The average age of the patients was 35.8 years, with 34% classified as obese, 44% having undergone laparotomy in the lower abdomen, and only 7.4% in postmenopause. Of the 162 patients, 63 (64.8%) underwent ultrasonography due to symptoms, with abnormal uterine bleeding being the most common (38.9%). Asymptomatic patients had transvaginal ultrasound indicated for various reasons, including verifying IUD position, controlling previous sonographic pelvic alterations, and investigating infertility. Clinical data are summarized in Table 1.
Table 1
Clinical characteristics among 162 patients evaluated
Characteristics
|
Mean (SD) or n (%)
|
Age
|
35.8 (12.2)
|
Menopausal status
|
|
Premenopause
|
150 (92.6)
|
Postmenopause
|
12 (7.4)
|
BMI (Kg/m2)*
|
|
< 30 (non-obese)
|
105 (66)
|
>= 30 (obese)
|
57 (34)
|
Previous laparotomy in the lower abdomen
|
|
No
|
90 (55.6)
|
Yes
|
72 (44.4)
|
Symptoms
|
|
AUB with or without pelvic pain
|
63 (38.9)
|
Pelvic pain only
|
32 (19.7)
|
Bleeding or pain in early pregnancy
|
10 (6.2)
|
Asymptomatic
|
57 (35.2)
|
Data are given as mean ± standard deviation (SD) or n (%). |
BMI, body mass index |
AUB, abnormal uterine bleeding |
* Frequency missing = 3 |
In our sample, two patients were hysterectomized, and in the remaining 160 patients, the uterus was identified by both types of US devices. The endometrium was measurable in 87% of cases by HUD and in 96.7% of cases by conventional US when the assessment of endometrium thickness was indicated (no intrauterine gestational sac). HUD characterized 80.2% of the ovaries, while conventional US identified 89.8% of them. Among the 37 ovaries visible by conventional US but not by HUD, 16 measured less than 2.5 cm³, 20 measured between 2.5 cm³ and 4 cm³, and one measured 7 cm³. The patient with one ovary of 7 cm³, seen on conventional US but not by HUD, was in premenopause, had one previous abdominal surgery in the lower abdomen, and had a body mass index of 42.2. HUD did not characterize any ovaries in eight of the 12 postmenopausal patients, and in the other four postmenopausal patients, it only found one ovary.
HUD and conventional US showed good or excellent reliability for most measurements of gynecological organs and their findings, with an interclass coefficient varying between 0.69 and 0.95 (see Table 2). Scatterplots of measurements of some pelvic structures are presented in Fig. 2.
Table 2
Agreement between transabdominal handheld ultrasound device (HUD) and conventional transvaginal US device for numerical variables
Pelvic findings characterized by
both devices
|
HUD
|
Conventional US
|
ICC
|
|
median
|
min
|
max
|
median
|
min
|
max
|
|
Uterine
longitudinal
diameter
n = 160
|
87.0
|
55.0
|
362.0
|
82.0
|
48.0
|
321.0
|
0.92
|
Uterine
Volume
n = 160
|
99.0
|
26.5
|
5350.9
|
101.1
|
20.3
|
7460.8
|
0.95
|
Endometrial
Thickness
n = 133
|
5.8
|
2.1
|
20.0
|
5.7
|
2.1
|
20.0
|
0.80
|
Fibroid larger
diameter n = 65
|
31.0
|
10.0
|
126.0
|
35
|
6.0
|
169.0
|
0.92
|
Median
gestational
sac diameter n = 6*
|
20.3
|
9.7
|
36.3
|
15.8
|
2.0
|
39.0
|
0.69
|
Embryo CCN
n = 4‡
|
10.5
|
5.4
|
23.0
|
13.5
|
10.7
|
22.6
|
0.85
|
Ovarian volume
n = 254
|
6.9
|
0.6
|
451.4
|
7.0
|
0.6
|
204.2
|
0.76
|
Adnexal mass maximum
diameter
n = 15
|
39.0
|
16.0
|
91.0
|
40.0
|
18.0
|
70.0
|
0.91
|
ICC, intraclass correlation coeficiente |
Diameters in mm; volumes in cm³ |
* five intrauterine pregnancies and one ectopic pregnancy |
‡ three intrauterine pregnancies and one ectopic pregnancy |
Sonographic images compatible with fibroids were the most common changes found by conventional US. Among the 46 patients with one to five fibroids, sizes ranged from 6 to 169 mm by conventional US (Table 2). The sensitivity was 84.4% for detecting fibroids measuring 20 mm or more and 22.9% for fibroids measuring less than 20 mm. Among 11 sonographic nodules compatible with polyps found by conventional US, HUD identified one (sensitivity of 9.1%). Regarding the adnexa, the sensitivity and specificity of HUD for detecting ovaries larger than 10 cm³ were 66.7% and 90.4%, respectively, and for detecting adnexal alterations overall were 53.6% and 98.5%, respectively. For the group of adnexal masses larger than or equal to 30 mm, the sensitivity increased to 68.7%, and the specificity was 95.9% (see Table 3).
