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OpenTrials
Completed

NCT Number: NCT00342550

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

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.

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Key information

Age range

15 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Hutzel Women's Hospital

Detroit, Michigan, 48201, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • INCLUSION CRITERIA - PRETERM LABOR AND INTACT MEMBRANES:
  • Singleton gestation;
  • Estimated gestational age between 20 and 35 weeks gestation;

3 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 < 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.

Treatment and study plan

Primary outcomes

  1. 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

    Data analysis is ongoing

Sponsors and collaborators

Lead sponsor

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

Nih

Registry information

Important dates

Study start
1998
Primary completion
2008
Study completion
2008
First posted
Jun 21, 2006
Registry last updated
Feb 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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