NCT00613977

Brief Summary

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.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2008

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 31, 2008

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 13, 2008

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
Last Updated

October 5, 2020

Status Verified

October 1, 2020

Enrollment Period

2.3 years

First QC Date

January 31, 2008

Last Update Submit

October 1, 2020

Conditions

Respiratory Distress Syndrome

Keywords

fetal lung maturitylamellar body count

Outcome Measures

Primary Outcomes (1)

  • cost/time to run test

    six months

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oklahoma State University Medical Center

Tulsa, Oklahoma, 74103, United States

Location

Related Publications (9)

  • 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. doi: 10.1016/s1084952102000551.

    PMID: 12243725BACKGROUND

  • 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. doi: 10.1016/s0002-9378(94)70386-8.

    PMID: 8296848BACKGROUND

  • 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. doi: 10.1093/ajcp/95.6.778.

    PMID: 2042585BACKGROUND

  • 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. doi: 10.1093/ajcp/95.6.781.

    PMID: 2042586BACKGROUND

  • 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.

    PMID: 8459979BACKGROUND

  • 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. doi: 10.1016/0029-7844(95)00120-g.

    PMID: 7617355BACKGROUND

  • 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.

    PMID: 7623354BACKGROUND

  • 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.

    PMID: 8817425BACKGROUND

  • 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. doi: 10.1016/s0029-7844(98)00416-5.

    PMID: 10074985BACKGROUND

Biospecimen

Retention: NONE RETAINED

Amniotic fluid for fetal lung maturity test

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration Disorders

Study Officials

  • Joseph R Johnson, D.O.

    OSU Center for Health Sciences Dept of Ob/Gyn

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 31, 2008

First Posted

February 13, 2008

Study Start

January 1, 2008

Primary Completion

May 1, 2010

Study Completion

May 1, 2010

Last Updated

October 5, 2020

Record last verified: 2020-10

Locations

US(1)