NCT00722085

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
177

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2008

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 23, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 25, 2008

Completed
Last Updated

July 25, 2008

Status Verified

July 1, 2008

Enrollment Period

2 months

First QC Date

July 23, 2008

Last Update Submit

July 23, 2008

Conditions

High Risk PregnancyIncompetent CervixCerclageAmniotic Fluid SludgeGestation Age at Delivery.

Keywords

Amniotic Fluid SludgeCerclageUltrasoundPreterm DeliveryNeonatal

Outcome Measures

Primary Outcomes (1)

  • AF Sludge as a predictor of preterm delivery in cerclage patients

    7 years

Secondary Outcomes (1)

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

    7 years

Study Arms (1)

Observational

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Patients at CMFM

You may qualify if:

  • Cerclage
  • Pregnancy Outcome data available
  • Neonatal Outcome data available
  • Pre and Post Cerclage Cervical length measurements
  • Hx of cervical procedures, if any, available

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center For Maternal Fetal Medicine

Las Vegas, Nevada, 89106, United States

Location

MeSH Terms

Conditions

Uterine Cervical IncompetencePremature Birth

Condition Hierarchy (Ancestors)

Uterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesAbortion, HabitualAbortion, SpontaneousPregnancy ComplicationsGenital DiseasesObstetric Labor, PrematureObstetric Labor Complications

Study Officials

  • Laura A Gorski, D.O.

    Center For Maternal Fetal Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 23, 2008

First Posted

July 25, 2008

Study Start

January 1, 2008

Primary Completion

March 1, 2008

Study Completion

May 1, 2008

Last Updated

July 25, 2008

Record last verified: 2008-07

Locations

US(1)