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

Respiratory Distress Syndrome, Newborn Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02332304
• Other study ID #: MHST2014-02
• Status: Completed
• Phase: Phase 3
• First received: January 4, 2015
• Last updated: January 4, 2015
• Start date: May 2014
• Est. completion date: December 2014

Study information

• Verified date: January 2015
• Source: Saint Thomas Hospital, Panama
• Contact: n/a
• Is FDA regulated: No
• Health authority: Panama: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: December 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Hyaline Membrane Disease
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn

Intervention

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

Locations

Country	Name	City	State
Panama	Saint Thomas Maternity Hospital	Panama

Sponsors (1)

Lead Sponsor	Collaborator
Saint Thomas Hospital, Panama

Country where clinical trial is conducted

Panama, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	1 month	No