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Comparison of Two Fetal Lung Maturity Tests

This study has been withdrawn prior to enrollment.
(Withdrawn)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00613977
First Posted: February 13, 2008
Last Update Posted: September 20, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Oklahoma State University Center for Health Sciences
  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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted: January 31, 2008
First Posted: February 13, 2008
Last Update Posted: September 20, 2011
Last Verified: September 2011

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

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