Among women with a short cervix, the use of a cervical pessary did not result in a reduction in preterm birth risk when compared with usual care, according to data from a National Institutes of Health (NIH)-funded phase 3 study.

The unblinded, randomized, controlled TOPS trial (ClinicalTrials.gov Identifier: NCT02901626) enrolled 544 participants with a singleton pregnancy at risk for preterm delivery. These patients had a cervical length of 20mm or less and were at gestations of 16 weeks through 24 weeks.

Study participants were randomly assigned to receive either a cervical pessary (n=280) or usual care (n=264; vaginal progesterone if they met the criteria per local standard of care). The primary endpoint was the number of participants with preterm delivery or fetal death at less than 37 weeks.

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Findings showed no significant difference between the groups; the primary endpoint occurred in 45.5% (127/280) of the pessary group and 45.6% (120/264) of the usual care group (relative risk, 1.00; 95% CI, 0.83-1.20). The study was stopped early because the risk of fetal or newborn death appeared to be higher in those who received the pessary compared with those who did not (13.3% vs 6.8%; relative risk, 1.94 [95% CI, 1.13-3.32]).

It was noted that participants in the usual care group were more likely to receive cervical cerclage, which may have influenced the outcome of the study.

References

  1. Cervical pessary no more effective than usual care in preventing preterm birth risk. National Institutes of Health. News release. July 25, 2023. https://www.nih.gov/news-events/news-releases/cervical-pessary-no-more-effective-usual-care-preventing-preterm-birth-risk.
  2. 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. Published online July 25, 2023. doi:10.1001/jama.2023.10812

This article originally appeared on MPR

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Obstetrics and Gynecology Pregnancy