NCT05858775

Mapping the Uterine Cervix Stiffness of Pregnant Women at Mid Gestation

MAPVIX: Mapping the Uterine Cervix Stiffness of Pregnant Women at Mid Gestation

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 30 (actual)
• Sponsor: Pregnolia AG · Industry
• Sex: Female
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
DEVICE	Pregnolia System	Cervical stiffness assessment with the Pregnolia System at 3 locations on the uterine cervix.

Timeline

• Start date: 2023-07-05
• Primary completion: 2025-10-10
• Completion: 2025-10-10
• First posted: 2023-05-15
• Last updated: 2026-02-05

Locations

2 sites across 1 country: Switzerland