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This study has been withdrawn prior to enrollment.

(Withdrawn)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

History of Changes

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

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

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:

Weaver TE, Na CL, Stahlman M. Biogenesis of lamellar bodies, lysosome-related organelles involved in storage and secretion of pulmonary surfactant. Semin Cell Dev Biol. 2002 Aug;13(4):263-70. Review.

Fakhoury G, Daikoku NH, Benser J, Dubin NH. Lamellar body concentrations and the prediction of fetal pulmonary maturity. Am J Obstet Gynecol. 1994 Jan;170(1 Pt 1):72-6.

Pearlman ES, Baiocchi JM, Lease JA, Gilbert J, Cooper JH. Utility of a rapid lamellar body count in the assessment of fetal maturity. Am J Clin Pathol. 1991 Jun;95(6):778-80.

Bowie LJ, Shammo J, Dohnal JC, Farrell E, Vye MV. Lamellar body number density and the prediction of respiratory distress. Am J Clin Pathol. 1991 Jun;95(6):781-6.

Ashwood ER, Palmer SE, Taylor JS, Pingree SS. Lamellar body counts for rapid fetal lung maturity testing. Obstet Gynecol. 1993 Apr;81(4):619-24.

Dalence CR, Bowie LJ, Dohnal JC, Farrell EE, Neerhof MG. Amniotic fluid lamellar body count: a rapid and reliable fetal lung maturity test. Obstet Gynecol. 1995 Aug;86(2):235-9.

Greenspoon JS, Rosen DJ, Roll K, Dubin SB. Evaluation of lamellar body number density as the initial assessment in a fetal lung maturity test cascade. J Reprod Med. 1995 Apr;40(4):260-6.

Lee IS, Cho YK, Kim A, Min WK, Kim KS, Mok JE. Lamellar body count in amniotic fluid as a rapid screening test for fetal lung maturity. J Perinatol. 1996 May-Jun;16(3 Pt 1):176-80.

Lewis PS, Lauria MR, Dzieczkowski J, Utter GO, Dombrowski MP. Amniotic fluid lamellar body count: cost-effective screening for fetal lung maturity. Obstet Gynecol. 1999 Mar;93(3):387-91. Review.

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
Respiratory Distress Syndrome, Adult
Lung Diseases
Respiratory Tract Diseases

Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases

ClinicalTrials.gov processed this record on June 18, 2013

To Top