Back to resultsAmniotic Fluid Optical Density Determination as a Test for Assessment of Fetal Lung Maturity.
Primary Purpose
Respiratory Distress Syndrome, Newborn
Status
Completed
Phase
Phase 3
Locations
Panama
Study Type
Interventional
Intervention
Preterm fetus
Sponsored by
About this trial
This is an interventional diagnostic trial for Respiratory Distress Syndrome, Newborn focused on measuring Respiratory Distress Syndrome, Newborn
Eligibility 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.
Sites / Locations
- Saint Thomas Maternity Hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Preterm fetus
Arm Description
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.
Outcomes
Primary Outcome Measures
Respiratory Distress Syndrome, Newborn
Diagnosis of Respiratory Distress Syndrome in the neonatal period. The diagnosis was made by the neonatologist in charge (using clinical and radiological parameters).
Secondary Outcome Measures
Full Information
NCT ID
NCT02332304
First Posted
January 4, 2015
Last Updated
January 4, 2015
Sponsor
Saint Thomas Hospital, Panama
1. Study Identification
Unique Protocol Identification Number
NCT02332304
Brief Title
Amniotic Fluid Optical Density Determination as a Test for Assessment of Fetal Lung Maturity.
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 Type
Interventional
2. Study Status
Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
May 2014 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Saint Thomas Hospital, Panama
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Distress Syndrome, Newborn
Keywords
Respiratory Distress Syndrome, Newborn
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Preterm fetus
Arm Type
Other
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Preterm fetus
Intervention Description
A sample of amniotic fluid was taken before the birth of fetus between 26 and 36 6/7 weeks of pregnancy.
Primary Outcome Measure Information:
Title
Respiratory Distress Syndrome, Newborn
Description
Diagnosis of Respiratory Distress Syndrome in the neonatal period. The diagnosis was made by the neonatologist in charge (using clinical and radiological parameters).
Time Frame
1 month
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Osvaldo Reyes, MD
Organizational Affiliation
Saint Thomas Hospital, Panama
Official's Role
Study Director
Facility Information:
Facility Name
Saint Thomas Maternity Hospital
City
Panama
Country
Panama
12. IPD Sharing Statement
Learn more about this trial
Amniotic Fluid Optical Density Determination as a Test for Assessment of Fetal Lung Maturity.
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