Implementing a Bundle for Evidence-based Cesarean Delivery May Not Be As Beneficial as Expected: A Multi-center, Pre- and Post- Study.

BACKGROUND: Standardization of procedures improves outcomes. Though systematic reviews have summarized the evidence-based steps (EBS) of cesarean delivery (CD), their bundled implementation has not been investigated. OBJECTIVE: In this pre- and post-implementation trial, we sought to ascertain if bundled EBS of CD, compared to surgeon's preference, improves outcomes. STUDY DESIGN: A StaRI (Standards for Reporting Implementation Studies) compliant, multi-center pre- and post-implementation trial at 4 teaching hospitals was conducted. The pre-implementation period consisted of CD done based on the physicians' preferences for 3 months; educational intervention (e.g., didactics, badge cards, posters, video) occurred at the 4th month. CDs in post-implementation period employed the bundled EBS. A pre-planned 10% randomized audit of both groups assessed adherence and uptake of EBS. The primary outcome was a composite maternal morbidity (CMM), which included estimated blood loss > 1,000 mL, blood transfusion, endometritis, post-partum fever, wound complications, sepsis, thrombosis, ICU admission, hysterectomy, or death. The secondary outcome was a composite neonatal morbidity (CNM) and some of its components were 5-min Apgar score < 7, positive pressure oxygen use, hypoglycemia, or sepsis. A priori Bayesian sample size calculation indicated 700 CD in each group was needed to demonstrate 20% relative reduction (from 15% to 12%) of CMM with 75% certainty. Bayesian logistic regression with neutral priors was used to calculate likelihood of net-improvement in adjusted relative risk (aRR) with 95% credible intervals (CrI). RESULTS: A total of 1,425 consecutive CD (721 in pre- and 704 in post-implementation group) were examined. Audited data indicated that the baseline EBS utilization rate during the pre-implementation period was 79%; after the implementation bundled EBS of CD the audited adherence was 89%-an uptake of 10.0% of the EBS. In four aspects, the maternal characteristics differed significantly in the pre- and post-implementation periods: race/ethnicity, hypertensive disorder, and the relative contribution of the 4 centers to the cohorts and the gestational age at delivery, but the indications for CD and whether its duration was < versus > 60 min did not. The rates of CMM in the pre- and post-implementation groups were 26% and 22%, respectively (aRR, 0.88; 95% CrI, 0.73-1.04), with a 94 % Bayesian probability of a reduction in CMM. The CNM occurred in 37% of the pre- and in 41% of the post-implementation group (aRR, 1.12; 95% CrI 0.98-1.39), with a 95% Bayesian probability of worsening in CNM. When CMM were segregated by preterm (<37 wks) and term (> 37 weeks) CD, the improvement in maternal outcomes persisted; when CNM were segregated by gestational age subgroupsthe potential for worsening neonatal outcomes persisted as well. CONCLUSIONS: Standardization of the evidence-based bundled steps of cesarean delivery resulted in a modest reduction of the composite maternal outcome; however, a paradoxical increase in neonatal composite morbidity was noted. Although individual evidence-based steps may be of value, while awaiting additional intervention trials a formal bundling of such steps is currently not recommended.

Abnormal Shape and Size of the Cardiac Ventricles Are Associated with a Higher Risk of Neonatal Death in Fetuses with Isolated Left Congenital Diaphragmatic Hernia.

