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

This study has been completed.
Sponsor:
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
July 23, 2008
July 23, 2008
January 2008
March 2008   (Final data collection date for primary outcome measure)
AF Sludge as a predictor of preterm delivery in cerclage patients [ Time Frame: 7 years ]
Same as current
No Changes Posted
Absence of AF Sludge as a predictor of preterm delivery in cerclage patients [ Time Frame: 7 years ]
Same as current
Not Provided
Not Provided
 
Amniotic Fluid Sludge in Cerclage Patients as an Indicator for Increased Risk of Preterm Delivery and Neonatal Outcome.
Amniotic Fluid Sludge in Cerclage Patients as an Indicator for Increased Risk of Preterm Delivery and Neonatal Outcome.
Amniotic Fluid "Sludge" Does Not Increase Risk of Preterm Delivery in Cerclage Patients.
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.
Observational
Observational Model: Cohort
Time Perspective: Retrospective
Not Provided
Not Provided
Probability Sample
Patients at CMFM
  • High Risk Pregnancy
  • Incompetent Cervix
  • Cerclage
  • Amniotic Fluid Sludge
  • Gestation Age at Delivery.
Not Provided
Observational
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
177
May 2008
March 2008   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
18 Years to 50 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00722085
1096165
Yes
Not Provided
Not Provided
Not Provided
Laura Ann Gorski D.O., Center For Maternal Fetal Medicine
Center For Maternal Fetal Medicine
Not Provided
Principal Investigator: Laura A Gorski, D.O. Center For Maternal Fetal Medicine
Center For Maternal Fetal Medicine
July 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP