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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05858775
Other study ID # F-405-11 v. 2.0, 2023-02-1
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date July 5, 2023
Est. completion date December 31, 2024

Study information

Verified date July 2023
Source Pregnolia AG
Contact Laura Bernardi
Phone +41 44 500 84 35
Email bernardi@pregnolia.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The assessment of cervical stiffness plays a major role in obstetrics, for example to assess the risk of preterm birth. 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date December 31, 2024
Est. primary completion date October 31, 2024
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 at GA 16+0 - 22+6 - Singleton pregnancy - 18 years or older - Nulliparous cohort: nulliparous pregnant woman - Multiparous cohort: multiparous pregnant woman Exclusion Criteria: - Lack of informed consent - 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)

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Pregnolia System
Cervical stiffness assessment with the Pregnolia System at 3 locations on the uterine cervix.

Locations

Country Name City State
Switzerland gynosense AG Uster
Switzerland University Hospital Zurich Zürich

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 at 16+0 - 22+6 Cervical Stiffness Index (CSI, in mbar) measured at 3 locations on the cervix (approximately 12, 4 and 8 o'clock, in a random order) at mid-pregnancy (16+0 - 22+6 gestational weeks). 16+0 - 22+6 gestational weeks
Secondary Cervical Stiffness Index (repetition) Cervical Stiffness Index (CSI, in mbar) measured 3 times at each location 16+0 - 22+6 gestational weeks and optional follow-up visits
Secondary Cervical Stiffness Index (cohort) Cervical Stiffness Index (CSI, in mbar) for each cohort. 16+0 - 22+6 gestational weeks and optional follow-up visits
Secondary Delivery data Delivery data 1-4 weeks after delivery or termination of the pregnancy
See also
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Completed NCT05200117 - Pregnolia System Intra-observer Variability
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