Pregnolia System Intra-observer Variability

Pregnolia

Status

Completed

Conditions

Cervical Stiffness

Cervix; Pregnancy

Treatments

Device: Pregnolia System

Study type

Observational

Funder types

Industry

Identifiers

NCT05200117

F-405-11 vs 3.0, 2023-07-21

Details and patient eligibility

About

The Pregnolia System is a CE-marked medical device assessing the mechanical stiffness of cervical tissue in women. The Pregnolia Probe has been engineered to minimize the influence of differences in handling and technique by the user.

This project aims to study intra-observer variability of the Pregnolia System in pregnant women in the clinical setting.

Furthermore, a same day repeated measurement serves to investigate the time period needed to recover the pre-measurement stiffness state due to viscoelasticity of the cervical tissue.

Enrollment

26 patients

Sex

Female

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Informed Consent signed by the subject
Pregnant woman
Singleton pregnancy
18 years or older
Nulliparous cohort: nulliparous pregnant woman
Multiparous cohort: multiparous pregnant woman

Exclusion criteria

Lack of informed consent
Placenta praevia totalis with haemorrhage (irrespective of severity)
Severe vaginal bleeding
Rupture of membranes before 34 weeks (to be excluded with pH test)
Visible tissue scarring at 12 o'clock position 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