The impact of a pessary treatment on the cervical stiffness and birth outcome in high-risk preterm birth pregnant women: a study protocol for a prospective trial

Background Preterm birth contributes in up to more than a half of overall perinatal mortality. Several studies have shown a significant clinical benefit in patients treated with a cervical pessary in pregnancies at risk for preterm birth. However, the underlying mechanisms by which pessaries reduce the risk of preterm birth remain elusive. This study aims to quantitatively assess the cervical stiffness in pregnancies with normal cervical length and in pregnancies with cervical shortening before and after pessary application.

Methods A prospective, longitudinal, cohort study in a tertiary maternity hospital to determine ectocervical stiffness and its changes measured prior and after the placement of a pessary, and the correlation of measured cervical stiffness or its changes with birth outcome in high-risk preterm birth pregnant women. A cervical stiffness measured with the Pregnolia System as the Cervical Stiffness Index (CSI, in mbar) will be the primary endpoint, whilst the perinatal outcome will be the secondary endpoint. In this study, up to 142 subjects will be enrolled to have a total of 120 subjects (estimated dropout rate of 15%) completed the study; Pessary cohort: 60 (up to 71 recruited), normal cohort: 60 (up to 71 recruited).

Discussion We hypothesize that the study will substantially improve our knowledge about cervical remodelling and preterm labour pathophysiology. We hope that our investigation will be able to elucidate ectocervical softening phenomenon both in high-risk preterm birth and in normal pregnant controls, as well as the impact of cervical pessary use on the CSI values.

Publikationsverlauf

Artikel online veröffentlicht:
11. Oktober 2022