Cervix; PregnancyMAPVIXNCT05858775
Mapping the Uterine Cervix Stiffness of Pregnant Women at Mid Gestation
An observational study of Cervix; Pregnancy, run by Pregnolia AG at 2 sites in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cervix; Pregnancy
- What is being tested?
- Pregnolia System
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 2 sitesSwitzerland
- Study dates
- 5 Jul 2023to 10 Oct 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Pregnant women at gestational ages between 16+0 - 22+6 weeks
Who may be able to join
- 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
Who cannot join
- 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)
Show all 9Show fewer
- Cervical dilation ≥ 3 cm
- Cerclage or pessary in place
- Vaginal or cervical infections (to be excluded with the Amsel criteria)
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: MAPVIX: Mapping the Uterine Cervix Stiffness of Pregnant Women at Mid Gestation
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.
Read more
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.
- Conditions
- Cervix; Pregnancy
- Being tested
- Pregnolia System
- Keywords
- Cervical Stiffness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pregnolia SystemDevice
Cervical stiffness assessment with the Pregnolia System at 3 locations on the uterine cervix.
| Study group | Role | What they receive |
|---|---|---|
| Nulliparous cohort | Nulliparous pregnant woman Receives: Device: Pregnolia System | |
| Multiparous cohort | Multiparous pregnant woman Receives: Device: Pregnolia System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 16+0 - 22+6 gestational weeks
Secondary outcomes (3)
Cervical Stiffness Index (repetition)
Cervical Stiffness Index (CSI, in mbar) measured 3 times at each location
Measured: 16+0 - 22+6 gestational weeks and optional follow-up visits
Cervical Stiffness Index (cohort)
Cervical Stiffness Index (CSI, in mbar) for each cohort.
Measured: 16+0 - 22+6 gestational weeks and optional follow-up visits
Delivery data
Delivery data
Measured: 1-4 weeks after delivery or termination of the pregnancy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2023
- Study start5 Jul 2023
- Primary completion10 Oct 2025
- Study completion10 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervix; PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pregnolia AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05858775
- Sponsor's protocol ID
- F-405-11 v. 2.0, 2023-02-1
- Acronym
- MAPVIX
- Status last verified
- Feb 2026
- First submitted
- 3 May 2023
- Last updated
- 5 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MAPVIX: Mapping the Uterine Cervix Stiffness of Pregnant Women at Mid Gestation
- ClinicalTrials.gov ID
- NCT05858775
- Acronym / sponsor ID
- MAPVIX / F-405-11 v. 2.0, 2023-02-1
- Conditions
- Cervix; Pregnancy
- Keywords
- Cervical Stiffness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Pregnolia AGIndustry (pharma, biotech, devices)
- Study start
- 5 Jul 2023 (actual)
- Primary completion
- 10 Oct 2025 (actual)
- Study completion
- 10 Oct 2025 (actual)
- First posted
- 15 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nulliparous cohort | – | Device: Pregnolia SystemNulliparous pregnant woman |
| Multiparous cohort | – | Device: Pregnolia SystemMultiparous pregnant woman |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Pregnant women at gestational ages between 16+0 - 22+6 weeks
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pregnolia SystemCervical stiffness assessment with the Pregnolia System at 3 locations on the uterine cervix. | Device | Multiparous cohort, Nulliparous cohort |
Primary outcome
Cervical Stiffness Index at 16+0 - 22+6
Time frame: 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).
3 secondary outcomes
Cervical Stiffness Index (repetition)
Time frame: 16+0 - 22+6 gestational weeks and optional follow-up visits
Cervical Stiffness Index (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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervix; Pregnancy, run by Pregnolia AG at 2 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cervical Stiffness Index at 16+0 - 22+6 (time frame: 16+0 - 22+6 gestational weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2026.