MedDataX Logo

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

NCT ID: NCT01463722

Last Updated: 2011-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

128 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2011-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to determine the accuracy of Amniotic fluid Lamellar Body Counting for Evaluating of Fetal Lung Maturity.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Retained Fetal Lung Fluid

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Amniotic fluid Lamellar Body Counting

Group Type OTHER

Amniotic fluid Lamellar Body Counting

Intervention Type 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).

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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).

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Isfahan University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Hamidreza Shemshaki

Research Assistant

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

farzaneh memarzadeh, MD

Role: STUDY_CHAIR

Isfahan University of Medical Sciences

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Al-zahra university hospital

Isfahan, Isfahan, Iran

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Iran

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ASD-1213-20

Identifier Type: -

Identifier Source: org_study_id