Clinical trial NCT00298480: Dynamic Cervical Change: Prediction of Preterm Labor in Symptomatic Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Dynamic Cervical Change in Preterm Labor Patients
Keywords: preterm labor
transvaginal ultrasound
dynamic cervical change
Lead sponsor: Memorial Health Services Research Council
Sponsor class: OTHER
First posted: 2006-03-02
Enrollment: 220
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Laguna Hills
country: United States
facility: Saddleback Memorial Medical Center
state: California
city: Long Beach
country: United States
facility: Long Beach Memorial Medical Center
state: California
city: Orange
country: United States
facility: University of California, Irvine Medical Center
state: California
Study officials:
affiliation: University of California, Irvine
name: Charlotte A Clock, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, Irvine
name: James Kurtzman, M.D.
role: PRINCIPAL_INVESTIGATOR
References: