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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05200117
Other study ID # F-405-11 vs 3.0, 2023-07-21
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
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Recruiting NCT05306405 - Comparative Study Between Only Vaginal Misoprostol and Vaginal Misoprostol and Estradiol Cream Phase 1/Phase 2
Recruiting NCT03472066 - Measurement of the Cervix During Pregnancy According to Age of Conization
Recruiting NCT05246579 - Prospective Evaluation of Pathways for Preterm Birth
Recruiting NCT04444206 - Prevention of Preterm Birth by Screening of the Consistency Index and Length of the Uterine Cervix in Women With a Single Pregnancy N/A
Completed NCT05260333 - Sound Check-Correlation Between Transperineal and Digital Cervical Exam in 3rd Trimester Pregnancy N/A