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Mechanical Environment Pregnancy With Short Cervix

NCT03865108 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2024-09-23

No results posted yet for this 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.

Conditions

Interventions

PROCEDURE

Ultrasound imaging

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

PROCEDURE

Cervical speculum examination

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

Sponsors & Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • Columbia University

    lead OTHER

Principal Investigators

  • Kristin Myers, PhD · Associate Professor of Mechanical Engineering

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-06-05
Primary Completion
2021-01-23
Completion
2021-01-23

Countries

  • United States

Study Locations

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Diseases
Companies

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 NCT03865108 on ClinicalTrials.gov