Biomechanics Based Prediction of Preterm Delivery

Preterm Delivery Clinical Trial

— Softcervix  

Official title:

Biomechanics Based Prediction of Preterm Delivery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02037334
• Other study ID #: KEK-ZH 2013-0244
• Secondary ID: 2013-MD-0036
• Status: Completed
• Start date: April 2014
• Est. completion date: December 8, 2022

Study information

• Verified date: December 2022
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1002
• Est. completion date: December 8, 2022
• Est. primary completion date: December 8, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Premature Birth
• Preterm Delivery

Intervention

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

Locations

Country	Name	City	State
Belgium	University Hospital of Leuven	Leuven
Switzerland	Kantonsspital Aarau, Frauenklinik	Aarau
Switzerland	Kantonsspital Baden, Frauenklinik	Baden
Switzerland	Universitätsspital Basel, Frauenklinik	Basel
Switzerland	Kantonsspital Frauenfeld, Frauenklinik	Frauenfeld
Switzerland	Hôpitaux universitaires de Genève (HUG)	Genève
Switzerland	Kantonsspital Luzern, Frauenklinik	Luzern
Switzerland	Kantonsspital Münsterlingen	Münsterlingen
Switzerland	Kantonsspital St. Gallen, Klinik für Gynäkologie und Geburtshilfe	St. Gallen
Switzerland	Kantonsspital Winterthur	Winterthur
Switzerland	Praxis Zollikon	Zollikon
Switzerland	Stadtspital Triemli, Frauenklinik	Zurich
Switzerland	University Hospital of Zurich, Dept. OB/Gyn	Zurich

Sponsors (3)

Lead Sponsor	Collaborator
David Scheiner	Swiss Federal Institute of Technology, Universitaire Ziekenhuizen KU Leuven

Countries where clinical trial is conducted

Belgium,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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