Biomechanics Based Prediction of Preterm Delivery

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02037334

Acronym

Softcervix

Enrollment

1002

Registered

2014-01-15

Start date

2014-04-30

Completion date

2022-12-08

Last updated

2022-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Preterm Delivery

Keywords

Preterm delivery, Diagnostics, Biomechanics

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).

Interventions

DEVICEPregnolia System

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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 60 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

Belgium, Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026