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

Abstract

Objective: To describe changes in the acceptance of transvaginal (TV) cervical length (CL) measurements, and in the variance of CL measurements among operators, after implementation of universal TV-CL measurements at 18+0-23+6 weeks/days of gestation. Study Design: Retrospective cohort study 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, Texas, for all women undergoing an anatomy ultrasound (US) between 18 0/6 and 23 6/7 weeks of gestation. Pregnant women carrying singletons without prior history of preterm delivery who underwent anatomy ultrasound evaluation between September 2017 and March 2020 (30 months) were included. The complete study period was divided in five epochs of six 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 ultrasound operators across the five epochs were evaluated. For this analysis, 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 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 one 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-SL 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 six months after implementation of a universal cervical length screening program, there was greater variation in CL measurements, lower acceptance for a TV ultrasound, and a higher number of women diagnosed with a CL ≤25 mm, as compared to subsequent epochs. After the first six 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 under estimate CL measurements.

First Trimester Prediction of Preterm Birth in Patient Plasma with Machine-Learning-Guided Raman Spectroscopy and Metabolomics

“…Current clinical standards that identify women at high risk of PTB include cervical length assessment and screening for fetal fibronectin, a protein elevated in the vaginal pool near birth . However, these approaches are inadequate and often inconclusive in predicting the complex phenotype of PTB. , Despite advances in biomarker discovery, prediction of the onset of PTB has remained a challenge because (1) current clinical assays have poor sensitivity and specificity which fail to identify relevant biomarkers; (2) single biomarker tests are ineffective due to low positive predictive values; (3) there are significant inter- and intra-assay disparities due to variations in the detection method, sample type used, and timing of sample collection which make comparative analysis of biomarkers difficult for PTB prediction; and (4) while some studies have reported multiplexed screening using the same sample type and platform, there were significant variations in the study designs and clear conclusions could not be drawn. An unmet clinical need exists for an effective screening tool that enables quantitative detection of unconventional biomarkers of PTB with high sensitivity and specificity at clinically relevant levels, yet simultaneously be low-cost allowing early, accurate, and affordable screening for patients.…”

Cervical assessment certification and its impact on performance quality in the context of universal cervical screening

“…5 Until recently, only a few studies assessed the sonographer's performance in obtaining TVCL images. Soto et al 24 In a prospective cohort study, Joly et al 25 evaluated 10 resident physicians who acquired five images of the cervix before and after completion of the theoretical course and images audit using a maximum score of 8 over the eight criteria suggested by CLEAR. 10 The overall performance was improved after obtaining the certification (mean score of 6.6 ± 0.9 vs 4.3 ± 2.1; P < 0.001) immediately after the training.…”

“…Until recently, only a few studies assessed the sonographer's performance in obtaining TVCL images. Soto et al 24 evaluated the changes over time after the implementation of TVCL screening in the success rate for performing TVCL scans according to the experience of the certified operators. The authors found that less experienced sonographers had a lower rate of TVCL scans (80.8% [56.4%–92.3%]) than those with more than 10 years of experience (85.8% [62.3%–97.2%]; P = 0.03) and that most, but not all, sonographers improved their success rate for obtaining TVCL measurements after the first 6 months after the introduction of universal TVCL screening.…”

Early prediction of pregnancy disorders with machine learning guided Raman spectroscopy, and metabolomics.

“…Note: none of these current clinical measures alone is predictive of PTL risk. [5][6][7] Finally, we wanted to compare Raman findings with clinical assays of protein biomarkers that are standard practice for prediction of PTL but have not been reliable measure of PTL diagnosis in 1 st trimester. Here we performed enzyme linked immunosorbent assay (ELISA)…”

“…4 The effectiveness of these tools is also inconclusive based on previous studies. [5][6][7] Patient history such as previous preterm births and miscarriages have in a strong correlation to PTL, but this is irrelevant for women experiencing their first pregnancy. 8 To diagnose and find appropriate solutions with sufficient time for treatment, a forecasting tool would ideally be able to take data from the first trimester and predict the likelihood of a mother developing PTL, with or without previous preterm births or miscarriage data.…”