We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00722085
First Posted: July 25, 2008
Last Update Posted: July 25, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Center For Maternal Fetal Medicine
  Purpose
Amniotic Fluid "Sludge" Does Not Increase Risk of Preterm Delivery in Cerclage Patients.

Condition
High Risk Pregnancy Incompetent Cervix Cerclage Amniotic Fluid Sludge Gestation Age at Delivery.

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Amniotic Fluid Sludge in Cerclage Patients as an Indicator for Increased Risk of Preterm Delivery and Neonatal Outcome.

Further study details as provided by Center For Maternal Fetal Medicine:

Primary Outcome Measures:
  • AF Sludge as a predictor of preterm delivery in cerclage patients [ Time Frame: 7 years ]

Secondary Outcome Measures:
  • Absence of AF Sludge as a predictor of preterm delivery in cerclage patients [ Time Frame: 7 years ]

Enrollment: 177
Study Start Date: January 2008
Study Completion Date: May 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts
Observational

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Patients at CMFM
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00722085


Locations
United States, Nevada
Center For Maternal Fetal Medicine
Las vegas, Nevada, United States, 89106
Sponsors and Collaborators
Center For Maternal Fetal Medicine
Investigators
Principal Investigator: Laura A Gorski, D.O. Center For Maternal Fetal Medicine
  More Information

Responsible Party: Laura Ann Gorski D.O., Center For Maternal Fetal Medicine
ClinicalTrials.gov Identifier: NCT00722085     History of Changes
Other Study ID Numbers: 1096165
First Submitted: July 23, 2008
First Posted: July 25, 2008
Last Update Posted: July 25, 2008
Last Verified: July 2008

Keywords provided by Center For Maternal Fetal Medicine:
Amniotic Fluid Sludge
Cerclage
Ultrasound
Preterm Delivery
Neonatal

Additional relevant MeSH terms:
Premature Birth
Uterine Cervical Incompetence
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Abortion, Habitual
Abortion, Spontaneous