Biomechanics Based Prediction of Preterm Delivery

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).

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Key information

Conditions

Preterm Delivery Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

18 year–60 year

Sex eligibility

Female

Study type

Observational

Primary location

University Hospital of Leuven, Leuven, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pregnolia System

Device

No intervention is done except for measuring the stiffness of the cervix in pregnant women

Primary outcomes

Difference in cervical stiffness in women with/without preterm delivery

Time frame: 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.

Sponsors and collaborators

Lead sponsor

David Scheiner

Other

Collaborators

Swiss Federal Institute of Technology
Universitaire Ziekenhuizen KU Leuven

Registry information

Acronym: Softcervix

Important dates

Study start: 2014
Primary completion: 2022
Study completion: 2022
First posted: Jan 15, 2014
Registry last updated: Dec 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed