Original Article
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Implementation of a Universal Cervical Length Screening Program for the Prevention of Preterm Birth Kelly M. Orzechowski, MD, MPH1 Sara S. Nicholas, MD1 Stuart Weiner, MD, MLA1 Vincenzo Berghella, MD1
Gynecology, Thomas Jefferson University, Philadelphia, Pennsylvania Am J Perinatol 2014;31:1057–1062.
Abstract
Keywords
► ► ► ►
preterm birth cervical length universal screening vaginal progesterone
Address for correspondence Kelly M. Orzechowski, MD, MPH, Department of Obstetrics and Gynecology, Thomas Jefferson University, 834 Chestnut Street, Suite 400, Philadelphia, PA 19103 (e-mail: [email protected]).
Objective The objective of this article is to evaluate the implementation and acceptability of a universal cervical length (CL) screening program for prediction and prevention of preterm birth (PTB). Study Design We performed a prospective observational study to evaluate the implementation and acceptability of a universal CL screening program. Between January 1, 2012, and December 31, 2012, women with singleton gestations, without a cerclage or prior spontaneous PTB, were offered transvaginal ultrasound (TVU) for CL between 180/7 and 236/7 weeks’ gestation. Sonographers and medical staff received education before implementation. Intervention for a short CL was interpreted according to a standard protocol. On June 1, 2012, our program was modified from “opt-in” to “opt-out.” SPSS 20.0 (released 2011, IBM statistics for Windows version 20, IBM Corp., Armonk, NY) was used for analysis. Results Over 12 months, 1,484 (87%) of 1,706 eligible women were offered CL screening, and 1,119 (75%) were actually screened. Women were more likely to accept CL screening if they were nulliparous versus multiparous (83 vs. 68%, p < 0.001) and if the sonographer was female versus male (83 vs. 42%, p < 0.001). Implementation of an “opt-out” protocol did not increase the overall number of women accepting CL screening compared with an “opt-in” approach (76 vs. 75%, p ¼ 0.81) Conclusion Universal CL screening can be feasibly implemented and is acceptable to most women.
Spontaneous preterm birth (PTB) is a leading cause of neonatal morbidity and mortality in developed as well as developing countries.1 Until recently, transvaginal ultrasound (TVU) cervical length (CL) screening for the prediction and prevention of PTB has only been recommended for singleton gestations with a prior spontaneous PTB to identify candidates for cerclage placement.2–4 However, a short cervix in the second trimester is a powerful predictor of spontaneous PTB regardless of obstetrical history.5,6 Recent randomized trials have demonstrated that daily administration of vaginal
progesterone in singleton gestations with a short CL can reduce the incidence of spontaneous PTB by approximately 45%.7,8 As more than 85% of spontaneous PTBs occur in women without a prior spontaneous PTB,8 universal TVU CL screening between 18 and 24 weeks’ gestation may identify “low-risk” women (i.e., singletons without prior spontaneous PTB) who are candidates for vaginal progesterone. In addition, universal TVU CL screening and treatment with vaginal progesterone in women with a short CL has been shown to be cost saving compared with other screening
received December 16, 2013 accepted after revision January 7, 2014 published online April 4, 2014
Copyright © 2014 by Thieme Medical Publishers, Inc., 333 Seventh Avenue, New York, NY 10001, USA. Tel: +1(212) 584-4662.
DOI http://dx.doi.org/ 10.1055/s-0034-1371710. ISSN 0735-1631.
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1 Division of Maternal Fetal Medicine, Department of Obstetrics and
Jason K. Baxter, MD, MSCP1
Implementation of a Universal CL Screening Program for PTB methods,9 and compared with no screening.10 On the basis of this data on universal CL screening for singletons without a prior spontaneous PTB, the Society for Maternal-Fetal Medicine (SMFM) states that “implementation of such a screening strategy can be viewed as reasonable”3; similarly, the American College of Obstetricians and Gynecologists (ACOG) states “this screening strategy may be considered.”4 However, even when a test theoretically meets clinical criteria for a good screening tool, there may be unidentified barriers to program implementation. Our objective was to describe the feasibility of implementation and patient acceptability of a universal TVU CL screening program for singleton gestations for the prediction and prevention of PTB, and to identify potential barriers to success.
Methods On January 1, 2012, our institution implemented universal TVU CL screening for all singleton gestations without a prior spontaneous PTB who were scheduled for an anatomy ultrasound between 180/7 and 236/7 weeks’ gestation. Women with multiple gestations or with cerclage in situ were excluded from universal CL screening. Women with a prior spontaneous PTB were also excluded from this one-time CL screening regimen because we perform serial CL screening in these women. The total number of daily appointment slots remained unchanged as it was anticipated that TVU CL would take no more than 5 to 10 additional minutes per anatomy ultrasound. Our five certified sonographers and the medical staff received education on the logistical aspects of the screening program, and eligible women received handouts describing TVU CL measurement at the time of check-in. Women were then verbally offered CL screening by the sonographer before the start of the anatomy ultrasound. The choice to perform TVU CL screening before or after the anatomy ultrasound was left to each individual sonographer based on his or her discussion with the patient. Sonographers waited outside the ultrasound room while women prepared for the TVU CL screening. Our male sonographer had a female chaperone during the TVU CL screening at all times. CL measurements were performed in a uniform fashion with TVU without prior transabdominal CL assessment. Women were asked to void, and a TVU probe was inserted into the anterior vaginal fornix to obtain a sagittal view of cervix with visualization of entire echogenic endocervical canal. The transvaginal probe was then withdrawn until the image became blurred and reinserted to avoid excessive pressure. The image was enlarged to occupy two-thirds of screen, and the CL was measured from the internal to external cervical os. Three measurements were obtained and the best, shortest image was used. Transfundal pressure was then applied for at least 15 seconds, and additional CL length measurements were obtained, but only the shortest best CL was recorded. Vaginal ultrasound probes received high-level disinfection after each use as required by The Joint Commission. After completion of the TVU, the disposable probe cover was removed and the probe was precleaned with soapy water American Journal of Perinatology
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Orzechowski et al.
