Arabin Cervical Pessary- Preterm Birth Prevention ARABIN Cerclage Pessary Perforated

The Arabin pessary is a silicone ring-shaped device that is inserted around the cervix to prevent preterm birth. It's designed to support the cervix, keep it closed, and incline it towards the sacrum. The Arabin pessary is considered a non-invasive alternative to surgical cerclage, which can have complications
Description

The cerclage pessary consists of high-quality silicone. It can be stored at temperatures from 0 to 50 °C protected from UV radiation without contact to reactive media, gas, ozone or mineral oil.

Since the introduction of the device the material and the consistency of the product have been improved. Since 202, objective compression values were adapted according to the to the indication (Model 3).

Application/Intended Purpose

The Cerclage pessary can stay in the virgina more than 30 days (Class IIb). The pessary consists of flexible comfortable silicone. Like all silicone pessaries it is elastic, can be folded and thus be inserted without side effects (pain). The cervical pessary is designed to support the lower uterine segment and the shape of the cervix. The risk of threatining preterm birth is nowadays detected by transviginal sonogrophy. A Cerclage pessary is only indicated in patients with (early or late) changes such as cervical shortening and/or an inner opening of the internal os (funneling). In cases with increased risk by either history (prevoius preterm birth, cervical operations such as cone biopsy) or multiple pregnancy an early transviginal sonography is indicated and should be repeated. If the transvaginal sonogrophy is performed as part of a screening procedure the same cervical changes such as cervical shortening and funneling can occur. The cerclage pessary is indicated for both risk and screening patients.

The treatment can be initiated from 12 gestational weeks onwards (in rare cases with pre-existing short cervix). The pessary is not intended to “close” the cervix but to rotate it towards the sacrum. Hereby, the uterocervical angle between the lower uterine segment and the cervix becomes significantly more acute as compared to the values before placement. In some patients, even funneling and cervival length may restore. In mild forms of genital prolapse (mainly in multiple pregnancy or multi-parous women) the subjective symptoms of pressure may become less after placement.
An increased vaginal discharge is a common side effect, whereby the perforations inside the pessary allow a better drainage. Nevertheless, vaginal discharge should not be confused with a so called “infection” and should not be routinely treated with antibiotics. It could be demonstrated that increased discharge is not associated with a change of the vaginal microbiome. Before insertion, bacterial swabs can be performed to exclude bacterial colonization (no absolute indication). In patients with U-shaped funnelling a wider upper diameter (35 mm) might prevent unnecessary prostaglandin release.

Note

The product is for single use only and must not be used in other patients.