Measuring cervical stiffness in pregnant women during mid-pregnancy
MAPVIX: Mapping the Uterine Cervix Stiffness of Pregnant Women at Mid Gestation
This study is testing a new device to measure how stiff the cervix is in pregnant women between 16 and 22 weeks to see if it can help understand risks for preterm birth.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | Female |
| Sponsor | Pregnolia AG Industry-sponsored |
| Locations | 2 sites (Uster and 1 other locations) |
| Trial ID | NCT05858775 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess cervical stiffness in pregnant women between 16 and 22 weeks of gestation using the Pregnolia System, a CE-certified device that measures stiffness objectively through slight negative pressure. The study will evaluate differences in stiffness at various locations on the cervix, moving away from traditional palpation methods that are subjective and dependent on the examiner's skill. By providing objective measurements, the study seeks to improve the understanding of cervical conditions that may affect pregnancy outcomes, particularly the risk of preterm birth.
Who should consider this trial
Good fit: Ideal candidates for this study are pregnant women aged 18 and older, with a singleton pregnancy, at gestational ages between 16 and 22 weeks.
Not a fit: Patients with conditions such as placenta praevia, severe vaginal bleeding, or cervical dilation of 3 cm or more may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better risk assessment for preterm birth in pregnant women.
How similar studies have performed: While the Pregnolia System represents a novel approach to measuring cervical stiffness, similar studies have shown the importance of cervical assessment in predicting pregnancy outcomes.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Uster and 1 other locations
- gynosense AG — Uster, Switzerland (Recruiting)
- University Hospital Zurich — Zürich, Switzerland (Recruiting)
Study contacts
- Study coordinator: Laura Bernardi
- Email: bernardi@pregnolia.com
- Phone: +41 44 500 84 35
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.