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Completed

NCT Number: NCT02332304

Amniotic Fluid Optical Density Determination as a Test for Assessment of Fetal Lung Maturity.

To determine the relationship between the result of amniotic fluid optical density between 26 and 36 6/7 weeks of pregnancy and the risk of developing neonatal respiratory distress syndrome.

Completed

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Key information

Conditions

Respiratory Distress Syndrome, Newborn Congenital, Hereditary, and Neonatal Diseases and Abnormalities Infant, Newborn, Diseases Infant, Premature, Diseases Lung Diseases Respiration Disorders Respiratory Distress Syndrome Respiratory Tract Diseases

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Saint Thomas Maternity Hospital

Panama City, Panama

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Pregnancy between 26 and 36 6/7 weeks.

Exclusion criteria

  • Problems in the handling of the amniotic fluid sample that prevented the calculation of the optical density.

Treatment and study plan

Preterm fetus

Procedure

A sample of amniotic fluid was taken before the birth of fetus between 26 and 36 6/7 weeks of pregnancy.

Primary outcomes

  1. Respiratory Distress Syndrome, Newborn

    Time frame: 1 month

    Diagnosis of Respiratory Distress Syndrome in the neonatal period. The diagnosis was made by the neonatologist in charge (using clinical and radiological parameters).

Sponsors and collaborators

Lead sponsor

Saint Thomas Hospital, Panama

Other

Registry information

Official study title

Amniotic Fluid Optical Density Determination Between 28 and 36 6/7 Weeks of Pregnancy and Its Relationship With the Diagnosis of Neonatal Respiratory Distress Syndrome.

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Jan 6, 2015
Registry last updated
Jan 6, 2015

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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