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NCT00722085 Clinical Trial

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

High Risk Pregnancy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00722085
Other study ID # 1096165
Secondary ID
Status Completed
Phase N/A
First received July 23, 2008
Last updated July 23, 2008
Start date January 2008
Est. completion date May 2008

Study information
Verified date July 2008
Source Center For Maternal Fetal Medicine
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

Amniotic Fluid "Sludge" Does Not Increase Risk of Preterm Delivery in Cerclage Patients.

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.

Recruitment information / eligibility
Status Completed
Enrollment 177
Est. completion date May 2008
Est. primary completion date March 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 50 Years
Eligibility 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 Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

Locations
Country Name City State
United States Center For Maternal Fetal Medicine Las vegas Nevada

Sponsors (1)
Lead Sponsor Collaborator
Center For Maternal Fetal Medicine

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary AF Sludge as a predictor of preterm delivery in cerclage patients 7 years No
Secondary Absence of AF Sludge as a predictor of preterm delivery in cerclage patients 7 years No
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