Pregnolia System Intra-observer Variability

N/ACompletedNCT05200117

Pregnolia AG26 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Cervix; Pregnancy Cervical Stiffness

Interventions

Pregnolia SystemDEVICE

The cervical stiffness is measured with the Pregnolia System three times over a two-day period.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Kantonsspital Frauenfeld

Frauenfeld, Switzerland

Outcomes

Primary Outcomes

Cervical Stiffness Index

Cervical Stiffness Index (CSI, in mbar) measured repeatedly after 2 to 4 hours and approximately 24 hours at three different locations on the uterine cervix.

Time frame: Measurements between 14+0 and 41+6 weeks gestational weeks

Secondary Outcomes

Cervical Stiffness Index (CSI, in mbar)

Time frame: Measurements between 14+0 and 41+6 weeks gestational weeks

Elapsed time between

The elapsed time between when the subject got out of bed until the measurements were taken

Time frame: Measurements between 14+0 and 41+6 weeks gestational weeks

Device-related adverse events

Device-related adverse events (incidence, severity, and seriousness)

Time frame: Measurements between 14+0 and 41+6 weeks gestational weeks

Data from ClinicalTrials.gov

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