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Trial record 16 of 277 for:    Panama

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
Sponsor:
Information provided by (Responsible Party):
Osvaldo A. Reyes T., Saint Thomas Hospital, Panama

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Respiratory Distress Syndrome, Newborn Procedure: Preterm fetus Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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


Arm Intervention/treatment
Preterm fetus
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.




Primary Outcome Measures :
  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).



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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


Locations
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Panama
Saint Thomas Maternity Hospital
Panama, Panama
Sponsors and Collaborators
Saint Thomas Hospital, Panama
Investigators
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Study Director: Osvaldo Reyes, MD Saint Thomas Hospital, Panama

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Responsible Party: Osvaldo A. Reyes T., Coordinator of Research, Saint Thomas Hospital, Panama
ClinicalTrials.gov Identifier: NCT02332304     History of Changes
Other Study ID Numbers: MHST2014-02
First Posted: January 6, 2015    Key Record Dates
Last Update Posted: January 6, 2015
Last Verified: January 2015

Keywords provided by Osvaldo A. Reyes T., Saint Thomas Hospital, Panama:
Respiratory Distress Syndrome, Newborn

Additional relevant MeSH terms:
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Syndrome
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Hyaline Membrane Disease
Disease
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases