Mapping the Uterine Cervix Stiffness of Pregnant Women at Mid Gestation

Cervix; Pregnancy Clinical Trial

— MAPVIX  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05858775
• Other study ID #: F-405-11 v. 2.0, 2023-02-1
• Status: Recruiting
• Start date: July 5, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: July 2023
• Source: Pregnolia AG
• Contact: Laura Bernardi
• Phone: +41 44 500 84 35
• Email: bernardi[@]pregnolia.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 31, 2024
• Est. primary completion date: October 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

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)

Related Conditions & MeSH terms

• Cervix; Pregnancy

Intervention

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

Locations

Country	Name	City	State
Switzerland	gynosense AG	Uster
Switzerland	University Hospital Zurich	Zürich

Sponsors (1)

Lead Sponsor	Collaborator
Pregnolia AG

Country where clinical trial is conducted

Switzerland, 

Outcome

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