to remove any gel or debris. The probe was then placed in 2.6% glutaraldehyde (Metricide activated dialdehyde solution, Metrex Research, Inc, Orange, CA) for 45 minutes as per manufacturer’s guidelines. Disinfection took place in properly ventilated rooms using secured containers. All ultrasound machines in our division are of the same model with interchangeable probes; therefore, a clean vaginal probe was always available for use as it could be borrowed from another machine. During the face-to-face evaluation and management portion of the ultrasound visit, the maternal fetal medicine (MFM) physician again offered TVU CL screening to the patient if the sonographer failed to offer CL screening previously or if she previously declined CL screening. If women accepted CL screening at that time, an attempt was made to perform TVU the same day. If the patient had to return for suboptimal views on the anatomy ultrasound, she was scheduled for both follow-up ultrasound and TVU CL on a different date but before 236/7 weeks’ gestation. The CL results were interpreted according to a standard protocol (►Fig. 1). Women with a TVU CL 20 mm were initially prescribed 90-mg vaginal progesterone gel. If approval for the vaginal gel could not be obtained from the patient’s insurance company, she was prescribed 200 mg of micronized progesterone gel capsules. Women were categorized as “not offered CL screening” if there was no written documentation by either the sonographer or the interpreting physician of the patient having declined CL screening. Women were categorized as “declined CL screening” if either the sonographer or MFM physician documented this information in the ultrasound report. On June 1, 2012, our program was modified from “opt-in” to “optout,” in effort to increase patient acceptance rates. This involved education of the sonographers to change the question from “Would you like to undergo TVU CL screening for
Fig. 1 Clinical management algorithm for universal cervical length screening program. Caption: This standardized management algorithm was used for all women participating in the universal TVU CL screening program. CL, cervical length; GA, gestational age; PTB, preterm birth; TVU, transvaginal ultrasound.
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Implementation of a Universal CL Screening Program for PTB
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data from January 1, 2012, to December 31, 2012. The primary outcome for this prospective observational study was the percentage of eligible women accepting TVU CL screening. Data were analyzed to identify variables that could influence CL screening rates such as parity, race/ethnicity, the presence of a language barrier, or sonographer gender. Independent samples t-test, one-way analysis of variance, Fisher exact tests and chi-square tests were performed using SPSS 20.0. Institutional review board approval was obtained for this study.
Fig. 2 Universal cervical length screening rates.Universal transvaginal ultrasound cervical length screening rates over a 12-month period. CL, cervical length; GA, gestational age; PTB, preterm birth.
prevention of preterm birth today?” to “Today we are going to evaluate your CL by TVU as part of your anatomy ultrasound.” We planned to evaluate the effectiveness of this new universal TVU CL screening program at 12 months, assessing
Over 12 months, 1,484 of 1,706 (87%) eligible women were offered CL screening (►Fig. 2). Women without a language barrier (90 vs. 66%, p < 0.001) and those scanned by a female sonographer (92 vs. 70%, p < 0.001) were more likely to have been offered CL screening compared with those with language barriers or those scanned by a male sonographer (►Table 1). Of the 61 women with a language barrier who were not offered CL screening, 58 (95%) were Asian and spoke Mandarin. Compared with an “opt-in” approach, implementation of an “opt-out” protocol significantly increased the percentage of women offered CL screening (92 vs. 80%, p < 0.001) (►Table 1). Of the 1,484 women offered CL screening, 1,119 (75%) accepted CL screening (►Fig. 2). Women were more likely to
Table 1 Factors influencing the percentage of women offered universal CL screening Offered, N ¼ 1,484 (87%)
Not offered, N ¼ 222 (13%)
p Value
Mean maternal age (y) ( SD)
28.7 (6.0)
29.0 (6.1)
0.455
Mean gestational age (wk) ( SD)
20.2 (1.4)
20.3 (1.3)
0.189
No, N (%)
713 (89)
93 (11)
0.087
Yes, N (%)
771 (86)
129 (14)
Caucasian, N (%)
425 (91)
42 (9)
Black, N (%)
676 (90)
76 (10)
Asian, N (%)
207 (72)
82 (28)
Hispanic, N (%)
93 (89)
11 (11)
Other/Unknown, N (%)
83 (88)
11 (12)
Female, N (%)
1,214 (92)
107 (8)
Male, N (%)
270 (70)
115 (30)
Yes, N (%)
116 (66)
61 (34)
No, N (%)
1,368 (90)
161 (10)
Opt-in, N (%)
584 (80)
146 (20)
Opt-out, N (%)
900 (92)
76 (8)
Parous
Race/Ethnicity < 0.001
Gender of sonographer < 0.001
Language barrier < 0.001
Screening program options < 0.001
Abbreviations: CL, cervical length; SD, standard deviation. American Journal of Perinatology
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Results
Implementation of a Universal CL Screening Program for PTB
Orzechowski et al.
Table 2 Factors influencing universal CL screening acceptance rates Accept, N ¼ 1,119 (75%)
Decline, N ¼ 365 (25%)
p Value
Mean maternal age (y) ( SD)
28.8 (6.0)
28.2 (5.8)
0.13
Mean gestational age (wk) ( SD)
20.2 (1.4)
20.2 (1.3)
0.80
Yes, N (%)
527 (68)
244 (32)
< 0.001
No, N (%)
592 (83)
121 (17)
Parous
Race/Ethnicity Caucasian, N (%)
324 (76)
101 (24)
Black, N (%)
508 (75)
168 (25)
Asian, N (%)
144 (70)
63 (30)
Hispanic, N (%)
79 (85)
14 (15)
Other/Unknown, N (%)
64 (77)
19 (23)
Yes, N (%)
70 (60)
46 (40)
No, N (%)
1,049 (77)
319 (23)
Female, N (%)
1,006 (83)
208 (17)
Male, N (%)
113 (42)
157 (58)
Opt-in, N (%)
438 (75)
146 (25)
Opt-out, N (%)
681 (76)
219 (24)
0.07
Language barrier < 0.001
Gender of sonographer < 0.001
Screening program options 0.77
Abbreviations: CL, cervical length; SD, standard deviation.
accept CL screening if they were nulliparous versus multiparous (83 vs. 68%, p < 0.001), if the sonographer was female versus male (83 vs. 42%, p < 0.001), and if they did not have a language barrier (77 vs. 60%, p < 0.001) (►Table 2). An opt-out approach did not improve overall CL screening acceptance rates compared with an opt-in approach (76 vs. 75%, p ¼ 0.77) (►Table 2). In total, 10 (0.9%) women undergoing CL screening had a CL 20 mm and were offered vaginal progesterone. Six (0.5%) women had a borderline CL between 21 and 24.9 mm requiring follow-up TVU, and on follow-up TVU 1 had a CL 20mm and was offered vaginal progesterone. Thus, a total of 11 women (1%) were diagnosed with a short CL of 20 mm during the screening period.
