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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01463722
First Posted: November 2, 2011
Last Update Posted: November 2, 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 (Responsible Party):
Hamidreza Shemshaki, Isfahan University of Medical Sciences
  Purpose
The purpose of this study is to determine the accuracy of Amniotic fluid Lamellar Body Counting for Evaluating of Fetal Lung Maturity.

Condition Intervention Phase
Retained Fetal Lung Fluid Other: Amniotic fluid Lamellar Body Counting Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Study of Accuracy of Amniotic Fluid Lamellar Body Counting for Evaluating of Fetal Lung Maturity

Resource links provided by NLM:


Further study details as provided by Hamidreza Shemshaki, Isfahan University of Medical Sciences:

Primary Outcome Measures:
  • 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.


Enrollment: 128
Study Start Date: March 2010
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Amniotic fluid Lamellar Body Counting 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).

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.
  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
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.
  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): NCT01463722


Locations
Iran, Islamic Republic of
Al-zahra university hospital
Isfahan, Iran, Islamic Republic of
Sponsors and Collaborators
Isfahan University of Medical Sciences
Investigators
Study Chair: farzaneh memarzadeh, MD Isfahan University of Medical Sciences
  More Information

Additional Information:
Responsible Party: Hamidreza Shemshaki, Research Assistant, Isfahan University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01463722     History of Changes
Other Study ID Numbers: ASD-1213-20
First Submitted: October 30, 2011
First Posted: November 2, 2011
Last Update Posted: November 2, 2011
Last Verified: October 2011

Keywords provided by Hamidreza Shemshaki, Isfahan University of Medical Sciences:
Respiratory distress syndrome
Lung maturity
lamellar body

Additional relevant MeSH terms:
Transient Tachypnea of the Newborn
Respiratory Distress Syndrome, Newborn
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Tachypnea
Infant, Premature, Diseases
Infant, Newborn, Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms