Randomized trial of cervical pessary for short cervix in singleton pregnancies

for the Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network, Bethesda, MD Randomized trials a cervical pessary prevention preterm delivery in singleton pregnancies with an ultrasound finding short cervix have been conflicting, few individuals enrolled US. Our objective was to evaluate effect Arabin preventing birth such pregnancies. We performed randomized multicenter trial comparing versus usual care non-anomalous transvaginal measurement length <20 mm from 14 weeks 0 days through 23 6 days. Women prior spontaneous were excluded. primary outcome 37 or fetal death at any time. Use vaginal progesterone discretion treating clinician. Although planned enrollment 850, following prespecified interim analysis, study stopped after recruiting 544 (64%) participants potential safety concern perinatal mortality addition futility. Baseline characteristics balanced between groups, including near universal receipt (Table 1). In intention treat occurred 45.5% people who received 45.6% (RR1.00- 95%CI 0.83-1.20). The proportion remaining pregnant each gestational age did not differ groups (p = 0.46; Figure Neonatal 13.3% women 6.8% (RR 1.96-95% CI 1.14-3.35). Other outcomes similar two groups. Placement gestations <20mm decrease risk birth. higher rate neonatal needs further investigation contributing factors.View Large Image ViewerDownload Hi-res image Download (PPT)