Amniotic Fluid Sludge in Cerclage Patients as an Indicator for Increased Risk of Preterm Delivery and Neonatal Outcome.

Tracking Information
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; (submitted: July 23, 2008)	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; (submitted: July 23, 2008)	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
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Probability Sample
Study Population	Patients at CMFM
Condition	High Risk Pregnancy; Incompetent Cervix; Cerclage; Amniotic Fluid Sludge; Gestation Age at Delivery.
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.
Recruitment Information
Recruitment Status	Completed
Actual Enrollment; (submitted: July 23, 2008)	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: Cerclage; Pregnancy Outcome data available; Neonatal Outcome data available; Pre and Post Cerclage Cervical length measurements; Hx of cervical procedures, if any, available Exclusion Criteria: Cervical ultrasound picture(s) unacceptable; Any missing maternal or fetal data as stated above; Fetal anomaly; Cervical dilation at time of cerclage; Placental previa or abruption; Preterm Labor
Sex/Gender	Sexes Eligible for Study: Female
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	Principal Investigator: Laura A Gorski, D.O. Center For Maternal Fetal Medicine
PRS Account	Center For Maternal Fetal Medicine
Verification Date	July 2008