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CompletedNCT00722085Updated Jul 25, 2008

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

An observational study in High Risk Pregnancy, Incompetent Cervix and Cerclage, sponsored by Center For Maternal Fetal Medicine. Completed at 1 site in United States. Open to female participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2008-07-25.

Sponsored by Center For Maternal Fetal Medicine · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
177
Ages
18 Years to 50 Years
Sex
Female
01

Study summary

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

Read the 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.

02

Conditions studied

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

Keywords

  • Amniotic Fluid Sludge
  • Cerclage
  • Ultrasound
  • Preterm Delivery
  • Neonatal
03

In context

Uterine Cervical Incompetence

35 studies on the registry are indexed under Uterine Cervical Incompetence; 10 are open to participants now.

This study's enrollment of 177 is above the median of 136 across 11 observational studies indexed under Uterine Cervical Incompetence.

Browse Uterine Cervical Incompetence studies →

Lead sponsor

This is the only study on the registry with Center For Maternal Fetal Medicine as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Patients at CMFM

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
177 participants (actual)

Groups and cohorts

  • Observational
06

What researchers measure

Primary outcomes

  1. AF Sludge as a predictor of preterm delivery in cerclage patients

    Time frame: 7 years

Secondary outcomes

  1. Absence of AF Sludge as a predictor of preterm delivery in cerclage patients

    Time frame: 7 years

07

Study locations

1 site
  • Center For Maternal Fetal Medicine
    Las Vegas, Nevada 89106, United States
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jan 2008, a primary completion of Mar 2008 and a completion of May 2008. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 23, 2008
First posted
Jul 25, 2008
Start
Jan 2008
Primary completionActual
Mar 2008
CompletionActual
May 2008
Last update
Jul 25, 2008
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 25, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00722085
Lead sponsor
Center For Maternal Fetal Medicine
First posted
Jul 25, 2008
Start date
Jan 2008
Primary completion
Mar 2008
Completion
May 2008
Last update
Jul 25, 2008

Study contacts

Laura A Gorski, D.O.
principal investigator · Center For Maternal Fetal Medicine

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2008. You cannot join it, but the record below documents what was studied.

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Discussion

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