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Prematurity

Poster Session 4

(964) Pessary versus progesterone in singleton pregnant women with a short cervix: a randomized controlled trial

Wednesday, February 14, 2024
1:00 PM – 2:30 PM  
Location: Prince George's Exhibit Hall CDE, Lower Atrium Level
Objective: In women with a singleton pregnancy and a short cervical length (CL), cervical pessary and vaginal progesterone are both used in preterm birth (PTB) prevention. We performed a head-to-head comparison between these two treatments.

Study Design: We conducted a multi-center, randomized clinical trial (NCT04300322) at three hospitals in Vietnam. Asymptomatic women with a singleton pregnancy and a CL ≤ 25mm (at 16-22 weeks) were randomized (1:1 ratio) to receive either an Arabin® cervical pessary or 200-mg vaginal progesterone daily. Primary outcome was PTB < 37 weeks of any cause. Secondary outcomes were maternal and neonatal complications. We planned to recruit 804 women to assess a 10% absolute risk reduction in PTB < 37 weeks (alpha-error 0.05, power 80%, 5% lost to follow-up). Analysis was by intention-to-treat. In view of the potential harm of pessary on perinatal mortality and PTB < 28 weeks reported recently in two trials (NTR 4414; NCT02901626), our study was halted in June 2023.

Results: Between May 2020 and May 2023, we randomized 301 women to pessary (N=150) and progesterone (N=151). Seven women withdrew consent and 13 were lost to follow-up, resulting in 281 women available from analysis (Arabin group N=139; progesterone group N=142). The primary outcome PTB < 37 weeks rate occurred in15.1% in the pessary group versus 14.1% in the progesterone group (RR 1.1, 95%CI 0.61 to 1.9). PTB < 28 weeks and perinatal death rates were almost doubled in the pessary group, although these differences did not reach statistical significance(7.9% versus 4.2%, RR 1.9, 95%CI 0.71 to 4.9 and 4.3% versus 2.8%, RR 1.5, 95%CI 0.44 to 5.3; respectively). Other secondary outcomes are presented in the Table.

Conclusion: In women with a singleton pregnancy and a CL ≤ 25 mm, pessary was not superior over progesterone in the PTB prevention and might increase the risk of perinatal death and PTB < 28 weeks.