Aspiration technique-based device is more reliable in cervical stiffness assessment than digital palpation.

BACKGROUND: The purpose of this study was to compare the reliability and reproducibility of the traditional qualitative method of assessing uterine cervical stiffness with those of a quantitative method using a novel device based on the aspiration technique. METHODS: Five silicone models of the uterine cervix were created and used to simulate different cervical stiffnesses throughout gestation. The stiffness of the five cervix models was assessed both by digital palpation (firm, medium and soft) and with the Pregnolia System. Five self-trained participants conducted the device-based assessment, whereas 63 obstetricians and midwives, trained in digital palpation, conducted the cervical palpation. RESULTS: The results of the two methods were analyzed in terms of inter-and intra-observer variability. For digital palpation, there was no common agreement on the assessment of the stiffness, except for the softest cervix. When assessing the same cervix model for a second time, 76% of the obstetricians and midwives disagreed with their previous assessment. In contrast, the maximum standard deviation for the device-based stiffness assessment for intra- and inter-observer variability was 3% and 3.4%, respectively. CONCLUSIONS: This study has shown that a device based on the aspiration technique provides obstetricians and midwives with a method for objectively and repeatably assess uterine cervical stiffness, which can eliminate the need to rely solely on a subjective interpretation, as is the case with digital palpation.

Cervical length after cerclage: comparison between laparoscopic and vaginal approach.

PURPOSE: The aim of our study was to investigate the sonographic changes of the cervical length during pregnancy after the placement of a transvaginal cervical cerclage (TVC) or a laparoscopic abdominal cerclage (LAC) in patients with cervical insufficiency (CI). METHODS: Between January 2008 and March 2015, a retrospective analysis of all women undergoing a prophylactic laparoscopic (LAC group) or transvaginal (TVC group) cerclage due to cervical insufficiency was conducted. Nonparametric variables were analysed with the Mann-Whitney (U) test, and categorical-type outcomes were analysed with the Fisher's exact test. A p value <0.05 was considered as significant. Data analysis was performed using Prism 5 for Mac OS X. RESULTS: Thirty-eight patients were included. Of these, 18 and 20 underwent an LAC and a TVC, respectively. Mean gestational age at surgery in the LAC and TVC groups was 11.4 ± 1.6 and 17 ± 3 weeks, respectively (p < 0.05). The cervical length prior to surgery was similar among the two groups. After cerclage placement, the distance between the tape and the external cervical os differed significantly between the two groups (LAC: 31.5 ± 8.8 mm vs TVC: 13.5 ± 4.9 mm; p < 0.0001) (Fig. 1). During pregnancy, the cervical length in the TVC group showed a significant shortening (from 26.6 ± 7 mm before surgery to 13.2 ± 7 mm at 33 weeks; p < 0.0001), while in the LAC group, the cervical length remained unchanged. CONCLUSIONS: In patients with CI, LAC is associated with a better preservation of the cervical length throughout pregnancy as compared to TVC.

Fundus Thickness Assessment by 3D Transvaginal Ultrasound Allows Metrics-Based Diagnosis and Treatment of Congenital Uterine Anomalies.

Purpose The development of a metric fundus assessment and definition of the uterine fundus thickness (FTH) for supporting objective diagnosis and treatment of congenital uterine anomalies (CUAs). Materials and Methods A) In a prospective cohort study, FTH was systematically assessed by 3 D transvaginal ultrasound (TVS) in patients, who presented a normal uterus. B) The mean normal FTH recorded was applied to uteri with fundal protrusions and septations, and compared to two CUA classification systems (ASF and ESHRE/ESGE). C) FTH was studied for preoperative metric planning and evaluation of the postoperative outcome. Results A) From August 2013 to January 2014, FTH was assessed in 100 normal uteri. An FTH of 12.02 +/- 2.03 mm (mean +/- SD) was recorded. B) Evaluating the 8 detected abnormal uteri, excellent correlation with the new ESHRE/ESGE classification system was observed, taking an FTH of 12 mm as the overall normal FTH equivalent to the individual normal wall thickness (WTH) stipulated in the classification and an FTH of 18 mm as the WTH + 50 %, serving as a cut-off value of (abnormal) septation. C) Metric fundus assessment was initially applied before and after septum resection and the following pregnancy could be monitored. Conclusion An FTH measurement in 3 D TVS paves the way for metric fundus diagnostics. This objectively distinguishes normal from abnormal fundi. It also has the potential to support accurate septum resection planning and objective postoperative evaluation. The value of the fundus assessment and metrics proposed in this study is not known. It should be investigated in prospective randomized controlled trials.

