Aim of the Type 2 PICD (Cat No 174774)

The type 2 Pre-Induction Cervical Dilator (PICD) is a double balloon catheter functioning as a mechanical device developed in order to facilitate the process of labor induction when the cervix is firm and unripe. Type 2 PICD provides a concomitant treatment option of a mechanical approach with intra-cervical application of PG gel preparations to the opening located between the two balloons corresponding to the cervical canal.

MECHANISM OF ACTION OF TYPE2 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.
• A ripening effect of the PG gel when applied to the cervical canal
   through the corresponding cervical valve marked C.

TYPE2 PICD COMPONENTS

The Type 2 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. Between the two balloons there is an opening (5) corresponding to the cervical canal for optional application of medications such as PG gel designated to reach the cervical canal located between the two inflated balloons. The cervical valve marked C (6) is located between the U and V valves.
Type 2 PICD includes one clamp (8) located at the uterine valve arm, this clamp is used to allow pre-inflation of 20ml of normal saline into the uterine arm. The pre-inflated solution trapped between the clamp (in closed position) and the uterine valve will facilitate the uterine balloon inflation holding the catheter in place with a long forceps, while the other hand is free to release the pre-inflated fluid trapped in the catheter arm (by opening the clamp and pressing that fluid into the uterine balloon).

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).

Applying Intra-cervical PG gel (optional in Type 2 PICD)
PG gel can be applied to the cervical canal following the insertion of the device through the corresponding cervical valve (marked C). One single application of PG gel is recommended. (The calculated space of the catheter lumen from the injection site to the cervical opening is 2 ml.)

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.
Warning: The device should not remain in place longer than 12 hours after insertion.

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.

Advantages

Type2 PICD offers the following advantages:
• Ripens and dilates the cervix by a mechanical device for better, more
  comfortable results.
• Type2 PICD provides a concomitant treatment option with its optional
   intra-cervical application of PG gel preparations in an opening located
   between the two balloons (the uterine and the vaginal) and
   corresponding to the cervical canal.
• 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.
Types 2 PICD have been approved by the CE and by the TGA (Australia)