INTRODUCTION: The objective of this study was to evaluate the association between fetal cardiac deformation analysis (CDA) and cardiac function with severe adverse perinatal outcomes in fetuses with isolated left congenital diaphragmatic hernia (CDH). METHODS: CDA in each ventricle (contractility, size, and shape), evaluated by speckle tracking and novel FetalHQ software, and markers of cardiac function (E/A ratios, pulmonary and aortic peak systolic velocities, and sigmoid annular valve diameters), were evaluated in fetuses with isolated left CDH. Two evaluations were performed: at referral (CDA and function) and within 3 weeks of delivery (CDA). Severe adverse neonatal outcomes were considered neonatal death (ND) or survival with CDH-associated pulmonary hypertension (CDH-PH). Differences and associations between CDA, cardiac function, and severe adverse outcomes were estimated. RESULTS: Fifty fetuses were included, and seventeen (34%) had severe adverse neonatal outcomes (11 ND and 6 survivors with CDH-PH). At first evaluation, the prevalence of a small left ventricle was 34% (17/50) with a higher prevalence among neonates presenting severe adverse outcomes (58.8 [10/17] vs. 21.2% [7/33]; p = 0.01; OR, 5.03 [1.4-19.1; p = 0.01]) and among those presenting with neonatal mortality (8/11 [72.7] vs. 9/39 [23.0%]; p = 0.03; OR, 8.9 [1.9-40.7; p = 0.005]). No differences in cardiac function or strain were noted between fetuses with or without severe adverse outcomes. Within 3 weeks of delivery, the prevalence of small left ventricle was higher (19/34; 55.8%) with a more globular shape (reduced transverse/longitudinal ratio). A globular right ventricle was significantly associated with ND or survival with CDH-PH (OR, 14.2 [1.5-138.3]; p = 0.02). CONCLUSION: Fetuses with isolated CDH at risk of perinatal death or survival with CDH-PH had a higher prevalence of a small left ventricle and abnormal shape of the right ventricle.

Factors associated with exclusive formula feeding among individuals with low-risk pregnancies in the United States.

BACKGROUND: Better understanding of the factors associated with formula feeding during the hospital stay can help in identifying potential lactation problems and promote early intervention. Our aim was to ascertain factors associated with exclusive formula feeding in newborns of low-risk pregnancies. METHODS: A population-based, retrospective study using the United States vital statistics datasets (2014-2018) evaluating low-risk pregnancies with a nonanomalous singleton delivery from 37 to 41 weeks. People with hypertensive disorders, or diabetes, were excluded. Primary outcome was newborn feeding (breast vs exclusive formula feeding) during hospital stay. Adjusted relative risks (aRRs) with 95% confidence intervals (CI) were calculated. RESULTS: Of the 19 623 195 live births during the study period, 11 605 242 (59.1%) met inclusion criteria and among them, 1 929 526 (16.6%) were formula fed. Factors associated with formula feeding included: age < 20 years (aRR 1.31 [95% CI 1.31-1.32]), non-Hispanic Black (1.42, 1.41-1.42), high school education (1.69, 1.69-1.70) or less than high school education (1.94, 1.93, 1.95), Medicaid insurance (1.52, 1.51, 1.52), body mass index (BMI) < 18.5 (1.10, 1.09-1.10), BMI 25-29.9 (1.09, 1.09-1.09), BMI 30-34.9 (1.19, 1.19-1.20), BMI 35-39.9 (1.31, 1.30-1.31), BMI ≥ 40 (1.43, 1.42-1.44), multiparity (1.29, 1.29-1.30), lack of prenatal care (1.49, 1.48-1.50), smoking (1.75, 1.74-1.75), and gestational age (ranged from 37 weeks [1.44, 1.43-1.45] to 40 weeks [1.11, 1.11-1.12]). CONCLUSIONS: Using a large cohort of low-risk pregnancies, we identified several modifiable factors associated with newborn feeding (eg, prepregnancy BMI, access to prenatal care, and smoking cessation). Improving the breast feeding initiation rate should be a priority in our current practice to ensure equitable care for all neonates.

Does Prediction of Neonatal Mortality by the Observed/Expected Lung-To-Head Ratio Change during Pregnancy in Fetuses with Left Congenital Diaphragmatic Hernia?

