Transvaginal ultrasonography predictive model for the detection of pelvic congestion syndrome.

Background: The diagnosis of pelvic congestion syndrome (PCS) remains a challenge given the lack of universally accepted criteria. Although venography (VG) is the current gold standard for the diagnosis of PCS, non-invasive techniques like transvaginal ultrasonography (TVU) appear to be a valid alternative. The aim of this study was to design a predictive model for the venographic diagnostic of PCS using the parameters identified by TVU in patients with clinical suspicion of PCS, in order to individually assess the need to perform an invasive diagnostic and therapeutic technique such as VG. Methods: An observational and cross-sectional prospective study was conducted including 61 consecutively recruited patients with clinical suspicion of PCS, who were referred by the Pelvic Floor, Gynecology and Vascular Surgery Units, who were distributed in two groups: 18 belonging to the normal group and 43 to the PCS's group. We implemented and compared 19 binary logistic regression models, including the parameters that showed statistical significance in the prior univariate analysis. We evaluated individual predictive values with a receiver operating characteristic (ROC) curve and the area under the curve (AUC). Results: The selected model, based on the presence of pelvic veins or venous plexus of 8 mm or larger, observed by transvaginal ultrasound, had an AUC of 0.79 (95% CI: 0.63-0.96; P<0.001), with a sensitivity of 0.90 and specificity of 0.69, while the VG had a sensitivity of 86.05%, a specificity of 66.67%, and a positive predictive value of 86.05%. Conclusions: This assessment presents a feasible alternative that could potentially be added to our usual gynecological practice.

Can clinicopathological factors improve the prediction of metastasis to nonsentinel lymph nodes in patients with breast cancer?

INTRODUCTION: To determine whether clinicopathological characteristics can improve the prediction of metastasis to nonsentinel lymph nodes (NSLNs) over the use of only mRNA copy number in sentinel lymph node (SLN) biopsies. METHODS: This was a retrospective, observational study that included a total of 824 patients with T1-3 breast cancer who had clinically negative, ultrasound-negative axilla without evidence of metastasis and who underwent one-step nucleic acid amplification in SLN biopsies. RESULTS: 118 required a complete axillary lymph node dissection (ALNhD). About 35.6% (42/118) had metastases to a NSLN, and 64.4% (76/118) had no metastasis to a NSLN. The ROC curve of the total tumor load (TTL) presented an area under the curve (AUC) of 0.651 (95%; CI: 0.552-0.751). The 7294 copies of CK19 mRNA were established as the optimal cutoff point, with sensitivity: 93%, specificity: 63%, positive predictive value: 44%, and negative predictive value: 91%. By associating the clinicopathological parameters (multicentricity, pooled immunohistochemistry [IHC], and progesterone receptors), the AUC went up to 0.752 (95% CI: 0.663-0.841). CONCLUSIONS: Clinicopathological factors should be considered together with the total CK19 mRNA copy number (the TTL) of the SLNs to improve the predictive capacity of metastatic involvement of the NSLNs.

INTRODUCCIÓN: Nuestro objetivo era determinar si la influencia de las características clínicopatológicas pueden mejorar la predicción de metástasis en los ganglios linfáticos no centinelas (GLNC) a partir de un punto de corte de copias de ARNm determinado en la biopsia del ganglio linfático centinela (GLC). MÉTODOS: Se realizó un estudio observacional retrospectivo incluyendo a un total de 824 pacientes con cáncer de mama T1-3, con axila clínica y ecográficamente negativa para metástasis en los ganglios axilares. Se les practicó una biopsia selectiva del GLC y estudio posterior mediante el método one step nucleic acid amplification (OSNA). RESULTADOS: 118 precisaron una disección completa de los ganglios linfáticos axilares. 35,6% (42/118) tuvieron metástasis en GLNC y 64.4% (76/118) no presentaron metástasis en GLNC. La curva ROC del log de la carga tumoral total (CTT) presentó un área bajo la curva de 0.651 (95%; IC: 0.552-0.751). Se estableció las 7294 copias de ARNm de CK19 como punto de corte óptimo, con sensibilidad: 93%, especificidad: 63%, valor predictivo positivo: 44% y valor predictivo negativo: 91%. Al asociar los parámetros clinicopatológicos (multicentricidad, inmunohistoquímica (IHQ) agrupado y receptores de progesterona) obtenemos un área bajo la curva mejorada de 0.752 (95% intervalo de confianza [IC] 0.663-0.841). CONCLUSIONES: Los factores clinicopatológicos deberían valorarse asociados al corte de copias de ARNm de la CTT de CK19 de los GLCs para mejorar la capacidad predictiva de afectación metastásica en los GLNCs.

