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Clinical trialNCT00298480UnknownObservational

Dynamic Cervical Change: Prediction of Preterm Labor in Symptomatic Patients

SponsorMemorial Health Services Research CouncilEnrollment220Dynamic Cervical Change in Preterm Labor Patients
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

Transvaginal ultrasound of the cervix has become a common tool to evaluate patients who are at risk for preterm delivery. A shortened cervical length has been associated with an increased risk of preterm delivery. Dynamic cervical change is visible shortening(\>6mm) of the cervix seen during the ultrasound examination. Prior studies have shown that the presence of dynamic change in patients with a shortened cervical length(\<3cm) is not independently predictive of preterm delivery. However, a subset of patients with normal initial cervical length(\>3cm) and dynamic change did demonstrate an increased rate of preterm delivery. Because this was a small sub-group, the present study was designed to obtain a larger sample size for further evaluation. The second focus of this study involves patients with a dilated cervix and whether cervical length adds predictive value to gestational age at delivery. Patients presenting to with symptomatic preterm labor(vaginal pressure or uterine contractions), who consent to the study, will undergo the standard evaluation for preterm labor(described in detail below.) The only additional evaluation is a prolonged transvaginal ultrasound of approximately 10 minutes to evaluate for the presence of dynamic change during a contraction. Null hypothesis: Symptomatic preterm labor patients, with normal initial cervical length(\>3cm), who exhibit dynamic cervical change deliver at a gestational age equal to those without dynamic change. Alternative hypothesis: Symptomatic preterm labor patients, with normal initial cervical length(\>3cm), who exhibit dynamic cervical change deliver at an earlier gestational age than those without dynamic change.

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

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Sites

3 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States
  • Saddleback Memorial Medical Center

    Laguna Hills, California, United States

    James Kurtzman, M.D.
    Recruiting
  • Long Beach Memorial Medical Center

    Long Beach, California, United States

    Recruiting
  • University of California, Irvine Medical Center

    Orange, California, United States

    Not, yet, recruiting

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

No drug or biological interventions are in our data for this study. It may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
28 Feb 2005
Primary completion
—
Completion
31 Jul 2007
Last update posted
19 Apr 2007
Registered enrollment
220
Registry id
NCT00298480

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.