Mapping the Uterine Cervix Stiffness of Pregnant Women at Mid Gestation
NCT ID: NCT05858775
Last Updated: 2024-11-07
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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RECRUITING
30 participants
OBSERVATIONAL
2023-07-05
2025-12-31
Brief Summary
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The Pregnolia System is a CE-certified measuring device that objectively determines cervical stiffness using a slight negative pressure. The Pregnolia System was developed in Switzerland and resulted from a research project of the ETH and the University Hospital Zurich.
Until now, the stiffness of the cervix was examined and individually assessed by palpation (palpation with fingers). The Pregnolia System was developed to make this measurement objective and independent of the examining person.
The aim of the study is to measure cervical stiffness at different locations on the cervix to see if there are differences between the measurement locations.
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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
Nulliparous pregnant woman
Pregnolia System
Cervical stiffness assessment with the Pregnolia System at 3 locations on the uterine cervix.
Multiparous cohort
Multiparous pregnant woman
Pregnolia System
Cervical stiffness assessment with the Pregnolia System at 3 locations on the uterine cervix.
Interventions
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Pregnolia System
Cervical stiffness assessment with the Pregnolia System at 3 locations on the uterine cervix.
Eligibility Criteria
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Inclusion Criteria
* Pregnant woman at GA 16+0 - 22+6
* Singleton pregnancy
* 18 years or older
* Nulliparous cohort: nulliparous pregnant woman
* Multiparous cohort: multiparous pregnant woman
Exclusion Criteria
* Placenta praevia
* Severe vaginal bleeding
* Rupture of membranes before 34 weeks (to be excluded with pH test)
* Visible tissue scarring at the measurement locations\* 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
* Vaginal or cervical infections (to be excluded with the Amsel criteria)
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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gynosense AG
Uster, , Switzerland
University Hospital Zurich
Zurich, , Switzerland
Countries
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Central Contacts
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Facility Contacts
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Maki Kashiwagi, Dr. med.
Role: primary
Katharina Quack Lötscher, PD Dr. med.
Role: primary
Other Identifiers
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F-405-11 v. 2.0, 2023-02-1
Identifier Type: -
Identifier Source: org_study_id
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