Identification of Pelvic Congestion Syndrome Using Transvaginal Ultrasonography. A Useful Tool.

The gold standard for the diagnosis of pelvic congestion syndrome (PCS) is venography (VG), although transvaginal ultrasound (TVU) might be a noninvasive, nonionizing alternative. Our aim is to determine whether TVU is an accurate and comparable diagnostic tool for PCS. An observational prospective study including 67 patients was carried out. A TVU was performed on patients, measuring pelvic venous vessels parameters. Subsequentially, a VG was performed, and results were compared for the test calibration of TVU. Out of the 67 patients included, only 51 completed the study and were distributed in two groups according to VG results: 39 patients belonging to the PCS group and 12 to the normal group. PCS patients had a larger venous plexus diameter (15.1 mm vs. 12 mm; p = 0.009) and higher rates of crossing veins in the myometrium (74.35% vs. 33.3%; p = 0.009), reverse or altered flow during Valsalva (58.9% vs. 25%; p = 0.04), and largest pelvic vein ≥ 8 mm (92.3% vs. 25%). The sensitivity and specificity of TVU were 92.3% (95% CI: 78.03-97.99%) and 75% (95% CI: 42.84-93.31%), respectively. In conclusion, transvaginal ultrasonography, with the described methodology, appears to be a promising tool for the diagnosis of PCS, with acceptable sensitivity and specificity.

Clinical and Economic Evaluation after Adopting Contingent Cell-Free DNA Screening for Fetal Trisomies in South Spain.

INTRODUCTION: Contingent cell-free (cf) DNA screening on the basis of the first-trimester combined test (FCT) results has emerged as a cost-effective strategy for screening of trisomy 21 (T21). OBJECTIVES: To assess performance, patients' uptake, and cost of contingent cfDNA screening and to compare them with those of the established FCT. METHODS: This is a prospective cohort study including all singleton pregnancies attending to their FCT for screening of T21 at 2 university hospitals in South Spain. When the FCT risk was ≥1:50, there were major fetal malformations, or the nuchal translucency was ≥3.5 mm, women were recommended invasive testing (IT); if the risk was between 1:50 and 1:270, women were recommended cfDNA testing; and for risks bellow 1:270, no further testing was recommended. Detection rate (DR), false-positive rate (FPR), patients' uptake, and associated costs were evaluated. RESULTS: We analyzed 10,541 women, including 46 T21 cases. DR of our contingent strategy was 89.1% (41/46) at 1.4% (146/10,541) FPR. Uptake of cfDNA testing was 91.2% (340/373), and overall IT rate was 2.0%. The total cost of our strategy was €1,462,895.7, similar to €1,446,525.7 had cfDNA testing not been available. CONCLUSIONS: Contingent cfDNA screening shows high DR, low IT rate, and high uptake at a similar cost than traditional screening.

Association between sexual dysfunction and avulsion of the levator ani muscle after instrumental vaginal delivery.

