Amniotic Fluid Optical Density Determination as a Test for Assessment of Fetal Lung Maturity.
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|ClinicalTrials.gov Identifier: NCT02332304|
Recruitment Status : Completed
First Posted : January 6, 2015
Last Update Posted : January 6, 2015
|Condition or disease||Intervention/treatment||Phase|
|Respiratory Distress Syndrome, Newborn||Procedure: Preterm fetus||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||200 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official 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.|
|Study Start Date :||May 2014|
|Actual Primary Completion Date :||November 2014|
|Actual Study Completion Date :||December 2014|
Patients with pregnancies between 26 and 36 6/7 weeks of pregnancy. Before the birth, a sample of amniotic fluid was taken and analyzed using optical density at 650nm. A value above 0.15 was considered an indication of fetal lung maturity.
Procedure: Preterm fetus
A sample of amniotic fluid was taken before the birth of fetus between 26 and 36 6/7 weeks of pregnancy.
- 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02332304
|Saint Thomas Maternity Hospital|
|Study Director:||Osvaldo Reyes, MD||Saint Thomas Hospital, Panama|