Comment Our data indicate that a universal TVU CL screening program can be successfully implemented, and CL screening is acceptable to the vast majority of women. Our CL screening program was implemented just before the publication of national guidelines on universal CL screening,3,4 and in our program, 87% of eligible women were offered TVU CL screening. However, of the 1,706 women eligible for universal CL screening, 1,120 (65.6%) were actually screened. We identified three factors that negatively impacted the percentage of women screened. American Journal of Perinatology
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First, our male sonographer was less likely to offer TVU CL screening to eligible women. This may be due to the inconvenience of needing to find a female chaperone for the procedure. Conversely, our data may indicate that women are more likely to decline TVU CL screening when a male sonographer performs the ultrasound. However, male sonographers are uncommon in obstetric ultrasound units, so this finding may not be generalizable to other institutions. The second factor that resulted in lower TVU CL screening rates was the presence of a language barrier. In our institution, most women with language barriers were Asian immigrants who spoke Mandarin. Attempts were made to minimize this barrier by providing an informational brochure written in Mandarin at the time of appointment check-in. If a woman was not offered TVU CL screening by the sonographer or if she declined screening, she was again offered CL screening by an MFM physician via a Mandarin interpreter during the evaluation and management portion of the ultrasound visit. Although it may be ideal to offer TVU CL screening in a woman’s native language before the start of the anatomy ultrasound, such translation services were not available due to inadequate resources and time. The third factor that resulted in lower TVU CL screening rates was the use of an opt-in approach. Women were less likely to be offered TVU CL screening utilizing an opt-in screening approach compared with an opt-out approach. An opt-out approach has been shown to increase HIV
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screening rates in pregnancy11; however, although this approach increased the percentage of eligible women who were offered CL screening, it did not significantly increase the overall number of women who underwent TVU CL screening. This may be due to the fact that sonographer compliance with an opt-in approach was not monitored and his or her attitude toward universal TVU CL screening could have negatively impacted acceptance rates. Overall, 75% of women offered TVU CL screening agreed to have it performed. Of those who were offered TVU CL screening, women with a prior delivery (full term or iatrogenic preterm), those assigned to a male sonographer, and those with a language barrier were more likely to decline. We did not collect specific data on the reasons women declined but some commonly cited reasons included having a priorterm delivery or fear of discomfort with TVU. The overall success rate of TVU CL screening may also have been influenced by the fact that our institution began universal TVU CL screening before national guidelines were published saying that this was “reasonable,”3 or “may be considered.”4 In our institution, universal TVU CL screening was successfully implemented without increasing space requirements and without increasing the number of staff. Education of existing front-desk staff and sonographers before implementation were critical to our program’s overall success. Without sonographer “buy-in,” eligible women may not be offered CL screening even when management has adopted a universal screening protocol. If women were not offered CL screening by the sonographer, the MFM physician attempted to offer CL screening during the evaluation and management portion of the visit. In such cases, women were sometimes scheduled for CL screening on a different date, increasing the possibility that she may fail to show up for the appointment. We did not collect data regarding the number of women who declined CL screening from the sonographer, but they accepted screening after discussion from the physician. Anecdotally, the number of women seeing the physician without CL measurements available decreased over time. Similarly, we were unable to collect information regarding patient wait times, but the implementation of TVU CL screening has neither appeared to negatively impact patient wait times, nor has it resulted in staff overtime. This is the first study to evaluate the clinical implementation of a universal TVU CL screening program, and to identify specific factors affecting program success. Study strengths included that data were collected prospectively over a 12month period. We also used a standardized protocol for the management of a short CL. In addition, all sonographers in our ultrasound unit were trained to perform TVU CL measurements in a standardized fashion and underwent image review by an attending physician. Sonographers had to pass CL measurement competency training in the past as our institution participated in several TVU CL clinical trials; training followed the Cervical Length Education and Review (CLEAR) guidelines available to sonographers online free of charge.12 One of the weaknesses of the study is that data were collected from only one academic institution. Barriers may
Orzechowski et al.
