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1 OBSTETRICS 56
2 57
3
Q1 The use of cervical sonography to differentiate true from 58
4
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false labor in term patients presenting for labor check 59
60
6 Nadia B. Kunzier, DO; Wendy L. Kinzler, MD; Martin R. Chavez, MD; Tracy M. Adams, DO; Donald Brand, PhD; 61
Q11
7 Anthony M. Vintzileos, MD 62
8 63
9 64
10 BACKGROUND: Cervical length by transvaginal ultrasound to predict true labor had shorter cervical length as compared to those in false 65
11 preterm labor is widely used in clinical practice. Virtually no data exist on labor: median 1.3 cm (range 0.5-4.1) vs 2.4 cm (range 1.0-5.0), 66
12 cervical length measurement to differentiate true from false labor in term respectively (P < .001). The area under the receiver operating 67
13 patients who present for labor check. False-positive diagnosis of true labor characteristic curve for primiparous patients was 0.88 (P < .001) Q3 68
14 at term may lead to unnecessary hospital admissions, obstetrical and for multiparous patients was 0.76 (P < .01), both demonstrating 69
15 interventions, resource utilization, and cost. good correlation. The area under the receiver operating character- 70
16 OBJECTIVE: We sought to determine if cervical length by transvaginal istic curves were not significantly different between primiparous and 71
17 ultrasound can differentiate true from false labor in term patients multiparous (P ¼ .23). The area under the receiver operating 72
18 presenting for labor check. characteristic curve for primiparous and multiparous patients com- 73
STUDY DESIGN: This is a prospective observational study of women bined was 0.8 (P < .0001), indicating a good overall correlation 74
19
presenting to labor and delivery with labor symptoms at 37-42 weeks, between cervical length and its ability to differentiate true from false
20 75
singleton cephalic gestation, regular uterine contractions (4/20 min), labor. Overall, a cervical length cutoff of 1.5 cm to predict true
21 76
intact membranes, and cervix 4 cm dilated and 80% effaced. Those labor had the highest specificity (84%), positive predictive value
22 77
patients with placenta previa and indications for immediate delivery were (83%), positive likelihood ratio (4.2), and negative likelihood ratio
23 excluded. The shortest best cervical length of 3 collected images was used (0.39). There were no differences in cervical length prediction be-
78
24 for analysis. Providers managing labor were blinded to the cervical length. tween primiparous and multiparous patients. Cervical length was 79
25 True labor was defined as spontaneous rupture of membranes or spon- positively correlated with time to delivery, regardless of the use of 80
26 taneous cervical dilation 4 cm and 80% effaced within 24 hours of oxytocin. 81
27 cervical length measurement. In the absence of these outcomes, labor CONCLUSION: In differentiating true from false labor in term patients 82
28 status was determined as false labor. Receiver operating characteristic who present for labor check, a cervical length of 1.5 cm was the most 83
