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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00342550
First Posted: June 21, 2006
Last Update Posted: October 27, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) )
  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: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cervical Volume by Three-Dimensional Ultrasound as a Predictor of Preterm Delivery

Further study details as provided by National Institutes of Health Clinical Center (CC) ( Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) ):

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 ]

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 ]
  • 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 ]

Estimated Enrollment: 680
Study Start Date: March 17, 1998
Detailed Description:

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 maternal and fetal biological markers, 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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA - PRETERM LABOR AND INTACT MEMBRANES:

    1. Singleton gestation;
    2. Estimated gestational age between 20 and 35 weeks gestation;

    3 Intact membranes;

    4. Signed informed consent for voluntary participation and serial endovaginal scans.

EXCLUSION CRITERIA - PRETERM LABOR AND INTACT MEMBRANES:

  1. Absent fetal cardiac activity;
  2. Desire not to have vaginal ultrasound scans.

INCLUSION CRITERIA - PATIENTS AT RISK FOR PRETERM DELIVERY:

  1. Estimated gestational age between 16 and < 24 weeks gestation;
  2. Planned cerclage placement due to increased preterm labor risk (i.e., short cervix or dilated cervix);
  3. Intact membranes;
  4. Signed informed consent for voluntary participation and serial endovaginal scans.

EXCLUSION CRITERIA - PATIENTS AT RISK FOR PRETERM DELIVERY:

  1. Absent fetal cardiac activity;
  2. Desire not to have vaginal ultrasound scans.

INCLUSION CRITERIA - PATIENTS IN SPONTANEOUS LABOR AT TERM:

  1. Term gestation (greater than 37 weeks);
  2. Intact membranes;
  3. Cervical dilatation less than 2 cm;
  4. Signed informed consent for voluntary participation and serial endovaginal scans.

EXCLUSION CRITERIA - PATIENTS IN SPONTANEOUS LABOR AT TERM:

  1. Absent fetal cardiac activity;
  2. Desire not to have vaginal ultrasound scans.

INCLUSION CRITERIA - PATIENTS UNDERGOING ELECTIVE INDUCTION OF LABOR:

  1. Term gestation (greater than 37 weeks);
  2. Intact membranes;
  3. Signed informed consent for voluntary participation and serial endovaginal scans.

EXCLUSION CRITERIA - PATIENTS UNDERGOING ELECTIVE INDUCTION OF LABOR:

  1. Absent fetal cardiac activity;
  2. Desire not to have vaginal ultrasound scans.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00342550


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

Publications:
Responsible Party: 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
First Submitted: June 19, 2006
First Posted: June 21, 2006
Last Update Posted: October 27, 2017
Last Verified: October 17, 2017

Keywords provided by National Institutes of Health Clinical Center (CC) ( Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) ):
Pregnancy
Preterm Birth
Pregnancy Complications

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