differ not only from institution to institution, but by type of institution (e.g., academic vs. private practice; radiology vs. MFM ultrasound units). In addition, we were unable to monitor how each sonographer verbally presented TVU CL screening to each patient. Differences in the verbal presentation, particularly during conversion from the “opt-in” to the “opt-out” approach may have influenced CL screening rates. Another study limitation is that we did not collect information on program costs, or billing and reimbursement, and therefore cannot comment on economic factors that may influence a particular institution’s decision to implement such a program. In our institution, the Current Procedural Terminology (CPT) code 76817, ultrasound, pregnant uterus, real time with image documentation, transvaginal was billed in women who received TVU CL screening, often in conjunction with other ultrasound services performed at the same session (e.g., 76805 or 76811). Our billing database was queried to identify all CPT 76817 codes submitted to insurance companies during the study period, the majority of which received some reimbursement from the insurance company. An additional limitation is that 1,120 (65.6%) of the 1,706 women eligible for universal CL screening were actually screened. One may theorize the lower screening rates may decrease cost-effectiveness, however, a cost-effective analysis found universal screening with TVU and treatment with daily vaginal progesterone was cost effective compared with no screening or treatment.10 In our institution, in total, 10 (0.9%) women undergoing CL screening had a CL 20 mm and were offered vaginal progesterone. This is less than the 1.7% incidence of CL 15 mm and less than the 2.3% incidence of CL 10 to 20 mm seen in the two trials on vaginal progesterone for short TVU CL in singletons.7,8 However, both of these trials included singletons with a prior spontaneous PTB, which may explain the lower incidence of a short CL in our population. Six (0.5%) women had a borderline CL between 21 and 24.9 mm and required follow-up TVU CL measurement. Of those, one woman had a CL< 20 mm on follow-up TVU. Soon after the implementation of our universal CL screening program on January 1, 2012, both the Society for Maternal Fetal Medicine3 and the ACOG4 issued clinical guidelines regarding universal CL screening. The two major concerns regarding universal CL screening pertained to quality control issues and the use of standardized management protocols.3,4 When any screening technique is employed universally, quality assurance issues may affect results. Therefore, it is important that institutions offering TVU CL screening utilize quality control methods to monitor performance. Institutions can ensure that their sonographers complete the CLEAR, which provides online educational lectures as well as an optional examination and scored cervical image review free of charge.12 The Fetal Medicine Foundation also offers online TVU CL training and credentialing.13 In addition, a collectively agreed-upon protocol for screening and management of a short CL (e.g., ►Fig. 1) should consistently be used to prevent practice variation. Overall, TVU CL performs well as a screening test. TVU CL screening can identify asymptomatic women in a “preclinical American Journal of Perinatology
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Implementation of a Universal CL Screening Program for PTB
Implementation of a Universal CL Screening Program for PTB phase” who are at high risk for spontaneous PTB. TVU can accurately detect a short cervix, and measurements are reproducible when a standardized technique is used.3,14 Perhaps most importantly, vaginal progesterone may be a beneficial intervention to reduce prematurity in women with a short CL, and both screening and treatment are well tolerated with no reported adverse effects to the mother or fetus. Randomized clinical trials have shown that daily use of vaginal progesterone in singleton gestations with a short CL can reduce the incidence of spontaneous PTB by approximately 45%,7,8 however, no formulation of vaginal progesterone is yet approved by the U.S. Food and Drug Administration (FDA) for this indication. On the basis of the results of the PREGNANT trail,8 a new drug application was submitted to the FDA in 2012 for approval of vaginal progesterone gel 8% in women with a short CL. The FDA performed a post hoc statistical analysis of the trial data, and found a nonsignificant reduction in PTB < 33 weeks among the US study subjects. Although the PREGNANT trial8 was not powered to reach statistical significance by geographic region, the FDA voted not to approve the use of progesterone vaginal gel 8% for the reduction of risk of PTB in women with short CL. FDA panel members generally agreed that progesterone vaginal gel 8% is safe, but that additional information is needed regarding its efficacy in the US population. However, US women with a short CL can still be prescribed vaginal progesterone for PTB risk reduction as an “off-label” indication. Currently, national guidelines state that TVU CL screening “can be viewed as reasonable, and can be considered by individual practitioners.”3 The findings of our study lend additional information to support the feasibility of implementing a universal TVU CL screening program. Note This article was presented at the SMFM Society for Maternal Fetal Medicine 33rd Annual Meeting, February 2013, San Francisco, CA.
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References 1 World Health Organization. March of Dimes; The Partnership for
Maternal, Newborn & Child Health; Save the Children. Born Too Soon: The Global Action Report on Preterm Birth. Available at:
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Orzechowski et al. http://www.who.int/pmnch/media/news/2012/preterm_birth_report/en/index.html. Accessed March 1, 2013 Berghella V, Rafael TJ, Szychowski JM, Rust OA, Owen J. Cerclage for short cervix on ultrasonography in women with singleton gestations and previous preterm birth: a meta-analysis. Obstet Gynecol 2011;117(3):663–671 Society for Maternal-Fetal Medicine Publications Committee, with assistance of Vincenzo Berghella. Progesterone and preterm birth prevention: translating clinical trials data into clinical practice. Am J Obstet Gynecol 2012;206(5):376–386 Committee on Practice Bulletins-Obstetrics. The American College of Obstetricians and Gynecologists. Practice bulletin no. 130: prediction and prevention of preterm birth. Obstet Gynecol 2012;120(4):964–973 Iams JD, Goldenberg RL, Meis PJ, et al; National Institute of Child Health and Human Development Maternal Fetal Medicine Unit Network. The length of the cervix and the risk of spontaneous premature delivery. N Engl J Med 1996;334(9):567–572 Leung TN, Pang MW, Leung TY, Poon CF, Wong SM, Lau TK. Cervical length at 18-22 weeks of gestation for prediction of spontaneous preterm delivery in Hong Kong Chinese women. Ultrasound Obstet Gynecol 2005;26(7):713–717 Fonseca EB, Celik E, Parra M, Singh M, Nicolaides KH; Fetal Medicine Foundation Second Trimester Screening Group. Progesterone and the risk of preterm birth among women with a short cervix. N Engl J Med 2007;357(5):462–469 Hassan SS, Romero R, Vidyadhari D, et al; PREGNANT Trial. Vaginal progesterone reduces the rate of preterm birth in women with a sonographic short cervix: a multicenter, randomized, doubleblind, placebo-controlled trial. Ultrasound Obstet Gynecol 2011; 38(1):18–31 Werner EF, Han CS, Pettker CM, et al. Universal cervical-length screening to prevent preterm birth: a cost-effectiveness analysis. Ultrasound Obstet Gynecol 2011;38(1):32–37 Cahill AG, Odibo AO, Caughey AB, et al. Universal cervical length screening and treatment with vaginal progesterone to prevent preterm birth: a decision and economic analysis. Am J Obstet Gynecol 2010;202(6):548.e1–548.e8 Yudin MH, Moravac C, Shah RR. Influence of an “opt-out” test strategy and patient factors on human immunodeficiency virus screening in pregnancy. Obstet Gynecol 2007;110(1):81–86 Cervical Length Education and Review (CLEAR) program. Available at: www.perinatalquality.com/CLEAR/deault.aspx. Accessed March 1, 2013 The Fetal Medicine Foundation. Online Education. Cervical assessment. Available at: http://www.fetalmedicine.com/fmf/onlineeducation/05-cervical-assessment/. Accessed May 13, 2013 Berghella V. Universal cervical length screening for prediction and prevention of preterm birth. Obstet Gynecol Surv 2012;67(10): 653–658
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Implementation of a Universal Cervical Length Screening Program for the Prevention of Preterm Birth Kelly M. Orzechowski, MD, MPH1 Sara S. Nicholas, MD1 Stuart Weiner, MD, MLA1 Vincenzo Berghella, MD1
Gynecology, Thomas Jefferson University, Philadelphia, Pennsylvania Am J Perinatol 2014;31:1057–1062.
