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

Pregnolia

Status

Completed

Conditions

Cervix; Pregnancy

Treatments

Device: Pregnolia System

Study type

Observational

Funder types

Industry

Identifiers

NCT05858775

F-405-11 v. 2.0, 2023-02-1

Details and patient eligibility

About

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.

Enrollment

30 patients

Sex

Female

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

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)