INTRODUCTION: The effects of levator ani muscle (LAM) avulsion after instrumental delivery on the sexual function of patients are currently unknown. Therefore, the objective of our study was to use a validated questionnaire, namely, the Female Sexual Function Index (FSFI), to compare the sexual function in patients with and without LAM avulsion after instrumental vaginal delivery. MATERIAL AND METHODS: This was a prospective observational study of 112 primiparous women after instrumental (vacuum or forceps) vaginal delivery. The obstetric and general characteristics of the population were studied. At 6 months postpartum, the contraceptive method used and the occurrence of LAM avulsion (using four-dimensional transperineal ultrasound) were determined, and the FSFI was administered. RESULTS: A total of 100 patients (62 without avulsion and 38 with avulsion) completed the study. Thirty-eight (38%) were diagnosed with avulsion (42.1% after Kielland forceps delivery, 57.9% after Malmström vacuum delivery; P = .837). Women with LAM avulsion had significantly lower scores for desire (2.9 ± 1.2 vs 3.4 ± 1.1; P = .049), arousal (2.8 ± 1.7 vs 3.6 ± 1.4; P = .014), lubrication (2.3 ± 1.4 vs 3.0 ± 1.2; P = .011), orgasm (2.6 ± 1.6 vs 3.3 ± 1.2; P = .006) and satisfaction (3.1 ± 1.8 vs 3.9 ± 1.5; P = .051) than did women without LAM avulsion. The overall FSFI score was lower in patients with avulsion (16.7 ± 8.9 vs 20.7 ± 6.9, P = .033). These results were obtained after controlling for confounders (delivery mode, induced labor, birthweight, perineal tears, avulsion degree, contraceptive method and group assignment for the parent study) in the multivariate analysis (F = 4.974, P = .001). CONCLUSIONS: Patients with LAM avulsion present a higher degree of sexual dysfunction compared wiith patients without avulsion at 6 months after instrumental vaginal delivery.

Prevalence of levator hiatal overdistension after vacuum and forceps deliveries.

INTRODUCTION: Levator ani avulsion rates after assisted vaginal delivery have been reported in the literature. However, there are no definitive data regarding the association between overdistention and assisted vaginal delivery. Therefore, our aim is to report overdistention rates after assisted vaginal delivery with a postpartum ultrasound examination. MATERIALS AND METHODS: This multicenter study involved a retrospective analysis of data from primiparous women (n = 602) who had previously been recruited at three tertiary hospitals between January 2015 and January 2017. Overdistention was assessed at 6 months postpartum using three-/four-dimensional transperineal ultrasound. Patients with levator ani muscle avulsion were excluded. Overdistention was defined as a levator hiatal area ≥ 25 cm2 on Valsalva. RESULTS: Of the 602 primiparous patients, 250 patients who satisfied the inclusion criteria (139 patients who underwent forceps delivery and 111 patients who underwent vacuum delivery) were evaluated. Overdistention occurred in 20% (50 of 250) of these patients. Overdistention was observed for 1% (1/111) of vacuum deliveries and 35.3% (49 of 139) of forceps deliveries. We found an increased risk of overdistention following forceps delivery compared to vacuum delivery, with a crude odds ratio (OR) of 59.9 (95% confidence interval [CI]: 8.1, 442.2) and an adjusted OR (adjusted for maternal age, second-stage duration, and head circumference) of 17.6 (95% CI: 2.3, 136.7). CONCLUSIONS: Postpartum overdistention occurred for 20% of assisted vaginal deliveries, with an increased risk of overdistention following forceps delivery compared to vacuum delivery.

Are there differences in the damage to the pelvic floor between malmstrom's and kiwi omnicup vacuums? A multicenter study.

