MedDataX Logo

Biomechanics Based Prediction of Preterm Delivery

NCT ID: NCT02037334

Last Updated: 2022-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

1002 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-04-30

Study Completion Date

2022-12-08

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Preterm Delivery

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Preterm delivery Diagnostics Biomechanics

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Pregnancy

Pregnolia System

Intervention Type DEVICE

No intervention is done except for measuring the stiffness of the cervix in pregnant women

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Pregnolia System

No intervention is done except for measuring the stiffness of the cervix in pregnant women

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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.

Exclusion Criteria

* 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
* Placenta praevia
* Müllerian anomalies
* known or suspected non-compliance, drug or alcohol abuse
* cerclage
* use of pessary
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role collaborator

Swiss Federal Institute of Technology

OTHER

Sponsor Role collaborator

David Scheiner

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

David Scheiner

Sponsor-Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

David A Scheiner, MD

Role: PRINCIPAL_INVESTIGATOR

University of Zurich

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University Hospital of Leuven

Leuven, , Belgium

Site Status

Kantonsspital Aarau, Frauenklinik

Aarau, , Switzerland

Site Status

Kantonsspital Baden, Frauenklinik

Baden, , Switzerland

Site Status

Universitätsspital Basel, Frauenklinik

Basel, , Switzerland

Site Status

Kantonsspital Frauenfeld, Frauenklinik

Frauenfeld, , Switzerland

Site Status

Hôpitaux universitaires de Genève (HUG)

Geneva, , Switzerland

Site Status

Kantonsspital Luzern, Frauenklinik

Lucerne, , Switzerland

Site Status

Kantonsspital Münsterlingen

Münsterlingen, , Switzerland

Site Status

Kantonsspital St. Gallen, Klinik für Gynäkologie und Geburtshilfe

Sankt Gallen, , Switzerland

Site Status

Kantonsspital Winterthur

Winterthur, , Switzerland

Site Status

Praxis Zollikon

Zollikon, , Switzerland

Site Status

University Hospital of Zurich, Dept. OB/Gyn

Zurich, , Switzerland

Site Status

Stadtspital Triemli, Frauenklinik

Zurich, , Switzerland

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Belgium Switzerland

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2013-MD-0036

Identifier Type: OTHER

Identifier Source: secondary_id

KEK-ZH 2013-0244

Identifier Type: -

Identifier Source: org_study_id