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  • Title: A Randomized Trial of a Cervical Pessary to Prevent Preterm Singleton Birth.
    Author: Nicolaides KH, Syngelaki A, Poon LC, Picciarelli G, Tul N, Zamprakou A, Skyfta E, Parra-Cordero M, Palma-Dias R, Rodriguez Calvo J.
    Journal: N Engl J Med; 2016 Mar 17; 374(11):1044-52. PubMed ID: 26981934.
    Abstract:
    BACKGROUND: Preterm birth is the leading cause of neonatal and infant death and of disability among survivors. It is unclear whether a pessary inserted around the cervix reduces the risk of preterm singleton birth. METHODS: We conducted a multicenter, randomized, controlled trial comparing pessary placement with expectant management (control) in girls and women who were pregnant with singletons (singleton pregnancies) and who had a cervical length of 25 mm or less at 20 weeks 0 days to 24 weeks 6 days of gestation. Participants in either group who had a cervical length of 15 mm or less, at randomization or at subsequent visits, received treatment with vaginal progesterone. The primary outcome was spontaneous delivery before 34 weeks of gestation. RESULTS: In an intention-to-treat analysis, there was no significant difference between the pessary group (465 participants) and the control group (467 participants) in the rate of spontaneous delivery before 34 weeks (12.0% and 10.8%, respectively; odds ratio in the pessary group, 1.12; 95% confidence interval, 0.75 to 1.69; P=0.57). There were no significant differences in the rates of perinatal death (3.2% in the pessary group and 2.4% in the control group, P=0.42), adverse neonatal outcome (6.7% and 5.7%, respectively; P=0.55), or neonatal special care (11.6% and 12.9%, respectively; P=0.59). The incidence of new or increased vaginal discharge was significantly higher in the pessary group than in the control group. CONCLUSIONS: Among girls and women with singleton pregnancies who had a short cervix, a cervical pessary did not result in a lower rate of spontaneous early preterm delivery than the rate with expectant management. (Funded by the Fetal Medicine Foundation; Current Controlled Trials number, ISRCTN01096902.).
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