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NCT04158401 · ClinicalTrials.gov registry record
Cervical Stiffness Measurement in Cervical Insufficiency
A clinical trial, sponsored by Tufts Medical Center.
- Completed
- Registry status
- 136
- Enrollment target
NCT04158401: Completed study, sponsored by Tufts Medical Center.
NCT04158401 is a clinical trial that has completed, run by Tufts Medical Center. The registered enrollment target is 136 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04158401 has completed, sponsored by Tufts Medical Center.
- COMPLETED
- Registry status
- 136 participants
- Enrollment target
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.
Primary Outcome
The primary outcome will be cervical stiffness, Pcl in patients presenting for cerclage versus normal controls.
Interventions
- DEVICE Pregnolia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 136 participants |
| Start Date | 2020-01-15 |
| Est. Completion | 2022-06-15 |
What the finished NCT04158401 record still lists
NCT04158401 is an observational study that tracks outcomes without assigning an intervention. The registered 136 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 1 intervention - of which Pregnolia is the first listed.
NCT04158401 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04158401 about?
NCT04158401 is a clinical study titled "Cervical Stiffness Measurement in Cervical Insufficiency". 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 norma...
What is the current status of trial NCT04158401?
This trial is currently completed. The enrollment target is 136 participants. The study started on 2020-01-15. Estimated completion is 2022-06-15.
What interventions are being tested in trial NCT04158401?
The interventions under investigation include: Pregnolia (DEVICE).
Who is sponsoring clinical trial NCT04158401?
This trial is sponsored by Tufts Medical Center, which has 169 total clinical trials registered on ClinicalTrials.gov.
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