29 curves were generated to assess the predictive ability of cervical length to clinically optimal cutoff with the lowest FPRedue to its highest Q4 84
30 differentiate true from false labor and were analyzed separately for pri- specificityeand highest positive predictive value and positive and negative 85
31 miparous and multiparous patients. The diagnostic accuracies of various likelihood ratios. Its use to decide admission in patients at term with labor 86
32 cervical length cutoffs were determined. The relationship of cervical length symptoms may prevent unnecessary admissions, obstetrical interventions, 87
33 and time to delivery was also analyzed including both use and nonuse of resource utilization, and cost. 88
34 oxytocin. 89
35 RESULTS: In all, 77 patients were included in the study; the Key words: cervical length, cervical sonography, false labor, labor 90
36 prevalence of true labor was 58.4% (45/77). Patients who were in check, term gestation, true labor 91
37 92
38 93
39 Introduction perception of contractions is a poor labor in prolonged pregnancies and also 94
40 The obstetrical patient presenting to la- predictor of labor and digital exams and in the prediction of successful labor 95
41 bor and delivery triage for a labor eval- therefore Bishop score have large intra- induction.13-16 96
42 uation at term is one of the most observer and interobserver variabilities,1 To our knowledge, there are no data 97
43 common clinical scenarios. Currently, providing low accuracy to predict true on CL measurements to differentiate 98
44 the diagnosis of true labor at term relies labor.2,3 true from false labor in term patients 99
45 on patient symptomatology and very There are several studies examining presenting for a labor check. Conse- 100
46 frequently on progressive cervical dila- the use of cervical length (CL) surveil- quences from false-positive diagnosis of 101
47 tion by digital vaginal exams. However, lance by transvaginal ultrasound true labor at term are unnecessary hos- 102
48 (TVUS) to predict spontaneous pre- pital admissions, unnecessary obstetrical 103
49 term birth in symptomatic as well as interventions, increased resource utili- 104
50 Cite this article as: Kunzier NB, Kinzler WL, Chavez MR, asymptomatic patients.4-12 As a matter zation, and increased cost.17,18 There- 105
51 et al. The use of cervical sonography to differentiate true of fact, the usefulness of CL to predict fore, the primary objective of this 106
from false labor in term patients presenting for labor preterm labor (PTL) has been docu- prospective study was to determine if CL
52 check. Am J Obstet Gynecol 2016;volume:x.ex-x.ex.
107
53 mented very well so that it is now by TVUS can differentiate true from 108
54 0002-9378/$36.00 routinely used in clinical practice.5-12 In false labor in term patients who present 109
ª 2016 Elsevier Inc. All rights reserved.
55 http://dx.doi.org/10.1016/j.ajog.2016.03.031 term patients the use of CL has been to the hospital for labor check. Our 110
limited to prediction of spontaneous secondary objective was to determine the

