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

July 23, 2008 updated by: Center For Maternal Fetal Medicine
Amniotic Fluid "Sludge" Does Not Increase Risk of Preterm Delivery in Cerclage Patients.

Study Overview

Status

Completed

Conditions

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

Enrollment (Actual)

177

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Nevada
      • Las vegas, Nevada, United States, 89106
        • Center For Maternal Fetal Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 48 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Patients at CMFM

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Observational

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
AF Sludge as a predictor of preterm delivery in cerclage patients
Time Frame: 7 years
7 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Absence of AF Sludge as a predictor of preterm delivery in cerclage patients
Time Frame: 7 years
7 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Center For Maternal Fetal Medicine

Investigators

  • Principal Investigator: Laura A Gorski, D.O., Center For Maternal Fetal Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Actual)

March 1, 2008

Study Completion (Actual)

May 1, 2008

Study Registration Dates

First Submitted

July 23, 2008

First Submitted That Met QC Criteria

July 23, 2008

First Posted (Estimate)

July 25, 2008

Study Record Updates

Last Update Posted (Estimate)

July 25, 2008

Last Update Submitted That Met QC Criteria

July 23, 2008

Last Verified

July 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1096165

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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