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Mapping the Uterine Cervix Stiffness of Pregnant Women at Mid Gestation

NCT05858775 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2026-02-05

No results posted yet for this study

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.

Conditions

  • Cervix; Pregnancy

Interventions

DEVICE

Pregnolia System

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

Sponsors & Collaborators

  • Pregnolia AG

    lead INDUSTRY

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-07-05
Primary Completion
2025-10-10
Completion
2025-10-10

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05858775 on ClinicalTrials.gov