Cervical softening occurs early in pregnancy: characterization of cervical stiffness in 100 healthy women using the aspiration technique.

OBJECTIVE: To quantitatively describe the evolution of ectocervical stiffness in normal pregnancy. METHODS: The stiffness of ectocervical tissue was measured by using the aspiration method. This non-invasive technique allows to safely and objectively determine the pressure required to displace cervical tissue to a predefined deformation level (pcl ). In this prospective study, 448 aspiration measurements were carried out on pregnant women (n = 50) at each of the eight routine pregnancy consultations and on nonpregnant subjects (reference, n = 50). pcl values were grouped as nonpregnant, first, second, third trimester, and postpartum. RESULTS: Stiffness in early pregnancy (first trimester) is significantly lower, by a factor >2 for the mean value than for the nonpregnant group. pcl continuously decreases during gestation, with significant differences between first and second trimester, but not between second and third trimester. After delivery, consistency is recovered to the level of early pregnancy. CONCLUSIONS: The aspiration method allows an objective description of the consistency of the ectocervix during pregnancy, indicating that the tissue softens already at the beginning of gestation, transforms continuously to lower consistency in the first two trimesters, stabilizes at a low level in the third trimester, and recovers its stiffness after delivery.

A novel aspiration technique to assess cervical remodelling in patients with or without cervical shortening: Sequence of first changes, definition of cut-off values and impact of cervical pessary, stratified for cervical length.

BACKGROUND: The therapeutic significance of the cervical pessary has been confirmed by several studies. However, the underlying mechanism by which pessaries reduce the risk of a preterm birth remains elusive. The aim of this study is to investigate the hypothesis whether the application of a cervical pessary may stabilize the ectocervical stiffness in order to achieve a cervical arrest. METHODS: This is a prospective, controlled, non-interventional, post-market, monocentric, longitudinal, cohort study in a tertiary maternity hospital to determine ectocervical stiffness and its changes measured before and after placement of a pessary in singleton pregnancies with cervical shortening in the mid trimester. In order to assess reference values for cervical stiffness, we measured also singleton pregnancies with normal cervical length in the same gestational week spectrum. The cervical stiffness measured with the Pregnolia System as the Cervical Stiffness Index (CSI, in mbar) shall be the primary endpoint, whilst patient delivery data (gestational age, mode of delivery and complications) will be the secondary endpoint. In this pilot study, up to 142 subjects will be enrolled to have a total of 120 subjects (estimated dropout rate of 15%) to complete the study; pessary cohort: 60 (up to 71 recruited), control group: 60 (up to 71 recruited). DISCUSSION: Our hypothesis is that patients with cervical shortening will present with lower CSI values and that pessary placement will be able to stabilize the CSI values through further prevention of cervical remodelling. The measurement of controls with normal cervical length shall serve as a reference.

A novel procedure for the mechanical characterization of the uterine cervix during pregnancy.

An in-vivo measurement procedure is presented to characterize the mechanical behavior of human uterine cervix during pregnancy. Based on the aspiration method, a new instrument was developed to provide an inherently safe and easy-to-use mechanical testing technique. Initial measurements were performed on non-pregnant women to develop an appropriate measurement protocol. An inverse analysis was carried out to determine representative model equations for cervical tissue. This model was used in a FE based parametric study focusing on the uncertainties related to the experiment. On this basis, a novel procedure was established which enabled for the first time to conduct mechanical measurements on 50 pregnant women in over 600 applications during gestation. An inverse analysis of the average tissue response at each trimester was performed to determine representative model equations for the cervix in the course of pregnancy.