Cervical InsufficiencyPilotProPreNCT07541313
Cervical Stiffness Assessment in High-risk Pregnancies for Preterm Birth
An observational study of Cervical Insufficiency and Cervical Stiffness, run by Luzerner Kantonsspital at 1 site in Switzerland.
Trial summary
Cervical length is usually measured using ultrasound, and if it is shortened, hormone therapy (progesterone) is recommended to reduce the risk of premature birth. The investigators want to find out what cervical stiffness is like in women with a shortened cervical length before and during hormone therapy. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervical Insufficiency, Cervical Stiffness
- How many people
- 21 participants
- Where
- 1 siteSwitzerland
- Study dates
- 27 Jul 2023to 29 Sep 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: pregnant women
Who may be able to join
- Informed consent signed by the participant
- Pregnant women more or equal to 18 years of age.
- Singleton gestation
- Weeks of pregnancy between 16 weeks 0 days and 32 weeks and 0 days
- Cervix less or equal to 25 mm (inferior to the 5th centile at 25 wp)
- No regular contractions
- Planned progesterone treatment
Who cannot join
- Cognitively impaired adults
- Cerclage or pessary on place
- Ongoing progesterone (if continued or started after 13+0 wp) treatment
- Multiple pregnancies
- Placenta praevia totalis with hemorrhage (irrespective of severity)
- Vasa praevia
Show all 15Show fewer
- Light bleeding (if the bleeding can be stopped it is no longer an exclusion criterion)
- Heavy vaginal bleeding, hematoma or chorioamniotic membrane separation
- Rupture of membranes (exclusion with ROM+ test if PPROM is suspected)
- History of cervical surgery only if visible scaring at 12 o'clock
- Cervical dilation more equal to 3 cm
- Signs of chorioamnionitis
- Symptomatic genital infection
- Known carrier of HIV or Hepatitis B/C
- Fetal malformations
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study of Cervical Stiffness Assessment With an Aspiration-based Device in High-risk Pregnancies for Preterm Birth
Cervical length is usually measured using ultrasound, and if it is shortened, hormone therapy (progesterone) is recommended to reduce the risk of premature birth.
The investigators want to find out what cervical stiffness is like in women with a shortened cervical length before and during hormone therapy. The investigators believe that this measurement will help to better assess the risk of premature birth in the future.
Read the detailed description
This is a prospective, non-interventional, post-market monocentric clinical investigation in a Swiss hospital (Lucerne Cantonal Hospital) to measure cervical stiffness on women at high risk of premature birth, defined as women with a cervical length less or equal to 25 mm presenting between 16+0 wp and 32 wp.
Cervical stiffness will be measured as Cervical Stiffness Index (CSI) using the Pregnolia System.
The primary objective is an initial characterization of the distribution of the median Cervical Stiffness Index (CSI, in mbar), corresponding to the median of three consecutive measurements at each presentation at pregnant women of gestational age between 16weeks 0 days and 32weeks 0 days with a cervical length less or equal to 25 mm before the initiation of progesterone treatment. Day 1 is when study inclusion criteria are met, informed consent is obtained and the first Cervical Stiffness Index is carried out.
Secondary objectives
- At each presentation three consecutive CSI measurements will be carried out and as a secondary objective the first, the highest, lowest and mean measurement will be analyzed for each secondary outcome.
- Evaluation of Cervical Stiffness Index 1, 2, 3 (CSI, in mbar) on day 10-14 and on day 24-28 after initiation of progesterone treatment, which is defined as day 1; further follow-up is not mandatory, but possible
- Determination of a first estimate of the correlation of the initial CSI and CSI changes with birth outcome (gestational age at birth)
- Determination of a first estimate of the correlation of CSI with cervical length (longer cervical length stiffer?)
- Determination of first signals for potential associations of CSI with additional treatments for preterm birth (tocolysis, cerclage, pessary)
- Determination of first signals for potential associations of CSI with neonatal outcome (birth weight, APGAR, arterial pH, admission to neonatal intensive care)
- Safety objective: safety of the device, by assessing incidence, severity, and seriousness of device-related adverse events (discomfort, bleeding, lesion, irritation).
