Pregnolia System Intra-observer Variability

Intra-observer Variability in the Assessment of Cervical Stiffness With the Pregnolia System

The Pregnolia System is a CE-marked medical device assessing the mechanical stiffness of cervical tissue in women. The Pregnolia Probe has been engineered to minimize the influence of differences in handling and technique by the user.

This project aims to study intra-observer variability of the Pregnolia System in pregnant women in the clinical setting.

Furthermore, a same day repeated measurement serves to investigate the time period needed to recover the pre-measurement stiffness state due to viscoelasticity of the cervical tissue.

Inclusion Criteria:

• Informed Consent signed by the subject
• Pregnant woman
• Singleton pregnancy
• 18 years or older
• Nulliparous cohort: nulliparous pregnant woman
• Multiparous cohort: multiparous pregnant woman

Exclusion Criteria:

• Lack of informed consent
• Placenta praevia totalis with haemorrhage (irrespective of severity)
• Severe vaginal bleeding
• Rupture of membranes before 34 weeks (to be excluded with pH test)
• Visible tissue scarring at 12 o'clock position on cervix
• Light bleeding (if the bleeding can be stopped, it is no longer an exclusion criterion)
• Cervical dilation ≥ 3 cm
• Cerclage or pessary in place