Study stopped early for futility and possibility the device may increase the risk for fetal or newborn death
By Lori Solomon HealthDay Reporter
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.
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 ≤20 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).
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.
“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.”
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