Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
26 participants
OBSERVATIONAL
2022-01-12
2023-12-17
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Nulliparous cohort
Cervical stiffness will be measured in the same subject sequentially between days and during the same day and at different gestational ages.
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.
Pregnolia System
The cervical stiffness is measured with the Pregnolia System three times over a two-day period.
Interventions
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Pregnolia System
The cervical stiffness is measured with the Pregnolia System three times over a two-day period.
Eligibility Criteria
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Inclusion Criteria
* Pregnant woman
* Singleton pregnancy
* 18 years or older
* Nulliparous cohort: nulliparous pregnant woman
* Multiparous cohort: multiparous pregnant woman
Exclusion Criteria
* 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
18 Years
60 Years
FEMALE
Yes
Sponsors
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Pregnolia AG
INDUSTRY
Responsible Party
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Locations
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Kantonsspital Frauenfeld
Frauenfeld, , Switzerland
Countries
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Other Identifiers
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F-405-11 vs 3.0, 2023-07-21
Identifier Type: -
Identifier Source: org_study_id
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