TOPS Trial Results: Does Pessary Prevent Preterm Birth in Singleton Pregnancies with a Short Cervix?
BACKGROUND AND PURPOSE:
Hoffman et al. (JAMA, 2023) studied whether cervical pessary placement decreases the risk of preterm birth or fetal death <37 weeks among individuals with a short cervix
Multicenter, randomized, unmasked trial
Trial of Pessary in Singleton Pregnancies With a Short Cervix (TOPS)
Nonlaboring individuals with singleton pregnancy
16w0d to 23w6d
Transvaginal ultrasound cervical length ≤20 mm
Cervical pessary placed by a trained clinician
Use of vaginal progesterone was at the discretion of treating clinicians
Exclusion: Prior spontaneous preterm birth
Delivery or fetal death <37 weeks
Pessary: 280 women | Usual care: 264 women
Mean age: 29.5 (SD, 6) years
Received vaginal progesterone: 98.9%
Study recruitment was stopped after the third interim analysis due to
Concern for fetal or neonatal/infant death
There was no difference in the incidence of delivery or fetal death <37 weeks between the groups
Pessary: 45.5% | Usual care: 45.6%
Relative risk (RR) 1.00 (95% CI, 0.83 to 1.20)
Fetal or neonatal/infant death was more frequent in the pessary group
Pessary: 13.3% | Usual care: 6.8%
RR 1.94 (95% CI, 1.13 to 3.32)
For nonlaboring individuals with a singleton pregnancy and a short cervix, the addition of a cervical pessary did not decrease the risk of preterm birth and was associated with a higher rate of fetal or neonatal death
The authors state
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
OBG Project CME requires a modern web browser (Internet Explorer 10+, Mozilla Firefox, Apple Safari, Google Chrome, Microsoft Edge). Certain educational activities may require additional software to view multimedia, presentation, or printable versions of their content. These activities will be marked as such and will provide links to the required software. That software may be: Adobe Flash, Apple QuickTime, Adobe Acrobat, Microsoft PowerPoint, Windows Media Player, or Real Networks Real One Player.
Disclosure of Unlabeled Use
This educational activity may contain discussion of published and/or investigational uses of agents that are not indicated by the FDA. The planners of this activity do not recommend the use of any agent outside of the labeled indications.
The opinions expressed in the educational activity are those of the faculty and do not necessarily represent the views of the planners. Please refer to the official prescribing information for each product for discussion of approved indications, contraindications, and warnings.
Participants have an implied responsibility to use the newly acquired information to enhance patient outcomes and their own professional development. The information
presented in this activity is not meant to serve as a guideline for patient management. Any procedures, medications, or other courses of diagnosis or treatment discussed or suggested in this activity should not be used by clinicians without evaluation of their patient’s conditions and possible contraindications and/or dangers in use, review of any applicable manufacturer’s product information, and comparison with recommendations of other authorities.
Jointly provided by
NOT ENOUGH CME HOURS
It appears you don't have enough CME Hours to take this Post-Test. Feel free to buy additional CME hours or upgrade your current CME subscription plan