Biomechanics Based Prediction of Preterm Delivery (Softcervix)

David Scheiner

Status: Completed

Conditions: Preterm Delivery

Treatments: Device: Pregnolia System

Study type: Observational

Funder types: Other

Identifiers

NCT02037334

KEK-ZH 2013-0244

2013-MD-0036 (Other Identifier)

Details and patient eligibility

About

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).

Enrollment: 1,002 patients

Sex: Female

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

1,002 participants in 1 patient group

Pregnancy

Treatment:

Device: Pregnolia System