Abstract
Keywords
► ► ► ►
preterm birth cervical length universal screening vaginal progesterone
Address for correspondence Kelly M. Orzechowski, MD, MPH, Department of Obstetrics and Gynecology, Thomas Jefferson University, 834 Chestnut Street, Suite 400, Philadelphia, PA 19103 (e-mail: [email protected]).
Objective The objective of this article is to evaluate the implementation and acceptability of a universal cervical length (CL) screening program for prediction and prevention of preterm birth (PTB). Study Design We performed a prospective observational study to evaluate the implementation and acceptability of a universal CL screening program. Between January 1, 2012, and December 31, 2012, women with singleton gestations, without a cerclage or prior spontaneous PTB, were offered transvaginal ultrasound (TVU) for CL between 180/7 and 236/7 weeks’ gestation. Sonographers and medical staff received education before implementation. Intervention for a short CL was interpreted according to a standard protocol. On June 1, 2012, our program was modified from “opt-in” to “opt-out.” SPSS 20.0 (released 2011, IBM statistics for Windows version 20, IBM Corp., Armonk, NY) was used for analysis. Results Over 12 months, 1,484 (87%) of 1,706 eligible women were offered CL screening, and 1,119 (75%) were actually screened. Women were more likely to accept CL screening if they were nulliparous versus multiparous (83 vs. 68%, p < 0.001) and if the sonographer was female versus male (83 vs. 42%, p < 0.001). Implementation of an “opt-out” protocol did not increase the overall number of women accepting CL screening compared with an “opt-in” approach (76 vs. 75%, p ¼ 0.81) Conclusion Universal CL screening can be feasibly implemented and is acceptable to most women.
Spontaneous preterm birth (PTB) is a leading cause of neonatal morbidity and mortality in developed as well as developing countries.1 Until recently, transvaginal ultrasound (TVU) cervical length (CL) screening for the prediction and prevention of PTB has only been recommended for singleton gestations with a prior spontaneous PTB to identify candidates for cerclage placement.2–4 However, a short cervix in the second trimester is a powerful predictor of spontaneous PTB regardless of obstetrical history.5,6 Recent randomized trials have demonstrated that daily administration of vaginal
progesterone in singleton gestations with a short CL can reduce the incidence of spontaneous PTB by approximately 45%.7,8 As more than 85% of spontaneous PTBs occur in women without a prior spontaneous PTB,8 universal TVU CL screening between 18 and 24 weeks’ gestation may identify “low-risk” women (i.e., singletons without prior spontaneous PTB) who are candidates for vaginal progesterone. In addition, universal TVU CL screening and treatment with vaginal progesterone in women with a short CL has been shown to be cost saving compared with other screening
received December 16, 2013 accepted after revision January 7, 2014 published online April 4, 2014
Copyright © 2014 by Thieme Medical Publishers, Inc., 333 Seventh Avenue, New York, NY 10001, USA. Tel: +1(212) 584-4662.
DOI http://dx.doi.org/ 10.1055/s-0034-1371710. ISSN 0735-1631.
Downloaded by: National University of Singapore. Copyrighted material.
1 Division of Maternal Fetal Medicine, Department of Obstetrics and
Jason K. Baxter, MD, MSCP1
Implementation of a Universal CL Screening Program for PTB methods,9 and compared with no screening.10 On the basis of this data on universal CL screening for singletons without a prior spontaneous PTB, the Society for Maternal-Fetal Medicine (SMFM) states that “implementation of such a screening strategy can be viewed as reasonable”3; similarly, the American College of Obstetricians and Gynecologists (ACOG) states “this screening strategy may be considered.”4 However, even when a test theoretically meets clinical criteria for a good screening tool, there may be unidentified barriers to program implementation. Our objective was to describe the feasibility of implementation and patient acceptability of a universal TVU CL screening program for singleton gestations for the prediction and prevention of PTB, and to identify potential barriers to success.
