Pregnolia System Intra-observer Variability

Completed

• Conditions: Cervix; Pregnancy; Cervical Stiffness

• Registration Number: NCT05200117
• Lead Sponsor: Pregnolia AG

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-01-06
• Study First Submitted QC: 2022-01-06
• Study Start: 2022-01-12
• Study First Posted: 2022-01-20
• Primary Completion: 2023-12-17
• Study Completion: 2023-12-17
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-28
• Last Update Posted: 2024-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 26

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cervical Stiffness Index	Measurements between 14+0 and 41+6 weeks gestational weeks	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.

Secondary Outcome Measures

Name	Time	Method
Elapsed time between	Measurements between 14+0 and 41+6 weeks gestational weeks	The elapsed time between when the subject got out of bed until the measurements were taken
Cervical Stiffness Index (CSI, in mbar)	Measurements between 14+0 and 41+6 weeks gestational weeks
Device-related adverse events	Measurements between 14+0 and 41+6 weeks gestational weeks	Device-related adverse events (incidence, severity, and seriousness)

Trial Locations

Locations (1)

Kantonsspital Frauenfeld; 🇨🇭 Frauenfeld, Switzerland