Mapping the Uterine Cervix Stiffness of Pregnant Women at Mid Gestation

Recruiting

• Conditions: Cervix; Pregnancy
• Interventions: Device: Pregnolia System

• Registration Number: NCT05858775
• Lead Sponsor: Pregnolia AG

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-05-03
• Study First Submitted QC: 2023-05-12
• Study First Posted: 2023-05-15
• Study Start: 2023-07-05
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-06
• Last Update Posted: 2024-11-07
• Primary Completion: 2025-10-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 30

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Multiparous cohort	Pregnolia System	Multiparous pregnant woman
Nulliparous cohort	Pregnolia System	Nulliparous pregnant woman

Primary Outcome Measures

Name	Time	Method
Cervical Stiffness Index at 16+0 - 22+6	16+0 - 22+6 gestational weeks	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).

Secondary Outcome Measures

Name	Time	Method
Delivery data	1-4 weeks after delivery or termination of the pregnancy	Delivery data
Cervical Stiffness Index (repetition)	16+0 - 22+6 gestational weeks and optional follow-up visits	Cervical Stiffness Index (CSI, in mbar) measured 3 times at each location
Cervical Stiffness Index (cohort)	16+0 - 22+6 gestational weeks and optional follow-up visits	Cervical Stiffness Index (CSI, in mbar) for each cohort.

Trial Locations

Locations (2)

gynosense AG; 🇨🇭 Uster, Switzerland

University Hospital Zurich; 🇨🇭 Zürich, Switzerland