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111 167
112 relationship between CL and time to 168
TABLE 1
113 delivery in these patients. 169
Comparison of demographic and obstetric variables for true vs false
114 labor patients 170
115 Materials and Methods 171
116 This was an international review True labor False labor 172
boardeapproved prospective observa- n ¼ 45 [58.4%] n ¼ 32 [41.5%] P value
117 173
118 tional study from 2013 through 2016 in Age, y 28.7  6.0 27.7  5.7 .47 174
119 term (37-42 weeks) patients presenting BMI, kg/m2 29.9  5.5 30.1  5.0 .85 175
120 to labor and delivery triage at Winthrop 176
University Hospital, Mineola, NY, with Race .71
121 177
labor symptoms. A history and physical White 20 (44.4) 12 (37.5)
122 178
123 was performed as standard of care. Black 13 (28.9) 12 (37.5) 179
124 Informed consent was obtained after 180
Hispanic 12 (26.7) 5 (15.6)
125 determining eligibility. Recruitment was 181
not consecutive secondary to time con- Other 0 (0.0) 3 (9.4)
126 182
127 straints because of a very busy labor and Gravidity 2 (1e5) 2 (1e6) .54
183
128 delivery unit where the study was con- Parity 0 (0e3) 0 (0e2) .30 184
tacted. Inclusion criteria were: singleton,
129 Gestational age, wk 39.3  0.9 38.7  1.1 <.01 185
130 live intrauterine pregnancy in cephalic 186
presentation, gestational age 37-42 Cesarean delivery 7 (15.6) 5 (15.6) 1.00
131 187
132 weeks, regular uterine contractions Birthweight, g 3285  434 3413  375 .18 188
133 (defined as 4 contractions/20 min on Cervical length, cm 1.3 (0.5e4.1) 2.4 (1.0e5.0) <.001 189
134
Q5 the tocometer), intact membranes, and 190
Data expressed as n (%), mean  SD, or median (interquartile range).
135 cervix <4 cm dilated and <80% effaced. 191
BMI, body mass index.
136 Exclusion criteria were: clinical cho- Kunzier et al. Cervical length to predict true labor at term. Am J Obstet Gynecol 2016. 192
137 rioamnionitis (defined as temperature 193
138 >100.4 F and 2 of the following: 194
139 malodorous discharge, maternal leuko- 195
cytosis, maternal tachycardia, fetal labor, spontaneous or artificial rupture Results
140 196
tachycardia, uterine tenderness), of membranes and timing, time of birth, In all, 101 patients were enrolled; 24
141 197
maternal or fetal indications for imme- birthweight, and mode of delivery. patients were excluded because of: in-
142 198
diate delivery, placenta previa, and pre- Several statistical analyses were per- duction prior to active labor (22), breech
143 199
vious cesarean delivery. formed. The demographic and clinical presentation after the CL measurement
144 200
TVUS was performed by residents characteristics of true vs false labor pa- (delivered by scheduled cesarean) (1),
145 201
previously trained on proper CL tech- tients were compared with parametric and spontaneous rupture of membranes
146 202
147 nique.19 Three images per patient were and nonparametric analysis. Receiver after the vaginal exam and before the
203
collected and the shortest best image was operating characteristic (ROC) curves of TVUS (1). Analysis was performed on
148 204
chosen to be analyzed in the study. CL in the prediction of true labor were the remaining 77 patients.
149 205
Providers making management de- generated and the diagnostic accuracy of Of the 77 patients analyzed, 45 were in
150 206
cisions were blinded to the CL mea- CL was determined for various CL cut- true labor (prevalence of true labor 45/77
151 207
surements. True labor was defined as offs for both primiparous and multipa- or 58.4%) and 32 (41.6%) were in false
152 208
spontaneous rupture of membranes or rous patients. The diagnostic accuracy of labor. The groups were similar in regards
153 209
154 spontaneous cervical dilation 4 cm and the various CL cutoffs was expressed by to maternal age, body mass index, race,
210
155 80% effaced within 24 hours of CL sensitivity, specificity, positive predictive gestational age, gravidity, parity, and
211
measurement. False labor was defined as value (PPV), negative predictive value mode of delivery (Table 1). Patients who ½T1
156 212
cases that did not fulfill the above (NPV), and positive and negative likeli- were in true labor had shorter CL mea-
157 213
definition of true labor. Patient’s hood ratios for both primiparous and surements at the time of presentation as
158 214
demographics and obstetrical variables multiparous patients separately as well as compared to those in false labor: median
159 215
were collected and included: patient’s combined. Lastly, the relationship be- 1.3 cm (range 0.5-4.1) vs 2.4 cm (range
160 216
age, prepregnancy body mass index, tween CL and time to delivery was 1.0-5.0), respectively (P < .001). Those
161 217
race, gravidity, parity, gestational age, determined by linear regression and who were in true labor were also of more
162 218
cervical exam, CL measurement upon scatter plot and the correlation coeffi- advanced gestational age compared to
163 219
presentation, date and time of CL mea- cient (r) was calculated. CL vs time to the false labor patients (P < .01)
164 220
surement, date of admission to or delivery was analyzed individually for (Table 1).
165 221
discharge from hospital, time of active patients who received oxytocin ROC curves were generated separately
166 222
labor, induction or augmentation of augmentation and those who did not. for primiparous and multiparous

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223 279
224 Cervical surveillance has been mainly 280
FIGURE 1 5-12
225 used to predict spontaneous PTL. In 281
---
226 using CL to detect or predict PTL, a high 282
227 Primiparous AUC= 0.88 sensitivity should be the driver in 283
CL ≤ 2.5 cm CL ≤ 3.0 cm
228 deciding the most optimal CL cutoff20 284
100
229 CL ≤ 2.0 cm because failure to diagnose PTL carries 285
230 CL ≤ 3.0 cm
significant consequences of withholding 286
80 CL ≤ 2.5 cm interventions such as vaginal progester-
231 CL ≤ 1.5 cm
287
MulƟparous AUC= 0.76 one, cervical cerclage, betamethasone,
232 CL ≤ 2.0 cm 288
Sensitivity (%)

233 60
and magnesium sulfate for neuro- 289
CL ≤ 1.5 cm
234 protection.21-24 This concept leads to the 290
235 used typical CL cutoffs of 20 mm or 291
40 Area under the curves do not 2.5 cm in the preterm population.24
236 292
differ significantly (p=0.23) However, the importance of differenti-
237 293
238 20
ating true from false labor at term should 294
239 have different clinical considerations. 295
240 High false-positive diagnosis (of true 296
0 labor) may lead to unnecessary hospital
241 297
0 20 40 60 80 100 admissions, unnecessary obstetrical in-
242 298
243 1 - Specificity (%) terventions, increased resource utiliza- 299
244Q9 tion, and increased cost.17,18 Therefore, in 300
Area under receiver operating characteristic (AUC) curves for cervical length (CL) in differentiating
245 true from false labor at term. Primiparous and multiparous gestations analyzed individually. choosing the most optimal cutoff, the FPR 301
246 Kunzier et al. Cervical length to predict true labor at term. Am J Obstet Gynecol 2016.
should be minimized (or the specificity 302
247 should be maximized), thus making the 303
248 CL cutoff of 1.5 cm appropriate with 304
249 accuracies being similar for both primip- 305
250½F1 (Figure 1). There were no statistically of 1.5 cm had the highest specificity arous and multiparous patients. In term 306
251 significant difference in the area under (and thus lowest FPR), PPV, and positive patients the consequences from false- 307
252 the ROC curves between primiparous and negative likelihood ratios. Utilizing a negative diagnosis are not as important 308
253 and multiparous (0.88 vs 0.76, respec- CL of 1.5 had a specificity of 84% as in preterm gestations; however, they 309
254 tively, P ¼ .23), therefore, the data were (thus, FPR of 16%), PPVof 83%, positive may include patient inconvenience or the 310
255½F2 combined (Figure 2). Table 2 shows the likelihood ratio of 4.2, and negative worst rare case scenario is delivery en 311
256 sensitivity, specificity, PPV, NPV, and likelihood ratio of 0.39. The sensitivity, route to a hospital setting. Given the 312
257½T2 positive and negative likelihood ratios of specificity, PPV, NPV, and positive and known inaccuracy of digital cervical 313
258 various CL cutoffs. Overall, the CL cutoff negative likelihood ratios were not exams1 in predicting true labor, CL by 314
259 significantly different for primiparous vs TVUS, along with the overall clinical 315
260 multiparous patients. Time to delivery assessment of the patient presenting for 316
261 FIGURE 2 was positively correlated with CL labor check, can provide an objective 317
262 ---
(P < .001), regardless of labor augmen- measurement to help patient manage- 318
263 tation (Figure 3) with a correlation ment. However, the decision of hospital ½F3 319
264 100 coefficient (r) of 0.48. admission cannot rely only on CL but it 320
CL ≤ 3.0 cm

265 CL ≤ 2.5 cm should take into consideration the indi- 321


80 CL ≤ 2.0 cm

266 Comment vidual factors of each case. Our sample 322


The main finding of this study was that
Sensitivity (%)

CL ≤ 1.5 cm

267
60 size did not allow for stratification by 323
268 Area under curve = 0.80 that in term patients who present for each gestational age from 37-42 weeks 324
40

269
P<0.0001* labor check there was a good correlation to investigate any differences in the accu- 325
270
20 between CL and its ability to differentiate racy of the CL cutoffs. Future, larger 326
271 0
true from false labor and that the most studies are needed to examine if the CL 327
272
0 20 40 60 80 100 optimal cutoff was 1.5 cm. This cutoff accuracy varies according to each gesta- 328
273
1 - Specificity (%) of 1.5 cm provides the lowest FPR tional week. 329
Receiver operating characteristic curves of because of its highest specificity and it Some caution should be exercised in
274Q10 330
275
cervical length (CL) in differentiating true from has the same accuracy for both primip- extrapolating our findings to other 331
false labor at term. Primiparous and multiparous arous and multiparous patients. We also populations. In our study we used a strict
276 gestations combined. 332
277 demonstrated a positive relationship definition of “labor” and as a result our 333
Kunzier et al. Cervical length to predict true labor at term.
278 Am J Obstet Gynecol 2016.
between CL and time to delivery, prevalence of disease (true labor) was 334
regardless of oxytocin use. 58.4% (45/77), which may not be

