Mapping the Uterine Cervix Stiffness of Pregnant Women at Mid Gestation

Pregnolia AG30 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Cervix; Pregnancy

Interventions

Pregnolia SystemDEVICE

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

Eligibility

Medical Language ↔ Plain English

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)

Locations (2)

gynosense AG

Uster, Switzerland

University Hospital Zurich

Zurich, Switzerland

Outcomes

Primary Outcomes

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).

Time frame: 16+0 - 22+6 gestational weeks

Secondary Outcomes

Cervical Stiffness Index (repetition)

Cervical Stiffness Index (CSI, in mbar) measured 3 times at each location

Time frame: 16+0 - 22+6 gestational weeks and optional follow-up visits

Cervical Stiffness Index (cohort)

Cervical Stiffness Index (CSI, in mbar) for each cohort.

Time frame: 16+0 - 22+6 gestational weeks and optional follow-up visits

Delivery data

Time frame: 1-4 weeks after delivery or termination of the pregnancy