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Biomechanics Based Prediction of Preterm Delivery

NCT02037334 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1002

Last updated 2022-12-09

No results posted yet for this study

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. 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

Interventions

DEVICE

Pregnolia System

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

Sponsors & Collaborators

  • Universitaire Ziekenhuizen KU Leuven

    collaborator OTHER

  • Swiss Federal Institute of Technology

    collaborator OTHER

  • David Scheiner

    lead OTHER

Principal Investigators

  • David A Scheiner, MD · University of Zurich

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-04-30
Primary Completion
2022-12-08
Completion
2022-12-08

Countries

  • Belgium
  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02037334 on ClinicalTrials.gov