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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) )
ClinicalTrials.gov Identifier:
NCT00342550
First received: June 19, 2006
Last updated: December 18, 2014
Last verified: November 2014
  Purpose

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.


Condition
Pregnancy
Preterm Delivery
Cervical Length Measurement

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Cervical Volume by Three-Dimensional Ultrasound as a Predictor of Preterm Delivery

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • Document cervical volume and funneling changes in women with preterm labor. Determine the relationship between cervical volume and funneling changes to the risk of preterm delivery. [ Time Frame: Ongoing ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Study inter- and intraobserver agreement for cervical and funnel volume measurements by 3DUS. Describe the sonographic anatomy of the cervix with 3DUS. Describe the changes in cervix anatomy and dimensions during normal labor at term with 3DUS. [ Time Frame: Ongoing ] [ Designated as safety issue: No ]
  • Determine the effect of cervical cerclage on cervical and cervical funnel volume as assessed by 3DUS. Determine diagnostic value of cervical 3DUS in assessing risk of preterm delivery improved with information provided by biological markers. [ Time Frame: Ongoing ] [ Designated as safety issue: No ]

Estimated Enrollment: 680
Study Start Date: March 1998
Detailed Description:

The studies conducted from data obtained under this protocol have been used to identify prognostic indicators of pregnancy complications by three-dimensional ultrasound (3DUS). Pregnant women were prospectively studied to characterize cervical morphology and volume as predictors of preterm delivery risk. We will continue to correlate these results with maternal and fetal biological markers, placental pathology and pregnancy outcome. The performance of conventional two-dimensional endovaginal ultrasound with three-dimensional ultrasound findings has been examined. The information derived from this protocol is expected to improve our understanding of the nature and timing of cervical change in relation to normal and adverse pregnancy.

  Eligibility

Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA - PRETERM LABOR AND INTACT MEMBRANES:

Singleton gestation;

Estimated gestational age between 20 and 35 weeks gestation;

Intact membranes;

Signed informed consent for voluntary participation and serial endovaginal scans.

EXCLUSION CRITERIA - PRETERM LABOR AND INTACT MEMBRANES:

Absent fetal cardiac activity;

Desire not to have vaginal ultrasound scans.

INCLUSION CRITERIA - PATIENTS AT RISK FOR PRETERM DELIVERY:

Estimated gestational age between 16 and less than 24 weeks gestation;

Planned cerclage placement due to increased preterm labor risk (i.e., short cervix or dilated cervix);

Intact membranes;

Signed informed consent for voluntary participation and serial endovaginal scans.

EXCLUSION CRITERIA - PATIENTS AT RISK FOR PRETERM DELIVERY:

Absent fetal cardiac activity;

Desire not to have vaginal ultrasound scans.

INCLUSION CRITERIA - PATIENTS IN SPONTANEOUS LABOR AT TERM:

Term gestation (greater than 37 weeks);

Intact membranes;

Cervical dilatation less than 2 cm;

Signed informed consent for voluntary participation and serial endovaginal scans.

EXCLUSION CRITERIA - PATIENTS IN SPONTANEOUS LABOR AT TERM:

Absent fetal cardiac activity;

Desire not to have vaginal ultrasound scans.

INCLUSION CRITERIA - PATIENTS UNDERGOING ELECTIVE INDUCTION OF LABOR:

Term gestation (greater than 37 weeks);

Intact membranes;

Signed informed consent for voluntary participation and serial endovaginal scans.

EXCLUSION CRITERIA - PATIENTS UNDERGOING ELECTIVE INDUCTION OF LABOR:

Absent fetal cardiac activity;

Desire not to have vaginal ultrasound scans.

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00342550

Locations
United States, Michigan
Hutzel Women's Hospital
Detroit, Michigan, United States, 48201
Sponsors and Collaborators
Investigators
Principal Investigator: Roberto Romero, M.D. Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  More Information

Publications:
Responsible Party: National Institutes of Health Clinical Center (CC) ( Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) )
ClinicalTrials.gov Identifier: NCT00342550     History of Changes
Other Study ID Numbers: 999998016, OH98-CH-N016
Study First Received: June 19, 2006
Last Updated: December 18, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Pregnancy
Preterm Birth
Pregnancy Complications

Additional relevant MeSH terms:
Premature Birth
Obstetric Labor Complications
Obstetric Labor, Premature
Pregnancy Complications

ClinicalTrials.gov processed this record on August 27, 2015