• Matthew K Hoffman, Rebecca G Clifton, Joseph R Biggio, George R Saade, Lynda G Ugwu, Monica Longo, Sabine Z Bousleiman, Kelly Clark, William A Grobman, Heather A Frey, Suneet P Chauhan, Lorraine Dugoff, Tracy A Manuck, Edward K Chien, Dwight J Rouse, Hyagriv N Simhan, M Sean Esplin, George A Macones, and National Institute of Child Health and Human Development Maternal-Fetal Medicine Units (MFMU) Network.
• Department of Obstetrics and Gynecology, Columbia University, New York, New York.
• JAMA. 2023 Jul 25; 330 (4): 340348340-348.

ImportanceA 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.ObjectiveTo 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 ParticipantsWe 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.InterventionsParticipants 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 MeasuresThe primary outcome was delivery or fetal death prior to 37 weeks.ResultsA 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 RelevanceCervical 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 RegistrationClinicalTrials.gov Identifier: NCT02901626.

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