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  • Title: Cervical Pessary for Prevention of Preterm Birth in Individuals With a Short Cervix: The TOPS Randomized Clinical Trial.
    Author: Hoffman MK, Clifton RG, Biggio JR, Saade GR, Ugwu LG, Longo M, Bousleiman SZ, Clark K, Grobman WA, Frey HA, Chauhan SP, Dugoff L, Manuck TA, Chien EK, Rouse DJ, Simhan HN, Esplin MS, Macones GA, National Institute of Child Health and Human Development Maternal-Fetal Medicine Units (MFMU) Network.
    Journal: JAMA; 2023 Jul 25; 330(4):340-348. PubMed ID: 37490086.
    Abstract:
    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.
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