- Conditions
- Cervical Insufficiency, Cervical Stiffness
- Keywords
- cervical insufficiency, cervical stiffness, short cervix, cervical lenght, preterm birth risk
- Medical subject headings
- Uterine Cervical Incompetence
What is being measured
The primary outcome is the main question the study is designed to answer.
cervical stiffness index (mbar) at enrollment
The median of three consecutive Cervical Stiffness Index (CSI, in mbar) measurements at gestational age of 16weeks 0 days up to 32weeks 0 days before progesterone start
Measured: 1 day
Secondary outcomes (2)
cervical stiffness index (mbar) at enrollment
The first, the highest, the lowest and the mean of three consecutive Cervical Stiffness Index (CSI, in mbar) measurements at gestational age of 16weeks 0 days up to 32weeks 0 days before progesterone start
Measured: 1 day
cervical stiffness index (mbar) follow-up after progesterone start
The median, the first, the highest, the lowest and the mean of three consecutive Cervical Stiffness Index (CSI, in mbar) measurements at two follow-up visits after 10 to 14 days
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2026
- Study start27 Jul 2023
- Primary completion29 Sep 2025
- Study completion29 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cervical InsufficiencyStudies 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
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Luzerner Kantonsspital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gülseven Gül, Luzerner Kantonsspital
- Investigators
- Gülseven Gül, MD, Principal investigator, Luzerner Kantonsspital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07541313
- Sponsor's protocol ID
- 2023-00032
- Other IDs
- 2023
- Acronym
- PilotProPre
- Status last verified
- May 2026
- First submitted
- 15 Feb 2026
- Last updated
- 29 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: This requires a permission of the Swiss Ethics Committee which needs to be requested.
Publications
Badir S, Mazza E, Zimmermann R, Bajka M. Cervical softening occurs early in pregnancy: characterization of cervical stiffness in 100 healthy women using the aspiration technique. Prenat Diagn. 2013 Aug;33(8):737-41. doi: 10.1002/pd.4116. Epub 2013 Apr 29.
PubMed 23553612Badir S, Bajka M, Mazza E. A novel procedure for the mechanical characterization of the uterine cervix during pregnancy. J Mech Behav Biomed Mater. 2013 Nov;27:143-53. doi: 10.1016/j.jmbbm.2012.11.020. Epub 2012 Dec 11.
PubMed 23274486Badir S, Bernardi L, Feijo Delgado F, Quack Loetscher K, Hebisch G, Hoesli I. Aspiration technique-based device is more reliable in cervical stiffness assessment than digital palpation. BMC Pregnancy Childbirth. 2020 Jul 6;20(1):391. doi: 10.1186/s12884-020-03080-x.
PubMed 32631265
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Cervical Stiffness Assessment With an Aspiration-based Device in High-risk Pregnancies for Preterm Birth
- ClinicalTrials.gov ID
- NCT07541313
- Acronym / sponsor ID
- PilotProPre / 2023-00032
- Conditions
- Cervical Insufficiency, Cervical Stiffness
- Keywords
- cervical insufficiency, cervical stiffness, short cervix, cervical lenght, preterm birth risk
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Luzerner KantonsspitalUniversity, hospital or other
- Study start
- 27 Jul 2023 (actual)
- Primary completion
- 29 Sep 2025 (actual)
- Study completion
- 29 Sep 2025 (actual)
- First posted
- 21 Apr 2026 (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.
Cervical length is usually measured using ultrasound, and if it is shortened, hormone therapy (progesterone) is recommended to reduce the risk of premature birth.
The investigators want to find out what cervical stiffness is like in women with a shortened cervical length before and during hormone therapy. The investigators believe that this measurement will help to better assess the risk of premature birth in the future.
Detailed description
This is a prospective, non-interventional, post-market monocentric clinical investigation in a Swiss hospital (Lucerne Cantonal Hospital) to measure cervical stiffness on women at high risk of premature birth, defined as women with a cervical length less or equal to 25 mm presenting between 16+0 wp and 32 wp.
