Evaluating sensitivity and specificity of handheld point-of-care ultrasound testing for gynecologic pathology: a pilot study for use in low resource settings.

BACKGROUND: Point-of-care ultrasound (POC-US) is a diagnostic test conducted at the site of patient care with direct interpretation by the clinician, providing immediate results. POC-US for gynecologic application is not well characterized by current literature yet has the potential to increase access in limited resource settings. We compared the diagnostics of three POC-US devices for gynecologic (GYN) pathology and then performed evaluation of sensitivity and specificity of a single best POC-US device for intended use in a low resource setting. METHODS: This is prospective, pilot descriptive study of 60 subjects. In part 1, comparison of three POC-US devices was performed. Twenty subjects underwent POC-US with three test units [GE Vscan (Vscan), Sonosite Iviz (Iviz), Philips Lumify (Lumify)] followed by diagnostic ultrasound (Dx-US) for reference imaging. Image quality and correlation for devices was scored by blinded reviewers and quantitative measurements of GYN pathology were compared. In part 2, forty subjects underwent POC-US validation with the highest scoring device (Lumify) and Dx-US for reference imaging. Concordance of POC-US operator-interpreted diagnosis with reference imaging interpretation were assessed by Cohen's unweighted kappa coefficient. Accuracy and agreement of POC-US were assessed by linear regression and Bland-Altman plot analysis. Sensitivity and specificity of POC-US for gynecologic pathologies were calculated. RESULTS: In aggregate qualitative measurements, Lumify and Iviz units performed superiorly to Vscan. There was no statistically significant difference in quantitative measurements between devices, but a trend towards lower mean error was seen for Lumify and Iviz as compared to Vscan. Lumify device had highest overall scoring and was selected for further testing. In validation comparison of Lumify to Dx-US, no statistically significant differences were found for measurements of endometrium, uterus, ovaries, adnexal pathology, or leiomyomata, (P < 0.02) with excellent agreement in operator-interpreted diagnosis (Kappa > 0.7). Sensitivity and specificity of detecting pathology was 80-100% with PPV and NPV 76-100%. CONCLUSION: Among three POC-US devices, Lumify and Iviz devices show highest potential for successful application to clinical gynecologic ultrasound. Clinician-performed POC-US has high diagnostic accuracy, sensitivity, and specificity for basic GYN anatomy and pathology. POC-US is an acceptable and feasible diagnostic tool with potential for future application in a low resource setting to increase access to ultrasound.

Second trimester uterocervical angle and spontaneous preterm birth in twins.

Objective: To determine if there is an association between uterocervical angle (UCA) and spontaneous preterm birth (sPTB) < 37 weeks for women with twins.Materials and methods: Retrospective cohort study from 2014 to 2017 of twin pregnancies with cervical length (CL) screening between 15 0/7 and 24 6/7 weeks. Monochorionic-monoamniotic twins were excluded. Post-hoc UCA measurements were analyzed as a continuous variable and a wide UCA was also defined as an angle >95° and >110°. The primary outcome was sPTB < 37 weeks. Secondary outcomes were sPTB <34 weeks, <32 weeks, CL, and performance metrics for UCA. Binary logistic regression controlled for age, tobacco use, prior sPTB, CL, and gestational age at CL measurement.Results: A total of 114 women were studied. The rate of sPTB <37 weeks was 35.0%, <34 weeks was 21.4%, and <32 weeks was 17.1%. As a continuous variable, mean UCA was 117.9° (SD 27.1°) for delivery ≥37 weeks and 133.1° (SD 23.1°) <37 weeks (p = .002). A wider mean UCA was also associated with sPTB <34 weeks (sPTB ≥34 weeks: 120.9° [SD 26.5°] vs. <34 weeks: 133.0° [SD 22.8°], p = .025) and sPTB <32 weeks (sPTB ≥32 weeks: 121.2° [SD 25.9°] vs. <32 weeks: 135.0° [SD 24.0°], p = .018). However, after controlling for age, prior sPTB, tobacco use, CL measurement, and gestational age at CL measurement, UCA was not associated with sPTB <37 weeks, <34 weeks, or <32 weeks. UCA >110° was associated with sPTB <37 weeks after controlling for confounders (aOR 3.6 [95% CI 1.2-10.5], p = 0.02). There was no association between UCA >110° and sPTB <34 or <32 weeks. Furthermore, a UCA >95° was not associated with sPTB <37, <34, or <32 weeks. As a screening tool for sPTB <37 weeks, a UCA of >110° had a sensitivity of 85.7%, specificity of 43.1%, positive predictive value of 53.2%, negative predictive value of 80.0%, positive likelihood ratio of 1.5, and negative likelihood ratio of 0.3.Conclusions: In a cohort of dichorionic-diamniotic and monochroionic-diamniotic twins, UCA >110° was associated with sPTB <37 weeks. However, second trimester UCA had a low positive likelihood ratio and was not a robust marker for the prediction of sPTB in twins.

Ultrasound Assessment of the Intrauterine Device.

As the use of intrauterine devices (IUDs) has expanded in the United States, both as a highly effective form of long-acting reversible contraception (LARC) and as a tool for effective management of other gynecologic conditions, effective imaging of IUDs has become increasingly important. Ultrasound is a cost-effective, accurate, safe, and accessible imaging solution for the assessment of IUDs. This article explores the role of ultrasound in evaluation of IUDs as well as the literature regarding ultrasound guidance for device placement. It also examines the evaluation and management of IUDs with a concurrent intrauterine pregnancy.