1766) was not significantly associated with the primary outcome (9.2% vs 9.2%; difference, 0% [95% CI, -1.4% to 1.4%]; aRR, 1.11 [95% CI, 0.94-1.32]) or cesarean birth (31.2% vs 32.4%; difference, -1.4% [95% CI, -3.6% to 0.8%]; aRR, 1.00 [95% CI, 0.93-1.07]). Conclusions and Relevance: Among pregnant and postpartum individuals at 17 US hospitals, SARS-CoV-2 infection was associated with an increased risk for a composite outcome of maternal mortality or serious morbidity from obstetric complications.

Disease Severity and Perinatal Outcomes of Pregnant Patients With Coronavirus Disease 2019 (COVID-19).

OBJECTIVE: To describe coronavirus disease 2019 (COVID-19) severity in pregnant patients and evaluate the association between disease severity and perinatal outcomes. METHODS: We conducted an observational cohort study of all pregnant patients with a singleton gestation and a positive test result for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) who delivered at 1 of 33 U.S. hospitals in 14 states from March 1 to July 31, 2020. Disease severity was classified by National Institutes of Health criteria. Maternal, fetal, and neonatal outcomes were abstracted by centrally trained and certified perinatal research staff. We evaluated trends in maternal characteristics and outcomes across COVID-19 severity classes and associations between severity and outcomes by multivariable modeling. RESULTS: A total of 1,219 patients were included: 47% asymptomatic, 27% mild, 14% moderate, 8% severe, 4% critical. Overall, 53% were Hispanic; there was no trend in race-ethnicity distribution by disease severity. Those with more severe illness had older mean age, higher median body mass index, and pre-existing medical comorbidities. Four maternal deaths (0.3%) were attributed to COVID-19. Frequency of perinatal death or a positive neonatal SARS-CoV-2 test result did not differ by severity. Adverse perinatal outcomes were more frequent among patients with more severe illness, including 6% (95% CI 2-11%) incidence of venous thromboembolism among those with severe-critical illness compared with 0.2% in mild-moderate and 0% in asymptomatic (P<.001 for trend across severity). In adjusted analyses, severe-critical COVID-19 was associated with increased risk of cesarean birth (59.6% vs 34.0%, adjusted relative risk [aRR] 1.57, 95% CI 1.30-1.90), hypertensive disorders of pregnancy (40.4% vs 18.8%, aRR 1.61, 95% CI 1.18-2.20), and preterm birth (41.8% vs 11.9%, aRR 3.53, 95% CI 2.42-5.14) compared with asymptomatic patients. Mild-moderate COVID-19 was not associated with adverse perinatal outcomes compared with asymptomatic patients. CONCLUSION: Compared with pregnant patients with SARS-CoV-2 infection without symptoms, those with severe-critical COVID-19, but not those with mild-moderate COVID-19, were at increased risk of perinatal complications.

Postpartum counseling in women with hypertensive disorders of pregnancy.

BACKGROUND: Hypertensive disorders of pregnancy are associated with increased cardiovascular disease risk across the lifespan. The American College of Obstetricians and Gynecologists and the American Heart Association emphasize the postpartum period as an important opportunity to identify and intervene women at high risk of future cardiovascular disease. OBJECTIVE: This study aimed to determine the proportion of women with documented counseling on risks and transitions of care after hypertensive disorders of pregnancy at the postpartum visit. STUDY DESIGN: This was a retrospective longitudinal descriptive study of women with hypertensive disorders of pregnancy who were enrolled in a text-based blood pressure program from September 2018 to February 2019. We abstracted counseling in the discharge summary and postpartum note from the electronic medical record. The primary outcome was counseling at the postpartum visit defined as documentation of (1) follow-up with primary care or cardiology, (2) risk of cardiovascular disease, or (3) recommendation for aspirin in a future pregnancy. We assessed demographic and clinical factors that may influence counseling through multivariable logistic regression. We also compared the proportion of women counseled on hypertensive disorders of pregnancy vs contraception and glucose tolerance tests at the postpartum visit. RESULTS: Of 320 eligible women, most women had gestational hypertension or preeclampsia without severe features (64%). Postpartum visits were scheduled in our hospital system for 284 women, of whom 253 attended (89%). Documented counseling occurred for 62 women (25%). Counseling on follow-up with primary care or cardiology, cardiovascular disease risk, and aspirin in future pregnancies was documented for 51 (20%), 15 (6%), and 1 (0.4%), respectively. Only 1 woman had documented counseling on all 3 components. In multivariable analysis, black race remained an independent factor that increased the likelihood of counseling on hypertensive disorders of pregnancy (adjusted odds ratio, 2.77; 95% confidence interval, 1.32-5.83). Women were significantly less likely to be counseled on hypertensive disorders of pregnancy than on contraceptives (99%, P<.001) or glucose tolerance testing after gestational diabetes mellitus (79%, P<.001). CONCLUSION: Postpartum counseling on hypertensive disorders of pregnancy merits urgent improvement efforts among obstetrical care providers.

