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Indication
Prevention of preterm birth
The cerclage pessary is made from high-quality silicone and can be stored at temperatures ranging from 0°C to 50°C, away from UV radiation and without exposure to reactive substances, gases, ozone, or mineral oil.
Since its introduction, both the material and consistency of the product have been enhanced. Starting in 202X, the objective compression values were adjusted to align with the specific indications.
The cerclage pessary can be safely used for up to 30 days (Class IIb). Made from flexible, comfortable silicone, it is elastic, foldable, and can be easily inserted without causing pain or other side effects. The pessary is designed to support the lower uterine segment and the shape of the cervix.
The risk of threatened preterm birth is typically detected through transvaginal sonography. A cerclage pessary is indicated for patients with early or late cervical changes, such as cervical shortening and/or funneling (internal os opening).
In cases with an increased risk—such as a history of preterm birth, cervical procedures like cone biopsy, or multiple pregnancies—early transvaginal sonography is recommended and should be repeated. When used as part of a screening procedure, the cerclage pessary may be indicated for both high-risk patients and those identified with cervical changes, such as shortening and funneling, regardless of the reason for screening.
Treatment can be initiated from 12 weeks of gestation onward, and in rare cases, even earlier for patients with a pre-existing short cervix. The pessary is not designed to “close” the cervix but to rotate it towards the sacrum. This adjustment significantly sharpens the uterocervical angle between the lower uterine segment and the cervix compared to its position before placement. In some patients, this may even lead to the restoration of cervical length and reduction in funneling. In mild cases of genital prolapse, particularly in women with multiple pregnancies or who are multiparous, the pessary may alleviate subjective symptoms of pressure after placement.
Increased vaginal discharge is a common side effect, as the perforations within the pessary promote better drainage. However, this discharge should not be mistaken for an infection and does not require routine antibiotic treatment. Studies have shown that increased discharge is not linked to changes in the vaginal microbiome. Before insertion, bacterial swabs may be performed to rule out bacterial colonization, though this is not an absolute requirement. For patients with U-shaped funneling, a wider upper diameter (35 mm) may help prevent unnecessary prostaglandin release.
The product is for single use only and should not be used by anyone other than the intended patient.
The cervical pessary is inserted in the lithotomy position. It is essential that the smaller diameter of the pessary faces upwards, while the larger diameter is supported by the pelvic floor. The pessary can be folded for insertion into the vaginal fornix, ensuring that the cervix is positioned within the upper circumference. After the initial placement, the patient should be re-examined within a week to verify the pessary’s position and confirm that the cervix is still encircled by the upper circumference. Throughout the treatment, the patient should receive ongoing care from the same healthcare provider, ideally within a specialized “preterm birth clinic.
Before removal, gently push the cervix back to facilitate the pessary’s removal. If the pessary becomes “stuck” due to edema or contractions, it is safer to cut the device (e.g., using episiotomy scissors) rather than applying force, which could risk cervical injury. In cases of bleeding or painful contractions, a speculum examination should be performed.
Under normal circumstances, the pessary should be removed at around 37 weeks in asymptomatic patients. However, in cases of premature rupture of membranes, signs of chorioamnionitis, vaginal bleeding, or painful contractions, the pessary must be removed to prevent cervical injury or the risk of ascending infection.
Transvaginal sonographic examinations are useful for assessing cervical shape and length; however, the pessary may obstruct visualization. To improve imaging, the transducer should be directed towards the anterior or below the posterior lip of the pessary. The position of the pessary can be clinically monitored during routine check-ups.
In patients scheduled for a cesarean section, the pessary should be removed in the operating room after the administration of anesthesia, before making the skin incision.
The cerclage pessary is made from high-quality silicone and can be stored at temperatures ranging from 0°C to 50°C, away from UV radiation and without exposure to reactive substances, gases, ozone, or mineral oil.
Since its introduction, both the material and consistency of the product have been enhanced. Starting in 202X, the objective compression values were adjusted to align with the specific indications.
The cerclage pessary can be safely used for up to 30 days (Class IIb). Made from flexible, comfortable silicone, it is elastic, foldable, and can be easily inserted without causing pain or other side effects. The pessary is designed to support the lower uterine segment and the shape of the cervix.
The risk of threatened preterm birth is typically detected through transvaginal sonography. A cerclage pessary is indicated for patients with early or late cervical changes, such as cervical shortening and/or funneling (internal os opening).
In cases with an increased risk—such as a history of preterm birth, cervical procedures like cone biopsy, or multiple pregnancies—early transvaginal sonography is recommended and should be repeated. When used as part of a screening procedure, the cerclage pessary may be indicated for both high-risk patients and those identified with cervical changes, such as shortening and funneling, regardless of the reason for screening.
Treatment can be initiated from 12 weeks of gestation onward, and in rare cases, even earlier for patients with a pre-existing short cervix. The pessary is not designed to “close” the cervix but to rotate it towards the sacrum. This adjustment significantly sharpens the uterocervical angle between the lower uterine segment and the cervix compared to its position before placement. In some patients, this may even lead to the restoration of cervical length and reduction in funneling. In mild cases of genital prolapse, particularly in women with multiple pregnancies or who are multiparous, the pessary may alleviate subjective symptoms of pressure after placement.
Increased vaginal discharge is a common side effect, as the perforations within the pessary promote better drainage. However, this discharge should not be mistaken for an infection and does not require routine antibiotic treatment. Studies have shown that increased discharge is not linked to changes in the vaginal microbiome. Before insertion, bacterial swabs may be performed to rule out bacterial colonization, though this is not an absolute requirement. For patients with U-shaped funneling, a wider upper diameter (35 mm) may help prevent unnecessary prostaglandin release.
The product is for single use only and should not be used by anyone other than the intended patient.
The cervical pessary is inserted in the lithotomy position. It is essential that the smaller diameter of the pessary faces upwards, while the larger diameter is supported by the pelvic floor. The pessary can be folded for insertion into the vaginal fornix, ensuring that the cervix is positioned within the upper circumference. After the initial placement, the patient should be re-examined within a week to verify the pessary’s position and confirm that the cervix is still encircled by the upper circumference. Throughout the treatment, the patient should receive ongoing care from the same healthcare provider, ideally within a specialized “preterm birth clinic.
Before removal, gently push the cervix back to facilitate the pessary’s removal. If the pessary becomes “stuck” due to edema or contractions, it is safer to cut the device (e.g., using episiotomy scissors) rather than applying force, which could risk cervical injury. In cases of bleeding or painful contractions, a speculum examination should be performed.
Under normal circumstances, the pessary should be removed at around 37 weeks in asymptomatic patients. However, in cases of premature rupture of membranes, signs of chorioamnionitis, vaginal bleeding, or painful contractions, the pessary must be removed to prevent cervical injury or the risk of ascending infection.
Transvaginal sonographic examinations are useful for assessing cervical shape and length; however, the pessary may obstruct visualization. To improve imaging, the transducer should be directed towards the anterior or below the posterior lip of the pessary. The position of the pessary can be clinically monitored during routine check-ups.
In patients scheduled for a cesarean section, the pessary should be removed in the operating room after the administration of anesthesia, before making the skin incision.
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