Shoulder Dystocia is a condition where during the delivery of a baby,
after the head of the baby has delivered, the baby’s shoulder gets stuck
behind the mother’s pubic bone and fails to deliver. This condition
occurs in 1%-3% of all vaginal deliveries. As the baby’s body is held in
the birth canal the umbilical cord is compressed and the blood flow and
oxygen supply to the baby are blocked.
If delivery of the baby does not occur within 7 minutes after the
delivery of the head then irreversible neurological brain damage will
develop and then death will occur.
In the frantic effort to release the fetal shoulder and deliver the
baby, frequently the baby sustains nerve injury or bone injury. Indeed,
Shoulder Dystocia is the number one cause of peripheral nerve and bone
injury during delivery. The hallmark injury of Shoulder Dystocia
involves the nerve complex between the baby's spine and his arm:
Brachial Plexus Injury. Every year 20,000-50,000 babies are left with
Permanent Brachial Plexus Injury, a lifelong handicap, without
mentioning those newborns that sustain permanent brain injury as a
result of failure to deliver them on time. In addition, injury to the
mother can also occur as a result of Shoulder Dystocia.
Today, in order to reduce birth injuries related to Shoulder Dystocia,
physicians are attempting to anticipate it before it occurs and offer
the mother delivery by cesarean section. When anticipation fails and
Shoulder Dystocia occurs manual maneuvers are used to deliver the baby.
In spite of the attempts to predict Shoulder Dystocia and the use of the
manual maneuvers, the incidence of Shoulder Dystocia and its related
injuries keeps rising.
Several decades ago there were two attempts to use rigid instruments in
order to deliver the baby during Shoulder Dystocia. Both failed to
deliver the baby safely without causing injuries to the mother or the
baby.
Our device, the shoulder tent, is a new medical device unlike ones used
up until now. Developed with few and relatively inexpensive components,
our device can be used worldwide to save lives.
For more information about Shoulder Dystocia and its management and the associated injuries, go to our website www.theshouldertent.com
THE SOLUTION
The Shoulder Tent is a simple device that was developed in order to
allow the safe delivery of the fetal shoulder when Shoulder Dystocia
occurs. Its structure is based on the relationship between the baby's
body and the birth canal of the mother.
The Shoulder Tent separates the role of force application from the role of engaging the fetal shoulder:
- Force application is achieved by two metal arms that slide safely and
easily on both sides of the fetal torso where there is ample space to
accommodate them
- Engagement of the fetal shoulder is achieved by an elastic element that
is brought effortlessly through the "S" shaped passage between the fetal
shoulder and the maternal pubic bone.
Initial tests that Dr. Yaari conducted by using the device on a pelvic
model with force measuring capabilities showed that device reduces both
the peak force applied to the shoulder and the time to delivery when
compared to the obstetric manual maneuvers.
The device and the concept behind it are simple and therefore can be
used worldwide, especially in developing countries where access to
trained medical personnel is limited. However, because it is a new
medical device tests need to be conducted to finalize its optimal design
and to find the most suitable materials. In addition, extensive
clinical trials in hospitals to check for the safety and efficacy of the
device will be required.
With your help we can turn this new concept into a reality.
HOW CAN YOU HELP US?
We are seeking $1.2 million for the development and testing of the device.
Why would such a simple device require such an investment in its development?
The
answer is that the major portion of the funds will go towards the the
clinical studies proving the Shoulder Tent's safety and efficacy.
Actually, when compared to the expenses related to development and
testing of other devices or medications, this sum is very modest.
Let us explain the planned steps for the development and testing of the device and the time frame:
WHAT IF...?
If all
three stages are completed successfully then we will use any surplus
funds to create training kits and workshops for hospitals in developing
countries and supply them with Shoulder Tent devices for their use.
If
we fail to collect enough funds to complete the testing of the device,
then we will seek research grants through other sources. This may
prolong the process.of bringing the Shoulder Tent to clinical use.
What if the Shoulder Tent is not found to be safe and effective?
In
such a case any extra funds left after the studies are done will be
donated for treatment and rehabilitation of children with Brachial
Plexus Injury.
Other Ways You Can Help
You can also help by liking and sharing us on facebook and helping us spread the word. Although Shoulder Dystocia occurs in about one percent of births, most people are still unaware of this condition. By sharing with your friends we can raise awareness and cut down instances where it occurs drastically.