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Softcervix: Biomechanics Based Prediction of Preterm Delivery

Sponsor
David Scheiner (Other)
Overall Status
Recruiting
CT.gov ID
NCT02037334
Collaborator
Universitaire Ziekenhuizen Leuven (Other), Swiss Federal Institute of Technology (Other)
763
Enrollment
13
Locations
93
Anticipated Duration (Months)
58.7
Patients Per Site
0.6
Patients Per Site Per Month

Study Details

Study Description

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 Phase
  • Device: Pregnolia System

Study Design

Study Type:
Observational
Anticipated Enrollment :
763 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Biomechanics Based Prediction of Preterm Delivery
Actual Study Start Date :
Apr 1, 2014
Anticipated Primary Completion Date :
Dec 31, 2021
Anticipated Study Completion Date :
Dec 31, 2021

Arms and Interventions

Arm Intervention/Treatment
Pregnancy

Device: Pregnolia System
No intervention is done except for measuring the stiffness of the cervix in pregnant women

Outcome Measures

Primary Outcome Measures

  1. Difference in cervical stiffness in women with/without preterm delivery [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

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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

Locations

Site City State Country Postal Code
1 University Hospital of Leuven Leuven Belgium 3000
2 Kantonsspital Aarau, Frauenklinik Aarau Switzerland
3 Kantonsspital Baden, Frauenklinik Baden Switzerland
4 Universitätsspital Basel, Frauenklinik Basel Switzerland
5 Kantonsspital Frauenfeld, Frauenklinik Frauenfeld Switzerland
6 Hôpitaux universitaires de Genève (HUG) Genève Switzerland
7 Kantonsspital Luzern, Frauenklinik Luzern Switzerland
8 Kantonsspital Münsterlingen Münsterlingen Switzerland
9 Kantonsspital St. Gallen, Klinik für Gynäkologie und Geburtshilfe St. Gallen Switzerland
10 Kantonsspital Winterthur Winterthur Switzerland
11 Praxis Zollikon Zollikon Switzerland
12 University Hospital of Zurich, Dept. OB/Gyn Zurich Switzerland 8091
13 Stadtspital Triemli, Frauenklinik Zurich Switzerland

Sponsors and Collaborators

  • David Scheiner
  • Universitaire Ziekenhuizen Leuven
  • Swiss Federal Institute of Technology

Investigators

  • Principal Investigator: David A Scheiner, MD, University of Zurich

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
David Scheiner, Sponsor-Investigator, University of Zurich
ClinicalTrials.gov Identifier:
NCT02037334
Other Study ID Numbers:
  • KEK-ZH 2013-0244
  • 2013-MD-0036
First Posted:
Jan 15, 2014
Last Update Posted:
Apr 27, 2021
Last Verified:
Apr 1, 2021
Keywords provided by David Scheiner, Sponsor-Investigator, University of Zurich
Preterm delivery
Diagnostics
Biomechanics
Additional relevant MeSH terms:
Premature Birth

Study Results

No Results Posted as of Apr 27, 2021