Amniotic Fluid Sludge in Cerclage Patients as an Indicator for Increased Risk of Preterm Delivery and Neonatal Outcome.
This study has been completed.
Sponsor:
Center For Maternal Fetal Medicine
Information provided by:
Center For Maternal Fetal Medicine
ClinicalTrials.gov Identifier:
NCT00722085
First received: July 23, 2008
Last updated: NA
Last verified: July 2008
History: No changes posted
| Tracking Information | |||||
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| First Received Date ICMJE | July 23, 2008 | ||||
| Last Updated Date | July 23, 2008 | ||||
| Start Date ICMJE | January 2008 | ||||
| Primary Completion Date | March 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
AF Sludge as a predictor of preterm delivery in cerclage patients [ Time Frame: 7 years ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE |
Absence of AF Sludge as a predictor of preterm delivery in cerclage patients [ Time Frame: 7 years ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Amniotic Fluid Sludge in Cerclage Patients as an Indicator for Increased Risk of Preterm Delivery and Neonatal Outcome. | ||||
| Official Title ICMJE | 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. |
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| 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. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | 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 |
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| Condition ICMJE |
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| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Observational | ||||
| Publications * | Not Provided | ||||
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* 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 ICMJE | Completed | ||||
| Enrollment ICMJE | 177 | ||||
| Completion Date | May 2008 | ||||
| Primary Completion Date | March 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||
| Ages | 18 Years to 50 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00722085 | ||||
| Other Study ID Numbers ICMJE | 1096165 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Laura Ann Gorski D.O., Center For Maternal Fetal Medicine | ||||
| Study Sponsor ICMJE | Center For Maternal Fetal Medicine | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Center For Maternal Fetal Medicine | ||||
| Verification Date | July 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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