Skip to content

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

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01463722
Enrollment
128
Registered
2011-11-02
Start date
2010-03-31
Completion date
2011-02-28
Last updated
2011-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Retained Fetal Lung Fluid

Keywords

Respiratory distress syndrome, Lung maturity, lamellar body

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.

Interventions

OTHERAmniotic 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).

Sponsors

Isfahan University of Medical Sciences
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
The statues of respiratory of neonatesat 2 minutes after deliveryDiagnosing 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.

Countries

Iran

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026