In vivo assessment of the elastic properties of women’s pelvic floor during pregnancy using shear wave elastography: design and protocol of the ELASTOPELV study

BACKGROUND: Animal studies have reported an increase in pelvic floor muscle stiffness during pregnancy, which might be a protective process against perineal trauma at delivery. Our main objective is to describe the changes in the elastic properties of the pelvic floor muscles (levator ani, external anal sphincter) during human pregnancy using shear wave elastography (SWE) technology. Secondary objectives are as follows: i) to look for specific changes of the pelvic floor muscles compared to peripheral muscles; ii) to determine whether an association between the elastic properties of the levator ani and perineal clinical and B-mode ultrasound measures exists; and iii) to provide explorative data about an association between pelvic floor muscle characteristics and the risk of perineal tears. METHODS: Our prospective monocentric study will involve three visits (14–18, 24–28, and 34–38 weeks of pregnancy) and include nulliparous women older than 18 years, with a normal pregnancy and a body mass index (BMI) lower than 35 kg.m(− 2). Each visit will consist of a clinical pelvic floor assessment (using the Pelvic Organ Prolapse Quantification system), an ultrasound perineal measure of the anteroposterior hiatal diameter and SWE assessment of the levator ani and the external anal sphincter muscles (at rest, during the Valsalva maneuver and during pelvic floor contraction), and SWE assessment of both the biceps brachii and the gastrocnemius medialis (at rest, extension and contraction). We will collect data about the mode of delivery and the occurrence of perineal tears. We will investigate changes in continuous variables collected using the Friedman test. We will look for an association between the elastic properties of the levator ani muscle and clinical / ultrasound measures using a Spearman test at each trimester. We will investigate the association between the elastic properties of the pelvic floor muscles and perineal tear occurrence using a multivariate analysis with logistic regression. DISCUSSION: This study will provide original in vivo human data about the biomechanical changes of pregnant women’s pelvic floor. The results may lead to an individualized risk assessment of perineal trauma at childbirth. TRIAL REGISTRATION: This study was registered on https://clinicaltrials.gov on July 26, 2018 (NCT03602196).