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Dynamic Cervical Change: Prediction of Preterm Labor in Symptomatic Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2007 by Memorial Health Services Research Council.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Memorial Health Services Research Council
ClinicalTrials.gov Identifier:
NCT00298480
First received: March 1, 2006
Last updated: April 18, 2007
Last verified: April 2007
  Purpose

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
Dynamic Cervical Change in Preterm Labor Patients

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Longitudinal

Further study details as provided by Memorial Health Services Research Council:

Estimated Enrollment: 220
Study Start Date: February 2005
Estimated Study Completion Date: July 2007
  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00298480

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

No publications provided

ClinicalTrials.gov Identifier: NCT00298480     History of Changes
Other Study ID Numbers: 230-04s
Study First Received: March 1, 2006
Last Updated: April 18, 2007
Health Authority: United States: Institutional Review Board

Keywords provided by Memorial Health Services Research Council:
preterm labor
transvaginal ultrasound
dynamic cervical change

Additional relevant MeSH terms:
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications

ClinicalTrials.gov processed this record on November 20, 2014