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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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.
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 group | Role | What they receive |
|---|---|---|
| light on | Active comparator | BPP done with lights on Receives: Behavioral: Lights on |
| light off | No intervention | Biophysical profile examinations done with the light off |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
- First posted25 May 2015 (estimated)
- Study startJan 2015
- Primary completionFeb 2017
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- More trials run by University of NebraskaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heather Said, University of Nebraska
- Investigators
- Heather Said, MD, Principal investigator, St. Louis University
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
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Light on the Fetal Biophysical Profile
- ClinicalTrials.gov ID
- NCT02453230
- Acronym / sponsor ID
- 17227
- Conditions
- Pregnancy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Feb 2017 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 25 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| light on | Active comparator | Behavioral: Lights onBPP done with lights on |
| light off | No intervention | –Biophysical profile examinations done with the light off |
Who may qualify
- Ages
- 14 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- Patient declines to participate.
- Multiple gestations (twins or more)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lights onDetermine if ambient room light stimulation changes the amount of time required to perform the fetal biophysical profile. | Behavioural | light on |
Primary outcome
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)
Measure if ambient room light stimulation changes the amount of time required to perform the fetal biophysical profile
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heather Said, MD principal investigator
St. Louis University
1 site in 1 country: see every site and its status.
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.