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

March 1, 2006
April 18, 2007
February 2005
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Complete list of historical versions of study NCT00298480 on ClinicalTrials.gov Archive Site
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Dynamic Cervical Change: Prediction of Preterm Labor in Symptomatic Patients
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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.

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Observational
Observational Model: Case Control
Time Perspective: Longitudinal
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Dynamic Cervical Change in Preterm Labor Patients
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
220
July 2007
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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
Female
18 Years to 45 Years
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Contact: Charlotte A Clock, M.D. 714-456-5967 cclock@uci.edu
United States
 
NCT00298480
230-04s
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Memorial Health Services Research Council
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Principal Investigator: Charlotte A Clock, M.D. University of California, Irvine
Principal Investigator: James Kurtzman, M.D. University of California, Irvine
Memorial Health Services Research Council
April 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP