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Trial record 16 of 287 for:    Panama

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE January 4, 2015
First Posted Date  ICMJE January 6, 2015
Last Update Posted Date January 6, 2015
Study Start Date  ICMJE May 2014
Actual Primary Completion Date November 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 4, 2015)
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).
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Amniotic Fluid Optical Density Determination as a Test for Assessment of Fetal Lung Maturity.
Official Title  ICMJE 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.
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Respiratory Distress Syndrome, Newborn
Intervention  ICMJE Procedure: Preterm fetus
A sample of amniotic fluid was taken before the birth of fetus between 26 and 36 6/7 weeks of pregnancy.
Study Arms  ICMJE 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.
Intervention: Procedure: Preterm fetus
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 4, 2015)
200
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2014
Actual Primary Completion Date November 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Panama
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02332304
Other Study ID Numbers  ICMJE MHST2014-02
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Osvaldo A. Reyes T., Saint Thomas Hospital, Panama
Study Sponsor  ICMJE Saint Thomas Hospital, Panama
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Osvaldo Reyes, MD Saint Thomas Hospital, Panama
PRS Account Saint Thomas Hospital, Panama
Verification Date January 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP