Pregnolia System Intra-observer Variability

March 28, 2024 updated by: Pregnolia AG

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

26

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Frauenfeld, Switzerland, 8501
        • Kantonsspital Frauenfeld

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Measurements between 14+0 and 41+6 weeks gestational weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cervical Stiffness Index (CSI, in mbar)
Time Frame: Measurements between 14+0 and 41+6 weeks gestational weeks
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
Measurements between 14+0 and 41+6 weeks gestational weeks
Device-related adverse events
Time Frame: Measurements between 14+0 and 41+6 weeks gestational weeks
Device-related adverse events (incidence, severity, and seriousness)
Measurements between 14+0 and 41+6 weeks gestational weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pregnolia AG

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 12, 2022

Primary Completion (Actual)

December 17, 2023

Study Completion (Actual)

December 17, 2023

Study Registration Dates

First Submitted

January 6, 2022

First Submitted That Met QC Criteria

January 6, 2022

First Posted (Actual)

January 20, 2022

Study Record Updates

Last Update Posted (Actual)

March 29, 2024

Last Update Submitted That Met QC Criteria

March 28, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • F-405-11 vs 3.0, 2023-07-21

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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