OBJECTIVES: The objective of this study is to investigate a multicenter study to establish if differences exist in the levator ani muscle avulsion (LAM) rates between deliveries performed with Malmstrom's vacuum and the Kiwi vacuum. STUDY DESIGN: A prospective, multicenter observational study with 199 primiparous subjects was performed. All patients had undergone vaginal delivery by vacuum (Malmstrom's or Kiwi). Avulsion was defined as an abnormal insertion of LAM in the lower pubic branch in the multiplanar mode, as identified in the three central sections by transperineal 3/4D echography 6 months after delivery. The area of ​​the levator hiatus was measured in the plane of minimum dimensions at rest, during the Valsalva maneuver and during contraction. RESULTS: LAM avulsion occurred in 33.1% of cases in which Malmstrom's vacuum was used and in 29.4% of cases in which the Kiwi vacuum was used (the difference was not statistically significant), which resulted in a crude odds ratio (OR) of 0.977 (0.426, 2.241; P = .957) and an adjusted OR of 2.90 (0.691; 12.20; P = .146). Women in the Malmstrom's vacuum group had a larger LHA at rest 14.77 vs 12.64 cm2 ; P = .001) and at maximum contraction (13.41 vs 10.83 cm2 ; P < 0.001) in comparison with the Kiwi group, although the difference did not reach statistical significance under Valsalva maneuver (18.71 vs 17.21 cm2 ; P = .051).Differences between both groups were detected in the measurements of the hiatus area levator at rest (14.77 vs 12.64 cm2 ), during the Valsalva maneuver (18.71 vs 17.21 cm2 ) and during maximum contraction (13.41 vs 10.83 cm2 ). CONCLUSIONS: In the present study, Malmstrom's vacuum was not associated with a higher risk of LAM in comparison with Kiwi's Omnicup.

A comparable rate of levator ani muscle injury in operative vaginal delivery (forceps and vacuum) according to the characteristics of the instrumentation.

INTRODUCTION: Forceps delivery is associated with a high rate of levator ani muscle (LAM) trauma (avulsion) at 35%-65% whereas data on avulsion rates after vacuum delivery vary greatly. Nevertheless, a common characteristic of all previous studies carried out to evaluate the association between instrumental deliveries (forceps and vacuum) and LAM avulsion, is the fact that characteristics of the instrumentation have not been described or evaluated. The objective of this study is to compare the rate of LAM avulsion between forceps and vacuum deliveries according to the characteristics of the instrumentation. MATERIAL AND METHODS: Prospective, observational study, including 263 nulliparous women, who underwent an instrumental delivery with either Malmström vacuum or Kielland forceps. The characteristics of the instrumentation, position (anterior position and other position) and height of the fetal head at the moment of instrumentation (low instrumentation [vertex at +2 station] and mid-instrumentation [head is involved but leading part above +2 station]) were assessed. Evaluation of LAM avulsion was performed at 6 months postpartum by three-/four-dimensional transperineal ultrasound. Using the multi-view mode, a complete avulsion was diagnosed when the abnormal muscle insertion was identified in all three central slices, that is, in the plane of minimal hiatal dimensions and the 2.5-mm and 5.0-mm slices cranial to this one. To detect a 30% or 15% difference in the LAM injury rate, with 80% power and 5% α-error, we needed, respectively 42 and 99 women per study group. RESULTS: In all, 263 nulliparous individuals have been evaluated (162 vacuum deliveries, 101 forceps deliveries). Instrumentation in an occipito-anterior position was more frequent in vacuum deliveries (75.3% vs 56.4%, P = .002), whereas other positions were more frequent in the forceps deliveries group (24.7% vs 43.6%). No statistically significant differences were noted regarding the height of the fetal head at the moment of instrumentation. No statistically significant differences were found in the presence of LAM avulsion (41.4% vs 38.6%) between vacuum and forceps deliveries. The univariate analysis of the crude odds ratio was 1.17, 95% CI 0.67-1.98, P = .70 for the avulsion of the LAM and the multivariate of the adjusted OR 0.90, 95% CI; 0.53-1.55, P = .71. CONCLUSIONS: We consider that, in our population, LAM avulsion rate should not be a factor taken into account when choosing the type of instrumentation (Malmström vacuum or Kielland forceps) in an operative delivery.

Intra and interobserver variability of intrapartum transperineal ultrasound measurements with contraction and pushing.

