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Sponsored by: |
Memorial Health Services Research Council |
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Information provided by: | Memorial Health Services Research Council |
ClinicalTrials.gov Identifier: | NCT00298480 |
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.
Condition |
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Dynamic Cervical Change in Preterm Labor Patients |
Study Type: | Observational |
Study Design: | Longitudinal, Case Control, Prospective Study |
Ages Eligible for Study: | 18 Years to 45 Years |
Genders Eligible for Study: | Female |
Inclusion Criteria:
Exclusion Criteria:
Contact: Charlotte A Clock, M.D. | 714-456-5967 | cclock@uci.edu |
United States, California | |
Saddleback Memorial Medical Center | Recruiting |
Laguna Hills, California, United States, 92653 | |
Contact: James Kurtzman, M.D. 949-452-7199 jtk@stanfordalumni.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 cclock@uci.edu | |
University of California, Irvine Medical Center | Not yet recruiting |
Orange, California, United States, 92868 | |
Contact: Charlotte Clock, M.D. 714-456-5967 cclock@uci.edu |
Principal Investigator: | Charlotte A Clock, M.D. | University of California, Irvine Medical Center |
Principal Investigator: | James Kurtzman, M.D. | University of California, Irvine Medical Center |
Study ID Numbers: | 230-04s |
Study First Received: | March 1, 2006 |
Last Updated: | April 18, 2007 |
ClinicalTrials.gov Identifier: | NCT00298480 |
Health Authority: | United States: Institutional Review Board |
preterm labor transvaginal ultrasound dynamic cervical change |
Pregnancy Complications Obstetric Labor, Premature Obstetric Labor Complications |