Dynamic Cervical Change: Prediction of Preterm Labor in Symptomatic Patients

April 18, 2007 updated by: Memorial Health Services Research Council

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.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment

220

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Laguna Hills, California, United States, 92653
        • Recruiting
        • Saddleback Memorial Medical Center
        • Contact:
        • Principal Investigator:
          • James Kurtzman, M.D.
      • Long Beach, California, United States, 90806
        • Recruiting
        • Long Beach Memorial Medical Center
        • Contact:
          • Charlotte A Clock, M.D.
          • Phone Number: 562-933-2730
          • Email: cclock@uci.edu
      • Orange, California, United States, 92868
        • Not yet recruiting
        • University of California, Irvine Medical Center
        • Contact:
          • Charlotte Clock, M.D.
          • Phone Number: 714-456-5967
          • Email: cclock@uci.edu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2005

Study Completion (ANTICIPATED)

July 1, 2007

Study Registration Dates

First Submitted

March 1, 2006

First Submitted That Met QC Criteria

March 1, 2006

First Posted (ESTIMATE)

March 2, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

April 19, 2007

Last Update Submitted That Met QC Criteria

April 18, 2007

Last Verified

April 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 230-04s

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe