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Cerclage Pessary Perforated

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£35.00
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L.C-ASQ
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Product Description

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 pessary placement.

 

Inserting a Cerclage Pessary

The 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

Aditional Information

 

Application: The cerclage pessary is made of flexible comfortable, tissue tolerant silicone. Like all silicone 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. The 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 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 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 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 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.

 

News artcles and medical studies

Cervical pessary in pregnant women with a short cervix (PECEP): an open-label randomised controlled trial

Summary

Background

Most previous studies of the use of cervical pessaries were either retrospective or case controlled and their results showed that this intervention might be a preventive strategy for women at risk of preterm birth; no randomised controlled trials have been undertaken. We therefore undertook a randomised, controlled trial to investigate whether the insertion of a cervical pessary in women with a short cervix identified by use of routine transvaginal scanning at 20—23 weeks of gestation reduces the rate of early preterm delivery.

Methods

The Pesario Cervical para Evitar Prematuridad (PECEP) trial was undertaken in five hospitals in Spain. Pregnant women (aged 18—43 years) with a cervical length of 25 mm or less were randomly assigned according to a computer-generated allocation sequence by use of central telephone in a 1:1 ratio to the cervical pessary or expectant management (without a cervical pessary) group. Because of the nature of the intervention, this study was not masked. The primary outcome was spontaneous delivery before 34 weeks of gestation. Analysis was by intention to treat. This study is registered with ClinicalTrials.gov, number NCT00706264.

Findings

385 pregnant women with a short cervix were assigned to the pessary (n=192) and expectant management groups (n=193), and 190 were analysed in each group. Spontaneous delivery before 34 weeks of gestation was significantly less frequent in the pessary group than in the expectant management group (12 [6%] vs 51 [27%], odds ratio 0·18, 95% CI 0·08—0·37; p<0·0001). No serious adverse effects associated with the use of a cervical pessary were reported.

Interpretation

Cervical pessary use could prevent preterm birth in a population of appropriately selected at-risk women previously screened for cervical length assessment at the midtrimester scan.

Funding

Instituto Carlos III.
Original infomation here: LINK

 

Read in Spanish? LINK

Read in French? - LINK


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Product Reviews

  1. Excellent product and service

    Posted by Rachel Humphrey on 23rd May 2014

    We have now ordered 20 of these, over four orders, for use by my OB patients. They have been consistently high quality and they are shipped very promptly. Great!


  2. Short Cervix with Twins

    Posted by Rey on 21st Apr 2014

    I am pregnant with twins and at 25 weeks, I was placed on bed rest because of a short cervix that measured 1.5cm. By 27 weeks, it had shortened to 0.6cm. Per my doctor's suggestion, I ordered the perforated cerclage pessary. Immediately after the pessary was placed, I felt less pressure from the weight of the babies. After one week, my cervix measured at 1.1cm and continues to lengthen. I am now 29 weeks along and am hopeful that I might make it to 34 weeks at the very least. I am very thankful for this product. This vendor has been great and the ordering/payment process was easy. I placed my order on a Saturday and received a confirmation of shipping the following Monday. Delivery was also very prompt considering I live in the US and this product shipped from England. I received the pessary in about one week. I would definitely recommend this product and vendor.


  3. simple to use

    Posted by pambam on 5th Apr 2011

    My cerclage was extremely simple to use even with my bump :)


  4. Great Service!

    Posted by emmaonthehill on 31st Mar 2011

    I accidentally ordered the wrong pessary for my Mum and MyPessary.com were quick to arrange a return and replacement order for which I am very grateful. Thank you and keep up the good work.



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