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Completed

NCT Number: NCT01463722

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.

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Key information

Conditions

Retained Fetal Lung Fluid Congenital, Hereditary, and Neonatal Diseases and Abnormalities Infant, Newborn, Diseases Infant, Premature, Diseases Lung Diseases Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Distress Syndrome Respiratory Distress Syndrome, Newborn Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory Tachypnea Transient Tachypnea of the Newborn

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Al-zahra university hospital

Isfahan, Iran

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Amniotic fluid Lamellar Body Counting

Other

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 outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Isfahan University of Medical Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Nov 2, 2011
Registry last updated
Nov 2, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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