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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT02332304
• Date of registration: 04/01/2015
• Prospective Registration: No
• Primary sponsor: Saint Thomas Hospital, Panama
• Public title: Amniotic Fluid Optical Density Determination as a Test for Assessment of Fetal Lung Maturity.
• Scientific 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.
• Date of first enrolment: May 2014
• Target sample size: 200
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT02332304
• Study type: Interventional
• Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
• Phase: Phase 3

Countries of recruitment

Panama

Contacts

• Name: Osvaldo Reyes, MD
• Affiliation: Saint Thomas Hospital, Panama

Key inclusion & exclusion 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.



Age minimum: N/A
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Respiratory Distress Syndrome, Newborn

Intervention(s)

Procedure: Preterm fetus

Primary Outcome(s)

Respiratory Distress Syndrome, Newborn [Time Frame: 1 month]

Secondary ID(s)

MHST2014-02

Source(s) of Monetary Support

Please refer to primary and secondary sponsors