Mapping the Uterine Cervix Stiffness of Pregnant Women at Mid Gestation

Study Overview
=================
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.

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

Conditions
-----------------
Cervix; Pregnancy

Intervention / Treatment
-----------------
* Device: Pregnolia System


Participation Criteria
=================
Eligibility Criteria
-----------------
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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Nulliparous cohort<br>Nulliparous pregnant woman | Device: Pregnolia System<br>* Cervical stiffness assessment with the Pregnolia System at 3 locations on the uterine cervix.<br>|
| Multiparous cohort<br>Multiparous pregnant woman | Device: Pregnolia System<br>* Cervical stiffness assessment with the Pregnolia System at 3 locations on the uterine cervix.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Cervical Stiffness Index (cohort) | Cervical Stiffness Index (CSI, in mbar) for each cohort. | 16+0 - 22+6 gestational weeks and optional follow-up visits | 
| Delivery data | Delivery data | 1-4 weeks after delivery or termination of the pregnancy | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cervical Stiffness