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The Effect of Light on the Fetal Biophysical Profile

NCT02453230 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2017-09-08

No results posted yet for this study

Summary

Since the 1960's, perinatal mortality in the United States has been declining at a steady rate. This decline has thought to be the result of improved surveillance of normal and abnormal fetal behavior and using that information to determine those babies at risk for stillbirth.

There are many tools available for surveillance. One of these tools, the bio-physical profile (BPP), incorporates a non-stress test (NST) with ultrasound assessment of fetal behavior . This test has been used for about the last 30 years with good safety and efficacy. The ultrasound evaluation includes monitoring fetal breathing, fetal gross and fine movement and amniotic fluid evaluation. NST and BPP have been found to have similar ability to predict fetal well-being, with similar safety and ease of performance. Several studies have observed the effect of sound as well as light on the NST and have found that it can shorten testing time without altering its ability to be interpreted properly or affecting fetal safety. However, similar studies have not been done with the BPP. Light stimulation has been proven to be safe for both the mother and the fetus with no harm having been demonstrated when used with NST.

Conditions

  • Pregnancy

Interventions

BEHAVIORAL

Lights on

Determine if ambient room light stimulation changes the amount of time required to perform the fetal biophysical profile.

Sponsors & Collaborators

  • University of Nebraska

    lead OTHER

Principal Investigators

  • Heather Said, MD · St. Louis University

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
14 Years
Max Age
60 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2017-02-28
Completion
2017-02-28

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02453230 on ClinicalTrials.gov