Devices to Assist Delivery

For assistance in vaginal deliveries

Treatment
Treatment
  • PREVENTION
  • DIAGNOSTIC
  • TREATMENT
  • OVERVIEW
  • TECHNOLOGY Characteristics
  • Devices to Assist Delivery
    Representative Product

     

    Condition
    Forceps or vacuum devices are used to assist delivery when labor is not progressing or when there are signs of  fetal distress. For nulliparous mothers without epidural anesthesia, no progress over two hours can serve as an indication (3 hours with epidural). If operative vaginal delivery fails, Cesarean section is often a backup plan for assisted delivery.

     

    Mechanism of Action
    Forceps and vacuum devices both help to manually extract the infant from the uterus. Forceps consist of two interlocking sides with smooth blades that fit around the fetus’s head. Vacuum devices employ a cup that is placed on the infant’s head. Using either a manual or electric pump to apply suction, the cup adheres to the head, and the attendant can help extract the infant. The higher up n the birth canal lies the babies head, the more difficult is extraction with either instrument and the greater the risk to the baby and mother. The maximum force required to deliver rarely exceeds 22 lbs, and higher forces can present risks. A Cochrane review of forceps vs. vacuum suggests that neither technology is clearly superior. Each has risks, but vacuum is more widely used.

    Current use in High-Resource Settings
    Approximately 4.5% of US vaginal births are “operative vaginal deliveries”, wherein forceps (0.8%) or vacuum devices (3.7%) are used to assist birth. The popularity of vacuum devices may be partially driven by their tendency to cause less trauma and discomfort for the mother, and the relative simplicity of placement. Although there is no conclusive, data-driven consensus on when to abandon vacuum, many clinicians will discontinue use after 2-3 cup detachments, 3 sets of pulls, or total vacuum of more than 15-30 minutes. The most common recourse is cesarean section.

    Application in Low-Resource Settings
    Forceps and/or vacuum-extraction are commonly available in hospital settings. Re-usable devices that can be autoclaved are favored in more remote settings. The experimental “Odon Device” which is a plastic bag that fits over the baby’s head, may offer an alternative, especially where attendants may not have the requisite skill for forceps or vacuum.

    Associated techs in development

    Odon Device

    REPRESENTATIVE DEVICES

    MAKE
    MODEL
    PRICE*
    TECH
    STATUS
    NOTES

    Medline

    Simpson –12”
    $190
    Forceps
    Marketed
    Standard forceps

    Cooper Surgical

    MityVac
    $125
    Vacuum
    Marketed
    Common vacuum

    Cooper Surgical

    Mystic II
    $30-$40
    Vacuum
    Marketed
    Hand pump vacuum

    Clinical Innovations

    Kiwi OmniCup
    $20-$30
    Vacuum
    Marketed
    Disposable, comes with mushroom cup

    * Prices are approximated. Actual pricing can, and will vary by marketplace and market conditions.

  • CHARACTERISTICS OF REPRESENTATIVE PRODUCT

    TECHNOLOGY CHARACTERISTICS

    OPERATIONAL PARAMETERS

    VACUUM DEVICES

    SKILLS

    REQUIRED

    Intended end user
    Training required
    Time required per use
    Physician, nurse, skilled birth attendant
    Hours
    Minutes

    Incorrect use of vacuum devices carries risks from minor lacerations of the scalp to intracranial hemorrhage and neonatal death and severe lacerations of the mother. Similar risks occur with forceps.

    ENVIRONMENT/ INFRASTRUCTURE

    Power required
    Waste collection
    Complementary technologies required
    Temperature and storage
    Maintenance
    None
    N/A
    Autoclave the suction cup and forceps between uses

    COST

    Device Cost (Approx)
    Cost/course (Approx)
    $20-$30

    An exchangeable plastic cup has been devised to make product reusable, but there are sometimes problems retaining vacuum after multiple uses.

    OTHER

    Portability
    Regulatory
    Efficacy
    <500g

    Additional devices required for impact: Partograph, timepiece, autoclave

Sources: Johanson FB, and Menon V. Vacuum extraction versus forceps for assisted vaginal delivery. The Cochrane Collaboration, 2007. Fauveau, V. Is vacuum extraction still known, taught and practiced? A worldwide KAP survey. International Journal of Gynecology & Obstetrics, 94, 2, 185-189, 2006. Martin, JA, Hamilton, BE, Sutton, PD, et al. Births: final data for 2006. Natl Vital Stat Rep 2009. Whitlow B.J., Tamizian O., Ashworth J., Kerry S., Penna L.K., Arulkumaran S. Validation of traction force indicator in ventouse devices. (2005) International Journal of Gynecology and Obstetrics, 90 (1), pp. 35-38