CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 136 enrolled
Drug / intervention
Pregnoliadevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04158401
NCT04158401N/ACompleted

Cervical Stiffness Measurement in Cervical Insufficiency

Tufts Medical Center·observational·Posted Nov 8, 2019·Updated Sep 21, 2022

In Brief

An observational study evaluating Pregnolia for Pregnancy Related and 2 related conditions. Completed, enrolled 136 participants across 1 site.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsPregnolia AG

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedNov 8, 2019
Enrollment StartJan 15, 2020
Primary CompletionJun 15, 2022
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 6.6 years ago

Interventions

Pregnoliadevice

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