Cervical stiffness will be measured as Cervical Stiffness Index (CSI) using the Pregnolia System.
The primary objective is an initial characterization of the distribution of the median Cervical Stiffness Index (CSI, in mbar), corresponding to the median of three consecutive measurements at each presentation at pregnant women of gestational age between 16weeks 0 days and 32weeks 0 days with a cervical length less or equal to 25 mm before the initiation of progesterone treatment. Day 1 is when study inclusion criteria are met, informed consent is obtained and the first Cervical Stiffness Index is carried out.
Secondary objectives
- At each presentation three consecutive CSI measurements will be carried out and as a secondary objective the first, the highest, lowest and mean measurement will be analyzed for each secondary outcome.
- Evaluation of Cervical Stiffness Index 1, 2, 3 (CSI, in mbar) on day 10-14 and on day 24-28 after initiation of progesterone treatment, which is defined as day 1; further follow-up is not mandatory, but possible
- Determination of a first estimate of the correlation of the initial CSI and CSI changes with birth outcome (gestational age at birth)
- Determination of a first estimate of the correlation of CSI with cervical length (longer cervical length stiffer?)
- Determination of first signals for potential associations of CSI with additional treatments for preterm birth (tocolysis, cerclage, pessary)
- Determination of first signals for potential associations of CSI with neonatal outcome (birth weight, APGAR, arterial pH, admission to neonatal intensive care)
- Safety objective: safety of the device, by assessing incidence, severity, and seriousness of device-related adverse events (discomfort, bleeding, lesion, irritation).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- pregnant women
Key inclusion criteria (7 listed)
- Informed consent signed by the participant
- Pregnant women more or equal to 18 years of age.
- Singleton gestation
- Weeks of pregnancy between 16 weeks 0 days and 32 weeks and 0 days
- Cervix less or equal to 25 mm (inferior to the 5th centile at 25 wp)
Key exclusion criteria (15 listed)
- Cognitively impaired adults
- Cerclage or pessary on place
- Ongoing progesterone (if continued or started after 13+0 wp) treatment
- Multiple pregnancies
- Placenta praevia totalis with hemorrhage (irrespective of severity)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
cervical stiffness index (mbar) at enrollment
Time frame: 1 day
The median of three consecutive Cervical Stiffness Index (CSI, in mbar) measurements at gestational age of 16weeks 0 days up to 32weeks 0 days before progesterone start
2 secondary outcomes
cervical stiffness index (mbar) at enrollment
Time frame: 1 day
cervical stiffness index (mbar) follow-up after progesterone start
Time frame: 28 days
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 29 May 2026.
- Background: PubMed 23553612Badir S, Mazza E, Zimmermann R, Bajka M. Cervical softening occurs early in pregnancy: characterization of cervical stiffness in 100 healthy women using the aspiration technique. Prenat Diagn. 2013 Aug;33(8):737-41. doi: 10.1002/pd.4116. Epub 2013 Apr 29.
- Background: PubMed 23274486Badir S, Bajka M, Mazza E. A novel procedure for the mechanical characterization of the uterine cervix during pregnancy. J Mech Behav Biomed Mater. 2013 Nov;27:143-53. doi: 10.1016/j.jmbbm.2012.11.020. Epub 2012 Dec 11.
- Background: PubMed 32631265Badir S, Bernardi L, Feijo Delgado F, Quack Loetscher K, Hebisch G, Hoesli I. Aspiration technique-based device is more reliable in cervical stiffness assessment than digital palpation. BMC Pregnancy Childbirth. 2020 Jul 6;20(1):391. doi: 10.1186/s12884-020-03080-x.
- medical device websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. This requires a permission of the Swiss Ethics Committee which needs to be requested.
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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.
Gülseven Gül, MD principal investigator
Luzerner Kantonsspital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Insufficiency and Cervical Stiffness, run by Luzerner Kantonsspital at 1 site 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 7 inclusion and 15 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 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 (mbar) at enrollment (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07541313, which also lists 3 linked publications.
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 29 May 2026.