INTRODUCTION: The aim of this study was to evaluate prediction of neonatal mortality in fetuses with isolated left congenital diaphragmatic hernia (CDH) when the observed/expected lung-to-head ratio (O/E LHR) was estimated at two different gestational time points during pregnancy. METHODS: Forty-four (44) fetuses with isolated left CDH were included. O/E LHR was estimated at the time of referral (first scan) and before delivery (last scan). The main outcome was neonatal death due to respiratory complications. RESULTS: There were 10/44 (22.7%) perinatal deaths. The areas under (AU) the ROC curves were: first scan, 0.76, best O/E LHR cut-off 35.5% with 76% sensitivity and 70% specificity; last scan, AU-ROC 0.79, best O/E LHR cut-off 35.2%, with 79.0% sensitivity and 80% specificity. Considering an O/E LHR cut-off ≤35% to define high-risk fetuses at any examination, prediction for perinatal mortality showed: 80% sensitivity, 73.5% specificity, 47.1% positive and 92.6% negative predictive values, and 3.02 (95% CI 1.59-5.73) positive and 0.27 (95% CI 0.08-0.96) negative likelihood ratios. Prediction was similar in the two evaluations as 16/21 (76.2%) of fetuses considered at risk had an O/E LHR ≤35% in the two examinations; in the remaining 5 cases, two were identified only in the first and three only in the last scan. CONCLUSION: The O/E LHR is a good predictor of perinatal death in fetuses with left isolated CDH. Approximately 80% of fetuses at risk of perinatal death can be identified with an O/E LHR ≤35%, and 90% of them will have similar O/E LHR values at the first and at the last ultrasound examinations prior to delivery. In general, 88.6% of all CDH fetuses have a similar severity classification based on the O/E LHR at the first diagnostic ultrasound or at the ultrasound examination prior to delivery.

Weekly Differences in the Prevalence of a Short Cervix at 18+0 to 23+6 Weeks of Gestation in Pregnant Women with and without a History of Preterm Delivery.

OBJECTIVE: The study aimed to estimate weekly differences in the prevalence of a short cervix during the period of 18+0 to 23+6 weeks of gestation in pregnant women with and without a history of previous preterm delivery (PTD). DESIGN: An observational study was conducted. METHODS: Setting and participants: 20,002 pregnant women, 18,591 without a history of previous PTD (low risk) and 1,411 with at least one previous PTD (high risk), were evaluated at 18+0 to 23+6 weeks + days of gestation. Weekly differences in the prevalence of a short cervix (≤25 mm, ≤20 mm, and ≤15 mm) between women with and without previous PTD were estimated. RESULTS: High-risk women had a significantly higher prevalence of a short cervix, defined as either ≤25 mm (4.4% vs. 2.2%; p < 0.0001) or ≤20 mm (2.4% vs. 1.2%; p < 0.0001) but not for ≤15 mm (1.2% vs. 0.9%; p < 0.2) as compared to low-risk pregnant women. The odds ratio for a short cervix ≤25 mm in high-risk as compared to low-risk women was 2.0 (95% CI 1.54-2.61; p < 0.0001). Among low-risk women, those evaluated at 22 or 23 weeks of gestation had a significantly higher prevalence of a short cervix ≤25 mm (3.8% vs. 1.9%; p < 0.0001), ≤20 mm (2.4% vs. 0.98%; p < 0.0001), and ≤15 mm (1.6% vs. 0.7%; p < 0.0001) than low-risk women scanned between 18 and 21 weeks of gestation. Similar results were observed for high-risk women. LIMITATIONS: No gestational age at delivery was evaluated. CONCLUSION: There is higher prevalence of short cervix when pregnant women are evaluated at 22+0 to 23+6 than at 18+0 to 21+6 weeks of gestation.

Implementing a Universal Cervical Length Screening Program in a Large Hospital System: It Takes Some Time to Achieve Consistent Results.

