Pregnolia System Intra-observer Variability

NCT05200117 | Completed

• 1 other identifier: F-405-11 vs 3.0, 2023-07-21
• Study Type: observational
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Cervix; Pregnancy; Cervical Stiffness

Keywords

Cervical Stiffness; Intra-Observer Variability; Pregnolia System; Cervical Stiffness Index; CSI; Stiffness measurement

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Cervical Stiffness Index (CSI, in mbar)

  Measurements between 14+0 and 41+6 weeks gestational weeks

• Elapsed time between

  Measurements between 14+0 and 41+6 weeks gestational weeks

• Device-related adverse events

  Measurements between 14+0 and 41+6 weeks gestational weeks

Study Arms (2)

Nulliparous cohort

Cervical stiffness will be measured in the same subject sequentially between days and during the same day and at different gestational ages.

Device: Pregnolia System

Multiparous cohort

Cervical stiffness will be measured in the same subject sequentially between days and during the same day and at different gestational ages.

Device: Pregnolia System

Interventions

Pregnolia System DEVICE

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

Multiparous cohort; Nulliparous cohort

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant women at gestational ages between 14+0 and 36+6 weeks.

You may qualify if:

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

You may not qualify if:

• 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
• Cervical dilation ≥ 3 cm
• Cerclage or pessary in place

Sponsors & Collaborators

• Pregnolia AG: lead

Study Sites (1)

Kantonsspital Frauenfeld

Frauenfeld, 8501, Switzerland

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2022
• First Posted: January 20, 2022
• Study Start: January 12, 2022
• Primary Completion: December 17, 2023
• Study Completion: December 17, 2023
• Last Updated: March 29, 2024

Record last verified: 2024-03

Locations

CH (1)