Abstract
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.