Biomechanics Based Prediction of Preterm Delivery

Completed

• Conditions: Preterm Delivery
• Interventions: Device: Pregnolia System

• Registration Number: NCT02037334
• Lead Sponsor: David Scheiner

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-01-13
• Study First Submitted QC: 2014-01-14
• Study First Posted: 2014-01-15
• Study Start: 2014-04
• Status Verified: 2022-12
• Primary Completion: 2022-12-08
• Study Completion: 2022-12-08
• Last Update Submitted: 2022-12-08
• Last Update Posted: 2022-12-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1002

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pregnancy	Pregnolia System	-

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (13)

Praxis Zollikon; 🇨🇭 Zollikon, Switzerland

Kantonsspital Aarau, Frauenklinik; 🇨🇭 Aarau, Switzerland

Hôpitaux universitaires de Genève (HUG); 🇨🇭 Genève, Switzerland

University Hospital of Leuven; 🇧🇪 Leuven, Belgium

Universitätsspital Basel, Frauenklinik; 🇨🇭 Basel, Switzerland

Kantonsspital Baden, Frauenklinik; 🇨🇭 Baden, Switzerland

Kantonsspital Frauenfeld, Frauenklinik; 🇨🇭 Frauenfeld, Switzerland

Kantonsspital Luzern, Frauenklinik; 🇨🇭 Luzern, Switzerland

Kantonsspital St. Gallen, Klinik für Gynäkologie und Geburtshilfe; 🇨🇭 St. Gallen, Switzerland

Kantonsspital Winterthur; 🇨🇭 Winterthur, Switzerland

University Hospital of Zurich, Dept. OB/Gyn; 🇨🇭 Zurich, Switzerland

Stadtspital Triemli, Frauenklinik; 🇨🇭 Zurich, Switzerland

Kantonsspital Münsterlingen; 🇨🇭 Münsterlingen, Switzerland