Pregnolia System Intra-observer Variability

Cervix; Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05200117
• Other study ID #: F-405-11 vs 3.0, 2023-07-21
• Status: Completed
• Start date: January 12, 2022
• Est. completion date: December 17, 2023

Study information

• Verified date: March 2024
• Source: Pregnolia AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: December 17, 2023
• Est. primary completion date: December 17, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Cervix; Pregnancy

Intervention

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

Locations

Country	Name	City	State
Switzerland	Kantonsspital Frauenfeld	Frauenfeld

Sponsors (1)

Lead Sponsor	Collaborator
Pregnolia AG

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Measurements between 14+0 and 41+6 weeks gestational weeks
Secondary	Cervical Stiffness Index (CSI, in mbar)		Measurements between 14+0 and 41+6 weeks gestational weeks
Secondary	Elapsed time between	The elapsed time between when the subject got out of bed until the measurements were taken	Measurements between 14+0 and 41+6 weeks gestational weeks
Secondary	Device-related adverse events	Device-related adverse events (incidence, severity, and seriousness)	Measurements between 14+0 and 41+6 weeks gestational weeks