Cervical Pessary may not Prevent Preterm Birth among individuals with short cervix: JAMA

Preterm birth is a major health concern it contributes to more than 50% of the overall perinatal mortality. Preterm birth has multiple risk factors including cervical incompetence and multiple pregnancy. Different management strategies have been tried to prevent preterm birth, including cervical cerclage.

Short cervix as assessed by transvaginal ultrasound is an established risk factor for preterm birth. Study findings for a cervical pessary to prevent preterm delivery in singleton pregnancies with transvaginal ultrasound evidence of a short cervix have been conflicting.

A recent randomized trial “TOPS” reveals that the rate of preterm birth or fetal death before 37 weeks did not show much difference, preterm delivery or neonatal death occurred in 45.5% of the pessary group compared to 45.6% of the usual care group. Fetal or neonatal/infant death occurred more frequently in those randomized to receive a pessary 13.3% than those 6.8% randomized to receive usual care. The findings of the study are published in JAMA Network.

Researchers performed a multicenter, randomized, unmasked trial comparing a cervical pessary vs usual care from February 2017 through November 5, 2021, at 12 centers in the US. Study participants were nonlaboring individuals with a singleton pregnancy and a transvaginal ultrasound cervical length of 20 mm or less at gestations of 16 weeks 0 days through 23 weeks 6 days. Individuals with a prior spontaneous preterm birth were excluded.

The findings of the study are

• A total of 544 participants (64%) of a planned sample size of 850 were enrolled in the study (mean age, 29.5 years [SD, 6 years]).

• Following the third interim analysis, study recruitment was stopped due to concern for fetal or neonatal/infant death as well as for futility.

• Baseline characteristics were balanced between participants randomized to pessary and those randomized to usual care; 98.9% received vaginal progesterone.

• In an as-randomized analysis, the primary outcome occurred in 127 participants (45.5%) randomized to pessary and 127 (45.6%) randomized to usual care (relative risk, 1.00; 95% CI, 0.83-1.20).

• Fetal or neonatal/infant death occurred in 13.3% of those randomized to receive a pessary and in 6.8% of those randomized to receive usual care (relative risk, 1.94; 95% CI, 1.13-3.32).

Researchers concluded that “Cervical pessary in nonlaboring individuals with a singleton gestation and with a cervical length of 20 mm or less did not decrease the risk of preterm birth and was associated with a higher rate of fetal or neonatal/infant mortality.”

Reference: Hoffman MK, Clifton RG, Biggio JR, et al. Cervical Pessary for Prevention of Preterm Birth in Individuals With a Short Cervix: The TOPS Randomized Clinical Trial. JAMA. 2023;330(4):340–348. doi:10.1001/jama.2023.10812.