Mapping the Uterine Cervix Stiffness of Pregnant Women at Mid Gestation

Last updated: November 6, 2024
Sponsor: Pregnolia AG
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Pregnolia System

Clinical Study ID

NCT05858775
F-405-11 v. 2.0, 2023-02-1
  • Ages 18-60
  • Female
  • Accepts Healthy Volunteers

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.

Eligibility Criteria

Inclusion

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

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 exclusioncriterion)

  • Cervical dilation ≥ 3 cm

  • Cerclage or pessary in place

  • Vaginal or cervical infections (to be excluded with the Amsel criteria)

Study Design

Total Participants: 30
Treatment Group(s): 1
Primary Treatment: Pregnolia System
Phase:
Study Start date:
July 05, 2023
Estimated Completion Date:
December 31, 2025

Connect with a study center

  • gynosense AG

    Uster,
    Switzerland

    Active - Recruiting

  • University Hospital Zurich

    Zürich,
    Switzerland

    Active - Recruiting

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