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

NCT ID: NCT02332304

Last Updated: 2015-01-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2014-12-31

Brief Summary

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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

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Conditions

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Respiratory Distress Syndrome, Newborn

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type OTHER

Preterm fetus

Intervention Type PROCEDURE

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

Interventions

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Preterm fetus

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Saint Thomas Hospital, Panama

OTHER

Sponsor Role lead

Responsible Party

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Osvaldo A. Reyes T.

Coordinator of Research

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Osvaldo Reyes, MD

Role: STUDY_DIRECTOR

Saint Thomas Hospital, Panama

Locations

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Saint Thomas Maternity Hospital

Panama City, , Panama

Site Status

Countries

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Panama

Other Identifiers

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MHST2014-02

Identifier Type: -

Identifier Source: org_study_id

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