Table 3
Diagnostic performance of transabdominal handheld ultrasound device (HUD) in predicting pelvic conditions
|
Sens (95%CI) (%)
|
Spec (95%CI) (%)
|
PPV
(%)
|
NPV (%)
|
Accuracy (%)
|
Uterine longitudinal diameter > 90 mm (n = 53)
|
81.1 (67.6–90.1)
|
74.8 (65.3–82.4)
|
61.4
|
88.9
|
76.9
|
Uterine volume >160 cm³ (n = 36)
|
86.1 (69.7–94.8)
|
97.6 (92.6–99.4)
|
91.2
|
96
|
95
|
Retroverted and axial uterus (n = 27)
|
63.0 (42.5–79.9)
|
97 (92–99)
|
80.9
|
92.8
|
91.2
|
Early pregnancy (n = 10)
|
|
|
|
|
|
Intrauterine pregnancy (n = 5)
|
100 (46.3–100)
|
100 (96.9–100)
|
100
|
100
|
100
|
Ectopic pregnancy (n = 2 )
|
100
(15.8–100)
|
100
(97.7–100)
|
100
|
100
|
100
|
Ovular remains (n = 3)
|
66.7 (12.5–98.2)
|
100 (96.9–100)
|
100
|
99.3
|
99.3
|
Fibroid
|
|
|
|
|
|
≥20 mm (n = 64)
|
84.4
(72.7–91.9)
|
99.7
(98.8–99.9)
|
96.4
|
98.6
|
98.4
|
< 20 mm
(n = 48)
|
22.9
(12.5–37.7)
|
99.7
(98.8–99.9)
|
84.6
|
94.9
|
94.8
|
overall
(n = 112)
|
58.0 (48.3–67.2)
|
99.7 (98.9–99.9)
|
97.0
|
93.7
|
93.9
|
Endometrial thicknesses (*) (n = 12)
|
58.3 (28.6–83.5)
|
99.2 (94.8–100)
|
87.5
|
96
|
95.5
|
Intracavitary content
(n = 16)
|
12.5 (1.55–38.5)
|
99.3 (90.1–100)
|
66.7
|
90.8
|
90.3
|
polyp
(n = 11)
|
9.1 (0.5–42.9)
|
100 (96.8–100)
|
100
|
93.5
|
93.5
|
nonspecific hyperechoic content
(n = 5)
|
20.0 (1.05–70.1)
|
99.3 (95.8–100)
|
50
|
97.4
|
96.8
|
Ovarian volume > 10 cm³ (n = 62)
|
66.7 (53.9–77.5)
|
90.4 (85.1–94.1)
|
71.0
|
88.5
|
84.2
|
Adnexal alterations‡
|
|
|
|
|
|
≥30 mm (n = 16 )
|
68.7
(61.2–76.3)
|
95.9
(86.4-105.3)
|
64.7
|
96.5
|
93.2
|
< 30mm (n = 12 )
|
33.3
(25.3–41.3)
|
98.5
(88.8-108.2)
|
66.7
|
94.3
|
93.1
|
overall (n = 28 )
|
53.6 (45.1–62)
|
98.5 (94.7-104.2)
|
88.2
|
91
|
90.7
|
Sens; sensitivity. Spec; specificity. PPV; positive predictive value. NPV; negative predictive value. CI; confidential interval |
* Considered > 14 mm in premenopause and > 5 mm in postmenopause. The endometrium of patients with early pregnancy or ovular remains was not measured |
‡ Including adnexal alterations of any size in postmenopause, unilocular/simple cysts ≥ 30 mm, and other types of cysts/nodules of any size in premenopause |
Among the adnexal masses measuring 30 mm or more seen by conventional US and not identified by HUD, five were unilocular cysts with anechoic content (two of them with a hydrosalpinx appearance), two were unilocular cysts with mixed contents compatible with dermoid cysts, and one was a multilocular cyst with anechoic content. No ascites or adnexal masses with a suspicious appearance were identified by either US examination. There was high agreement between the US devices to describe the type of adnexal mass according to International Ovarian Tumor Analysis (IOTA) terms (kappa of 0.84), to identify uteri with at least one fibroid (kappa of 0.78), and to describe fibroids according to the FIGO classification system (kappa 0.78). The agreement to differentiate between anteverted, axial, and retroverted uterus was intermediate (kappa 0.68) (data not shown).
The data included ten patients with early pregnancy, five viable, and five pathological. The gestational sac of the five intrauterine pregnancies was identified by HUD. The embryo and heartbeat were visible in all of them by conventional US and in three cases by HUD. Conventional US gave gestational ages between 5 weeks 4 days and 9 weeks. Among the two cases of ectopic pregnancy, one HUD identified the adnexal gestational sac containing the embryo with the heartbeat, and in another case, a solid adnexal mass next to the ovary was found by HUD. Among three miscarriages, HUD identified two cases of ovular remains, and in the other one, a nonspecific heterogeneous endometrium with a thickness of 14 mm was seen.
Ultrasonographic images of some pelvic findings found by HUD and conventional US are shown in Figs. 3, 4 and 5. A video of a left adnexal ectopic pregnancy captured by HUD is available (Online Resource 1).