CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 36 enrolled
Drug / intervention
Ultrasound imaging +1 moreprocedure
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/NCT03865108
NCT03865108N/ACompleted

Quantifying the Mechanical Environment of Pregnancy Complicated With a Short Cervix With Ultrasound Imaging and Aspiration - Ancillary Study to the Trial of Pessary in Singleton Pregnancies Trial

Columbia University·interventional·Posted Mar 6, 2019·Updated Sep 23, 2024

In Brief

A clinical study evaluating Ultrasound imaging and Cervical speculum examination for Preterm Birth. Completed, enrolled 36 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPreterm Birth
CountriesUnited States

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedMar 6, 2019
Enrollment StartJun 5, 2017
Primary CompletionJan 23, 2021
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 7.3 years ago

Interventions

Ultrasound imagingprocedure

This standard of care procedure is being done for research purposes and used to collect information and measure the maternal and fetal anatomy.

Cervical speculum examinationprocedure

This standard of care procedure is being done for research purposes and used to collect tissue and measure the strength and stiffness of cervix.