Perforated Cerclage Pessaries
This Cerclage pessary is used to treat pregnant women with cervical incompetence in order to support the cervix and turn it towards the sacrum.
It may be indicated in pregnancies with a history of premature labour, multiple pregnancies or mothers who are exposed to physical strain (e.g. standing for a long time). It may also be indicated in pregnant women suffering from prolapse of the genital organs.
Using transvaginal sonography in recumbent or upright position we have established normal values for the cervical length and an opening of the cervical os (funnelling) for singleton and twin pregnancies. Low values of the cervical length and high values of the opening of the cervical os (Funneling) help identify patients who might benefit from cerclage pessary placement.
IMPORTANT - MUST READ
The Cerlclage pessary is NOT FDA listed in the United States of America, this product can only be used for research purposes and clinical trials, Digitimer will take no responsibility for misuse of this product.
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Inserting a Cerclage Pessary
This cervix pessary can easily be folded and inserted without pain. Before the application, it is recommended to exclude and treat if necessary cervical or vaginal infection. In general, cerclage pessaries should have a height of 17-25mm in singleton and a height of 25-30mm in twin or multiple pregnancies or pregnant patients with complaints of prolapse.
The width of the upper and lower diameter should be chosen depending on the individual constitution of the pregnant patient.
Sizes and Models - Cerclage Pessary
Perforated Cerclage pessaries are classified according to;
- The lower larger diameter - 65mm or 70mm
- The height - 17mm, 21mm, 25mm or 30mm
- The diameter of the upper hole - 32mm or 35mm
Application: The cerclage pessary is made of flexible comfortable, tissue tolerant silicone. Like all silicone cervix pessaries it is elastic, and can thus be folded and inserted without pain. The cerclage pessary is designed for the treatment of pregnant women. It is to support the cervix especially by patients with additional complaints of prolapse (,,painful pressure downwards, mostly during standing and walking"), pregnant women who are exposed to physical strain (e.g. standing for a long time) or increased intrauterine pressure, or when an ultrasound shows signs of an incompetent cervix. Before insertion bacterial swabs should be performed to exclude bacterial colonization. The treatment should start early in pregnancy before the cervix might be effaced (at about 15-20 weeks).Transvaginal ultrasound at regular intervals can help to determine funneling of the internal os and detect the cervical length. This cervix pessary is not meant to close the cervix but rather to support it and to shift the cervix towards the sacrum.
Sizes: Cerclage pessaries differ in their outer diameter (65mm to 70mm) as well as in the height of the curvature (each 17mm, 21mm, 25mm, 30mm). The inner diameter is either 32mm or 35mm. The higher cervix pessary models are preferred under more severe conditions.
Use: The cerclage pessary is inserted in the recumbent position by the obstetrician. It is vital that the curvature of the pessary faces upwards so that the larger diameter is supported by the pelvic floor. The pessary is folded and pushed into the vaginal fornix. While doing this, the cervix should be placed within the upper ring diameter. The obstetrician should
ontrol that the cervix is not surrounded too firmly by the upper ring of the pessary. After the insertion, the patient is asked to stand up and should hereby not feel the cervix pessary when it is correctly placed. Possible prolapse complaints are directly redressed, which can motivate patient and team physician to continue with the treatment. The insertion of the cervix pessary can be facilitated by applying a gliding compound, preferably an antibiotic cream preserving the natural flora. The pessary may stay until delivery, or at least until 37 weeks respectively. In cases of increased discharge it may be changed and cleaned in between, but this is not mandatory if manipulations are to be better avoided. Vaginal sonographic examinations can help identifying the cervical shape and length, the position of the pessary can easily be controlled manually during routine controls.
Side Effects/Complications: The right positioning of the cervix pessary (with the curvature and the smaller diameter upwards) is the key to success of the treatment, otherwise the supporting effect is insufficient. There might be some increase of abacterial discharge, however, the spectrum of the vaginal flora will not be substantially altered.
Advice: The product should be used by one patient only. It can be stored by room temperature. The pessary can be cleaned under warm running water without using disinfectants.
This product is currently registered in Europe, Malaysia, Japan, Thailand, Vietnam, Korea, Brazil, Chile, Columbia, Cuba, Russia and all the former countries of the Russian Empire.
In Canada and the US, the pessaries are only allowed to be used within research studies or when a physician has informed the patient that he is using a product off-label.
News artcles and medical studies
Cervical pessary in pregnant women with a short cervix (PECEP): an open-label randomised controlled trial
Only to be used for research purposes in USA.
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