Perinatal Quality Foundation (www.perinatalquality.org) The CLEAR program Perinatal Quality Foundation (www.perinatalquality.org)

Lecture Need for quality education / image review CLEAR program requirements Image review scoring

Training/Quality Control Regardless of whether practitioners choose to screen universally or selectively, correct technique is critical to avoiding incorrect diagnosis and treatment. SMFM: TVU CL needs to be performed with proper technique in order to yield accurate results, with quality control and monitoring Berghella, SMFM Publication Committee, Am J Obstet Gynecol 2012:10:1016

Components: Course presentations Examination including images Image Submission and Review Outcomes Available: Continuing Medical Education Credit Documentation of Completion of CLEAR

Why CLEAR? Measuring cervical length accurately requires training Surprisingly high percentage of incorrect images were submitted (after training) for cervical length studies Study “failed” images Preterm Prediction Study (MFMU Network) 20% SCAN Trial (MFMU Network) 15% NuMOM2b Network 30% CerviLenz Study 11.5% PREGNANT Trial 10%

Why complete CLEAR? Accurate cervical measurements are essential for PTB screening performance. Proper technique and standard criteria are essential for accurate measurement. Specialized training and image review are essential for proper technique mastery. CL Standard Techniques and Image Criteria Training & Image Review

CLEAR Image Review Process

Cervical Screening Measurement Image Criteria Transvaginal Image Cervix occupies 75% of the image Anterior Width = Posterior Width Maternal Bladder Empty Internal Os Seen External Os Seen Cervical Canal Visible throughout Caliper Placement Correct Cervix Mobility Considered

Image Submission Submit 5 images for initial batch Shortest, Best CL measure from 5 different exams Complete datasheets on-line Upload or mail images Receive results by e-mail Review image scores on-line www.perinatalquality.org

Data Sheet Information Required Practice where image taken Date of examination Time of first transvaginal cervix image during examination Time of last transvaginal cervix image during examination Time of shortest, best image submitted Method for consideration of cervix mobility other than time Gestational Age by Ultrasound at time of examination

Image Evaluation Points CLEAR Image Review Questions YES NO Transvaginal Image   Cervix Occupies 75% of the Image Anterior Width = Posterior Width Maternal Bladder Empty Internal Os Seen External Os Seen Cervical Canal Seen Throughout Caliper Placement Correct Cervix Mobility Considered Each image is scored on the basis of 9 points. All images must have 7/9 points to pass. Comments: In this example the image score is 7/9

Pass Criteria CL images from 5 separate exams Each submitted image scores a minimum of 7/9 AND Batch of images has a cumulative score of ≥ 80% No single criteria missed by all images Caliper placement is correct on all images

Fail Criteria Any submitted image scores less than 7/9 OR The batch has cumulative score of < 80 % One or more of the 9 criteria missed on all images Caliper placement is incorrect on any image Duplicate images are submitted

Internal Quality Review All batches scoring 75 – 85 % get a second review The second review determines the final score Random review of 5% of all batches

2nd, 3rd, … Image Batch 3 images if failure due to one image or 1 criteria 3 images if final score 60% – 79% 5 images if final score less than 60 %

For further information perinatalquality.org 405-753-6534

References

Lecture 1 American College of Obstetricians and Gynecologists: ACOG Committee Opinion No. 522, April 2012, Incidentally Detected Short Cervical Length. Obstet Gynecol 2012; 119:879-82. Berghella V, Rafael TJ, Szychowski JM, Rust OA, Owens J. Cerclage for short cervix on ultrasonography in women with singleton gestations and previous preterm birth: a meta-analysis. Obstet Gynecol 2011; 117:663-71. Berghella V, Figueroa D, Szychowski JM, Owen J, Hankins GD, Iams JD, et al. 17-alpha-hydroxyprogesterone caproate for the prevention of preterm birth in women with prior preterm birth and a short cervical length. Vaginal Ultrasound Trial Consortium. Am J Obstet Gynecol 2010; 202:351.e1-351.e6. Berghella V, The Society for Maternal-Fetal Medicine: Publications Committee, Progesterone and Preterm Birth Prevention: Translating Clinical Trials Data into Clinical Practice. Am J Obstet Gynecol 2012; 10:1016. Carlan SJ, O’Brien WF, Parsons MT, Lense JJ. Preterm premature rupture of membranes: a randomized study of home versus hospital management. Obstet Gyecol 1993; 81:61-4. Fonseca EB, Celik E, Parra M, Singh M, Nicolaides KH. Progesterone and the risk of preterm birth among women with a short cervix. Fetal Medicine Foundation Second Trimester Screening Group. N Engl J Med 2007; 357:462-9.

Lecture 1 (continued) Hassan SS, Romero R, Vidyadhari D, Fusey S, Baxter JK, Khandelwal M, et al. Vaginal progesterone reduces the rate of preterm birth in women with a sonographic short cervix: a multicenter, randomized, double-blind, placebo- controlled trial. PREGNANT Trial. Ultrasound Obstet Gynecol 2011; 38:18- 31. Iams JD, Goldenberg RL, Meis PJ, Mercer BM, Moaward A, Das A, et al. The length of the cervix and the risk of spontaneous premature delivery. National Institute of Child Health and Human Development Maternal Fetal Medicine Unit Network. N Engl J Med 1996; 334:567-72. Owen J, Hankins G, Iams JD, Berghella V, Sheffield JS, Perez-Delboy A, et al. Multicenter randomized trial of cerclage for preterm birth prevention in high- risk women with shortened midtrimester cervical length. Am J Obstet Gynecol 2009; 201:375.e1-375.e8.  Romero R, Nicolaides K, Conde-Agudelo A, Tabor A, O’Brien J, Cetingoz E, et al. Vaginal progesterone in women with an asymptomatic sonographic short cervix in the midtrimester decreases preterm delivery and neonatal morbidity: a systematic review and metaanalysis of individual patient data. Am J Obstet Gynecol 2012; 206:123.e1-124.e19.

