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Cervical Stiffness Measurement in Cervical Insufficiency

NCT04158401 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 136

Last updated 2022-09-21

No results posted yet for this study

Summary

The goal of this cross sectional study is to evaluate the differences in cervical stiffness between patients who present for cerclage placement versus normal pregnancies.

The central hypothesis is that women for whom a cerclage is indicated will have cervical stiffness measurements lower than normal controls. Cervical stiffness will be objectively measured by the closing pressure Pcl using the Pregnolia measurement device. This is performed during a speculum exam by placing the measurement probe on the ectocervix.

In current clinical care, there is no objective measurement of cervical stiffness. An accurate measurement of cervical stiffness that correlates with clinical outcome will advance the field. Successful completion of the current study will spark future studies that correlate cervical stiffness pcl in a prospective study.

Conditions

Interventions

DEVICE

Pregnolia

The Pregnolia measurement device (CE Mark for commercialization in the EU) will be used to measure the cervical stiffness (Pcl) on all subjects.

Sponsors & Collaborators

  • Pregnolia AG

    collaborator INDUSTRY

  • Tufts Medical Center

    lead OTHER

Principal Investigators

  • Michael House, MD · Tufts Medical Center

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-01-15
Primary Completion
2022-06-15
Completion
2022-06-15

Countries

  • United States

Study Locations

More Related Trials

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 NCT04158401 on ClinicalTrials.gov