Biomechanics Based Prediction of Preterm Delivery (Softcervix)

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 Overview

• Status: Completed
• Conditions: Preterm Delivery
• Intervention / Treatment: Device: Pregnolia System

• Study Type: Observational
• Enrollment (Actual): 1002

Contacts and Locations

Study Locations

• Belgium
  • Leuven, Belgium, 3000
    • University Hospital of Leuven
• Switzerland
  • Aarau, Switzerland
    • Kantonsspital Aarau, Frauenklinik
  • Baden, Switzerland
    • Kantonsspital Baden, Frauenklinik
  • Basel, Switzerland
    • Universitatsspital Basel, Frauenklinik
  • Frauenfeld, Switzerland
    • Kantonsspital Frauenfeld, Frauenklinik
  • Genève, Switzerland
    • Hopitaux Universitaires de Geneve (HUG)
  • Luzern, Switzerland
    • Kantonsspital Luzern, Frauenklinik
  • Münsterlingen, Switzerland
    • Kantonsspital Münsterlingen
  • St. Gallen, Switzerland
    • Kantonsspital St. Gallen, Klinik für Gynäkologie und Geburtshilfe
  • Winterthur, Switzerland
    • Kantonsspital Winterthur
  • Zollikon, Switzerland
    • Praxis Zollikon
  • Zurich, Switzerland, 8091
    • University Hospital of Zurich, Dept. OB/Gyn
  • Zurich, Switzerland
    • Stadtspital Triemli, Frauenklinik

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• 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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Pregnancy	Device: Pregnolia System; No intervention is done except for measuring the stiffness of the cervix in pregnant women

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Measurements between 18+0/7 and 22+0/7 weeks of pregnancy and postpartum

Collaborators and Investigators

• Sponsor: David Scheiner
• Collaborators: Universitaire Ziekenhuizen KU Leuven; Swiss Federal Institute of Technology
• Investigators: Principal Investigator: David A Scheiner, MD, University of Zurich

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2014
• Primary Completion (Actual): December 8, 2022
• Study Completion (Actual): December 8, 2022

Study Registration Dates

• First Submitted: January 13, 2014
• First Submitted That Met QC Criteria: January 14, 2014
• First Posted (Estimate): January 15, 2014

Study Record Updates

• Last Update Posted (Estimate): December 9, 2022
• Last Update Submitted That Met QC Criteria: December 8, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: Biomechanics; Diagnostics; Preterm delivery
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Premature Birth
• Other Study ID Numbers: KEK-ZH 2013-0244; 2013-MD-0036 (Other Identifier: Swissmedic)