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

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.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02332304

Enrollment

200

Registered

2015-01-06

Start date

2014-05-31

Completion date

2014-12-31

Last updated

2015-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory Distress Syndrome, Newborn

Keywords

Respiratory Distress Syndrome, Newborn

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.

Interventions

PROCEDUREPreterm fetus

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Respiratory Distress Syndrome, Newborn	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).

Countries

Panama

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026