Methods On January 1, 2012, our institution implemented universal TVU CL screening for all singleton gestations without a prior spontaneous PTB who were scheduled for an anatomy ultrasound between 180/7 and 236/7 weeks’ gestation. Women with multiple gestations or with cerclage in situ were excluded from universal CL screening. Women with a prior spontaneous PTB were also excluded from this one-time CL screening regimen because we perform serial CL screening in these women. The total number of daily appointment slots remained unchanged as it was anticipated that TVU CL would take no more than 5 to 10 additional minutes per anatomy ultrasound. Our five certified sonographers and the medical staff received education on the logistical aspects of the screening program, and eligible women received handouts describing TVU CL measurement at the time of check-in. Women were then verbally offered CL screening by the sonographer before the start of the anatomy ultrasound. The choice to perform TVU CL screening before or after the anatomy ultrasound was left to each individual sonographer based on his or her discussion with the patient. Sonographers waited outside the ultrasound room while women prepared for the TVU CL screening. Our male sonographer had a female chaperone during the TVU CL screening at all times. CL measurements were performed in a uniform fashion with TVU without prior transabdominal CL assessment. Women were asked to void, and a TVU probe was inserted into the anterior vaginal fornix to obtain a sagittal view of cervix with visualization of entire echogenic endocervical canal. The transvaginal probe was then withdrawn until the image became blurred and reinserted to avoid excessive pressure. The image was enlarged to occupy two-thirds of screen, and the CL was measured from the internal to external cervical os. Three measurements were obtained and the best, shortest image was used. Transfundal pressure was then applied for at least 15 seconds, and additional CL length measurements were obtained, but only the shortest best CL was recorded. Vaginal ultrasound probes received high-level disinfection after each use as required by The Joint Commission. After completion of the TVU, the disposable probe cover was removed and the probe was precleaned with soapy water American Journal of Perinatology
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to remove any gel or debris. The probe was then placed in 2.6% glutaraldehyde (Metricide activated dialdehyde solution, Metrex Research, Inc, Orange, CA) for 45 minutes as per manufacturer’s guidelines. Disinfection took place in properly ventilated rooms using secured containers. All ultrasound machines in our division are of the same model with interchangeable probes; therefore, a clean vaginal probe was always available for use as it could be borrowed from another machine. During the face-to-face evaluation and management portion of the ultrasound visit, the maternal fetal medicine (MFM) physician again offered TVU CL screening to the patient if the sonographer failed to offer CL screening previously or if she previously declined CL screening. If women accepted CL screening at that time, an attempt was made to perform TVU the same day. If the patient had to return for suboptimal views on the anatomy ultrasound, she was scheduled for both follow-up ultrasound and TVU CL on a different date but before 236/7 weeks’ gestation. The CL results were interpreted according to a standard protocol (►Fig. 1). Women with a TVU CL 20 mm were initially prescribed 90-mg vaginal progesterone gel. If approval for the vaginal gel could not be obtained from the patient’s insurance company, she was prescribed 200 mg of micronized progesterone gel capsules. Women were categorized as “not offered CL screening” if there was no written documentation by either the sonographer or the interpreting physician of the patient having declined CL screening. Women were categorized as “declined CL screening” if either the sonographer or MFM physician documented this information in the ultrasound report. On June 1, 2012, our program was modified from “opt-in” to “optout,” in effort to increase patient acceptance rates. This involved education of the sonographers to change the question from “Would you like to undergo TVU CL screening for
Fig. 1 Clinical management algorithm for universal cervical length screening program. Caption: This standardized management algorithm was used for all women participating in the universal TVU CL screening program. CL, cervical length; GA, gestational age; PTB, preterm birth; TVU, transvaginal ultrasound.
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data from January 1, 2012, to December 31, 2012. The primary outcome for this prospective observational study was the percentage of eligible women accepting TVU CL screening. Data were analyzed to identify variables that could influence CL screening rates such as parity, race/ethnicity, the presence of a language barrier, or sonographer gender. Independent samples t-test, one-way analysis of variance, Fisher exact tests and chi-square tests were performed using SPSS 20.0. Institutional review board approval was obtained for this study.
Fig. 2 Universal cervical length screening rates.Universal transvaginal ultrasound cervical length screening rates over a 12-month period. CL, cervical length; GA, gestational age; PTB, preterm birth.
prevention of preterm birth today?” to “Today we are going to evaluate your CL by TVU as part of your anatomy ultrasound.” We planned to evaluate the effectiveness of this new universal TVU CL screening program at 12 months, assessing
Over 12 months, 1,484 of 1,706 (87%) eligible women were offered CL screening (►Fig. 2). Women without a language barrier (90 vs. 66%, p < 0.001) and those scanned by a female sonographer (92 vs. 70%, p < 0.001) were more likely to have been offered CL screening compared with those with language barriers or those scanned by a male sonographer (►Table 1). Of the 61 women with a language barrier who were not offered CL screening, 58 (95%) were Asian and spoke Mandarin. Compared with an “opt-in” approach, implementation of an “opt-out” protocol significantly increased the percentage of women offered CL screening (92 vs. 80%, p < 0.001) (►Table 1). Of the 1,484 women offered CL screening, 1,119 (75%) accepted CL screening (►Fig. 2). Women were more likely to
Table 1 Factors influencing the percentage of women offered universal CL screening Offered, N ¼ 1,484 (87%)
Not offered, N ¼ 222 (13%)
p Value
Mean maternal age (y) ( SD)
28.7 (6.0)
29.0 (6.1)
0.455
Mean gestational age (wk) ( SD)
20.2 (1.4)
20.3 (1.3)
0.189
No, N (%)
713 (89)
93 (11)
0.087
Yes, N (%)
771 (86)
129 (14)
Caucasian, N (%)
425 (91)
42 (9)
Black, N (%)
676 (90)
76 (10)
Asian, N (%)
207 (72)
82 (28)
Hispanic, N (%)
93 (89)
11 (11)
Other/Unknown, N (%)
83 (88)
11 (12)
Female, N (%)
1,214 (92)
107 (8)
Male, N (%)
270 (70)
115 (30)
Yes, N (%)
116 (66)
61 (34)
No, N (%)
1,368 (90)
161 (10)
Opt-in, N (%)
584 (80)
146 (20)
Opt-out, N (%)
900 (92)
76 (8)
Parous
Race/Ethnicity < 0.001
Gender of sonographer < 0.001
Language barrier < 0.001
Screening program options < 0.001
Abbreviations: CL, cervical length; SD, standard deviation. American Journal of Perinatology
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Table 2 Factors influencing universal CL screening acceptance rates Accept, N ¼ 1,119 (75%)
Decline, N ¼ 365 (25%)
p Value
Mean maternal age (y) ( SD)
28.8 (6.0)
28.2 (5.8)
0.13
Mean gestational age (wk) ( SD)
20.2 (1.4)
20.2 (1.3)
0.80
Yes, N (%)
527 (68)
244 (32)
< 0.001
No, N (%)
592 (83)
121 (17)
Parous
Race/Ethnicity Caucasian, N (%)
324 (76)
101 (24)
Black, N (%)
508 (75)
168 (25)
Asian, N (%)
144 (70)
63 (30)
Hispanic, N (%)
79 (85)
14 (15)
Other/Unknown, N (%)
64 (77)
19 (23)
Yes, N (%)
70 (60)
46 (40)
No, N (%)
1,049 (77)
319 (23)
Female, N (%)
1,006 (83)
208 (17)
Male, N (%)
113 (42)
157 (58)
Opt-in, N (%)
438 (75)
146 (25)
Opt-out, N (%)
681 (76)
219 (24)
0.07
Language barrier < 0.001
Gender of sonographer < 0.001
Screening program options 0.77
Abbreviations: CL, cervical length; SD, standard deviation.
accept CL screening if they were nulliparous versus multiparous (83 vs. 68%, p < 0.001), if the sonographer was female versus male (83 vs. 42%, p < 0.001), and if they did not have a language barrier (77 vs. 60%, p < 0.001) (►Table 2). An opt-out approach did not improve overall CL screening acceptance rates compared with an opt-in approach (76 vs. 75%, p ¼ 0.77) (►Table 2). In total, 10 (0.9%) women undergoing CL screening had a CL 20 mm and were offered vaginal progesterone. Six (0.5%) women had a borderline CL between 21 and 24.9 mm requiring follow-up TVU, and on follow-up TVU 1 had a CL 20mm and was offered vaginal progesterone. Thus, a total of 11 women (1%) were diagnosed with a short CL of 20 mm during the screening period.
Comment Our data indicate that a universal TVU CL screening program can be successfully implemented, and CL screening is acceptable to the vast majority of women. Our CL screening program was implemented just before the publication of national guidelines on universal CL screening,3,4 and in our program, 87% of eligible women were offered TVU CL screening. However, of the 1,706 women eligible for universal CL screening, 1,120 (65.6%) were actually screened. We identified three factors that negatively impacted the percentage of women screened. American Journal of Perinatology
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First, our male sonographer was less likely to offer TVU CL screening to eligible women. This may be due to the inconvenience of needing to find a female chaperone for the procedure. Conversely, our data may indicate that women are more likely to decline TVU CL screening when a male sonographer performs the ultrasound. However, male sonographers are uncommon in obstetric ultrasound units, so this finding may not be generalizable to other institutions. The second factor that resulted in lower TVU CL screening rates was the presence of a language barrier. In our institution, most women with language barriers were Asian immigrants who spoke Mandarin. Attempts were made to minimize this barrier by providing an informational brochure written in Mandarin at the time of appointment check-in. If a woman was not offered TVU CL screening by the sonographer or if she declined screening, she was again offered CL screening by an MFM physician via a Mandarin interpreter during the evaluation and management portion of the ultrasound visit. Although it may be ideal to offer TVU CL screening in a woman’s native language before the start of the anatomy ultrasound, such translation services were not available due to inadequate resources and time. The third factor that resulted in lower TVU CL screening rates was the use of an opt-in approach. Women were less likely to be offered TVU CL screening utilizing an opt-in screening approach compared with an opt-out approach. An opt-out approach has been shown to increase HIV
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screening rates in pregnancy11; however, although this approach increased the percentage of eligible women who were offered CL screening, it did not significantly increase the overall number of women who underwent TVU CL screening. This may be due to the fact that sonographer compliance with an opt-in approach was not monitored and his or her attitude toward universal TVU CL screening could have negatively impacted acceptance rates. Overall, 75% of women offered TVU CL screening agreed to have it performed. Of those who were offered TVU CL screening, women with a prior delivery (full term or iatrogenic preterm), those assigned to a male sonographer, and those with a language barrier were more likely to decline. We did not collect specific data on the reasons women declined but some commonly cited reasons included having a priorterm delivery or fear of discomfort with TVU. The overall success rate of TVU CL screening may also have been influenced by the fact that our institution began universal TVU CL screening before national guidelines were published saying that this was “reasonable,”3 or “may be considered.”4 In our institution, universal TVU CL screening was successfully implemented without increasing space requirements and without increasing the number of staff. Education of existing front-desk staff and sonographers before implementation were critical to our program’s overall success. Without sonographer “buy-in,” eligible women may not be offered CL screening even when management has adopted a universal screening protocol. If women were not offered CL screening by the sonographer, the MFM physician attempted to offer CL screening during the evaluation and management portion of the visit. In such cases, women were sometimes scheduled for CL screening on a different date, increasing the possibility that she may fail to show up for the appointment. We did not collect data regarding the number of women who declined CL screening from the sonographer, but they accepted screening after discussion from the physician. Anecdotally, the number of women seeing the physician without CL measurements available decreased over time. Similarly, we were unable to collect information regarding patient wait times, but the implementation of TVU CL screening has neither appeared to negatively impact patient wait times, nor has it resulted in staff overtime. This is the first study to evaluate the clinical implementation of a universal TVU CL screening program, and to identify specific factors affecting program success. Study strengths included that data were collected prospectively over a 12month period. We also used a standardized protocol for the management of a short CL. In addition, all sonographers in our ultrasound unit were trained to perform TVU CL measurements in a standardized fashion and underwent image review by an attending physician. Sonographers had to pass CL measurement competency training in the past as our institution participated in several TVU CL clinical trials; training followed the Cervical Length Education and Review (CLEAR) guidelines available to sonographers online free of charge.12 One of the weaknesses of the study is that data were collected from only one academic institution. Barriers may
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differ not only from institution to institution, but by type of institution (e.g., academic vs. private practice; radiology vs. MFM ultrasound units). In addition, we were unable to monitor how each sonographer verbally presented TVU CL screening to each patient. Differences in the verbal presentation, particularly during conversion from the “opt-in” to the “opt-out” approach may have influenced CL screening rates. Another study limitation is that we did not collect information on program costs, or billing and reimbursement, and therefore cannot comment on economic factors that may influence a particular institution’s decision to implement such a program. In our institution, the Current Procedural Terminology (CPT) code 76817, ultrasound, pregnant uterus, real time with image documentation, transvaginal was billed in women who received TVU CL screening, often in conjunction with other ultrasound services performed at the same session (e.g., 76805 or 76811). Our billing database was queried to identify all CPT 76817 codes submitted to insurance companies during the study period, the majority of which received some reimbursement from the insurance company. An additional limitation is that 1,120 (65.6%) of the 1,706 women eligible for universal CL screening were actually screened. One may theorize the lower screening rates may decrease cost-effectiveness, however, a cost-effective analysis found universal screening with TVU and treatment with daily vaginal progesterone was cost effective compared with no screening or treatment.10 