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

This study has been completed.

First Received: July 23, 2008 No Changes Posted

Sponsored by:	Center For Maternal Fetal Medicine
Information provided by:	Center For Maternal Fetal Medicine
ClinicalTrials.gov Identifier:	NCT00722085

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.

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, 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 ]

Biospecimen Retention: None Retained

Biospecimen Description:

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

Keywords provided by Center For Maternal Fetal Medicine:

Amniotic Fluid Sludge
Cerclage
Ultrasound
Preterm Delivery
Neonatal

Study placed in the following topic categories:

Genital Diseases, Female
Uterine Cervical Diseases
Pregnancy Complications
Obstetric Labor, Premature
Abortion, Habitual

Obstetric Labor Complications
Uterine Diseases
Uterine Cervical Incompetence
Abortion, Spontaneous
Premature Birth

Additional relevant MeSH terms:

Genital Diseases, Female
Uterine Cervical Diseases
Pregnancy Complications
Obstetric Labor, Premature
Abortion, Habitual

Obstetric Labor Complications
Uterine Diseases
Uterine Cervical Incompetence
Abortion, Spontaneous
Premature Birth

ClinicalTrials.gov processed this record on May 07, 2009