Patient satisfaction with the laborist model of care in a large urban hospital.

BACKGROUND: The obstetric practice environment is evolving to include more laborists staffing obstetric units, with the hope of improving quality of care and provider satisfaction, yet there are scant data on the impact of a laborist care model on patient satisfaction or delivery outcomes. We sought to assess patient satisfaction after implementation of the laborist model of obstetric care in a large urban teaching hospital. METHODS: Postpartum patients were asked to complete an anonymous survey assessing their satisfaction with care, particularly with regard to the laborist model. Survey questions included rating the overall experience of labor and delivery. All responses were based on a five-point Likert scale. Press-Ganey results were compared from before and after initiation of the model. Descriptive statistics were used to analyze the results. RESULTS: Post-laborist implementation obstetric and delivery experience surveys were collected from 4166 patients, representing a 54% response rate. Ninety percent of patients reported that they were highly satisfied with the overall experience in the labor and delivery unit. A subgroup was asked to rate their experience with the practitioner for their current delivery. Of the 687 respondents, 75% answered excellent, 18% answered good/very good, and 3.4% answered neutral. Eighty-five percent of this subgroup stated that they were informed during prenatal care that they may be delivered by someone other than the practitioner or group that they saw during the pregnancy. Thirty-seven percent (n = 1553) of the total respondents reported that they had had a previous delivery at this institution, 97% (n = 1506) of whom stated "yes" to having their next delivery at this institution. Press-Ganey results were similarly favorable in both time periods (91.3 [n = 811] versus 93.4 [n = 747], P = 0.08). CONCLUSION: Patient satisfaction does not appear to be adversely affected by initiation of the laborist model. Additional research is needed to understand further the implications of this model for provider satisfaction, and maternal and neonatal outcomes.

Can transabdominal ultrasound identify women at high risk for short cervical length?

OBJECTIVE: To determine whether transabdominal cervical length screening could identify women at high risk for having a short cervix on transvaginal ultrasound. DESIGN: Retrospective cohort study. SETTING: Tertiary referral center. POPULATION: A total of 703 patients with a singleton pregnancy at 18 to 23(+6) weeks of gestation who underwent transabdominal and transvaginal cervical length assessment during anatomy ultrasound at a single institution between January 2007 and October 2011. METHODS: Electronic medical records were reviewed to identify women who met the study criteria. MAIN OUTCOME MEASURES: The primary outcome was the number of women with a short transabdominal cervical length (defined as ≤ 30 mm) who needed to undergo transvaginal ultrasound to detect one woman with a short transvaginal cervical length of ≤ 20 mm. RESULTS: In all, 703 patients were included in the primary analysis; 3.42 women with transabdominal cervical length ≤ 30 mm needed to undergo transvaginal ultrasound to detect one woman with transvaginal ultrasound cervical length ≤ 20 mm. Of women with short transvaginal cervical length ≤ 20 mm, 89.8% had a transabdominal measurement ≤ 30 mm and 96.7% had a transabdominal measurement ≤ 33 mm. CONCLUSIONS: Screening of transabdominal cervical length may represent a useful strategy for detecting women with short cervix on transvaginal ultrasound.

Comparison of the efficiency of second-trimester nasal bone hypoplasia and increased nuchal fold in Down syndrome screening.

