Preterm DeliverySoftcervixNCT02037334
Biomechanics Based Prediction of Preterm Delivery
An observational study of Preterm Delivery, run by David Scheiner at 13 sites in 2 countries.
Trial summary
Quantitative information on the biomechanical properties of the ecto-cervix in mid-pregnancy will be compared between women with term vs. preterm delivery. We aim to demonstrate that biomechanical data (ASP and CCI) might complement morphological data (CL) to improve prediction of preterm delivery. 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
- Preterm Delivery
- What is being tested?
- Pregnolia System
- Type of treatment
- Medical device
- How many people
- 1,002 participants
- Where
- 13 sitesin 2 countries
- Study dates
- Apr 2014to 8 Dec 2022
- 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: All pregnant women at our institutions between 18+0/7 and 22+0/7 weeks of pregnancy and postpartum
Who may be able to join
- All pregnant women presenting at their mid pregnancy consultation (18+0 - 22+0 weeks of pregnancy) are eligible
- Signed informed consent after being informed is a prerequisite for enrollment.
Who cannot join
- Communication problems
- Missing consent
- Age<18
- Active bleeding / Premature Rupture of Membranes (PROM)
- Active genital infection
- Known carrier of HIV or Hepatitis B or C
Show all 11Show fewer
- Placenta praevia
- Müllerian anomalies
- known or suspected non-compliance, drug or alcohol abuse
- cerclage
- use of pessary
Trial locations and contacts
13 sites in 2 countries.
13 sites in 2 countries
Switzerland12 sites
Kantonsspital Aarau, Frauenklinik
Aarau
Kantonsspital Baden, Frauenklinik
Baden
Universitätsspital Basel, Frauenklinik
Basel
Kantonsspital Frauenfeld, Frauenklinik
Frauenfeld
Hôpitaux universitaires de Genève (HUG)
Geneva
Kantonsspital Luzern, Frauenklinik
Lucerne
Kantonsspital Münsterlingen
Münsterlingen
Kantonsspital St. Gallen, Klinik für Gynäkologie und Geburtshilfe
Sankt Gallen
Kantonsspital Winterthur
Winterthur
Praxis Zollikon
Zollikon
University Hospital of Zurich, Dept. OB/Gyn
Zurich, 8091
Stadtspital Triemli, Frauenklinik
Zurich
About this study
Quantitative information on the biomechanical properties of the ecto-cervix in mid-pregnancy will be compared between women with term vs. preterm delivery. We aim to demonstrate that biomechanical data (ASP and CCI) might complement morphological data (CL) to improve prediction of preterm delivery. It is expected that women with preterm delivery will show stronger weakening of cervical tissue. Aspiration (ASP) and cervical CCI (cervical consistency index) measurements are performed at mid-pregnancy: detection at this time point is useful for therapy and biomechanical modifications are already significant so to enable differentiation by biomechanical measurements (ASP and CCI).
- Conditions
- Preterm Delivery
- Being tested
- Pregnolia System
- Keywords
- Preterm delivery, Diagnostics, Biomechanics
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pregnolia SystemDevice
No intervention is done except for measuring the stiffness of the cervix in pregnant women
| Study group | Role | What they receive |
|---|---|---|
| Pregnancy | Not described Receives: Device: Pregnolia System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in cervical stiffness in women with/without preterm delivery
The biomechanical measurements and morphological data obtained at mid-pregnancy are compared between women with/without preterm delivery and are expected to significantly differ. The diagnostic power for preterm delivery of aspiration, CCI and the other factors will be determined.
Measured: Measurements between 18+0/7 and 22+0/7 weeks of pregnancy and postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2014 (estimated)
- Study startApr 2014
- Primary completion8 Dec 2022
- Study completion8 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm DeliveryStudies 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
- 1,002 participants (actual)
Sponsor and investigators
- Lead sponsor
- David Scheiner
- Sponsor type
- University, hospital or other
- Collaborators
- Universitaire Ziekenhuizen KU Leuven, Swiss Federal Institute of Technology
- Responsible party
- Sponsor-investigator, David Scheiner, University of Zurich
- Investigators
- David A Scheiner, MD, Principal investigator, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02037334
- Sponsor's protocol ID
- KEK-ZH 2013-0244
- Other IDs
- 2013-MD-0036
- Acronym
- Softcervix
- Status last verified
- Dec 2022
- First submitted
- 13 Jan 2014
- Last updated
- 9 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomechanics Based Prediction of Preterm Delivery
- ClinicalTrials.gov ID
- NCT02037334
- Acronym / sponsor ID
- Softcervix / KEK-ZH 2013-0244
- Conditions
- Preterm Delivery
- Keywords
- Preterm delivery, Diagnostics, Biomechanics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,002 participants (actual)
- Lead sponsor
- David ScheinerUniversity, hospital or other
- Collaborators
- Universitaire Ziekenhuizen KU Leuven, Swiss Federal Institute of Technology
- Study start
- Apr 2014 (actual)
- Primary completion
- 8 Dec 2022 (actual)
- Study completion
- 8 Dec 2022 (actual)
- First posted
- 15 Jan 2014 (estimated)
- 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.
Quantitative information on the biomechanical properties of the ecto-cervix in mid-pregnancy will be compared between women with term vs. preterm delivery. We aim to demonstrate that biomechanical data (ASP and CCI) might complement morphological data (CL) to improve prediction of preterm delivery. It is expected that women with preterm delivery will show stronger weakening of cervical tissue. Aspiration (ASP) and cervical CCI (cervical consistency index) measurements are performed at mid-pregnancy: detection at this time point is useful for therapy and biomechanical modifications are already significant so to enable differentiation by biomechanical measurements (ASP and CCI).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pregnancy | – | Device: Pregnolia System |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- All pregnant women at our institutions between 18+0/7 and 22+0/7 weeks of pregnancy and postpartum
Key inclusion criteria (2 listed)
- All pregnant women presenting at their mid pregnancy consultation (18+0 - 22+0 weeks of pregnancy) are eligible
- Signed informed consent after being informed is a prerequisite for enrollment.
Key exclusion criteria (11 listed)
- Communication problems
- Missing consent
- Age<18
- Active bleeding / Premature Rupture of Membranes (PROM)
- Active genital infection
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 SystemNo intervention is done except for measuring the stiffness of the cervix in pregnant women | Device | Pregnancy |
Primary outcome
Difference in cervical stiffness in women with/without preterm delivery
Time frame: Measurements between 18+0/7 and 22+0/7 weeks of pregnancy and postpartum
The biomechanical measurements and morphological data obtained at mid-pregnancy are compared between women with/without preterm delivery and are expected to significantly differ. The diagnostic power for preterm delivery of aspiration, CCI and the other factors will be determined.
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 9 Dec 2022.
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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.
David A Scheiner, MD principal investigator
University of Zurich
13 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Preterm Delivery, run by David Scheiner at 13 sites in 2 countries.
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 2 inclusion and 11 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 9 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Switzerland, Belgium. 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?
Difference in cervical stiffness in women with/without preterm delivery (time frame: Measurements between 18+0/7 and 22+0/7 weeks of pregnancy and postpartum). 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 9 Dec 2022.