Pessary inserted by ObGyn as an outpatient procedure
Vaginal swab collected prior to insertion
Tocolysis and corticosteroids were considered <34 weeks | Atosiban administered as first-line tocolytic
Vaginal progesterone and cervical cerclage were not allowed under the protocol
Sample size: 308 pregnancies for 80% power to detect primary outcome | Type I error of 0.05
Study designed for intention to treat (ITT) | Per-protocol analysis also conducted to exclude protocol violations (e.g., progesterone following inclusion)
Composite of adverse neonatal outcomes including
Peripartum death | Neonatal death | Significant neonatal morbidity prior to hospital discharge
Spontaneous preterm birth
Pessary side effects
Pessary: 157 individuals | Standard care: 158 individuals
Missing data for primary endpoint: 10.8%
In the ITT analysis, there was no significant difference in the adverse composite neonatal outcome between groups
Standard care: 22.5%
RR 0.69 (95% CI, 0.39 to 1.23); P=0.210
The per-protocol analysis also did not find a significant difference between the groups
There was also no difference between the groups in
Spontaneous preterm birth
There were no serious side effects associated with pessary use
The use of pessary in twin pregnancies with short cervix was not associated with any significant reduction in preterm birth, or other adverse neonatal outcomes, compared to standard care
The authors state that in addition
…neither early gestational age at pessary insertion (16-19 weeks) nor a very short cervix (<15 mm) were 394 associated with the Arabin pessary’s effectiveness in preventing adverse neonatal outcomes or 395 preterm deliveries <34 weeks
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