Safe Delivery Using a Belt on the Belly of Pregnant Woman
Condition: Other Obstetric Trauma - Delivered
Intervention: Baby-guardTM
Intervention description: 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
Phase: Phase 2
Study type: Interventional
Primary purpose: Health Services Research
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 80.0
Sex: Female
Minimum age: 23 Years
Maximum age: 42 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Safe Delivery; reduction of pain; reduction stage of labor

Summary:

      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 may 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.

      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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  women in active labor at term in primipara with maternal age ranging from 23 to 42
             years, with a singleton fetus in vertex presentation.

          -  the onset of second stage was defined as full dilatation of the cervix identified by
             digital examination

        Exclusion Criteria:

          -  preterm labor (gestational age below 37 weeks)

          -  breech or transverse presentation

          -  suspected fetal macrosomia

          -  gestational diabetes

          -  pregnancy-induced hypertension

          -  abnormalities of placentation (low lying placenta, abruptio placenta)

          -  uterine structural abnormalities

          -  history of previous uterine scar

          -  fetal heart rate abnormalities at the time of enrollment (bradycardia, tachycardia or
             prolonged variable decelerations).