Dynamic Cervical Change in Preterm Labor PatientsNCT00298480
Dynamic Cervical Change: Prediction of Preterm Labor in Symptomatic Patients
An observational study of Dynamic Cervical Change in Preterm Labor Patients, run by Memorial Health Services Research Council at 3 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Dynamic Cervical Change in Preterm Labor Patients
- How many people
- 220 participants
- Where
- 3 sitesUnited States
- Study dates
- Feb 2005to Jul 2007
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Adult
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites, 3 recruiting
- Recruiting
Saddleback Memorial Medical Center
Laguna Hills, California, 92653
James Kurtzman, M.D., 949-452-7199, jtk@stanfordalumni.org
James Kurtzman, M.D.
- Recruiting
Long Beach Memorial Medical Center
Long Beach, California, 90806
Charlotte A Clock, M.D., 562-933-2730, cclock@uci.edu
- Not yet recruiting
University of California, Irvine Medical Center
Orange, California, 92868
Charlotte Clock, M.D., 714-456-5967, cclock@uci.edu
About this study
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.
Read more
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.
- Keywords
- preterm labor, transvaginal ultrasound, dynamic cervical change
- Medical subject headings
- Obstetric Labor, Premature
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2006 (estimated)
- Study startFeb 2005
- Study completionJul 2007 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dynamic Cervical Change in Preterm Labor PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 220 participants
Sponsor and investigators
- Lead sponsor
- Memorial Health Services Research Council
- Sponsor type
- University, hospital or other
- Investigators
- Charlotte A Clock, M.D., Principal investigator, University of California, IrvineJames Kurtzman, M.D., Principal investigator, University of California, Irvine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00298480
- Sponsor's protocol ID
- 230-04s
- Status last verified
- Apr 2007
- First submitted
- 1 Mar 2006
- Last updated
- 19 Apr 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dynamic Cervical Change: Prediction of Preterm Labor in Symptomatic Patients
- ClinicalTrials.gov ID
- NCT00298480
- Acronym / sponsor ID
- 230-04s
- Keywords
- preterm labor, transvaginal ultrasound, dynamic cervical change
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 220 participants
- Lead sponsor
- Memorial Health Services Research CouncilUniversity, hospital or other
- Study start
- Feb 2005
- Study completion
- Jul 2007 (estimated)
- First posted
- 2 Mar 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2007.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charlotte A Clock, M.D. principal investigator
University of California, Irvine
James Kurtzman, M.D. principal investigator
University of California, Irvine
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dynamic Cervical Change in Preterm Labor Patients, run by Memorial Health Services Research Council at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Apr 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Charlotte A Clock, M.D. (714-456-5967, cclock@uci.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2007.