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Phase 2 N=80 Randomized Single-blind Health Services Research

Safe Delivery Using a Belt on the Belly of Pregnant Woman

Other Obstetric Trauma - Delivered

Enrolled (actual)
80
Serious AEs
0.0%
Results posted
Dec 2016
Primary outcome: Primary: Partecipant With Perineal Laceration — 3; 31 participants

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
Baby-guardTM (Device)
Age
Adult · 23+ yrs
Sex
Female
Sponsor
University of Padova
Primary completion
Mar 2011

Outcome Measures

OutcomeResultp-value
PRIMARY
Partecipant With Perineal Laceration
3; 31

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).
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01566331). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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