Cervical Pessary for Prevention of Preterm Birth in Individuals With a Short Cervix: The TOPS Randomized Clinical Trial
IMPORTANCE: A short cervix as assessed by transvaginal ultrasound is an established risk factor for preterm birth. Study findings for a cervical pessary to prevent preterm delivery in singleton pregnancies with transvaginal ultrasound evidence of a short cervix have been conflicting. OBJECTIVE: To determine if cervical pessary placement decreases the risk of preterm birth or fetal death prior to 37 weeks among individuals with a short cervix. DESIGN, SETTING, AND PARTICIPANTS: We performed a multicenter, randomized, unmasked trial comparing a cervical pessary vs usual care from February 2017 through November 5, 2021, at 12 centers in the US. Study participants were nonlaboring individuals with a singleton pregnancy and a transvaginal ultrasound cervical length of 20 mm or less at gestations of 16 weeks 0 days through 23 weeks 6 days. Individuals with a prior spontaneous preterm birth were excluded. INTERVENTIONS: Participants were randomized 1:1 to receive either a cervical pessary placed by a trained clinician (n = 280) or usual care (n = 264). Use of vaginal progesterone was at the discretion of treating clinicians. MAIN OUTCOME AND MEASURES: The primary outcome was delivery or fetal death prior to 37 weeks. RESULTS: A total of 544 participants (64%) of a planned sample size of 850 were enrolled in the study (mean age, 29.5 years [SD, 6 years]). Following the third interim analysis, study recruitment was stopped due to concern for fetal or neonatal/infant death as well as for futility. Baseline characteristics were balanced between participants randomized to pessary and those randomized to usual care; 98.9% received vaginal progesterone. In an as-randomized analysis, the primary outcome occurred in 127 participants (45.5%) randomized to pessary and 127 (45.6%) randomized to usual care (relative risk, 1.00; 95% CI, 0.83-1.20). Fetal or neonatal/infant death occurred in 13.3% of those randomized to receive a pessary and in 6.8% of those randomized to receive usual care (relative risk, 1.94; 95% CI, 1.13-3.32). CONCLUSIONS AND RELEVANCE: Cervical pessary in nonlaboring individuals with a singleton gestation and with a cervical length of 20 mm or less did not decrease the risk of preterm birth and was associated with a higher rate of fetal or neonatal/infant mortality. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02901626.
Hoffman, Matthew K.; Clifton, Rebecca G.; Biggio, Joseph R.; Saade, George R.; Ugwu, Lynda G.; Longo, Monica; Bousleiman, Sabine Z.; Clark, Kelly; Grobman, William A.; Frey, Heather A.; Chauhan, Suneet P.; Dugoff, Lorraine; Manuck, Tracy A.; Chien, Edward K.; Rouse, Dwight J.; Simhan, Hyagriv N.; Esplin, M Sean; and Macones, George A., "Cervical Pessary for Prevention of Preterm Birth in Individuals With a Short Cervix: The TOPS Randomized Clinical Trial" (2023). GW Authored Works. Paper 3030.