Primary outcome: Proportion of spontaneous preterm delivery <34 weeks
Proportion of spontaneous preterm births <37 and <28 weeks | Rate of PROM <34 and <37 weeks | Need of tocolysis and corticosteroid | Vaginal side effects | Maternal outcomes such as rate of chorioamnionitis etc.| Newborn outcomes such as birthweight and adverse events (e.g., perinatal death etc.)
Sample size: 254 women were required to show noninferiority of the pessary to progesterone
Noninferiority margin of 4% with a 0.025 one-sided α level (i.e., if the 95% CI upper bound exceeds 4%, the pessary could not be deemed noninferior)
Statistical power of 80%
Assumed dropout rate of 5%
254 patients were enrolled and 246 included in the intention-to-treat analysis
The rate of spontaneous delivery before 34 weeks of gestation was
14% (n=18/127) in the pessary group
14% (n=17/119) in the progesterone group
Risk difference: −0.11% (95% CI −8.85% to 8.62%; P=.99)
Noninferiority was not shown for the pessary
Adverse events were higher in the pessary group compared to progesterone
Incidence of increased vaginal discharge: 87% vs 71% (P=.002)
Discomfort: 27% vs 3% (P<.001)
Cervical pessary was not noninferior to vaginal progesterone
95% CI of the difference exceeded the 4% prespecified non-inferiority margin of 4%
Cervical pessary was associated with increased vaginal discharge and discomfort
Authors recommend vaginal progesterone as the first line treatment as a “first option” but
…the pessary could be considered a similar effective alternative and could be a preferred choice for women reluctant to use daily medication
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