Amniotic Fluid Sludge in Cerclage Patients as an Indicator for Increased Risk of Preterm Delivery and Neonatal Outcome.
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ClinicalTrials.gov Identifier: NCT00722085 |
Recruitment Status
:
Completed
First Posted
: July 25, 2008
Last Update Posted
: July 25, 2008
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Sponsor:
Center For Maternal Fetal Medicine
Information provided by:
Center For Maternal Fetal Medicine
Tracking Information | ||||
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First Submitted Date | July 23, 2008 | |||
First Posted Date | July 25, 2008 | |||
Last Update Posted Date | July 25, 2008 | |||
Study Start Date | January 2008 | |||
Actual Primary Completion Date | March 2008 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures |
AF Sludge as a predictor of preterm delivery in cerclage patients [ Time Frame: 7 years ] | |||
Original Primary Outcome Measures | Same as current | |||
Change History | No Changes Posted | |||
Current Secondary Outcome Measures |
Absence of AF Sludge as a predictor of preterm delivery in cerclage patients [ Time Frame: 7 years ] | |||
Original Secondary Outcome Measures | Same as current | |||
Current Other Outcome Measures | Not Provided | |||
Original Other Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title | Amniotic Fluid Sludge in Cerclage Patients as an Indicator for Increased Risk of Preterm Delivery and Neonatal Outcome. | |||
Official Title | Amniotic Fluid Sludge in Cerclage Patients as an Indicator for Increased Risk of Preterm Delivery and Neonatal Outcome. | |||
Brief Summary | Amniotic Fluid "Sludge" Does Not Increase Risk of Preterm Delivery in Cerclage Patients. | |||
Detailed Description | 177 patients were selected from a data base of 1890. 60 patients had sludge, 117 did not have sludge. Conclusion AF sludge on ultrasound had no association with increased risk of preterm delivery in patients with cerclage. | |||
Study Type | Observational | |||
Study Design | Observational Model: Cohort Time Perspective: Retrospective |
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Target Follow-Up Duration | Not Provided | |||
Biospecimen | Not Provided | |||
Sampling Method | Probability Sample | |||
Study Population | Patients at CMFM | |||
Condition |
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Intervention | Not Provided | |||
Study Groups/Cohorts | Observational | |||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status | Completed | |||
Actual Enrollment |
177 | |||
Original Actual Enrollment | Same as current | |||
Actual Study Completion Date | May 2008 | |||
Actual Primary Completion Date | March 2008 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years to 50 Years (Adult) | |||
Accepts Healthy Volunteers | Yes | |||
Contacts | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number | NCT00722085 | |||
Other Study ID Numbers | 1096165 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Laura Ann Gorski D.O., Center For Maternal Fetal Medicine | |||
Study Sponsor | Center For Maternal Fetal Medicine | |||
Collaborators | Not Provided | |||
Investigators |
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PRS Account | Center For Maternal Fetal Medicine | |||
Verification Date | July 2008 |