OBJECTIVE: The aim of the study was to describe changes in the acceptance of transvaginal (TV) cervical length (CL) assessment and in the variance of CL measurements among operators, after implementation of universal TV-CL screening at 18+0 - to 23+6 weeks/days of gestation. DESIGN: Retrospective cohort. PARTICIPANTS/MATERIALS, SETTING, METHODS: This study was performed after universal TV-CL screening was implemented at the University of Texas Health Science Center in Houston, TX, USA, for all women undergoing an anatomy ultrasound (US) between 18 0/6 and 23 6/7 weeks/days of gestation. Pregnant women carrying singletons without prior history of preterm delivery who underwent anatomy US evaluation between September 2017 and March 2020 (30 months) were included. The complete study period was divided into five epochs of 6 months each. Changes in patient's acceptance for the TV scan, in CL distribution, in the prevalence of short cervix defined as ≤15, ≤20, or ≤25 mm, and in the performance of US operators across the five epochs were evaluated. Success rate was defined as the percentage of TV-CL measurements obtained in relation to the number of second-trimester anatomy scans. RESULTS: A total of 22,207 low-risk pregnant women evaluated by 36 trained sonographers (operators) were analyzed. Overall, the acceptance for TV-CL measurement was 82.3% (18,289/22,207), increasing from 76.7% in the first epoch to 82.8% (p < 0.0001) in the last epoch. The mean CL did not significantly change from 38.6 mm in the first epoch to 38.5 mm in the last epoch (p = 0.7); however, the standard deviation decreased from 7.9 mm in the first epoch to 7.04 mm in the last epoch (p = <0.01). The prevalence of a short cervix ≤25 mm was 2.2% (n = 399/18,289), ≤20 mm was 1.2% (224/18,289), and ≤15 mm was 0.9% (162/18,289). This prevalence varied only for CL ≤25 mm from 3.02% (88/2,907) in the first epoch to 1.77% (64/3,615) in the last epoch (p = 0.0009). There was a variation in CL measurements among operators (mean 3.3 mm). Sonographers with less than 1 year of experience had a lower success rate for completing TV-CL examinations than more experienced sonographers (80.8% vs. 85.8%; p < 0.03). In general, 77% (27/35) of operators had a success rate ≥80% for completing TV-CL scans. LIMITATIONS: Characteristics of individuals who accepted versus those who declined TV-CL were not compared; CL values were not correlated with clinical outcomes. CONCLUSIONS: During the first 6 months after implementation of a universal CL screening program, there was greater variation in CL measurements, lower acceptance for TV US, and a higher number of women diagnosed with a CL ≤25 mm, as compared to subsequent epochs. After the first 6 months, these metrics improved and remained stable. Most operators improved their performance over time; however, there were a few with a low success rate for TV-CL and others who systematically over- or underestimate CL measurements.

Novel Speckle Tracking Analysis Showed Excellent Reproducibility for Size and Shape of the Fetal Heart and Good Reproducibility for Strain and Fractional Shortening.

INTRODUCTION: This study aimed to evaluate reproducibility and agreement of fetal cardiac shape and deformation using FetalHQ. METHODS: Fifty normal fetuses at 20-38 weeks of gestation were evaluated. Two operators independently selected an optimal cardiac cycle using FetalHQ®™software for speckle tracking analysis. Intra- and interobserver correlation coefficient and limits of agreement for cardiac shape and deformation were estimated. RESULTS: Global cardiac markers: high correlation (r = 0.98) and agreement (mean difference, standard deviation [MD, SD] 5.07, 75.8) for ventricular area; moderate correlation (r = 0.78) and agreement (MD, SD: 0.016, 0.08) for global sphericity index (SI) and for left ventricle (LV) global strain (r = 0.65; MD, SD: -4.48, 11.9); and low but still significant correlation (r = 0.58) and agreement (MD, SD: -3.77, 12.27) for right ventricle (RV) global strain. For individual ventricular parameters: high correlation for LV ([median r; range] 0.98; 0.93-0.99) and RV (r = 0.98; 0.97-1.0) SI, and for LV (r = 0.92: 0.56-0.99) and RV (r = 0.96; 0.67-0.99) end diastolic diameters; moderate correlation for LV fractional shortening (r = 0.53; 0.87-0.98); and no significant correlation for RV fractional shortening (r = 0.36; 0.32-0.97). Inter- and intraobserver correlation and agreement were similar for all evaluated parameters. CONCLUSION: Speckle tracking analysis of the fetal heart provides reliable estimations of global and LV shape and deformation. Low correlation in the RV can be related to anatomical structures such as the moderator band.

Maternal and Neonatal Outcomes of Gunshot Wounds in Pregnancy: A Systematic Review of Case Reports.

A systematic review was performed to compare adverse maternal and neonatal outcomes among pregnant patients with gunshot wounds (GSW) to the abdominopelvic vs other region(s) at > 20 weeks gestation. A search of Medline Ovid, Elsevier Embase, EBSCO CINAHL, and Cochrane Library in July 2022 and reference searches resulted in 1742 studies, which were screened. The 41 included studies reported outcomes for 59 pregnant patients with GSW, of which 31 (52.5%) had an isolated abdominopelvic GSW and 28 (47.5%) had an extremity, thorax, head/neck, back/spine, poly-site, or other/unknown GSW. Stillbirth occurred in 26.7% of abdominopelvic GSW and 26% of non-abdominopelvic GSW. Maternal death occurred in 3.7% of abdominopelvic GSW and 10.7% of non-abdominopelvic GSW. Neonatal death occurred in 9.1% of abdominopelvic GSW and 5.3% of non-abdominopelvic GSW. Further research is needed to standardize the approach for the evaluation and management of patients with GSW in pregnancy.

