Status:
COMPLETED
Pregnolia System Intra-observer Variability
Lead Sponsor:
Pregnolia AG
Conditions:
Cervix; Pregnancy
Cervical Stiffness
Eligibility:
FEMALE
18-60 years
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 h...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 12 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 17 2023
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT05200117
Start Date
January 12 2022
End Date
December 17 2023
Last Update
March 29 2024
Active Locations (1)
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1
Kantonsspital Frauenfeld
Frauenfeld, Switzerland, 8501