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Accuracy of Amniotic Fluid Lamellar Body Counting for Evaluating of Fetal Lung Maturity

Primary Purpose

Retained Fetal Lung Fluid

Status
Completed
Phase
Phase 2
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Amniotic fluid Lamellar Body Counting
Sponsored by
Isfahan University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Retained Fetal Lung Fluid focused on measuring Respiratory distress syndrome, Lung maturity, lamellar body

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Women, with 28-37 weeks of gestational age, who had been decided to terminate their pregnancy, were enrolled in the study

Exclusion Criteria:

  • Chorioamnionitis
  • Intra Uterine Fetal Death (IUFD)
  • Blood in amniotic fluid
  • Rupture of placenta and patient dissatisfaction were the exclusion criteria.

Sites / Locations

  • Al-zahra university hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Amniotic fluid Lamellar Body Counting

Arm Description

Outcomes

Primary Outcome Measures

The statues of respiratory of neonates
Diagnosing of immaturity is based on the following criteria: 1-Physical examinations such as: nasal flaring, retraction, grunting, and tachypnea. 2-Oxygen needing more than 24 hours with three chest x-ray findings.

Secondary Outcome Measures

Full Information

First Posted
October 30, 2011
Last Updated
November 1, 2011
Sponsor
Isfahan University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01463722
Brief Title
Accuracy of Amniotic Fluid Lamellar Body Counting for Evaluating of Fetal Lung Maturity
Official Title
Study of Accuracy of Amniotic Fluid Lamellar Body Counting for Evaluating of Fetal Lung Maturity
Study Type
Interventional

2. Study Status

Record Verification Date
October 2011
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
February 2011 (Actual)
Study Completion Date
February 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Isfahan University of Medical Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to determine the accuracy of Amniotic fluid Lamellar Body Counting for Evaluating of Fetal Lung Maturity.
Detailed Description
Respiratory distress syndrome (RDS) is one of important cause of mortality in neonates. This study was designed to evaluate the amniotic fluid lamellar body counting for predicting fetal lung maturity.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Retained Fetal Lung Fluid
Keywords
Respiratory distress syndrome, Lung maturity, lamellar body

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
N/A
Enrollment
128 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Amniotic fluid Lamellar Body Counting
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Amniotic fluid Lamellar Body Counting
Intervention Description
fluid samples were obtained by amniocentesis during normal delivery or before rupturing the membrane in cesarean. The samples were sent to the lab as soon as possible and after centrifuging with 500 round per minute for 3 minutes, they were placed in the cell counter machine (STKR coulter).
Primary Outcome Measure Information:
Title
The statues of respiratory of neonates
Description
Diagnosing of immaturity is based on the following criteria: 1-Physical examinations such as: nasal flaring, retraction, grunting, and tachypnea. 2-Oxygen needing more than 24 hours with three chest x-ray findings.
Time Frame
at 2 minutes after delivery

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Women, with 28-37 weeks of gestational age, who had been decided to terminate their pregnancy, were enrolled in the study Exclusion Criteria: Chorioamnionitis Intra Uterine Fetal Death (IUFD) Blood in amniotic fluid Rupture of placenta and patient dissatisfaction were the exclusion criteria.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
farzaneh memarzadeh, MD
Organizational Affiliation
Isfahan University of Medical Sciences
Official's Role
Study Chair
Facility Information:
Facility Name
Al-zahra university hospital
City
Isfahan
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Links:
URL
http://www.mui.ac.ir
Description
(Isfahan university of medical science)

Learn more about this trial

Accuracy of Amniotic Fluid Lamellar Body Counting for Evaluating of Fetal Lung Maturity

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