In our institution, in total, 10 (0.9%) women undergoing CL screening had a CL 20 mm and were offered vaginal progesterone. This is less than the 1.7% incidence of CL 15 mm and less than the 2.3% incidence of CL 10 to 20 mm seen in the two trials on vaginal progesterone for short TVU CL in singletons.7,8 However, both of these trials included singletons with a prior spontaneous PTB, which may explain the lower incidence of a short CL in our population. Six (0.5%) women had a borderline CL between 21 and 24.9 mm and required follow-up TVU CL measurement. Of those, one woman had a CL< 20 mm on follow-up TVU. Soon after the implementation of our universal CL screening program on January 1, 2012, both the Society for Maternal Fetal Medicine3 and the ACOG4 issued clinical guidelines regarding universal CL screening. The two major concerns regarding universal CL screening pertained to quality control issues and the use of standardized management protocols.3,4 When any screening technique is employed universally, quality assurance issues may affect results. Therefore, it is important that institutions offering TVU CL screening utilize quality control methods to monitor performance. Institutions can ensure that their sonographers complete the CLEAR, which provides online educational lectures as well as an optional examination and scored cervical image review free of charge.12 The Fetal Medicine Foundation also offers online TVU CL training and credentialing.13 In addition, a collectively agreed-upon protocol for screening and management of a short CL (e.g., ►Fig. 1) should consistently be used to prevent practice variation. Overall, TVU CL performs well as a screening test. TVU CL screening can identify asymptomatic women in a “preclinical American Journal of Perinatology
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Implementation of a Universal CL Screening Program for PTB
Implementation of a Universal CL Screening Program for PTB phase” who are at high risk for spontaneous PTB. TVU can accurately detect a short cervix, and measurements are reproducible when a standardized technique is used.3,14 Perhaps most importantly, vaginal progesterone may be a beneficial intervention to reduce prematurity in women with a short CL, and both screening and treatment are well tolerated with no reported adverse effects to the mother or fetus. Randomized clinical trials have shown that daily use of vaginal progesterone in singleton gestations with a short CL can reduce the incidence of spontaneous PTB by approximately 45%,7,8 however, no formulation of vaginal progesterone is yet approved by the U.S. Food and Drug Administration (FDA) for this indication. On the basis of the results of the PREGNANT trail,8 a new drug application was submitted to the FDA in 2012 for approval of vaginal progesterone gel 8% in women with a short CL. The FDA performed a post hoc statistical analysis of the trial data, and found a nonsignificant reduction in PTB < 33 weeks among the US study subjects. Although the PREGNANT trial8 was not powered to reach statistical significance by geographic region, the FDA voted not to approve the use of progesterone vaginal gel 8% for the reduction of risk of PTB in women with short CL. FDA panel members generally agreed that progesterone vaginal gel 8% is safe, but that additional information is needed regarding its efficacy in the US population. However, US women with a short CL can still be prescribed vaginal progesterone for PTB risk reduction as an “off-label” indication. Currently, national guidelines state that TVU CL screening “can be viewed as reasonable, and can be considered by individual practitioners.”3 The findings of our study lend additional information to support the feasibility of implementing a universal TVU CL screening program. Note This article was presented at the SMFM Society for Maternal Fetal Medicine 33rd Annual Meeting, February 2013, San Francisco, CA.
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References 1 World Health Organization. March of Dimes; The Partnership for
Maternal, Newborn & Child Health; Save the Children. Born Too Soon: The Global Action Report on Preterm Birth. Available at:
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Orzechowski et al. http://www.who.int/pmnch/media/news/2012/preterm_birth_report/en/index.html. Accessed March 1, 2013 Berghella V, Rafael TJ, Szychowski JM, Rust OA, Owen J. Cerclage for short cervix on ultrasonography in women with singleton gestations and previous preterm birth: a meta-analysis. Obstet Gynecol 2011;117(3):663–671 Society for Maternal-Fetal Medicine Publications Committee, with assistance of Vincenzo Berghella. Progesterone and preterm birth prevention: translating clinical trials data into clinical practice. Am J Obstet Gynecol 2012;206(5):376–386 Committee on Practice Bulletins-Obstetrics. The American College of Obstetricians and Gynecologists. Practice bulletin no. 130: prediction and prevention of preterm birth. Obstet Gynecol 2012;120(4):964–973 Iams JD, Goldenberg RL, Meis PJ, et al; National Institute of Child Health and Human Development Maternal Fetal Medicine Unit Network. The length of the cervix and the risk of spontaneous premature delivery. N Engl J Med 1996;334(9):567–572 Leung TN, Pang MW, Leung TY, Poon CF, Wong SM, Lau TK. Cervical length at 18-22 weeks of gestation for prediction of spontaneous preterm delivery in Hong Kong Chinese women. Ultrasound Obstet Gynecol 2005;26(7):713–717 Fonseca EB, Celik E, Parra M, Singh M, Nicolaides KH; Fetal Medicine Foundation Second Trimester Screening Group. Progesterone and the risk of preterm birth among women with a short cervix. N Engl J Med 2007;357(5):462–469 Hassan SS, Romero R, Vidyadhari D, et al; PREGNANT Trial. Vaginal progesterone reduces the rate of preterm birth in women with a sonographic short cervix: a multicenter, randomized, doubleblind, placebo-controlled trial. Ultrasound Obstet Gynecol 2011; 38(1):18–31 Werner EF, Han CS, Pettker CM, et al. Universal cervical-length screening to prevent preterm birth: a cost-effectiveness analysis. Ultrasound Obstet Gynecol 2011;38(1):32–37 Cahill AG, Odibo AO, Caughey AB, et al. Universal cervical length screening and treatment with vaginal progesterone to prevent preterm birth: a decision and economic analysis. Am J Obstet Gynecol 2010;202(6):548.e1–548.e8 Yudin MH, Moravac C, Shah RR. Influence of an “opt-out” test strategy and patient factors on human immunodeficiency virus screening in pregnancy. Obstet Gynecol 2007;110(1):81–86 Cervical Length Education and Review (CLEAR) program. Available at: www.perinatalquality.com/CLEAR/deault.aspx. Accessed March 1, 2013 The Fetal Medicine Foundation. Online Education. Cervical assessment. Available at: http://www.fetalmedicine.com/fmf/onlineeducation/05-cervical-assessment/. Accessed May 13, 2013 Berghella V. Universal cervical length screening for prediction and prevention of preterm birth. Obstet Gynecol Surv 2012;67(10): 653–658
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