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Importance: 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.Objective: 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.Interventions: 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.Results: 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.Trial Registration: clinicaltrials.gov Identifier: NCT02716909. [ABSTRACT FROM AUTHOR]

Objective: To evaluate effects of exercise during pregnancy in asymptomatic singleton pregnancies without prior spontaneous preterm birth (SPTB) but with short transvaginal ultrasound cervical length (TVU CL).Study Design: This is a secondary analysis of the Italian Pessary Trial for the Italian Preterm Birth Prevention (IPP) Working Group. In the original prospective randomized controlled trial asymptomatic singleton pregnancies without prior SPTB but with TVU CL ≤ 25 mm at 18 0/6-23 6/7 weeks were randomized into 1:1 ratio to either cervical pessary or no pessary. During their follow-up visits, women were asked about their activity. For the purpose of this secondary analysis, women were classified in the following groups, using the information obtained in the follow-up visit one month after randomization: 1) Exercise group, defined as women performing exercise ≥2 days a week for ≥20 min each day. 2) No exercise group, defined as women performing exercise <2 days a week for ≥20 min each day. The primary outcome of this secondary analysis was PTB < 37 weeks.Results: 300 women were included in this analysis. 99 (33.0%) were included in the exercise group. 201 (67.0%) were included in the no exercise group. Of the 201 women in the no exercise group, 90 (44.8%) affirmed that they had reduced their activity after the diagnosis of short cervix despite the research staff recommendations, while the other 111 (55.2%) women performed a sedentary life style even before the diagnosis of short cervix. PTB < 37 weeks occurred in 22 women (22.2%) in the exercise group, and 66 women (32.8%) in the no exercise group (aOR 0.65, 95% CI 0.33-1.03).Conclusion: In asymptomatic singleton pregnancies with short cervix, performing exercise ≥2 days a week for ≥20 min each day does not increase the risk of PTB but is indeed associated with a non-significant reduction in PTB < 37 weeks by 32%. [ABSTRACT FROM AUTHOR]