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Dynamic Cervical Change: Prediction of Preterm Labor in Symptomatic Patients

NCT ID: NCT00298480

Last Updated: 2007-04-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

220 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-02-28

Study Completion Date

2007-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Dynamic Cervical Change in Preterm Labor Patients

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Memorial Health Services Research Council

OTHER

Sponsor Role lead

Principal Investigators

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Charlotte A Clock, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of California, Irvine

James Kurtzman, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of California, Irvine

Locations

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Saddleback Memorial Medical Center

Laguna Hills, California, United States

Site Status RECRUITING

Long Beach Memorial Medical Center

Long Beach, California, United States

Site Status RECRUITING

University of California, Irvine Medical Center

Orange, California, United States

Site Status NOT_YET_RECRUITING

Countries

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United States

Central Contacts

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Charlotte A Clock, M.D.

Role: CONTACT

[email protected]
714-456-5967

Facility Contacts

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James Kurtzman, M.D.

Role: primary

[email protected]
949-452-7199

Charlotte A Clock, M.D.

Role: primary

[email protected]
562-933-2730

Charlotte Clock, M.D.

Role: primary

[email protected]
714-456-5967

Other Identifiers

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230-04s

Identifier Type: -

Identifier Source: org_study_id