Our study
Goya et al. 201213
Saccone et al. 201714
Goya et al. 201617
Dang et al. 201919
Liem et al. 201316 Nicolaides et al. 201615 Nicolaides et al. 201618
Dugoff et al. 201830
Norman et al. 202122
Investigated device Arabin pessary Arabin pessary Arabin pessary Arabin pessary Arabin pessary Arabin pessary Arabin pessary Arabin pessary Bioteque cup pessaries Arabin pessary
Number of subjects with pessary placed (n) 166 190 150 68 148 401 460 588 60 250
Singleton/Twin pregnancies Singletons and twins Singletons Singletons Twins Twins Twins Singletons Twins Singletons Twins
Teaching/ Audit Details Yes The treatment was performed by three clinicians who had received extensive training before
Not specified
Yes The physicians had received practical training in the placement of the device. Pessary insertion training consisted of a didactic session and a hands-on session. Yes The central team in turn instructed the other centers in the use of the pessary Yes Well-trained staff involved in pessary treatment No No specific training was provided Yes The research-team members who inserted the pessaries had received practical training in the placement of the device. No Many research team doctors were involved in the insertion of the pessary and they did not receive supervised training in doing so Yes In addition to didactic and hands-on training, all staff was required to demonstrate competence in pessary placement on a live model Yes (only by video) Inserting obstetricians watched a training video on pessary insertion, were provided with written guidance on pessary management, and (at their discretion) practised pessary insertion on a model prior to first insertion.
Vaginal discharge 42.2% 100% 86.7% 100% 70% 26% 10.5% 42.1% 73.3% Not specified
Early removal due to discomfort/pain
0.6%
<1% (one patient who needed removal and replacement of the pessary)
0
Not specified
Not specified
<28 weeks: 30% 28-32 weeks: 9% 32 - 36 weeks: 0 32-36 weeks: 4% 10.2% of participants requested early removal for: -discomfort (5.4%) - vaginal discharge (4.1%) - vaginal bleeding (0.7%)
5%
1.7% expelled it during sexual intercourse 1.7% requested pessary removal due to apprehension regarding potential discomfort with sexual intercourse
11.3%
Discomfort during treatment
13.9%
Mean pain score: 4 (scale 0–10) during pessary insertion
3.3%
Mean pain score: 4 (scale 0–10) during pessary insertion
Discomfort (17%) Pain 4%
4%
11.4%
5.8%
1.7% removal for discomfort during sexual intercourse
11.3%
Pain during removal (mean score on a 0-10 scale) 6.7 7 Not specified 7 Not specified Not specified Not specified Not specified Not specified Uncomfortable in 41.3%
Clinical results 22% of singleton and 37% of twin pregnancies delivered before 34 weeks. Among women with CL≤25 mm, spontaneous delivery < 34 weeks of gestation and neonatal composite adverse outcomes were significantly less frequent in the pessary group than in the expectant management group Among women with asymptomatic short CL ≤25 mm, use of a cervical pessary, compared with no pessary resulted in a lower rate of spontaneous preterm birth at less than 34 weeks of gestation Cervical pessary associated with significant reduction of PTB < 34w in twin pregnancies with short CL ≤25 mm In women with twin pregnancies and cervical length <38 mm cervical pessary and 400 mg vaginal progesterone resulted in similar rates of PTB at < 34 weeks. The pessary reduced poor perinatal outcomes. In women with CL <28 mm, pessary reduced PTB <34 weeks and improved composite poor perinatal outcome. No significant difference in total group but a 6-fold reduction of composite poor perinatal outcome y in the pessary group in patients with a CL< 38 mm between 16 and 20 weeks No significant differences in preterm birth <34 weeks between singleton pregnancies with pessary placed for short CL<25 mm and the expectant management group. No significant differences in preterm birth <34 weeks between unselected twin pregnancies with pessary and the expectant management group. Cervical pessary use was not associated with prevention of PTB in women with a singleton pregnancy, short CL and no prior sPTB Cervical pessary did not reduce preterm birth <34 weeks nor composite adverse neonatal outcome in twin pregnancies with CL ≤35 mm when compared to standard care