ventouse delivery; vacuum extractor; vacuum extraction; vacuum-assisted delivery

New Operative Delivery Device May Be a Safe Alternative

Operative devices such as forceps have been used to assist in vaginal delivery for centuries.  Forceps are a type of delivery instrument that resemble a pair of tongs and can be used to help pull the baby out of the birth canal.  A vacuum extractor is another type of  delivery device, and it uses a small, soft cup that is applied to the top and back of the baby’s head.  Suction from the vacuum assists in pulling the baby’s head out of the pelvis.  In the hands of well-trained physicians who follow medical standards of care, these devices usually are safe and effective.  However, when standards of care are not followed or the physician is unskilled, very serious injuries to the baby can result.

Forceps’ injuries can range from mild swelling and bruising, and more severe problems include the following:

ventouse delivery; vacuum extractor; vacuum extraction; vacuum-assisted deliveryVacuum extractor injuries can cause mild lacerations and bruising, or even more devastating injuries, such as severe brain damage and death of the baby.  Injuries commonly associated with vacuum extraction include the following:

  • Blood clots
  • Cephalohematoma
  • Seizures
  • Hemorrhages and bleeding in the brain
  • Nerve damage

Operative device complications can result in permanent injuries, such as cerebral palsy and hypoxic ischemic encephalopathy (HIE).

A NEW, POTENTIALLY SAFER DELIVERY DEVICE

A new operative device, called the Odon device, is being tested in multicountry research trials.  If approved, this device will be the first simple new tool for assisted delivery since forceps and vacuum extractors were first introduced.  Early research suggests that this device may be safer than forceps and vacuum extractors, especially for assisted delivery in low resource areas.

Physicians sometimes use operative devices when there is a prolonged second stage of labor.  Indeed, complications due to a prolonged second stage include potentially fatal newborn complications, such as hypoxia / asphyxia (severe oxygen deprivation) and trauma.  Potentially fatal maternal complications include hemorrhage and infection.

The Odon device was developed by the World Health Organization (WHO), and is a low cost instrument used to help deliver the baby when complications occur during the second stage of labor.  The device is made of a film-like polyethylene material and may be safer and easier to apply than forceps and vacuum extractors.  In addition, it may be a safe alternative to C-sections in settings that have limited skilled practitioners and restricted surgical capacity.  By reducing contacts between the baby’s head and the birth canal, the Odon device can help prevent infections during delivery.

Use of the Odon device is very simple.  Listed below are steps for its use:

  • The inserter is applied on the head of the baby.  A soft plastic bell assures perfect adaptation to the fetal head and prevents damage.
  • The inserter progressively positions the Odon device around the head of the baby.  Positioning occurs as the inserter gently produces sliding of the two surfaces of the folded sleeve along the birth canal and around the baby’s head.
  • When positioned properly, a marker on the Odon insertion handle becomes cleary visible on the reading window.  A minimal and self-limited amount of air is pumped into an air chamber in the inner surface.
  • Step # 3 produces a secure grasp around the head of the baby that fixes the inner surface and allows for traction.  The inserter is removed.
  • The baby’s head is delivered, taking advantage of the sliding effect of the two surfaces of the folded sleeve.  Lubrication of the surfaces further facilitates the extraction process.  If necessary, traction can be applied up to 19 kg, which is equivalent to the force applied with the metal vacuum extractor.

The Odon device is an exciting potential alternative to forceps and vacuum extractors.  The device was presented at the following international conferences:

  • Birth World Congress: Clinical Challenges in Labor and Delivery (Chicago, USA 9-11 September 2011)
  • XX World Congress of Perinatal Medicine (Punta del Este, Uruguay 8-11 November, 2011)
  • 10th World Congress of Maternal and Neonatal Health (Rome, Italy 18-20 December 2011)

Feedback from global opinion leaders participating in the conferences was optimistic about the potential of the Odon device for clinical care in the all settings around the world.  The device won the first prize at the competition for technological innovation at INNOVAR 2011, and was also a winner in the “Saving Lives at Birth: a Grand Challenge for Development” global competition.

ALTERNATIVES TO VACUUM EXTRACTOR AND FORCEPS DELIVERY

Given the potential for severe injury when forceps and vacuum extractors are used, it is important for physicians to be knowledgeable about operative delivery alternatives.

Alternatives to instrument delivery include the following:

  • C-section.  A C-section is performed when a vaginal delivery would put the baby’s or mother’s life or health at risk.  Some conditions that require the baby to be delivered immediately include fetal distress, uterine rupture and cord prolapse.  Sometimes physicians fail to perform an emergency C-section when one is indicated, or they wait too long to perform one.  Other times, the C-section may be ordered, but the physician lacks skill in the procedure, or the hospital is ill-equipped for it.  Delay in performing a C-section can lead to permanent injuries in the baby, such as cerebral palsy and HIE.  Indeed, in many cases, a C-section is the safest way to deliver the baby.  Thus it is critical that physicians be skilled and prepared for the procedure.
  • Expectant management.  This involves non-intervention by the physician and allowing the pregnancy to progress.  When expectant management is utilized, very close monitoring of the mother and baby is essential.  Expectant management can include delayed pushing, maternal rest, change in maternal position, reduction in anesthesia, and emotional support.
  • Use of Pitocin (oxytocin).  This is a labor induction drug that is used to induce or speed up labor.  In some instances, Pitocin is effective, and the baby is born without complications.  In other cases, this drug can be very dangerous.  There is no way to predict the effects the drug will have on the mother and baby; its effects vary from person to person.  Pitocin can cause a condition called hyperstimulation of the uterus, which means that the mother’s contractions are very strong and frequent.  When hyperstimulation occurs, the uterus is in an almost constant state of contraction.  Contractions push or impinge on the blood vessels that deliver oxygen-rich blood to the baby through the umbilical cord.  When contractions are almost constant, the vessels cannot recharge with a fresh supply of oxygen-rich blood for the baby.  This can cause severe oxygen deprivation and fetal distress.  Pitocin can be helpful during delivery, but due to its risky nature, it must only be used in very select circumstances, and the mother and baby must be closely monitored.

DELIVERY DEVICES AND A SAFE BIRTH

In certain situations and when properly used, delivery devices can be helpful during birth.  Due to the risks involved with delivery devices, it is imperative that physicians be very skilled in using these devices, and understand which device is the most appropriate for each situation.  Physicians must be aware and skilled in alternatives to device-assisted delivery, and standards of care must be followed at all times.  Failure to act skillfully and in a timely manner during delivery is negligence.  It also is negligent when physicians or medical personnel fail to follow standards of care.  If negligence leads to injury of the mother or baby, it is medical malpractice.

If your baby suffered any birth complications and has been diagnosed with injuries such as HIE and cerebral palsy, please contact the nationally recognized birth injury attorneys at Reiter & Walsh ABC Law Centers.  For decades, we have been helping families in Michigan and throughout the nation whose children have birth injuries.  We have numerous multi-million dollar verdicts that attest to our success, and we will fight to obtain the compensation you and your family deserve.  We will evaluate your case to determine if your child suffered injuries due to the negligence of the physician or medical staff, and you never pay any money until we win your case.  Call us at 888-419-2229.

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