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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
  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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Absence of AF Sludge as a predictor of preterm delivery in cerclage patients [ Time Frame: 7 years ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 50 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Laura Ann Gorski D.O., Center For Maternal Fetal Medicine
ClinicalTrials.gov Identifier: NCT00722085     History of Changes
Other Study ID Numbers: 1096165
Study First Received: July 23, 2008
Last Updated: July 23, 2008
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on May 22, 2013