Cerclage Pessary Non-Perforated

£45.00 exc. VAT

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Lower larger diameter/height/diameter of the upper hole

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SKU: L.C-CA Category: Pessaries

Description
Additional information

Description

DESCRIPTION

Cerclage Pessary Insertion

Using transvaginal sonography in the 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 (funnelling) help identify patients who might benefit from Cerclage Pessary placement.

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.

The Cerclage 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, a Cerclage Pessary or Cerclage Ring should have a height between 17mm and 25mm in singleton pregnancies and a height between 25mm and 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.

A Cerclage Pessary is 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

Additional Information

Application: The Cerclage Pessary Non Perforated is made of flexible comfortable, tissue tolerant silicone.

Like all silicone pessaries, it is elastic and can thus be folded and inserted without pain or discomfort. The Cerclage Pessary Non Perforated is designed for the treatment of pregnant women. It is to support the cervix especially for 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 the funnelling of the internal os and detect the cervical length. The Cerclage Pessary Non Perforated 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 control 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 the patient and the team physician to continue with the treatment. The insertion of the Cerclage Pessary can be facilitated by applying lubrication, 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 to identify the cervical shape and length, the position of the pessary can easily be controlled manually during routine controls.

Side Effects/Complications: Correctly positioning the pessary (with the curvature and the smaller diameter upwards) is the key to the success of the treatment, otherwise the supporting effect is compromised somewhat. There might be some increase of bacterial 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 articles 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 the 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 a 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. The 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 Cerclage 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

A Cerclage 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.