Dynamic Cervical Change: Prediction of Preterm Labor in Symptomatic Patients
|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.|
|ClinicalTrials.gov Identifier: NCT00298480|
Recruitment Status : Unknown
Verified April 2007 by Memorial Health Services Research Council.
Recruitment status was: Recruiting
First Posted : March 2, 2006
Last Update Posted : April 19, 2007
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.
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.
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.
|Condition or disease|
|Dynamic Cervical Change in Preterm Labor Patients|
|Study Type :||Observational|
|Enrollment :||220 participants|
|Observational Model:||Case Control|
|Study Start Date :||February 2005|
|Estimated Study Completion Date :||July 2007|
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): NCT00298480
|Contact: Charlotte A Clock, M.D.||email@example.com|
|United States, California|
|Saddleback Memorial Medical Center||Recruiting|
|Laguna Hills, California, United States, 92653|
|Contact: James Kurtzman, M.D. 949-452-7199 firstname.lastname@example.org|
|Principal Investigator: James Kurtzman, M.D.|
|Long Beach Memorial Medical Center||Recruiting|
|Long Beach, California, United States, 90806|
|Contact: Charlotte A Clock, M.D. 562-933-2730 email@example.com|
|University of California, Irvine Medical Center||Not yet recruiting|
|Orange, California, United States, 92868|
|Contact: Charlotte Clock, M.D. 714-456-5967 firstname.lastname@example.org|
|Principal Investigator:||Charlotte A Clock, M.D.||University of California, Irvine|
|Principal Investigator:||James Kurtzman, M.D.||University of California, Irvine|