Recruiting

Observational Study

Sponsor:

Memorial Health Services Research Council

Code:

NCT00298480

Conditions

Dynamic Cervical Change in Preterm Labor Patients

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Not accepted

Study Details

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.

Conditions

Dynamic Cervical Change in Preterm Labor Patients

Study ID

NCT00298480

Start date

Feb, 2005

Status verified date

Apr, 2007

Completion date

Jul, 2007

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

220 participants

Interventions and Outcome Measures

Central Contacts and Locations

Central contacts

Charlotte A Clock, M.D.

714-456-5967cclock@uci.edu

Locations

Saddleback Memorial Medical Center

Recruiting

Laguna Hills, California, United States, 92653

Contacts

Principal Investigator:

James Kurtzman, M.D.

Long Beach Memorial Medical Center

Recruiting

Long Beach, California, United States, 90806

Contacts

Charlotte A Clock, M.D.

562-933-2730cclock@uci.edu

More Information

Sponsor

Memorial Health Services Research Council

Last update posted

Apr 19, 2007

Last verified

Apr, 2007

Keywords

  • preterm labor
  • transvaginal ultrasound
  • dynamic cervical change

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Memorial Health Services Research Council on 2007-04-19.