Comparison of Two Fetal Lung Maturity Tests

This study has been withdrawn prior to enrollment.
(Withdrawn)
Sponsor:
Information provided by:
Oklahoma State University Center for Health Sciences
ClinicalTrials.gov Identifier:
NCT00613977
First received: January 31, 2008
Last updated: September 19, 2011
Last verified: September 2011
  Purpose

The investigators wish to compare the difference in both cost and time to result for determining fetal lung maturity for the Lamellar Body Count method and the Fetal Lung Maturity II. Our hypothesis is that the time to result will be significantly less using the Lamellar Body Count method, and the cost associated with this method over the traditional FLM II will be favorable.


Condition
Respiratory Distress Syndrome

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pilot Study-A Cost and Time Savings Comparison of Lamellar Body Count and FLM II

Resource links provided by NLM:


Further study details as provided by Oklahoma State University Center for Health Sciences:

Primary Outcome Measures:
  • cost/time to run test [ Time Frame: six months ] [ Designated as safety issue: No ]

Biospecimen Retention:   None Retained

Amniotic fluid for fetal lung maturity test


Estimated Enrollment: 10
Study Start Date: January 2008
Estimated Study Completion Date: May 2010
Estimated Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Women delivering a term infant by cesarean section at Oklahoma State University Medical Center.

Criteria

Inclusion Criteria:

  • Term intrauterine gestations beyond 37 completed weeks with dating calculated by their sure last menstrual period (LMP) using Negel's rule or utilizing a first trimester crown rump length ultrasound.
  • Women with a previous C/S scheduled for repeat C/S.
  • Women who are undergoing a scheduled C-Section for malpresentation

Exclusion Criteria:

  • Presence of gross blood in amniotic sample
  • Hematocrit count greater than 1% on ADVIA 2120
  • Presence of meconium in sample
  • Patients with oligohydramnios defined as an amniotic fluid index of less than 5 cm or polyhydramnios defined as an amniotic fluid index of more than 24 cm.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00613977

Locations
United States, Oklahoma
Oklahoma State University Medical Center
Tulsa, Oklahoma, United States, 74103
Sponsors and Collaborators
Oklahoma State University Center for Health Sciences
Investigators
Principal Investigator: Joseph R Johnson, D.O. OSU Center for Health Sciences Dept of Ob/Gyn
  More Information

Publications:

Responsible Party: Joseph R. Johnson, D.O., OSU Center for Health Sciences Dept of Ob/Gyn
ClinicalTrials.gov Identifier: NCT00613977     History of Changes
Other Study ID Numbers: 2007013
Study First Received: January 31, 2008
Last Updated: September 19, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Oklahoma State University Center for Health Sciences:
fetal lung maturity
lamellar body count

Additional relevant MeSH terms:
Respiratory Distress Syndrome, Newborn
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases

ClinicalTrials.gov processed this record on August 28, 2014