|
Aim
of the Type 3 PICD (Cat No 174775)
Type3 Pre-Induction Cervical Dilator (PICD)
is a double balloon catheter with extra-amniotic instillation
facilities functioning as a mechanical device and as an instillation
device developed in order to facilitate the process of labor induction
when the cervix is firm and unripe. Type3 PICD has a concomitant
extra-amniotic instillation option. It has multiple openings located
at the end of the catheter's long tip, corresponding to the extra-amniotic
space. Continuous administration of normal saline solution (for
IOL) can be performed through a corresponding valve (marked I).
Continuous extra-amniotic administration of diluted prostaglandin
solutions such as PGE2 or PGF2 alpha are optional concomitant
methods in patients with intra-uterine fetal demise or other indications
necessitating late termination.
Important
Directions for Usage of the AID for late pregnant termination
Late
termination of pregnancy publications
MECHANISM
OF ACTION OF TYPE3 PICD
• Gradual dilatation of the cervix
by the pressure applied by the inflated
balloons, which are located on both openings of the
cervix.
• Release of endogenous prostaglandin from the decidua adjacent
to the
inflated uterine balloon and from the membrane where
the
extra-amniotic saline solution is installed.
• Concomitant uterine contractility function in consequence
of the
continuous extra-amniotic instillation of the PG
diluted solution.
Important
Directions for Usage of the AID for late pregnant termination
Late
termination of pregnancy publications
TYPE3
PICD COMPONENTS
Type 3 PICD consists of a double balloon
catheter with two corresponding valves: the uterine marked U and
the vaginal marked V. One balloon is inflated at the location
of the internal cervical ostium which is the uterine balloon (1).
The second balloon located at the external cervical ostium which
is the vaginal balloon (2). For each balloon a corresponding inflating
and deflating valve is located at the other extremity of the catheter.
The valves are marked U (3) for the uterine balloon and V (4)
for the vaginal balloon. Multiple openings are located at the
end of a long tip of the device corresponding to the extra-amniotic
space for optional instillation of normal saline solution or diluted
PG solutions designated to reach the extra-amniotic space. An
Instillation valve marked I (6) is located between the U and V
valves. Connection of that valve to an infusion bag will provide
continuous instillation of the bag solution to the extra-amniotic
space.
•
Type3 PICD has a concomitant extra-amniotic instillation option.
It has
multiple openings located at the end of the catheter's
long tip,
corresponding to the extra-amniotic space. Continuous
administration of
normal saline solution (for IOL) can be performed
through a
corresponding valve (marked I). Continuous extra-amniotic
administration of diluted prostaglandin solutions
such as PGE2 or PGF2
alpha are optional concomitant methods in patients
with intra-uterine
fetal demise or other indications necessitating late
termination.
Important
Directions for Usage of the AID for late pregnant termination
Late
termination of pregnancy publications
INSERTION
TECHNIQUE:
Preparing the device for insertion
Before inserting the device, the clamp located in the uterine
arm is closed off. Twenty (20) ml of physiologic saline solution
are administered into the region between the U-valve and the clamp
(Fig. A).
Inserting
the device and inflating the uterine balloon
With the patient in lithotomic position, insert a large vaginal
speculum into the vagina. . Expose the cervix and prepare it for
insertion of the device.
The device is then inserted into the cervix and advanced until
both balloons have entered the cervical canal up to the demarcation
ring (7). The clamp is then released, and manual pressure on the
pre-inflated uterine valve forces the fluid into the uterine balloon
(1)
(Figure B and C).
Once
the uterine balloon is inflated, the device is pulled out until
the uterine balloon is held in place against the internal cervical
os.
Inflating
the vaginal balloon and removing the speculum
At this stage the vaginal balloon is inflated with twenty
(20) ml of normal saline and the speculum removed. (Fig D).
Additional
inflating of the balloons and fixing the position of the PICD
More fluid is now added to each balloon in turn, in increments
of 20 ml, until each balloon contains 80ml of fluid. At that point,
the end of the device is being taped to the patient's thigh.
(Figure E and F).
Administering
normal saline continuously (optional in Type 3 PICD)
Using an infusion set, connect a 1 liter NS (sterile) bag
to the instillation valve (marked I). The recommended extra-amniotic
infusion rate is 50 ml per hour.
Continuous
Extra-amniotic Instillation of diluted PG solutions
Type3
provides the optional continuous extra-amniotic instillation of
diluted prostaglandin solutions such as PGE2 or PGF2 alpha as
methods of treatment in selected patients such as in pregnancies
with intra-uterine fetal demise or other indications necessitating
late terminations. In those cases the extra-amniotic instillation
is carried on until the process of termination is completed.
Removing
the device
Deflate both balloons through the corresponding valves (marked
U and V). It is recommended to begin the procedure of introducing
the device late in the afternoon or evening, at the patient's
and doctor's convenience. The device is then removed the following
morning. After removing the device, a cervical dilatation of 3
cm or greater can be expected.
FURTHER
LABOR MANAGEMENT
Labor can be induced by artificial rupture
of the membranes and by administration of intravenous oxytocin.
If the membranes rupture spontaneously before removing the device,
deflate the balloons and remove the device since contractions
signaling active labor usually develop.
Spontaneous
expulsion of the device
Spontaneous expulsion might occur if uterine contractions
are regular, active labor has begun, and with cervical dilatation
greater than 5 cm. After spontaneous expulsion of the device it
is recommended to assess the cervical dilatation and the stage
of labor.
Caution:
In cases of labor induction with concomitant continuous normal
saline instillation, it is recommended not to keep the device
in place for more than the following morning after the insertion.
Advantages
Type3 PICD offers
the following advantages:
• Ripens and dilates the cervix by a mechanical device
for better, more
comfortable results.
• Eliminates the side effects of repeat medications.
• Affords excellent results with minimal discomfort.
• Adapts to contour of the cervical canal for easy insertion.
• Suits patients where prolonged uterine contractions are
preferably
avoided (IUGR, postdates) as well as those who have delivered
previously by Caesarean section.
• Gives patients the ability to move and walk around while
the device in
place and is ideal for planned overnight cervical dilation
and next day
delivery.
• Is a cost-effective method with high success rates that
have been
documented by clinical trials.
• Type3 PICD has a concomitant extra-amniotic instillation
option. It has
multiple openings located at the end of the catheter's long tip,
corresponding to the extra-amniotic space. Continuous
administration of
normal saline solution (for IOL) can be performed
through a
corresponding valve (marked I). Continuous extra-amniotic
administration of diluted prostaglandin solutions
such as PGE2 or PGF2
alpha are optional concomitant methods in patients
with intra-uterine
fetal demise or other indications necessitating late
termination.
Types 3 PICD have been approved by the CE and by the TGA (Australia)
|
