Does use of a cervical pessary reduce the rate of spontaneous delivery before 34 weeks of gestation among women with singleton pregnancies, short cervical length, and no prior spontaneous preterm birth?
In this randomized trial of 300 women, the rates of spontaneous preterm birth at less than 34 weeks were 7.3% with a cervical pessary compared with 15.3% without cervical pessary use, a significant difference.
The use of a cervical pessary among women with singleton pregnancies, short cervical length, and no prior spontaneous preterm birth reduced the risk of spontaneous preterm birth at less than 34 weeks of gestation.
Spontaneous preterm birth is a major cause of perinatal morbidity and mortality. It is unclear if a cervical pessary can reduce the risk of spontaneous preterm delivery.
To test whether in asymptomatic women with singleton pregnancies and no prior spontaneous preterm birth but with short cervical length on transvaginal ultrasound, use of a cervical pessary would reduce the rate of spontaneous preterm birth at less than 34 weeks of gestation.
Design, Setting, and Participants
Parallel-group, nonblinded, randomized clinical trial conducted from March 1, 2016, to May 25, 2017, at a single center in Italy. Asymptomatic women with singleton gestations, no previous spontaneous preterm births, and cervical lengths of 25 mm or less at 18 weeks 0 days to 23 weeks 6 days of gestation were eligible.
Patients were randomized 1:1 to receive either cervical pessary (n = 150) or no pessary (n = 150). The pessary was removed between 37 weeks 0 days and 37 weeks 6 days of gestation or earlier if clinically indicated. The control group received standard care. For cervical length of 20 mm or shorter, women in both groups were prescribed vaginal progesterone, 200 mg/d, until 36 weeks 6 days of gestation. No bed rest or activity restriction was recommended.
Main Outcomes and Measures
The primary end point was spontaneous preterm birth at less than 34 weeks of gestation. Secondary outcomes were adverse events.
Among 300 women who were randomized (mean age, 29 [SD, 6.3] years; mean gestational age, 22 [SD, 1.3] weeks), 100% completed the trial. The primary end point occurred in 11 women (7.3%) in the pessary group and 23 women (15.3%) in the control group (between-group difference, −8.0% [95% CI, −15.7% to −0.4]; relative risk, 0.48 [95% CI, 0.24-0.95]). During follow-up, the pessary group had a higher rate of increased or new vaginal discharge (86.7% vs 46.0%; between-group difference, +40.7% [95% CI, +30.1%-+50.3%]; relative risk, 1.88 [95% CI, 1.57-2.27]).
Conclusions and Relevance
Among women without prior spontaneous preterm birth who had asymptomatic singleton pregnancies and short transvaginal cervical length, use of a cervical pessary, compared with no pessary use, resulted in a lower rate of spontaneous preterm birth at less than 34 weeks of gestation. The results of this single-center, nonblinded study among selected pregnant women require confirmation in multicenter clinical trials.
clinicaltrials.gov Identifier: NCT02716909
Saccone G, Maruotti GM, Giudicepietro A, Martinelli P, . Effect of Cervical Pessary on Spontaneous Preterm Birth in Women With Singleton Pregnancies and Short Cervical LengthA Randomized Clinical Trial. JAMA. 2017;318(23):2317–2324. doi:10.1001/jama.2017.18956