Pessary or cerclage (PC study) to prevent recurrent preterm birth: a non-inferiority, randomised controlled trial.

ABSTRACT:

Background

Previous spontaneous preterm birth (sPTB) is a strong risk indicator for recurrent preterm birth (PTB). Cervical cerclage is an accepted intervention to prevent recurrent PTB in high risk patients. Cervical pessary might be a less invasive alternative. The objective of this study is to determine whether a cervical pessary is non-inferior to cerclage in the prevention of recurrent PTB.

Methods

We performed an international, open-label, non-inferiority, randomised controlled trial in 21 hospitals between March 2014 and December 2022. We included singleton pregnancies with an indication for cerclage based on either multiple previous sPTBs <34 weeks or with a previous sPTB <34 weeks and an asymptomatic mid-trimester short cervix (≤25 mm). Randomisation was 1:1, strati

SUBMITTER: van Gils AL 

PROVIDER: S-EPMC11626620 | biostudies-literature | 2024 Dec

REPOSITORIES: biostudies-literature