Critical Question Facing Clinicians and Parents During Labor Answered
SAN FRANCISCO, May 18 /PRNewswire/ -- Almost a third of all childbirths in
the United States are marked by a period of uncertainty for obstetricians,
nurses, midwives and parents over the safety of the baby due to an abnormal
heart rate pattern. But a new medical technology introduced today that uses
light to measure the amount of oxygen in the baby's blood provides a more
complete and accurate assessment of the baby's condition in the womb than has
ever before existed.
Fetal oxygen monitoring technology, developed by Mallinckrodt, provides
clinicians for the first time with a reliable, direct measure of fetal oxygen
status. As in adults, oxygen deficiency in an unborn child can lead to brain
damage, neurological disorders or even death.
For more than 30 years, obstetrical teams have relied on fetal heart rate
(FHR) to determine how well a baby is tolerating labor. In about 30 percent of
all labors (1.17 million), the fetal heart rate pattern becomes abnormal, or
"non-reassuring," at some point in time. In these instances, the obstetrical
staff is faced with a dilemma. The non-reassuring heart rate could be the
result of a dangerous lack of oxygen to the baby or a more innocuous
situation, such as the baby falling asleep. However, the fetal heart rate
monitor often fails to distinguish between the two.
Without a direct way to determine the oxygen saturation of the baby, and
with low tolerance for prolonging a situation in which the health and safety
of the baby could be compromised, often the only choice is to intervene on
behalf of the child. Interventions range from providing the mother with extra
oxygen or audibly and physically stimulating the baby, to more invasive
procedures, such as taking a fetal blood sample, attaching an electrode to the
fetal scalp or delivering the baby with the use of forceps, a vacuum extractor
or by cesarean delivery.
Clinical studies have demonstrated that fetal oxygen monitoring, used in
conjunction with fetal heart rate monitoring, provides additional information
about the baby's status that enables the obstetrician, midwife and parents to
decide whether labor can progress safely through these non-reassuring patterns
or if an intervention is needed.
"Fetal oxygen monitoring allows me to measure the fundamental issue that
I'm concerned about - the fetal oxygen status," explains Dr. Richard Porreco,
director of Maternal Fetal Medicine at Presbyterian/St. Luke's Medical Center
in Denver, and a participant in the U.S. clinical trial of fetal oxygen
monitoring technology. "Our current fetal heart monitoring technology, which
has been around for 30 years, provides exceptional sensitivity but little
specificity. It can identify tiny changes in the fetal heart rate, but cannot
specify the underlying cause of those changes. Fetal oxygen monitoring, in
conjunction with fetal heart rate monitoring, provides a more complete picture
and will have a dramatic impact on the practice of obstetrics."
How Fetal Oxygen Monitoring Works
Mallinckrodt Inc., a leading provider of oxygen saturation monitoring
devices, introduced OxiFirst(TM) fetal oxygen monitoring technology in the
United States after more than a decade of research and development. The
technology is based on the same principle as pulse oximetry, which is the
standard of care in operating rooms, emergency departments and intensive care
units around the world.
In a conventional pulse oximeter, red and infrared light shines into the
skin via a sensor attached to a finger, toe, earlobe or forehead. A
photosensor collects the light that is not absorbed by hemoglobin in the
blood. The detected light is analyzed to determine the amount of oxygen
present in the blood. This fraction is displayed on a monitor screen as a
percentage.
The OxiFirst fetal oxygen monitor utilizes a single-use, disposable sensor
that is inserted through the birth canal once the membranes have ruptured and
the cervix is dilated past two centimeters. The sensor rests against the fetal
cheek, forehead or temple and is held in place by the uterus. As with
conventional pulse oximetry, harmless red and infrared light shines into the
baby's skin and the reflected light is captured and analyzed. The oxygen
saturation is displayed on a monitor screen as a percentage. The normal oxygen
saturation for a baby in the womb, receiving oxygenated blood from the
placenta, is usually between 30 and 70 percent.
The Impact of Fetal Oxygen Monitoring
In a randomized, controlled clinical trial of more than 1,000 births
conducted at nine sites throughout the United States, fetal oxygen monitoring
proved to be safe and effective for measuring the oxygenation of a fetus
during periods of non-reassuring fetal heart rate patterns. Use of the
OxiFirst System as an adjunct to traditional FHR monitoring did not result in
a reduction in the overall rate of deliveries by cesarean-section. Cesarean
deliveries for non-reassuring fetal status (NRFS) were reduced in the test
group (FHR + OxiFirst) by 50 percent. For reasons not explained by the study
data, cesarean deliveries for dystocia were increased in the test group to
offset the reduction in cesarean deliveries for NRFS.
"We all try to remember for our patients that the birthing process is a
very natural thing. Our goal is to let nature take its course when you have a
healthy mom and a healthy baby," said Dr. Thomas Garite, director of
Obstetrics and Gynecology at the University of California, Irvine, and the
lead investigator in the U.S. clinical trial of fetal oxygen monitoring. "In
the clinical trial we demonstrated that the addition of fetal oxygen
monitoring enables the clinician to allow labor to progress when it is safe to
do so. We have gained an important level of security and confidence that we
are making clinical decisions based on the right information."
Mallinckrodt's OxiFirst fetal oxygen monitoring technology has been
available in Europe since 1996 and Canada since 1998. More than 35,000 births
have been monitored with OxiFirst. The technology is available as either the
standalone N-400 fetal oxygen monitor sold by Mallinckrodt, or as an
integrated feature in electronic fetal monitors sold by Agilent Technologies
(formerly Hewlett-Packard) and GE Medical Systems (Corometrics) - the world's
two largest providers of maternal/fetal monitors. Both standalone and
integrated systems require the FS-14 single-use fetal oxygen sensor. The N-400
is approved for sale in the United States. Agilent and Corometrics integrated
solutions are currently the subjects of pending U.S. FDA Pre Market Approval
applications (PMA).
The N-400 monitor can be interfaced with certain Agilent, Corometrics,
Oxford Medical and other fetal monitors. The fetal oxygen saturation is
automatically recorded on the monitor strip along with uterine activity and
fetal heart rate.
Mallinckrodt Healthy Mother and Baby Division
The introduction of fetal oxygen monitoring in the United States also
marks the creation of a new strategic business unit - Mallinckrodt's Healthy
Mother and Baby Division. This new division was created to meet the unique
needs of mothers and their children during the 21 months from conception to
baby's first birthday. The Healthy Mother and Baby Division will bring
advanced technologies, like fetal oxygen monitoring to market and will provide
education and information to parents and clinicians around the world via the
Healthy Mother and Baby website: http://www.healthymotherandbaby.com.
About Mallinckrodt
Mallinckrodt Inc. is a global manufacturer and marketer of specialty
medical products designed to sustain breathing, diagnose disease and relieve
pain. Named one of America's most admired medical products and equipment
companies by Fortune magazine, Mallinckrodt does business in more than 100
countries. In fiscal 1999, combined net sales were $2.6 billion for
Mallinckrodt's respiratory, imaging and pharmaceutical product lines. Based in
St. Louis, Missouri, Mallinckrodt's web site address is: http://www.mallinckrodt.com.
Note: OxiFirst photography available at http://www.newstream.com
SOURCE Mallinckrodt Inc.
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Related links:
http://www.mallinckrodt.com
CONTACT:
Tony Labriola, tlabriola@mullen.com or Kara
Nadeau, knadeau@mullen.com of Mullen PR, 978-468-1155 or Barbara
Abbett of Mallinckrodt Inc., 314-654-5230, barbara.abbett@mkg.com
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