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

Tracking Information

First Received Date ^ICMJE

July 23, 2008

Last Updated Date

July 23, 2008

Start Date ^ICMJE

January 2008

Primary Completion Date

March 2008 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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 ^ICMJE

Observational

Study Design ^ICMJE

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 ^ICMJE

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

Intervention ^ICMJE

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 ^ICMJE

Completed

Enrollment ^ICMJE

177

Completion Date

May 2008

Primary Completion Date

March 2008 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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 ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

United States

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00722085

Other Study ID Numbers ^ICMJE

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 ^ICMJE

Center For Maternal Fetal Medicine

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Laura A Gorski, D.O.

Center For Maternal Fetal Medicine

PRS Account

Center For Maternal Fetal Medicine

Verification Date

July 2008

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

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