NCT02037334

Biomechanics Based Prediction of Preterm Delivery

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,002 (actual)
• Sponsor: David Scheiner · Academic / Other
• Sex: Female
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

Quantitative information on the biomechanical properties of the ecto-cervix in mid-pregnancy will be compared between women with term vs. preterm delivery. We aim to demonstrate that biomechanical data (ASP and CCI) might complement morphological data (CL) to improve prediction of preterm delivery. It is expected that women with preterm delivery will show stronger weakening of cervical tissue. Aspiration (ASP) and cervical CCI (cervical consistency index) measurements are performed at mid-pregnancy: detection at this time point is useful for therapy and biomechanical modifications are already significant so to enable differentiation by biomechanical measurements (ASP and CCI).

Conditions

• Preterm Delivery

Interventions

Type	Name	Description
DEVICE	Pregnolia System	No intervention is done except for measuring the stiffness of the cervix in pregnant women

Timeline

• Start date: 2014-04-01
• Primary completion: 2022-12-08
• Completion: 2022-12-08
• First posted: 2014-01-15
• Last updated: 2022-12-09

Locations

13 sites across 2 countries: Belgium, Switzerland