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Biomechanics Based Prediction of Preterm Delivery (Softcervix)

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ClinicalTrials.gov Identifier: NCT02037334
Recruitment Status : Recruiting
First Posted : January 15, 2014
Last Update Posted : March 4, 2020
Sponsor:
Collaborators:
Universitaire Ziekenhuizen Leuven
Swiss Federal Institute of Technology
Information provided by (Responsible Party):
David Scheiner, University of Zurich

Study Description
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Brief 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).

Condition or disease Intervention/treatment
Preterm Delivery Device: Pregnolia System

Study Design
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Study Type : Observational
Estimated Enrollment : 763 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Biomechanics Based Prediction of Preterm Delivery
Actual Study Start Date : April 2014
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021
Groups and Cohorts
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Group/Cohort Intervention/treatment
Pregnancy Device: Pregnolia System
No intervention is done except for measuring the stiffness of the cervix in pregnant women


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
All pregnant women at our institutions between 18+0/7 and 22+0/7 weeks of pregnancy and postpartum
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02037334


Contacts
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Contact: David A Scheiner, MD 00 41 44 255 93 08 david.scheiner@usz.ch
Contact: Simone Kälin simone.kaelin@kssg.ch

Locations
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Belgium
University Hospital of Leuven Recruiting
Leuven, Belgium, 3000
Contact: Jute Richter, MD    003216340829    jute.richter@uzleuven.be   
Principal Investigator: Jan Deprest, Prof.         
Sub-Investigator: Jute Richter, MD         
Sub-Investigator: Sander Galjaard         
Sub-Investigator: Julio Jimenez         
Switzerland
Kantonsspital Aarau, Frauenklinik Recruiting
Aarau, Switzerland
Contact: Monya Todesco, MD         
Principal Investigator: Monia Tedesco         
Kantonsspital Baden, Frauenklinik Recruiting
Baden, Switzerland
Contact: Leonard Schäffer, MD         
Principal Investigator: Leonard Schäffer, MD         
Universitätsspital Basel, Frauenklinik Recruiting
Basel, Switzerland
Contact: Irene Hösli, Prof.         
Principal Investigator: Irene Hösli, Prof.         
Kantonsspital Frauenfeld, Frauenklinik Recruiting
Frauenfeld, Switzerland
Contact: Gundula Hebisch, MD         
Principal Investigator: Gundula Hebisch         
Hôpitaux universitaires de Genève (HUG) Recruiting
Genève, Switzerland
Contact: Begona Martinez de Tejeda, Prof         
Kantonsspital Luzern, Frauenklinik Recruiting
Luzern, Switzerland
Contact: Alice Winkler, MD         
Principal Investigator: Alice Winkler, MD         
Kantonsspital Münsterlingen Recruiting
Münsterlingen, Switzerland
Contact: Markus Kuther, MD         
Kantonsspital St. Gallen, Klinik für Gynäkologie und Geburtshilfe Recruiting
St. Gallen, Switzerland
Contact: Tina Fischer, MD         
Kantonsspital Winterthur Recruiting
Winterthur, Switzerland
Contact: Elke Prentl, MD         
Praxis Zollikon Recruiting
Zollikon, Switzerland
Contact: Alexander Krafft, MD         
University Hospital of Zurich, Dept. OB/Gyn Recruiting
Zurich, Switzerland, 8091
Contact: David A Scheiner, MD    0041442559308    david.scheiner@usz.ch   
Principal Investigator: Roland Zimmermann, Prof.         
Sub-Investigator: Kathrin Rohling         
Sub-Investigator: Katarina Quack         
Stadtspital Triemli, Frauenklinik Recruiting
Zurich, Switzerland
Contact: Stephanie von Orelli, MD         
Principal Investigator: Stephanie von Orelli         
Sponsors and Collaborators
David Scheiner
Universitaire Ziekenhuizen Leuven
Swiss Federal Institute of Technology
Investigators
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Principal Investigator: David A Scheiner, MD University of Zurich
More Information
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Responsible Party: David Scheiner, Sponsor-Investigator, University of Zurich
ClinicalTrials.gov Identifier: NCT02037334    
Other Study ID Numbers: KEK-ZH 2013-0244
2013-MD-0036 ( Other Identifier: Swissmedic )
First Posted: January 15, 2014    Key Record Dates
Last Update Posted: March 4, 2020
Last Verified: March 2020
Keywords provided by David Scheiner, University of Zurich:
Preterm delivery
Diagnostics
Biomechanics
Additional relevant MeSH terms:
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Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications