Mapping the Uterine Cervix Stiffness of Pregnant Women at Mid Gestation

NCT05858775 | Completed

• 1 other identifier: F-405-11 v. 2.0, 2023-02-1
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Cervical Stiffness

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Cervical Stiffness Index (repetition)

  16+0 - 22+6 gestational weeks and optional follow-up visits

• Cervical Stiffness Index (cohort)

  16+0 - 22+6 gestational weeks and optional follow-up visits

• Delivery data

  1-4 weeks after delivery or termination of the pregnancy

Study Arms (2)

Nulliparous cohort

Nulliparous pregnant woman

Device: Pregnolia System

Multiparous cohort

Multiparous pregnant woman

Device: Pregnolia System

Interventions

Pregnolia System DEVICE

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

Multiparous cohort; Nulliparous cohort

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant women at gestational ages between 16+0 - 22+6 weeks

You may qualify if:

• Informed Consent signed by the subject
• Pregnant woman at GA 16+0 - 22+6
• Singleton pregnancy
• years or older
• Nulliparous cohort: nulliparous pregnant woman
• Multiparous cohort: multiparous pregnant woman

You may not qualify if:

• 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
• Cervical dilation ≥ 3 cm
• Cerclage or pessary in place
• Vaginal or cervical infections (to be excluded with the Amsel criteria)

Sponsors & Collaborators

• Pregnolia AG: lead

Study Sites (2)

gynosense AG

Uster, Switzerland

Location

University Hospital Zurich

Zurich, Switzerland

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2023
• First Posted: May 15, 2023
• Study Start: July 5, 2023
• Primary Completion: October 10, 2025
• Study Completion: October 10, 2025
• Last Updated: February 5, 2026

Record last verified: 2026-02

Locations

CH (2)