Study stopped early for futility and possibility the device may increase the risk for fetal or newborn death<\/p>\n<\/h3>\n
By Lori Solomon HealthDay Reporter<\/b><\/p>\n
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MONDAY, July 31, 2023 (HealthDay News) — A cervical pessary does not benefit pregnancies in patients with a short cervical length, according to a study published in the July 25 issue of the Journal of the American Medical Association<\/em>.<\/p>\n Matthew K. Hoffman, M.D., from Columbia University in New York City, and colleagues evaluated whether placement of a cervical pessary reduces the rate of preterm birth or fetal death <37 weeks in nonlaboring singleton pregnancies with a cervical length \u00e2\u0089\u00a420 mm. The analysis included 544 singleton pregnancies randomly assigned to a cervical pessary placed by a trained clinician (280 patients) or usual care (264 patients).<\/p>\n The researchers found that the primary outcome of delivery or fetal death <37 weeks occurred in 45.5 percent of participants randomly assigned to a pessary and 45.6 percent assigned to usual care (relative risk, 1.00; 95 percent confidence interval, 0.83 to 1.20). Among those randomly assigned to receive a pessary, fetal or neonatal\/infant death occurred in 13.3 percent compared with 6.8 percent of those assigned to receive usual care (relative risk, 1.94; 95 percent confidence interval, 1.13 to 3.32). Study recruitment was stopped following the third interim analysis due to concern for fetal or neonatal\/infant death, as well as for futility.<\/p>\n “This trial raises a new concern, given the higher rate of fetal or neonatal\/infant death among individuals who received a pessary; this finding has not been reported in other randomized trials,” the authors write. “Our ability to detect this may be due to recruitment of a particularly high-risk group of individuals with severe cervical length shortening found early in gestation, which was more common in those who experienced a fetal or neonatal\/infant death.”<\/p>\n Abstract\/Full Text (subscription or payment may be required)<\/a><\/p>\n Editorial (subscription or payment may be required)<\/a><\/p>\n <\/i><\/p>\n