MedTrace Logo

Cervical Volume by Three-Dimensional Ultrasound as a Predictor of Preterm Delivery

NCT00342550 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 648

Last updated 2023-02-24

No results posted yet for this study

Summary

Preterm labor is a leading cause of perinatal morbidity and mortality. Several investigators have reported that ultrasound evaluation of the cervix can predict the risk of preterm delivery. Three-dimensional ultrasound may provide additional information about how to best counsel parents about the chances of premature birth. This technology has the capability for accurate volume measurements of irregular structures that is superior to conventional ultrasound. Therefore, it is possible that three-dimensional ultrasound methods may better characterize cervical changes and the risk for preterm delivery.

Our protocol will attempt to identify prognostic indicators of adverse pregnancy outcome by three-dimensional ultrasound. A maximum of 680 pregnant women with the diagnosis of preterm labor will be prospectively studied to characterize cervical morphology and volume as predictors of preterm delivery risk. These results will be correlated with placental pathology and pregnancy outcome. We will also compare the performance of conventional two-dimensional endovaginal ultrasound with three-dimensional ultrasound findings. This information is expected to improve our understanding about the nature and timing of cervical volume changes in relation to pregnancy outcome.

Conditions

Sponsors & Collaborators

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

    lead NIH

Principal Investigators

  • Roberto Romero, M.D. · Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Eligibility

Min Age
15 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
1998-03-11
Primary Completion
2008-05-01
Completion
2008-05-01

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT00342550 on ClinicalTrials.gov