Prevention of preterm birth with pessary in singletons (PoPPS): randomized controlled trial

2018 
Objective To determine if pessary use prevents preterm birth in singleton gestations with a short transvaginal ultrasound cervical length and without a prior spontaneous preterm birth. Methods In this open-label multicenter randomized trial we enrolled asymptomatic women with singleton gestations with a transvaginal ultrasound cervical length ≤ 25 mm at 180-236 weeks and no prior spontaneous preterm birth. Subjects were randomized to receive the Bioteque cup pessary or no pessary. Pessaries were inserted by trained maternal fetal medicine staff.. Vaginal progesterone was recommended to women with a cervical length ≤20mm. The primary outcome was preterm birth < 37weeks. A sample size of 121 per group (n=242) was needed to detect a reduction in the primary outcome from 30% in the no pessary group to 15% in the pessary group. The trial was stopped early before complete enrollment. Results From March 17, 2014 through July 29, 2016, 17,383 women were screened with transvaginal ultrasound cervical length. 422 (2.4 %) had a cervical length ≤25mm. 391 (92.7 %) met eligibility criteria and 122 (31.2 %) of eligible subjects agreed to randomization. Sixty-one (50%) women were randomized to the pessary and 61 (50%) to the no pessary groups. Baseline characteristics were similar between groups. There were no significant differences between the pessary and no pessary groups in rates of the primary outcome, preterm birth <37weeks (43% vs 40%, RR 1.09, 95% CI 0.71, 1.68), as well as other outcomes, such as preterm birth <34 weeks, preterm birth <28 weeks, gestational age at delivery, birth weight and composite adverse neonatal outcome. Discussion Cervical pessary use was not associated with prevention of preterm birth in women with singleton gestations with a short transvaginal ultrasound cervical length and without a prior spontaneous preterm birth in this small underpowered randomized controlled trial. This trial was registered on ClinicalTrials.gov, number NCT 02056652.
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