Cervix; Pregnancy
Conditions
Keywords
Cervical Stiffness
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.
Interventions
DEVICEPregnolia System
Cervical stiffness assessment with the Pregnolia System at 3 locations on the uterine cervix.
Sponsors
Pregnolia AG
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 60 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Delivery data | 1-4 weeks after delivery or termination of the pregnancy | Delivery data |
Countries
Switzerland
Outcome results
None listed