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PregnancyNCT02453230

The Effect of Light on the Fetal Biophysical Profile

A study testing Lights on in people with Pregnancy, run by University of Nebraska at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 14 to 60 years, women only
Conditions the study is for
Pregnancy
What is being tested?
Lights on
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
1 siteUnited States
Study dates
Jan 2015to Feb 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 14 to 60 years
  • Women only
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • St. Mary's Health Center

    St Louis, Missouri, 63117

Other trials in United States

About this study

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.

Read the detailed description

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.

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 as well as neonatal and infant care. However, there is still a large percentage of mortality that is related to antenatal fetal and maternal complications. There has been much research in this area, to help predict which fetuses are more likely to have a poor outcome, and may benefit from intervention, such as early delivery. Several tests have been developed to help monitor fetal behavior and differentiate between fetal well-being and identify those at risk for adverse outcomes. Some of these tests include the contraction-stress test (CST) and the bio-physical profile (BPP), which incorporates the NST with ultrasound assessment of fetal behavior. These tests accurately reflect the acid-base status of the fetus as well as the level of fetal oxygenation.

The biophysical profile was originally developed as a method of assessing fetal health and help determine whether or not a complication of pregnancy was severe enough to warrant delivery. The time length needed to complete a biophysical profile is variable. The test is considered completed if the fetus meets all criteria. The test consists of four ultrasound components, and electronic fetal monitoring component: fetal heart rate reactivity by non-stress test, fetal breathing movements, fetal gross body movements, fetal tone/posture and amniotic fluid evaluation.

These components are scored as a "2" for present and "0" if not present. This makes for a maximum score of 10. Scores of 8 or greater are generally considered reassuring. A score of 6 is considered equivocal and requires further evaluation and follow-up. A score of 4 is concerning and delivery plan should be initiated soon. A score of 2 or 0 should means the fetus should be delivered immediately.

Fetal heart rate reactivity is assessed with a fetal non-stress test using a external electronic fetal monitor. The mother has an external tocodynomometer and a small doppler device placed over the area of the fetal chest placed on her abdomen. The test is considered "reactive" when there are two defined accelerations of the fetal heart rate above the baseline rate during the 20 to 30 minute testing period. The size of the acceleration required depends on the gestational age of the fetus. Testing time can be extended up to 60 minutes to obtain reactivity if the fetus happens to be in a passive sleep state during the test.

Fetal breathing movements have been seen by ultrasound beginning in the early second trimester. The consist of intermittent "practice" breathing by the fetus where the diaphragm can be seen moving similarly to adults. These movements last greater than 30 seconds but are not continuous. This is the first finding to be lost when fetal hypoxemia is present.

Body or limb movements are generally decreased in fetuses that are hypoxic. This corresponds to decreased activity level for metabolic conservation in those fetuses that are compromised. Three or more discrete movements are required for this to be considered present.

Fetal tone and posture are demonstration of active extension with rapid return to flexion of fetal limbs and brisk repositioning or trunk rotation. Opening and closing of hand or mouth, kicking, and so on. One example must be observed for this to be considered present during the exam.

Amniotic fluid evaluation is considered present when at least one pocket of fluid is seen on ultrasound measuring greater than 2 centimeters without umbilical cord present.

Response of fetuses to light stimulation has been known since 1975 when Polishuk reporting fetal movement after 26 weeks gestation in fetuses stimulated by light. In 1980, Peleg and Goldman performed amnioscopy and noted an acceleration in the fetal heart rate in 80% of patients after being exposed to the light of the amnioscope. Caridi et al. noted that fetuses stimulated with halogen light took less time to become reactive on a non-stress test than fetuses that were not stimulated. No study has noted an adverse maternal or fetal event from use of light stimulation.

Conditions
Pregnancy
Being tested
Lights on

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lights onBehavioural

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

Study groups in NCT02453230
Study groupRoleWhat they receive
light onActive comparatorBPP done with lights on
Receives: Behavioral: Lights on
light offNo interventionBiophysical profile examinations done with the light off

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 May 2015 (estimated)
  2. Study startJan 2015
  3. Primary completionFeb 2017
  4. Study completionFeb 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02453230
Sponsor's protocol ID
17227
Status last verified
Sep 2017
First submitted
16 Jan 2015
Last updated
8 Sep 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Lights on in people with Pregnancy, run by University of Nebraska at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Amount of time needed to complete the biophysical profile (time frame: Patients to be followed from initiation of biophysical profiles until delivery an expected average of 8 weeks)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2017.

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