Dynamic Cervical Change: Prediction of Preterm Labor in Symptomatic Patients
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| ClinicalTrials.gov Identifier: NCT00298480 |
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Recruitment Status : Unknown
Verified April 2007 by Memorial Health Services Research Council.
Recruitment status was: Recruiting
First Posted : March 2, 2006
Last Update Posted : April 19, 2007
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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.
| Condition or disease |
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| Dynamic Cervical Change in Preterm Labor Patients |
| 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 |
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| Ages Eligible for Study: | 18 Years to 45 Years (Adult) |
| Sexes Eligible for Study: | Female |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00298480
| Contact: Charlotte A Clock, M.D. | 714-456-5967 | cclock@uci.edu |
| 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 | |
| Principal Investigator: | Charlotte A Clock, M.D. | University of California, Irvine | |
| Principal Investigator: | James Kurtzman, M.D. | University of California, Irvine |
| ClinicalTrials.gov Identifier: | NCT00298480 History of Changes |
| Other Study ID Numbers: |
230-04s |
| First Posted: | March 2, 2006 Key Record Dates |
| Last Update Posted: | April 19, 2007 |
| Last Verified: | April 2007 |
Keywords provided by Memorial Health Services Research Council:
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preterm labor transvaginal ultrasound dynamic cervical change |
Additional relevant MeSH terms:
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Premature Birth Obstetric Labor, Premature Obstetric Labor Complications Pregnancy Complications |