OBJECTIVE: The purpose of this study was to compare the efficiency of second-trimester nasal bone hypoplasia (NB) and increased nuchal fold (NF) in Down syndrome screening. STUDY DESIGN: This was a prospective multicenter cohort study of women who underwent an anatomic survey between 16 and 22 weeks of gestation. The fetal NB and other markers of fetal aneuploidy that included NF were evaluated. NB was defined either as an absent NB or length of <0.75 multiples of the median for the gestational age. Two definitions of increased NF (>5 mm and >6 mm) were evaluated. Fetuses or infants with Down syndrome were compared with those fetuses without for the presence of NB and increased NF. RESULTS: Among 4373 pregnancies that were evaluated over a 5-year period, there were 50 pregnancies with Down syndrome. NB evaluation was obtained in 3936 of 4373 pregnancies (90%); NF was evaluated in all of the fetuses. Absent NB was seen in 14/49 cases (29%), and NF of >6 mm was seen in 6 of 50 cases (12%) with Down syndrome. CONCLUSION: Nasal bone and nuchal fold are efficient markers for Down syndrome. Absent nasal bone was a better predictor of Down syndrome, compared with nuchal fold, and should be a standard marker when a second-trimester genetic sonogram is performed.

Defining nasal bone hypoplasia in second-trimester Down syndrome screening: does the use of multiples of the median improve screening efficacy?

OBJECTIVE: The purpose of this study was to compare the efficacy of the use of nasal bone (NB) multiples of the median (MoM) with the biparietal diameter (BPD)/NB ratio as definitions of NB hypoplasia that is associated with Down syndrome in the second trimester. STUDY DESIGN: We conducted a prospective cohort study of women who underwent an anatomic survey between 16 and 22 weeks of gestation. The fetal NB and other markers of fetal aneuploidy were evaluated. MoMs for the NB length at each gestational age category were calculated and adjusted for maternal race. NB hypoplasia was defined either as an absent NB or by a ratio of the BPD/NB >11 or by NB lengths <0.75, 0.5, and 0.25 MoM for the gestational age, respectively. Fetuses or infants with Down syndrome were compared with those without for the presence of NB hypoplasia. RESULTS: Among 3634 women whose condition was evaluated, NB assessment was obtained in 3197 women (88%). There were 23 cases of Down syndrome that were detected. Receiver operating characteristic curve comparison revealed NB MoM <0.75 to be the best definition of NB hypoplasia (area under receiver operating characteristic curve, 0.75). NB <0.75 MoM had a sensitivity and specificity of 49% (95% CI, 26-69) and 92% (95% CI, 91%-93%), respectively, compared with 61% (95% CI, 38%-80%) and 84% (95% CI, 82%-85%), respectively for BPD/NB >11. The difference in the sensitivity of 12% (95% CI, -5-31) with the BPD/NB ratio >11 vs with an NB MoM <0.75 was not significant (P < .25). The difference in the specificity of 8% (95% CI, 7.5-9.5) with the BPD/NB ratio >11 vs an NB MoM <0.75 was significant (P < .0001). CONCLUSION: In the second trimester of pregnancy, the use of nasal bone length <0.75 MoM for the gestational age was the best definition for Down syndrome detection and resulted in improved specificity.

Evaluating the thresholds of abnormal second trimester multiple marker screening tests associated with intra-uterine growth restriction.

Our objective was to evaluate the optimal thresholds for unexplained abnormal multiple marker screening (MMS) results that are associated with intrauterine growth restriction (IUGR). This was a case-control study from our perinatal database. MMS analyte levels (multiples of median [MoM]) of cases with IUGR (birthweight < 5th percentile for gestational age) were compared with a control group without IUGR. Pregnancies with fetal anomalies were excluded. Biochemical markers evaluated include alpha-fetoprotein (AFP), human chorionic gonadotropin (hCG), and unconjugated estriol (uE3). Using receiver operating characteristic curves, the optimal thresholds of MMS (OTMs) associated with IUGR were determined. We identified 255 (12.3%) cases with IUGR and complete MMS records from the database. These were compared with 1785 controls without IUGR randomly selected from our perinatal database in a 1:7 ratio. The OTMs associated with IUGR were AFP > 2.0 MoM (odds ratio [OR] = 2.3; 95% confidence interval [CI], 1.4 to 3.7), hCG > 2.5 MoM (OR = 1.8; 95% CI, 1.1 to 3.2) and uE3 < 0.9 MoM (OR = 2.7; 95% CI, 2.0 to 3.7). The sensitivity, specificity, and positive and negative predictive values for predicting IUGR in the presence of at least one abnormal MMS were 46, 66, 11, and 90%, respectively. Elevated AFP > 2.0 MoM and hCG > 2.5 MoM were the most specific markers for MMS, with specificity of 94 and 95%, respectively. When all three analytes were abnormal, the specificity for predicting IUGR increased to 99%. Abnormal MMS results are associated with IUGR. As a screening tool for IUGR, the biochemical markers were associated with poor sensitivity. Elevated AFP and hCG, however, were highly specific in predicting IUGR. The provided thresholds could be useful in designing policies regarding women who would benefit most from sonographic screening for IUGR.

Advanced maternal age is an independent risk factor for intrauterine growth restriction.

Reports on the association between advanced maternal age (AMA) and intrauterine growth restriction (IUGR) are conflicting. Our objective was to determine if AMA is an independent risk factor for IUGR. Our case-control study compared cases with IUGR (birthweight<10th percentile for gestational age) and a control group without IUGR. Gestational ages were all confirmed by ultrasound. The study included only singletons and fetal anomalies were excluded. Both groups were evaluated for maternal demographics and clinical risk factors. AMA was defined as maternal age>35 years. Univariate and multivariate analyses were used to examine associations. During the study period, there were 824 cases with IUGR meeting the inclusion criteria; these were compared with 1648 controls (no IUGR) randomly selected from the same population during the same study period. The significant factors associated with IUGR multivariate analyses were black race (odds ratio [OR], 22.4; 95% confidence interval [CI], 17.8 to 28); chronic hypertension (OR, 2.2; 95% CI, 1.5 to 3.2); pregestational diabetes (OR, 3.3; 95% CI, 1.6 to 7) illicit drug use (OR, 3.3; 95% CI, 2.2 to 5.2), and AMA (OR, 1.4; 95% CI, 1.1 to 1.8). There was a positive dose-response association between increasing maternal age and increasing risk for IUGR. At maternal age of 40 years or older, the OR and 95% CI for IUGR was 3.2 and 1.9 to 5.4, respectively. AMA is an independent risk factor for IUGR. Our findings suggest that screening for IUGR is indicated in women age 35 years or older.

Evaluating the efficiency of using second-trimester nasal bone hypoplasia as a single or a combined marker for fetal aneuploidy.

OBJECTIVE: Although second-trimester nasal bone (NB) hypoplasia has been associated with fetal aneuploidy, its role as a single marker is still uncertain. Our objective was to evaluate the efficiency of NB hypoplasia as an independent marker for fetal aneuploidy. METHODS: This was a prospective cohort study of women undergoing an anatomic survey between 16 and 22 weeks' gestation. The fetal NB and other markers of fetal aneuploidy, including nuchal fold, femur and humeral lengths, choroid plexus cysts, major fetal anomalies, echogenic bowel, pyelectasis, and hypoplastic fifth digits, were evaluated. Nasal bone hypoplasia was defined either as an absent NB or by a ratio of the biparietal diameter to NB. Fetuses or infants with fetal aneuploidy were compared with those without for the presence of NB hypoplasia either as a single marker or in the presence of other markers for aneuploidy. RESULTS: Of 2885 women evaluated, NB measurements were obtained in 2465 (85%). There were 35 (1.4%) cases with fetal aneuploidy. The sensitivity and specificity of a single NB in detecting Down syndrome varied from 23% to 64% and 57% to 99%, respectively, depending on the definition of NB hypoplasia used. There was an improvement in the efficiency of using the NB when combined with other markers, with sensitivity and specificity increasing from 59% to 82% and 74% to 87%, respectively. CONCLUSIONS: Nasal bone hypoplasia is a marker for fetal aneuploidy. The combination of the NB with other makers was associated with an improvement in detection of fetal aneuploidy.

A cost-effectiveness analysis of prenatal screening strategies for Down syndrome.

OBJECTIVE: To evaluate which Down syndrome screening strategy is the most cost-effective. METHODS: Using decision-analysis modeling, we compared the cost-effectiveness of 9 screening strategies for Down syndrome: 1) no screening, 2) first-trimester nuchal translucency (NT) only, 3) first-trimester combined NT and serum screen, 4) first-trimester serum only, 5) quadruple screen, 6) integrated screening, 7) sequential screening, 8) integrated serum only, or 9) maternal age. Costs included cost of tests and resources used for raising a child with Down syndrome. One-way and multiway sensitivity analyses were performed for all model variables. The main outcome measures were cost per Down syndrome case detected, rate of delivering a liveborn neonate with Down syndrome, and rate of diagnostic procedure-related pregnancy loss for each strategy. RESULTS: Sequential screening detected more Down syndrome cases compared with the other strategies, but it had a higher procedure-related loss rate. Integrated serum screening was the most cost-effective strategy. Sensitivity analyses revealed the model to be robust over a wide range of values for the variables. The addition of the cost of genetic sonogram to the second-trimester strategies resulted in first-trimester combined screening becoming the most cost-effective strategy. CONCLUSION: Within our baseline assumptions, integrated serum screening was the most cost-effective screening strategy for Down syndrome. If the cost of nuchal translucency is less than dollars 57 or when genetic sonogram is included in the second-trimester strategies, first-trimester combined screening became the most cost-effective strategy. LEVEL OF EVIDENCE: III.

The association between fetal nasal bone hypoplasia and aneuploidy.

OBJECTIVE: To determine the association between fetal nasal bone hypoplasia and aneuploidy in women undergoing prenatal diagnosis. METHODS: A prospective cohort study involving women undergoing chorionic villus sampling and amniocentesis for an increased risk of aneuploidy. Fetal biometric and nasal bone measurements were obtained at the time of prenatal diagnosis and compared with karyotypes. Nasal bone hypoplasia was defined as nasal bone less than 2.5th percentile for the gestational age. RESULTS: A total of 632 fetuses were evaluated. Twenty-nine (4.6%) had an aneuploidy (18 trisomy 21, 5 trisomy 18, 1 Turner's syndrome, one Marker chromosome 1, 2 sex chromosome anomalies, and 2 triploidy). Nasal bone measurements were documented in 29 aneuploid fetuses. The nasal bone was either absent or hypoplastic in 12 of 29 (41%) fetuses with aneuploidy and in 8 of 18 (44%) with trisomy 21. By using receiver operating characteristics curves, the optimal threshold of nasal bone hypoplasia associated with fetal aneuploidy was a biparietal diameter/nasal bone ratio of 11 or greater. The sensitivity, specificity, and positive and negative predictive values for the detection of fetal aneuploidy were 50%, 93%, 24%, and 98%, respectively. CONCLUSION: Absent or hypoplastic nasal bone is a marker for fetal aneuploidy in a high-risk population. However, this marker needs to be evaluated by larger prospective studies in low-risk populations before adoption for clinical use.

The effects of the time interval from antenatal corticosteroid exposure to delivery on neonatal outcome of very low birth weight infants.

OBJECTIVE: The purpose of this study was to determine whether the interval between antenatal steroid exposure and delivery influences neonatal outcome in very low birth weight infants. STUDY DESIGN: A retrospective review was performed of all live-born singleton infants who weighed between 500 and 1500 g and who were exposed to a partial course (1 dose) or a complete course (2 12-mg doses of betamethasone given 24 hours apart) of antenatal corticosteroids. Infants were divided into 4 groups, depending on the interval between the first dose of antenatal corticosteroids and delivery (<24 hours, between 24 and 48 hours, between 48 hours and 7 days, and >7 days). Logistic regression was used to control for differences between the 4 groups. RESULTS: Three hundred twenty-five singleton deliveries were reviewed. Gestational age at delivery and birth weight were similar for all 4 groups. The babies in the last group were treated with antenatal corticosteroids at a slightly earlier gestational age. There was no statistical difference between the groups with respect to respiratory distress syndrome treated with surfactant, intraventricular hemorrhage, necrotizing enterocolitis, and deaths. CONCLUSION: In infants who weighed 500 to 1500 g, the time interval between exposure to antenatal corticosteroids and delivery does not appear to affect neonatal outcome. Further studies should evaluate the effects of antenatal corticosteroids and the effects of the interval from exposure to delivery in very low birth weight infants.