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335 391
336 life setting with residents who were 392
TABLE 2
337 trained in CL measurements performing 393
Diagnostic accuracy of cervical length to predict true labor at term
338 the TVUS. Having residents undergo 394
339 CL <1.5 cm CL2 CL2.5 CL3 specific educational intervention has 395
n (%) n (%) n (%) n (%) been shown to affect competence in
340 396
341 Primiparous and multiparous, n ¼ 77 performing accurate examinations.19 397
342 Fourth, the practitioners making man- 398
Sensitivity 30/45 (67) 37/45 (82) 41/45 (93) 43/45 (96)
343 agement decisions were blinded to the 399
Specificity 26/32 (84) 20/32 (63) 12/32 (38) 7/32 (22) CLs measured, thereby decreasing bias in
344 400
Positive predictive value 30/36 (83) 37/49 (76) 41/61 (67) 43/68 (63) admissions and interventions.
345 401
346 Negative predictive value 26/41 (63) 20/28 (71) 12/16 (75) 7/9 (78) In summary, we analyzed various CL 402
347 cutoffs and showed that the use of the CL 403
Positive likelihood ratio 67/16 (4.2) 82/37 (2.2) 93/62 (1.5) 96/78 (1.2)
348 cutoff of 1.5 is the most optimal in an 404
Negative likelihood ratio 33/84 (0.39) 18/63 (0.29) 7/38 (0.18) 4/22 (0.18) attempt to prevent unnecessary admis-
349 405
Primiparous, n ¼ 47 sions with resulting obstetrical in-
350 406
351 Sensitivity 20/31 (66) 26/31 (84) 31/31 (100) 31/31 (100) terventions, resource utilization, and 407
352 increased costs in term patients pre- 408
Specificity 14/16 (88) 10/16 (63) 6/16 (38) 5/16 (31)
353 senting for labor check. Further studies 409
Positive predictive value 20/22 (91) 26/32 (81) 31/41 (76) 31/42 (74) are needed to include a larger number of
354 410
Negative predictive value 14/25 (56) 10/15 (67) 6/6 (100) 5/5 (100) patients of a diverse population to
355 411
356 Positive likelihood ratio 66/12 (5.5) 84/37 (2.3) 100/63 (1.6) 100/69 (1.4) confirm our results. n 412
357 Negative likelihood ratio 34/88 (0.39) 16/63 (0.25) 0/38 (0) 0/31 (0) 413
358 References 414
Multiparous, n ¼ 30
359 1. Phelps JY, Higby K, Smyth, et al. Accuracy 415
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---
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400
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442
0
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465 ultrasound assessment of the cervix for predic- 859-67. Mineola; and Department of Obstetrics and Gynecology, 521
tion of time to onset of labor and time to delivery 21. Schoen CN, Tabbah S, Iams JD, Division of Maternal Fetal Medicine, Stony Brook Medi-
466 cine, Stony Brook (Drs Kunzier and Adams), NY.
522
in prolonged pregnancy. Ultrasound Obstet Caughey AB, Berghella V. Why the United States
467 Received March 2, 2016; revised March 9, 2016; 523
Gynecol 2006;28:298-305. preterm birth rate is declining. Am J Obstet
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469 nographic cervical measurement as a predictor 22. Hassan SS, Romero R, Vidyadhari D, et al. The authors report no conflict of interest. 525
470 of successful labor induction. Am J Obstet Vaginal progesterone reduces the rate of pre- Presented as a poster at the 36th annual meeting of 526
Gynecol 2000;182:1030-2. term birth in women with a sonographic short the Society for Maternal-Fetal Medicine, Atlanta, GA, Feb.
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16. Comas M, Cochs B, Martí L, et al. Ultra- cervix: a multicenter, randomized, double-blind,
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sound examination at term for predicting the placebo-controlled trial. Ultrasound Obstet Corresponding author: Nadia B. Kunzier, DO.
473 outcome of delivery in women with a previous Gynecol 2011;38:18-31. nbennett@nyit.edu 529
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