Dynamic Cervical Change in Preterm Labor Patients Clinical Trial
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.
| Status | Recruiting |
| Enrollment | 220 |
| Est. completion date | July 2007 |
| Est. primary completion date | |
| Accepts healthy volunteers | |
| Gender | Female |
| Age group | 18 Years to 45 Years |
| Eligibility |
Inclusion Criteria: - Pregnant women between the ages of 18 and 45 years. - Intrauterine pregnancy with gestational age between 22 0/7 and 34 6/7 weeks gestation. - Presenting with symptomatic preterm labor (e.g. Regular uterine contractions, uterine cramping, or pelvic pressure). Exclusion Criteria: - Cervical cerclage - Ruptured membranes noted on initial speculum examination - Cervical os dilation >4 cm noted on initial digital examination - Known HIV-positive or active HSV(to minimize the risk of perinatal exposure) - Presence of multiple genital warts - Patients under extreme duress from their uterine contractions |
Observational Model: Case Control, Time Perspective: Longitudinal
| Country | Name | City | State |
|---|---|---|---|
| United States | Saddleback Memorial Medical Center | Laguna Hills | California |
| United States | Long Beach Memorial Medical Center | Long Beach | California |
| United States | University of California, Irvine Medical Center | Orange | California |
| Lead Sponsor | Collaborator |
|---|---|
| Memorial Health Services Research Council |
United States,