- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01463722
Accuracy of Amniotic Fluid Lamellar Body Counting for Evaluating of Fetal Lung Maturity
November 1, 2011 updated by: Hamidreza Shemshaki, Isfahan University of Medical Sciences
Study of Accuracy of Amniotic Fluid Lamellar Body Counting for Evaluating of Fetal Lung Maturity
The purpose of this study is to determine the accuracy of Amniotic fluid Lamellar Body Counting for Evaluating of Fetal Lung Maturity.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
128
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Isfahan, Iran, Islamic Republic of
- Al-Zahra University Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Amniotic fluid Lamellar Body Counting
|
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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The statues of respiratory of neonates
Time Frame: at 2 minutes after delivery
|
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.
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at 2 minutes after delivery
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: farzaneh memarzadeh, MD, Isfahan University of Medical Sciences
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2010
Primary Completion (Actual)
February 1, 2011
Study Completion (Actual)
February 1, 2011
Study Registration Dates
First Submitted
October 30, 2011
First Submitted That Met QC Criteria
November 1, 2011
First Posted (Estimate)
November 2, 2011
Study Record Updates
Last Update Posted (Estimate)
November 2, 2011
Last Update Submitted That Met QC Criteria
November 1, 2011
Last Verified
October 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ASD-1213-20
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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