Lecture 2 Althuisius SM, Dekker GA, Hummel P, et al. Final results of the cervical incompetence prevention randomized cerclage trial (CIPRACT): Therapeutic cerclage with bed rest versus bed rest alone. Am J Obstet Gynecol. 2001; 185:1106-12. American Institute of Ultrasound in Medicine. AIUM Guidelines for Cleaning and Preparing Endocavitary Ultrasound Transducers Between Patients. Approved 2003. American College of Radiology. ACR Appropriateness Criteria: Assessment of Gravid Cervix. Date of Origin 1999, last review date 2011. Berghella V, Bega G. Ultrasound evaluation of the cervix, in Callen PW (ed): Ultrasonography in Obstetrics and Gynecology (ed 5). Philadelphia, PA, Saunders Elsevier. 2008: 698-720. Berghella V, Bega G, Tolosa JE, Berghella M. Ultrasound Assessment of the Cervix. Clin Obstet Gynecol 2003; 46:947-62. Berghella V, Kuhlman K, Weiner S, et al. Cervical funneling: sonographic criteria predictibe of preterm delivery. Ultrasound Obstet Gynecol 1997; 10:161-166.

Lecture 2 (continued) Burger M, Weber-Rossler T, Willmann M. Measurement of the pregnant cervix by transvaginal sonography: an interobserver study and new standards to improve the interobserver variability. Ultrasound Obstet Gynecol 1997; 9:188- 93. Fonseca EB, Celik E, Parra M, Singh M, Nicolaides KH. Progesterone and the risk of preterm birth among women with a short cervix. Fetal Medicine Foundation Second Trimester Screening Group. N Engl J Med 2007; 357:462-9. Guzman ER, Mellon C, Vintzileos AM, et al. Longitudinal assessment of endocervical canal length between 15 and 24 weeks’ gestation in women at risk for pregnancy loss or preterm birth. Obstet Gynecol. 1998: 92:31-7. Guzman ER, Benito C, and Hanley M. Sonography in the evaluation of the cervix during pregnancy. Curr Opin Obstet Gynecol 1996; 8:99-105. Hassan SS, Romero R, Berry SM, Dang K, Blackwell SC, Treadwell MC, Wolfe HM. Patients with an ultrasonographic cervical length less than or equal to 15 mm have nearly a 50% risk of early spontaneous preterm delivery. Am J Obstet Gynecol 2000; 182:1458-67.

Lecture 2 (continued) Hernandez-Andrade E, Romero R, Ahn H, Hussein Y, Yeo L, Korzeniewski SJ, Chaiworapongsa T, Hassan S. Transabdominal evaluation of uterine cervical length during pregnancy fails to identify a substantial number of women with a short cervix. Journal of Maternal-Fetal and Neonatal Medicine 2012; Iams JD, Goldenberg RL, Meis PJ, Mercer BM, Moaward A, Das A, et al. The length of the cervix and the risk of spontaneous premature delivery. National Institute of Child Health and Human Development Maternal Fetal Medicine Unit Network. N Engl J Med 1996; 334:567-72. Mason GC, Maresh MJ. Alterations in bladder volume and the ultrasound appearance of the cervix. Br J Obstet Gynaecol 1990; 97:457-58. Mella MT, Berghella V. Prediction of Preterm Birth: Cervical Sonography. Semin Perinatol 2009: 33;317-24. Owen J, Yost N, Berghella V, Thom E, Swain M, Dildy GA 3rd, et al. Mid-trimester endovaginal sonography in women at high-risk for spontaneous preterm birth. National Institute of Child Health and Human Development, Maternal-Fetal Medicine Units Network. JAMA 2001; 286:1340-8.  

Lecture 2 (continued) Rust OA, Atlas RO, Reed J, et al. Revisiting the short cervix detected by transvaginal ultrasound in the second trimester: Why cerclage therapy may not help. Am J Obstet Gynecol 2001; 185:1098-1105. Saul LL, Kurtzman JT, Hagemann C, Ghamsary M, Wing DA. Is transabdominal sonography of the cervix after voiding a reliable method of cervical length assessment? J Ultrasound Med 2008; 27:1305-11. Stone PR, Chan EH, McCowan LM, Taylor RS, Mitchell JM; SCOPE Consortium. Transabdominal scanning of the cervix at the 20-week morphology scan: comparison with transvaginal cervical measurements in a healthy nulliparous population. Aust N Z J Obstet Gynaecol 2010; 50:523-27. To MS, Alfirevic Z, Heath VC, Cicero S, Cacho AM, Williamson PR, et al. Cervical cerclage for prevention of preterm delivery in women with short cervix: randomized controlled trial. Lancet 2004; 363:1849-53.

Lecture 3 American College of Obstetricians and Gynecologists: ACOG Committee Opinion No. 522, April 2012, Incidentally Detected Short Cervical Length. Obstet Gynecol 2012; 119:879-82. Berghella V, The Society for Maternal-Fetal Medicine: Publications Committee, Progesterone and Preterm Birth Prevention: Translating Clinical Trials Data into Clinical Practice. Am J Obstet Gynecol 2012; 10:1016.