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

Saint Thomas Hospital (HST)

Status and phase: Completed; Phase 3

Conditions: Respiratory Distress Syndrome, Newborn

Treatments: Procedure: Preterm fetus

Study type: Interventional

Funder types: Other

Identifiers

NCT02332304

MHST2014-02

Details and patient eligibility

About

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.

Enrollment: 200 patients

Sex: Female

Volunteers: No 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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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200 participants in 1 patient group

Preterm fetus

Other group

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.

Treatment:

Procedure: Preterm fetus