Dynamic Cervical Change: Prediction of Preterm Labor in Symptomatic Patients

Sponsor

Memorial Health Services Research Council (Other)

Overall Status

Unknown status

CT.gov ID

NCT00298480

Collaborator

(none)

220

Enrollment

Locations

28.9

Duration (Months)

73.3

Patients Per Site

2.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Dynamic Cervical Change in Preterm Labor Patients

Study Design

Study Type:

Observational

Observational Model:

Case-Control

Time Perspective:

Prospective

Study Start Date :

Feb 1, 2005

Anticipated Study Completion Date :

Jul 1, 2007

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Female

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Saddleback Memorial Medical Center	Laguna Hills	California	United States	92653
2	Long Beach Memorial Medical Center	Long Beach	California	United States	90806
3	University of California, Irvine Medical Center	Orange	California	United States	92868

Sponsors and Collaborators

Memorial Health Services Research Council

Investigators

Principal Investigator: Charlotte A Clock, M.D., University of California, Irvine
Principal Investigator: James Kurtzman, M.D., University of California, Irvine