Rate of preterm delivery and latency period in asymptomatic patients undergoing cerclage for very short cervix ≤10.0 mm.

BACKGROUND: In asymptomatic women with cervical length ≤10 mm, vaginal progesterone has a limited effect in reducing the rate of preterm delivery. OBJECTIVE: This study aimed to estimate the rate of preterm delivery and mean latency period to delivery in asymptomatic women with no history of preterm delivery and a cervical length of ≤10.0 mm undergoing or not undergoing cerclage and who were not treated with vaginal progesterone. STUDY DESIGN: This was a retrospective analysis of asymptomatic patients with singleton pregnancies and no history of preterm delivery with an incidental finding of a cervical length of ≤10.0 mm measured by transvaginal ultrasound during midtrimester scan. Of note, 56 patients (63.6%) underwent cerclage placement and 32 patients (36.4%) did not, none of them received vaginal progesterone. Patients with evidence of advanced dilation, prolapsing membranes, ruptured membranes, or positive signs of infection were not candidates for cerclage placement and were excluded from the analysis. Differences in the prevalence of preterm delivery, mean gestational age at delivery, and mean latency from very short cervix identification to delivery between the 2 groups were calculated. Associations between cerclage and preterm delivery adjusted for maternal characteristics and fetal weight were estimated. RESULTS: The median gestational ages at the time of cervical length measurement were 20 6/7 weeks (interquartile range, 17 5/7 to 23 3/7) in the cerclage group and 21 5/7 weeks (interquartile range, 17 6/7 to 23 6/7) in the no-cerclage group (P=.02). No difference in cervical length was observed between patients who had a cerclage (5.9±3.1 mm) and those who did not have a cerclage (6.5±3.2 mm) (P=.4). The prevalence of preterm delivery in women with cerclage vs women without cerclage was as follows: PTD at <37 weeks of gestation (31/56 [55.3%] in the cerclage group vs 28/32 [87.5%] in the no-cerclage group; adjusted odds ratio, 0.17; 95% confidence interval, 0.05-0.62; P=.008), PTD at ≤34 weeks of gestation (27/56 [48.2%] in the cerclage group vs 24/32 [75.0%] in the no-cerclage group; adjusted odds ratio, 0.16; 95% confidence interval, 0.05-0.55; P=.02), and PTD at ≤28 weeks of gestation (19/56 [33.9%] in the cerclage group vs 22/32 [68.7%] in the no-cerclage group; adjusted odds ratio, 0.15; 95% confidence interval, 0.05-0.51; P=.002). The median gestational ages at delivery were 32 6/7 weeks (interquartile range, 19 1/7 to 40 1/7) in the cerclage group and 28 1/7 weeks (interquartile range, 20 1/7 to 40 2/7) in the no-cerclage group (P=.001). The median latencies from the time of cervical length measurement to delivery were 84 days (interquartile range, 8-144) in the cerclage group and 43 days (interquartile range, 1-146) in the no-cerclage group (P=.003). CONCLUSION: Among low-risk asymptomatic women with a very short cervix (≤10.0 mm) in the midtrimester of pregnancy, women treated with cerclage have an increased latency to delivery and a lower prevalence of preterm delivery than those treated with expectant management.

Maternal and obstetrical factors associated with short cervical length at midtrimester in women with no history of preterm delivery.

AIM: To evaluate associations between maternal characteristics and a short cervix in patients without history of preterm delivery, and to determine if these characteristics can predict the presence of a short cervix. MATERIALS AND METHODS: This is a retrospective cohort study that included 18,592 women with singleton pregnancies without history of previous preterm deliveries who underwent universal transvaginal cervical length (TVCL) screening between 18 + 0 and 23 + 6 weeks/days of gestation. A short cervix was defined as a cervical length (CL) ≤25 mm, ≤20 mm, and ≤15 mm. Associations between maternal age, weight, height, body mass index (BMI), previous term deliveries, and history of previous miscarriages, with a short cervix were evaluated using logistic regression models. RESULTS: The prevalence of a short cervix in our population was: CL ≤25 mm, 2.2% (n = 403); CL ≤20 mm, 1.2% (n = 224); and CL ≤15 mm, 0.9% (n = 161). Women with BMI >30 and/or previous abortions constituted 45.5% of the total population (8463/18,582). Significant associations with short cervix were observed for women with BMI ≥30, and for women with at least one previous abortion (p < .001). Parous women had a significantly lower association with a short cervix than nulliparous women (p < .001). Maternal age or height were not associated with a short cervix. Prediction of short cervix based on presence of any of the following: BMI ≥ 30 or previous abortions showed sensitivities of 55.8% (≤25 mm), 61.6% (≤20 mm), and 63.4% (≤15 mm) with similar specificity (50.1-54.6%) and likelihood ratio positive (1.2-1.5); and prediction based on BMI ≥ 30 and previous abortions showed sensitivities of 11.1% (≤25 mm), 14.7% (≤20 mm), and 16.7% (≤15 mm) with specificity 93%. CONCLUSIONS: Among low risk women for spontaneous preterm delivery, those with a BMI ≥30 and/or previous miscarriages had a significantly increased risk for a short cervix at 18 + 0 and 23 + 6 weeks/days of gestation. Despite these significant associations, screening by maternal risk factors in a low risk population of pregnant women should not be an alternative to mid-trimester universal CL measurement.

In pregnant women evaluated at 18/0 and 23/6 weeks + days of gestation without history of preterm delivery, a 16.7% detection rate for short cervix ≤15 mm can be achieved by risk factors BMI ≥30, and at least one previous miscarriage. Nevertheless, screening for short cervix by risk factors among low risk women might not be an effective alternative to universal cervical length screening.

Rates of Maternal and Perinatal Mortality and Vertical Transmission in Pregnancies Complicated by Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-Co-V-2) Infection: A Systematic Review.

OBJECTIVE: To ascertain the frequency of maternal and neonatal complications, as well as maternal disease severity, in pregnancies affected by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. DATA SOURCES: MEDLINE, Ovid, ClinicalTrials.gov, MedRxiv, and Scopus were searched from their inception until April 29, 2020. The analysis was limited to reports with at least 10 pregnant patients with SARS-CoV-2 infection that reported on maternal and neonatal outcomes. METHODS OF STUDY SELECTION: Inclusion criteria were pregnant women with a confirmed diagnosis of SARS-CoV-2 infection. A systematic search of the selected databases was performed by implementing a strategy that included the MeSH terms, key words, and word variants for "coronavirus," "SARS-CoV-2," "COVID-19," and "pregnancy.r The primary outcomes were maternal admission to the intensive care unit (ICU), critical disease, and death. Secondary outcomes included rate of preterm birth, cesarean delivery, vertical transmission, and neonatal death. Categorical variables were expressed as percentages with number of cases and 95% CIs. TABULATION, INTEGRATION, AND RESULTS: Of the 99 articles identified, 13 included 538 pregnancies complicated by SARS-CoV-2 infection, with reported outcomes on 435 (80.9%) deliveries. Maternal ICU admission occurred in 3.0% of cases (8/263, 95% CI 1.6-5.9) and maternal critical disease in 1.4% (3/209, 95% CI 0.5-4.1). No maternal deaths were reported (0/348, 95% CI 0.0-1.1). The preterm birth rate was 20.1% (57/284, 95% CI 15.8-25.1), the cesarean delivery rate was 84.7% (332/392, 95% CI 80.8-87.9), the vertical transmission rate was 0.0% (0/310, 95% CI 0.0-1.2), and the neonatal death rate was 0.3% (1/313, 95% CI 0.1-1.8). CONCLUSION: With data from early in the pandemic, it is reassuring that there are low rates of maternal and neonatal mortality and vertical transmission with SARS-CoV-2. The preterm birth rate of 20% and the cesarean delivery rate exceeding 80% seems related to geographic practice patterns. SYSTEMATIC REVIEW REGISTRATION: PROSPERO, CRD42020181497.