Cervical pessary versus progesterone for preterm birth prevention in twin pregnancy with short cervix
This randomized clinical trial, conducted at a single center in Australia, enrolled 34 individuals with a twin pregnancy and a mid-trimester cervical length at or below the 25th percentile (≤38 mm). Participants were randomized to receive either placement of a cervical pessary (Arabin pessary, n=16) or self-administered daily vaginal progesterone (200 mg, n=18). One participant in the progesterone group withdrew consent after randomization, leaving 33 individuals for analysis.
The primary outcome was a composite adverse neonatal outcome. This occurred in 41% of neonates (13/32) in the pessary group compared to 29% of neonates (10/34) in the progesterone group (risk ratio [RR] 1.38, 95% CI 0.71-2.69). For the secondary outcome of delivery before 28 weeks, the rate was 19% (3/16 individuals) in the pessary group versus 5.9% (1/17) in the progesterone group (RR 3.19, 95% CI 0.37-27.58). Neither comparison was statistically significant, as all confidence intervals included 1.0.
Safety and tolerability data were not reported. The study has important limitations: it was halted early after other studies indicated no benefit from pessary, resulting in a very small sample size. This early termination, combined with the wide confidence intervals, means the evidence has low certainty. The findings do not demonstrate harm from the pessary or superiority of progesterone, but they do not support a benefit of cervical pessary over progesterone for preventing preterm birth in this specific population.