The Effect of Light on the Fetal Biophysical Profile

NCT02453230 | Completed

• 1 other identifier: 17227
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Amount of time needed to complete the biophysical profile

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

  Patients to be followed from initiation of biophysical profiles until delivery an expected average of 8 weeks)

Study Arms (2)

light on

ACTIVE COMPARATOR

BPP done with lights on

Behavioral: Lights on

light off

NO INTERVENTION

Biophysical profile examinations done with the light off

Interventions

Lights on BEHAVIORAL

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

light on

Eligibility Criteria

• Age: 14 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Mothers age 14-60 years old with singleton pregnancies at 20 0/7th weeks to 42 6/7th weeks gestational age
• Biophysical testing has been ordered for any indication other than higher order multiple gestations.

You may not qualify if:

• Patient declines to participate.
• Multiple gestations (twins or more)

Sponsors & Collaborators

• University of Nebraska: lead

Study Sites (1)

St. Mary's Health Center

St Louis, Missouri, 63117, United States

Location

Study Officials

• Heather Said, MD

  St. Louis University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: D.O.

Study Record Dates

• First Submitted: January 16, 2015
• First Posted: May 25, 2015
• Study Start: January 1, 2015
• Primary Completion: February 1, 2017
• Study Completion: February 1, 2017
• Last Updated: September 8, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)