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NCT03865108 · ClinicalTrials.gov registry record · NA
Mechanical Environment Pregnancy With Short Cervix
A NA study, sponsored by Columbia University.
- Completed
- Registry status
- NA
- Development phase
- 36
- Enrollment target
NCT03865108: Completed NA study, sponsored by Columbia University.
NCT03865108 is a NA study that has completed, run by Columbia University. The registered enrollment target is 36 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03865108, a NA study, has completed, sponsored by Columbia University.
- COMPLETED
- Registry status
- NA
- Development phase
- 36 participants
- Enrollment target
Study Summary
The objective of this study is to quantify the mechanical environment of pregnancies complicated by a short cervix and randomized in the Trial of Pessary in Singleton Pregnancies with a Short Cervix study with ultrasound imaging and aspiration. Aim 1: To determine the biomechanical properties of a prematurely remodeled cervix. Aim 2: To determine the impact of pessary placement on the biomechanical properties of a prematurely remodeled cervix and establish if the pessary reduces the mechanical load on the cervix through computer modeling informed by ultrasonographic measurement and cervical stiffness measurements. Aim 3: To determine if the differences in the cervical biomechanical properties after pessary placement lead to improved birth outcomes as compared to the progesterone only group.
Primary Outcome
The mechanical compliance index of the cervix is the percentage of the cervical tissue above a 1.2 stretch threshold under a uniform IUP. This index is calculated using finite element computational methods, given the maternal anatomy and cervical stiffness measured from the aspiration tool. The mechanical compliance index of the cervix will be measured at both time points within the study timeframe, and the change of the mechanical compliance index between the two time points will be assessed. T
Interventions
- PROCEDURE Ultrasound imaging
- PROCEDURE Cervical speculum examination
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2017-06-05 |
| Est. Completion | 2021-01-23 |
| Phase | NA |
What the finished NCT03865108 record still lists
NCT03865108 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 2 interventions - of which Ultrasound imaging is the first listed.
NCT03865108 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03865108 about?
NCT03865108 is a clinical study titled "Mechanical Environment Pregnancy With Short Cervix". The objective of this study is to quantify the mechanical environment of pregnancies complicated by a short cervix and randomized in the Trial of Pessary in Singleton Pregnancies with a Short Cervix study with ultrasound imaging and aspiration. Aim 1: To determine the biomechanical properties of a ...
What is the current status of trial NCT03865108?
This trial is currently completed. It is a NA study. The enrollment target is 36 participants. The study started on 2017-06-05. Estimated completion is 2021-01-23.
What interventions are being tested in trial NCT03865108?
The interventions under investigation include: Ultrasound imaging (PROCEDURE), Cervical speculum examination (PROCEDURE).
Who is sponsoring clinical trial NCT03865108?
This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03865108's enrollment target sits among peer trials
36 1541st of 2000 higher than 437 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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