Safe Delivery Using a New Device Namely a Belt on the Belly of Pregnant Woman (SDB)

Safety of natural, vaginal labor for parturient, fetus and newborn is one of most important goal among obstetricians, midwifes, scientific society all over the world. Maternal and newborn clinical problems and complications following vaginal delivery cause a big amount of medico-legal problems and high costs in the sanitary field.

Among the maneuvers that are used in the second stage of labor, uterine fundal pressure is one of the most controversial and often diffuse in all over the world, generally not documented, or under reported in medical records . Many Authors affirms that a different new way to push could be of help. This maneuver was introduced by Kristeller, that in 1867 minutely described a procedure to shorten, through the application of a pressure on the uterine fundus whose intensity was quantified by a dynamometer and the duration measured in seconds, the length of the second phase of the labor. Although uterine fundal pressure maneuver was described by Kristeller as the placement of two hands on the uterine fundus and the consequential application of longitudinal steady pressure at a 30- to 45-degree angle directed toward the pelvis, with the avoidance of direct pressure toward the maternal spine, there is no clear definition of the maneuver and no indication for its use has been formally described to date. Situations in which fundal pressure may be used include non-reassuring fetal heart rate tracings with a need to expedite delivery, assistance with vacuum or outlet forceps delivery in the case of maternal exhaustion, stabilization of the fetal head for artificial rupture of membranes to prevent cord prolapse, or for easier application of a fetal scalp electrode. However, its use continues to be one of the most controversial maneuvers in obstetrics case, due to the maternal and fetal adverse effects attributed to the use of fundal pressure. Manual fundal pressure cannot be measured: that is the reason why could be very dangerous for parturient and/or fetus. This reason together with a "non standardize" manual pushing cause the absence of documentation of the benefits of its use. Indeed, is demonstrated an increased incidence of third- and fourth-degree lacerations (4), hypotension, abdominal bruising, respiratory distress, uterine rupture, fractured ribs and ruptured liver have been reported in the mother, whilst fetal injuries comprise brachial plexus damage, humerous and clavicular fracture, thoracic spinal cord injuries. Moreover, since uterine fundal pressure causes alteration in fetal cerebral blood flow it has been associated also to cerebral palsy and asphyxia complications, as well as to increase of intra-cranial pressure leading to non-reassuring fetal heart rate pattern, umbilical cord compression, hypoxemia, and sub-galeal hemorrhage. Moreover, by forcing a fetal head through the pelvis that would not have passed in the normal process of labor, uterine fundal pressure may also cause shoulder dystocia mainly when that procedure is associated with vacuum and forceps extraction.

The aim of this study was therefore to assess whether the use of the Baby-guardTM system, through its ergonomic, three chamber, inflatable abdominal belt, engineered after studies of biomechanics and biophysics, that follows obstetric semiotics, that applies fundal pressure during the second stage of labor in the direction of the pelvic outlet, may be of maternal and fetus aid for a safe natural childbirth for their better outcomes.