Dynamic Cervical Change: Prediction of Preterm Labor in Symptomatic Patients

Study Description

Go to 

Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Dynamic Cervical Change in Preterm Labor Patients

Study Design

Go to 

Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Observational
Enrollment :	220 participants
Observational Model:	Case Control
Time Perspective:	Longitudinal
Time Perspective:	Prospective
Study Start Date :	February 2005
Estimated Study Completion Date :	July 2007

Groups and Cohorts

Go to 

Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Outcome Measures

Go to 

Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Eligibility Criteria

Go to 

Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years to 45 Years (Adult)
Sexes Eligible for Study:	Female

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

Contacts and Locations

Go to 

Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Contacts

Contact: Charlotte A Clock, M.D.	714-456-5967	cclock@uci.edu

Locations

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

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

More Information

Go to 

Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

ClinicalTrials.gov Identifier:	NCT00298480 History of Changes
Other Study ID Numbers:	230-04s
First Posted:	March 2, 2006
Last Update Posted:	April 19, 2007
Last Verified:	April 2007

Keywords provided by Memorial Health Services Research Council:

preterm labor; transvaginal ultrasound; dynamic cervical change

Additional relevant MeSH terms:

Premature Birth; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications