Pregnolia System Intra-observer Variability

• ClinicalTrials.gov Identifier: NCT05200117
• Recruitment Status: Recruiting
• First Posted: January 20, 2022
• Last Update Posted: August 25, 2022
• Sponsor: Pregnolia AG
• Information provided by (Responsible Party): Pregnolia AG

Tracking Information

• First Submitted Date: January 6, 2022
• First Posted Date: January 20, 2022
• Last Update Posted Date: August 25, 2022
• Actual Study Start Date: January 12, 2022
• Estimated Primary Completion Date: December 31, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 22, 2022)

Cervical Stiffness Index [ Time Frame: 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.

Original Primary Outcome Measures (submitted: January 6, 2022)

Cervical Stiffness Index [ Time Frame: Measurements between 14+0 and 31+6 weeks gestational weeks ]

Cervical Stiffness Index (CSI, in mbar) measured repeatedly after 2 to 4 hours and approximately 24 hours

Current Secondary Outcome Measures (submitted: August 22, 2022)

• Cervical Stiffness Index (CSI, in mbar) [ Time Frame: Measurements between 14+0 and 41+6 weeks gestational weeks ]
• Elapsed time between [ Time Frame: 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
• Device-related adverse events [ Time Frame: Measurements between 14+0 and 41+6 weeks gestational weeks ]
  Device-related adverse events (incidence, severity, and seriousness)

Original Secondary Outcome Measures (submitted: January 6, 2022)

• Cervical Stiffness Index (CSI, in mbar) [ Time Frame: Measurements between 14+0 and 31+6 weeks gestational weeks ]
• Elapsed time between [ Time Frame: Measurements between 14+0 and 31+6 weeks gestational weeks ]
  The elapsed time between when the subject got out of bed until the measurements were taken
• Device-related adverse events [ Time Frame: Measurements between 14+0 and 31+6 weeks gestational weeks ]
  Device-related adverse events (incidence, severity, and seriousness)

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Pregnolia System Intra-observer Variability
• Official Title: Intra-observer Variability in the Assessment of Cervical Stiffness With the Pregnolia System

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 Provided
• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: Pregnant women at gestational ages between 14+0 and 36+6 weeks.

Condition

• Cervix; Pregnancy
• Cervical Stiffness

Intervention

Device: Pregnolia System

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

Study Groups/Cohorts

• Nulliparous cohort
  Cervical stiffness will be measured in the same subject sequentially between days and during the same day and at different gestational ages.
  Intervention: 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.
  Intervention: Device: Pregnolia System

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: August 22, 2022): 30
• Original Estimated Enrollment (submitted: January 6, 2022): 10
• Estimated Study Completion Date: March 31, 2024
• Estimated Primary Completion Date: December 31, 2023 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 18 Years to 60 Years (Adult)
• Accepts Healthy Volunteers: Yes

Contacts

Contact: Laura Bernardi; +41 44 500 84 35; bernardi@pregnolia.com

• Listed Location Countries: Switzerland

Administrative Information

• NCT Number: NCT05200117
• Other Study ID Numbers: F-405-11 vs 3.0, 2023-07-21
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Current Responsible Party: Pregnolia AG
• Original Responsible Party: Same as current
• Current Study Sponsor: Pregnolia AG
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Pregnolia AG
• Verification Date: August 2022