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

Phase 2

Completed

• Conditions: Retained Fetal Lung Fluid
• Interventions: Other: Amniotic fluid Lamellar Body Counting

• Registration Number: NCT01463722
• Lead Sponsor: Isfahan University of Medical Sciences

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.

Study Timeline

• Study Start: 2010-03
• Primary Completion: 2011-02
• Study Completion: 2011-02
• Status Verified: 2011-10
• Study First Submitted: 2011-10-30
• Study First Submitted QC: 2011-11-01
• Last Update Submitted: 2011-11-01
• Study First Posted: 2011-11-02
• Last Update Posted: 2011-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 128

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Amniotic fluid Lamellar Body Counting	Amniotic fluid Lamellar Body Counting	-

Primary Outcome Measures

Name	Time	Method
The statues of respiratory of neonates	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.

Trial Locations

Locations (1)

Al-zahra university hospital; 🇮🇷 Isfahan, Iran, Islamic Republic of