NCT04158401

Cervical Stiffness Measurement in Cervical Insufficiency

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 136 (actual)
• Sponsor: Tufts Medical Center · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The goal of this cross sectional study is to evaluate the differences in cervical stiffness between patients who present for cerclage placement versus normal pregnancies. The central hypothesis is that women for whom a cerclage is indicated will have cervical stiffness measurements lower than normal controls. Cervical stiffness will be objectively measured by the closing pressure Pcl using the Pregnolia measurement device. This is performed during a speculum exam by placing the measurement probe on the ectocervix. In current clinical care, there is no objective measurement of cervical stiffness. An accurate measurement of cervical stiffness that correlates with clinical outcome will advance the field. Successful completion of the current study will spark future studies that correlate cervical stiffness pcl in a prospective study.

Conditions

• Pregnancy Related
• Cervical Insufficiency
• Preterm Birth

Interventions

Type	Name	Description
DEVICE	Pregnolia	The Pregnolia measurement device (CE Mark for commercialization in the EU) will be used to measure the cervical stiffness (Pcl) on all subjects.

Timeline

• Start date: 2020-01-15
• Primary completion: 2022-06-15
• Completion: 2022-06-15
• First posted: 2019-11-08
• Last updated: 2022-09-21

Locations

1 site across 1 country: United States