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NCT00342550

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

Completed Last updated 24 February 2023
What this trial tests

trial in Pregnancy in 648 participants. Completed in 1 May 2008.

Timeline
11 March 1998
Primary endpoint
1 May 2008
1 May 2008

Quick facts

Lead sponsorEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
StatusCompleted
Study typeOBSERVATIONAL
Enrollment648
Start date11 March 1998
Primary completion1 May 2008
Estimated completion1 May 2008
Sites1 location across United States

Conditions studied

Sponsor

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

Who can join

15 and older, female only, with Pregnancy or Preterm Birth. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own 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 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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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