Cervical pessary is not beneficial for the prevention of preterm birth, may be harmful

Référence

Hoffman MK, Clifton RG, Biggio JR, et al, for the National Institute of Child Health and Human Development Maternal-Fetal Medicine Units (MFMU) Network. Cervical pessary for prevention of preterm birth in individuals with short cervix: The TOPS randomized clinical trial. JAMA 2023;330(4):340-348.

Sommaire

In this unmasked randomized controlled trial, cervical pessary (n = 280) was compared with no cervical pessary (n = 264) for pregnant patients with singleton gestation, cervical length of 20 mm or less, and no history of preterm birth. Patients were enrolled at between 16 0/7 and 23 6/7 weeks' gestation. Cervical length was measured by trained ultrasound technologists as routine screening. Exclusion criteria included history of prior spontaneous preterm birth, cervical dilatation of 3 cm or more, prolapsed amniotic membranes, premature rupture of membranes, evidence of preterm labor, major fetal anomalies, planned cerclage, or conditions likely to indicate medical need for preterm birth. Nearly all patients received vaginal progesterone (98.9%). All personnel for the study, including those placing pessaries, were specifically trained and certified for their role. The study was planned for a sample size of 850 with complete data for 511 participants. The trial was terminated early by the data and safety monitoring board because of a statistically significant increase in fetal or neonatal deaths (pessary: 36/275 [13.1%] vs no pessary: 18/263 [6.8%]; relative risk [RR] 191; 95% CI 1.11 - 3.29; P = .02; number needed to treat to harm = 16; 9 - 84). There was no benefit in reducing the incidence of preterm birth (127/279 [45.5%] vs 120/263 [45.6%]; NS).