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Cervical Softening and the Prediction of Preterm Birth

NCT05477381 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 390

Last updated 2023-09-05

No results posted yet for this study

Summary

Currently, transvaginal cervical length measurement is used to screen in asymptomatic pregnant women with a history of PTB. In symptomatic women, presenting with threatened PTB cervical length in combination with the fibronectin test is used to identify women at high risk to deliver preterm. However, the predictive capacity of transvaginal cervical length measurement is limited. In pregnant women with a history of PTB, it only identifies a proportion of women who will have recurrent PTB. For symptomatic women, 30-60% of these women admitted to the hospital, do not deliver within seven days, leading to overtreatment of these women.

Cervical softening is precursor of cervical shortening, effacement and dilatation and therefore cervical softening is a promising new marker that is based on tissue elasticity. However, the predictive value of cervical softening and the relation with spontaneous PTB still has to be determined. With the newly developed Pregnolia® System cervical softness could be measured on a standardized and safe manner. This study could help to improve care for women with a history of spontaneous PTB.

Conditions

  • Preterm Birth
  • Threatened Preterm Labor
  • Premature Birth
  • Premature Labor
  • Diagnosis
  • Cervical Incompetence, With Delivery
  • Cervical Incompetence in Pregnancy as Antepartum Condition

Interventions

DIAGNOSTIC_TEST

Measurement of cervical stiffness by Pregnolia Device

The Pregnolia® System is designed to provide information about the mechanical properties of the cervical tissue by assessing the CSI (Cervical Stiffness Index) through a probe that will create a weak vacuum to retract tissue. The Pregnolia® System is designed with the purpose to provide an alternative diagnostic marker to identify women at risk of spontaneous PTB. The Pregnolia® System is a CE-marked device developed for quantitative assessment of softening of the uterine cervix. The Pregnolia® System will be applied within its intended use.

Sponsors & Collaborators

  • Pregnolia AG

    collaborator INDUSTRY

  • Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

    lead OTHER

Principal Investigators

  • Eva Pajkrt, Prof. Dr. · Amsterdam UMC, location AMC

  • Martijn Oudijk, Prof. Dr. · Amsterdam UMC, location AMC

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-18
Primary Completion
2024-09-30
Completion
2024-12-31

Countries

  • Netherlands

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05477381 on ClinicalTrials.gov