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

This study has been completed.
Sponsor:
Collaborator:
University of Florence
Information provided by (Responsible Party):
Erich Cosmi MD, PhD, University of Padua
ClinicalTrials.gov Identifier:
NCT01566331
First received: March 19, 2012
Last updated: March 26, 2012
Last verified: March 2012
  Purpose

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.


Condition Intervention Phase
Safe Delivery
Device: Baby-guardTM
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Supportive Care
Official Title: Safe Natural Delivery by Using a New Inflatable Ergonomic Three Chambers Belt

Further study details as provided by University of Padua:

Primary Outcome Measures:
  • Composite maternal and fetal outcome in pregnant women delivering with Baby Guard Belt device [ Time Frame: 15 days after delivery ] [ Designated as safety issue: Yes ]
    Maternal reduction of pain, reduction of perineal laceration and fetal morbidity and mortality.


Secondary Outcome Measures:
  • Maternal morbidity [ Time Frame: 15 days ] [ Designated as safety issue: Yes ]
    Perineal and cervical lacerations incidence, ; psychological and physical maternal fatigue, maternal request of cesarean section during labor,

  • reduction of second stage of labor and delivery and cesarean section rate [ Time Frame: 15 days ] [ Designated as safety issue: Yes ]
    reduction of second stage of labor and cesarean section rate.


Enrollment: 80
Study Start Date: January 2011
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Baby-guardTM
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
Device: Baby-guardTM
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
Other Name: Safety baby guard
No Intervention: no intervention
natural delivery

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   23 Years to 42 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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).
  Contacts and Locations
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No Contacts or Locations Provided
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Erich Cosmi MD, PhD, Director of Maternal and Fetal Medicine, Department of Woman and Child Health, University of Padua
ClinicalTrials.gov Identifier: NCT01566331     History of Changes
Other Study ID Numbers: unipd
Study First Received: March 19, 2012
Last Updated: March 26, 2012
Health Authority: BS EN ISO 14155-1:2009; UNI EN ISO 14155-2:2009
Italy: Ministry of Health

Keywords provided by University of Padua:
Safe Delivery
reduction of pain
reduction stage of labor

ClinicalTrials.gov processed this record on October 21, 2014