Ignite Creation Date:
2024-05-05 @ 4:41 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00298480
Status:
UNKNOWN
Last Update Posted:
2007-04-19
First Post:
2006-03-01
Brief Title:
Dynamic Cervical Change Prediction of Preterm Labor in Symptomatic Patients
Sponsor:
Memorial Health Services Research Council
Organization:
Memorial Health Services Research Council
Study Overview
Official Title:
None
Status:
UNKNOWN
Status Verified Date:
2007-04
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 shortening6mm of the cervix seen during the ultrasound examination Prior studies have shown that the presence of dynamic change in patients with a shortened cervical length3cm is not independently predictive of preterm delivery However a subset of patients with normal initial cervical length3cm 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 laborvaginal pressure or uterine contractions who consent to the study will undergo the standard evaluation for preterm labordescribed 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 length3cm 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 length3cm who exhibit dynamic cervical change deliver at an earlier gestational age than those without dynamic change
Patients presenting to with symptomatic preterm laborvaginal pressure or uterine contractions who consent to the study will undergo the standard evaluation for preterm labordescribed 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 length3cm 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 length3cm who exhibit dynamic cervical change deliver at an earlier gestational age than those without dynamic change
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None