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Pregnolia System Intra-observer Variability

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

Study Description
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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.


Condition or disease Intervention/treatment
Cervix; Pregnancy Cervical Stiffness Device: Pregnolia System

Study Design
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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Intra-observer Variability in the Assessment of Cervical Stiffness With the Pregnolia System
Actual Study Start Date : January 12, 2022
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : March 31, 2024
Groups and Cohorts
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Group/Cohort Intervention/treatment
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
The cervical stiffness is measured with the Pregnolia System three times over a two-day period.
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
The cervical stiffness is measured with the Pregnolia System three times over a two-day period.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Cervical Stiffness Index (CSI, in mbar) [ Time Frame: Measurements between 14+0 and 41+6 weeks gestational weeks ]
  2. 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

  3. Device-related adverse events [ Time Frame: Measurements between 14+0 and 41+6 weeks gestational weeks ]
    Device-related adverse events (incidence, severity, and seriousness)


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Pregnant women at gestational ages between 14+0 and 36+6 weeks.
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05200117


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

Locations
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Switzerland
Kantonsspital Frauenfeld Recruiting
Frauenfeld, Switzerland, 8501
Contact: Gundula Hebisch, MD         
Sponsors and Collaborators
Pregnolia AG
More Information
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Responsible Party: Pregnolia AG
ClinicalTrials.gov Identifier: NCT05200117    
Other Study ID Numbers: F-405-11 vs 3.0, 2023-07-21
First Posted: January 20, 2022    Key Record Dates
Last Update Posted: August 25, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pregnolia AG:
Cervical Stiffness
Intra-Observer Variability
Pregnolia System
 Cervical Stiffness Index
CSI
Stiffness measurement