Cervical pessary in singleton gestations with arrested preterm labor: a randomized clinical trial.

BACKGROUND

Cervical pessary has been proven to be effective in reducing the rate of preterm birth in asymptomatic women with singleton gestations and short cervical length in the midtrimester of pregnancy; however, the efficacy of this device in women with arrested preterm labor is still a subject of debate.

OBJECTIVE

This study aimed to test the hypothesis that the use of a cervical pessary in women with singleton pregnancy and arrested preterm labor would reduce the risk of preterm birth at <37 weeks of gestation.

STUDY

DESIGN

This study is a parallel group, nonblinded, randomized trial. Participants included in the study were women with a diagnosis of arrested preterm labor between 24 0/7 and 33 6/7 weeks of gestations. The participants were randomized to either the cervical pessary group or no pessary group in a 1:1 ratio. The primary endpoint was preterm birth at <37 weeks of gestation. A sample size of 120 participants was determined, but the trial was concluded before the completion of enrollment.

RESULTS

A total of 61 women with singleton pregnancies and arrested preterm labor at 24 0/7 to 33 6/7 weeks of gestation were enrolled in the trial. Of the 61 women, 32 were randomized to the cervical pessary group and 29 to the control group. Preterm birth at <37 weeks of gestation occurred in 14 women (43.8%) in the pessary group and 6 women (20.7%) in the control group (relative risk, 2.98; 95% confidence interval, 0.96-9.30).

CONCLUSION

In this underpowered trial, among women with singleton pregnancies and arrested preterm labor, compared with no pessary use, the use of a cervical pessary does not result in a lower rate of preterm birth at <37 weeks of gestation.