The aim of this study was to evaluate the inter- and intraobserver correlation of the different intrapartum-transperineal-ultrasound-parameters(ITU) (angle of progression (AoP), progression-distance (PD), head-direction (HD), midline-angle (MLA) and head-perineum distance (HPD)) with contraction and pushing. We evaluated 28 nulliparous women at full dilatation under epidural analgesia. We performed a transperineal ultrasound evaluating AoP and PD in the longitudinal plane, and MLA and HPD in the transverse plane. Interclass correlation coefficients (ICC) with 95% CIs and Bland-Altman analysis were used to assess intra- and interobserver measurement's repeatability. The ICC of the ITU for the same observer was adequate for all the parameters (p < .005) AoP 0.98 (95%CI, 0.96-0.99), PD 0.98 (95%CI, 0.97-0.99), MLA 0.99 (95%CI, 0.97-0.99), HPD 0.96 (95%CI, 0.88-0.99). The ICC of the ITU for interobserver was: AoP 0.93 (95%CI, 0.79-0.98), PD 0.92 (95%CI, 0.76-0.97), MLA 0.77 (95%CI, 0.42-0.92), HPD 0.47 (95%CI, -0.12-0.8). The HD had an interobserver correlation of 0.53 (95%CI, 0.1-0.9) (Kappa C). The mean difference of the AoP was 2.42°, of the PD 1 mm and 0.28° MLA (Bland-Altman test). ITU has an adequate intra- and interobserver correlation for its use with contraction and pushing under epidural analgesia. Impact statement What is already known on this subject: The intrapartum transperineal ultrasound parameters can be used with contraction and pushing under epidural analgesia. What the results of this study add to what we know: ITU may be used to evaluate the difficulty of instrumental delivery/to evaluate the difficulty of instrumentation in vaginal operative deliveries and this study concludes that ITU is reproducible during uterine contraction with pushing. What the implications are of these findings for clinical practice and/or further research: Therefore, ITU could be used without difficulty with an adequate intra- and interobserver correlation for the prediction of instrumentation difficulty in operative vaginal deliveries.

Intrapartum transperineal ultrasound used to predict cases of complicated operative (vacuum and forceps) deliveries in nulliparous women.

INTRODUCTION: The objective of this study was to investigate the predictive value of intrapartum transperineal ultrasound in the identification of complicated operative (vacuum or forceps) deliveries in nulliparous women. MATERIAL AND METHODS: Prospective observational study of nulliparous women with an indication for operative delivery who underwent intrapartum transperineal ultrasound before fetal extraction. Managing obstetricians were blinded to the ultrasound data. Intrapartum transperineal ultrasound was performed immediately before blade application, both at rest and concurrently with contractions and active pushing. Operative delivery was classified as complicated when one or more of the following situations occurred: three or more tractions; a third-/fourth-degree perineal tear; significant bleeding during the episiotomy repair; major tear or significant traumatic neonatal lesion. RESULTS: A total of 143 nulliparous women were included in the study (82 vacuum-assisted deliveries and 61 forceps-assisted deliveries), with 20 fetuses in occiput posterior position. Forty-seven operative deliveries were classified as complicated deliveries (28 vacuum-assisted deliveries, 19 forceps-assisted deliveries). No differences in obstetric, intrapartum or neonatal characteristics were observed between the study groups, with the following exceptions: birthweight (3229 ± 482 uncomplicated deliveries vs. 3623 ± 406 complicated deliveries; p < 0.003) and number of vacuum tractions (1.4 uncomplicated deliveries, 4.5 complicated deliveries; p < 0.0005). The strongest predictors of a complicated delivery, using the area under the receiver-operating characteristics curve (AUC), were the angle of progression with active pushing (AoP2) (AUC 86.9%) and the progression distance with active pushing (PD2) (AUC 74.5%). The optimal cut-off value for predicting a difficult operative delivery was an AoP2 of 153.5° (sensitivity 95.2%; false-positive rate 5.9%) or PD2 of 58.5 mm (sensitivity 95.2%; false-positive rate 7.1%). CONCLUSIONS: The sonographic parameters AoP2 and PD2 can be used to predict cases of complicated operative deliveries in nulliparous women.