Fetal DevelopmentBPPNCT02561364
Biophysical Profile in Preterm Pregnancies
An observational study of Fetal Development, run by University of Tennessee at 2 sites in United States.
Trial summary
The purpose of this study is to evaluate the fetal biophysical profile (BPP) scoring in pregnant women from 20 weeks-0 days' to 36 weeks-6 days' gestation. A biophysical profile (BPP) is a score that is intended to assess fetal well-being. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fetal Development
- How many people
- 100 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2015to Mar 2017
- How long will I take part?
- 4 Weeks
- Phase
- Observational
- 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 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Pregnant patients that meet the all of the inclusion criteria and do not meet the exclusion criteria, will be approached during their routine prenatal care regarding their interest in participation. Women must be between 20 weeks to 36 weeks of their pregnancy.
Who may be able to join
- pregnant women between 20 wks 0 days and 36 wks and 6 days
- singleton or multiple pregnancies
- able to provide informed consent
- age 18 to 45 years old
Who cannot join
- lethal fatal anomalies
- those not providing informed consent
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Regional One Health Ob-Gyn Clinic
Memphis, Tennessee, 38103
Regional One Health Center for High Risk Pregnancies
Memphis, Tennessee, 38120
About this study
Official title: Pattern of Human Fetal Biophysical Profile Scoring in Relationship to Gestational Age.
The purpose of this study is to evaluate the fetal biophysical profile (BPP) scoring in pregnant women from 20 weeks-0 days' to 36 weeks-6 days' gestation. A biophysical profile (BPP) is a score that is intended to assess fetal well-being. This test will be performed within the expected time of the routine ultrasound exam.
Read the detailed description
- PURPOSE: To determine whether human fetal biophysical profile (BPP) scoring varies according to gestational age in preterm pregnancies.
- RATIONALE: Fetal BPP and non-stress tests (NST) are useful tools in the assessment of fetal well-being in term fetuses. While for NST it has been established that the criteria for reassuring well-being are less strict in premature fetuses below 32 weeks' gestation, the pattern of BPP scoring according to preterm gestational age has not been fully investigated. The investigators consider that in premature fetuses, a reassuring BPP scoring does not need to be as strict as that used in term fetuses.
- STUDY/PROJECT POPULATION: The Investigators' aim to use BPP scoring during routine ultrasound visits that pregnant patients undergo as part of their prenatal care. A routine ultrasound visit is performed during 30 to 60 minutes. The use of BPP will not add additional time to that taken by the routine ultrasound visit. The investigators will use BPP scoring in women from 20 to 36 weeks' gestation who attend routine ultrasound visits at the MedPlex Outpatient Clinic - Regional One Health. The sonographers are trained in the performance of BPP. The investigators will include women with singleton and multiple pregnancies who are able to provide informed consent. The investigators will exclude women who do not consent for the study, those unable to provide informed consent, and those with lethal fetal anomalies.
- RESEARCH DESIGN Descriptive study with prospective collection of data.
- STUDY/PROJECT PROCEDURES: The study will involve the performance of a biophysical profile (BPP) scoring during routine ultrasound exams. The BPP is not intended to last more than 30 minutes. A BPP score is composed by ultrasound assessment of:
- amniotic fluid volume (normal = 2 points, low = 0 points)
- fetal movements (3 or more movements = 2 points, less movements = 0 points); we will record the total number of movements during the testing period
- fetal breathing (sustained 30 second breathing = 2 points, <30 seconds = 0 points); we will record time of sustained breathing during the testing period
- fetal tone (extension and flexion = 2 points, lack of extension/flexion = 0 points) For those patients undergoing standard of care scheduled BPP, information will be abstracted from the scheduled test. For those patients undergoing standard of care ultrasound but are not scheduled for BPP, additional BPP will be obtained within the time allotted for the already scheduled ultrasound. The investigators will correlate the BPP scoring with the non-stress test (NST) or Doppler flow reports in those fetuses already undergoing NST or Doppler studies for other obstetric indications not related to the purpose of this study.
- OUTCOME MEASURES:
Primary outcome: fetal or neonatal survival
Secondary outcomes:
- gestational age at delivery
- need for NST
- hospitalization
- need for antenatal steroids use
- fetal growth restriction
- spontaneous or indicated preterm delivery
- neonate apgars
- neonatal morbidity: respiratory, gastrointestinal, neurologic, metabolic
- Conditions
- Fetal Development
- Keywords
- Fetal Biophysical Profile
What is being measured
The primary outcome is the main question the study is designed to answer.
Fetal or neonatal survival measured as live birth or fetal demise
will be monitored and recorded on all participants
Measured: 20 weeks 0 days up to 36 weeks and 6 days
Secondary outcomes (8)
gestational age at delivery as measured by ultrasound calculations
will be monitored and recorded on all participants
Measured: 20 weeks 0 days up to 36 weeks and 6 days
need for non-stress test as necessary for related health issue, determined by the health history and measured by occurrence with supporting health documentation
will be monitored and recorded on all participants
Measured: 20 weeks 0 days up to 36 weeks and 6 days
hospitalization measured as necessary for related health issue with documentation of procedures and length of stay
will be monitored and recorded on all participants
Measured: 20 weeks 0 days up to 36 weeks and 6 days
need for antenatal steroids use as indicated for high risk of preterm delivery measured as necessary for related health issue, and utilized.
will be monitored and recorded on all participants
Measured: 20 weeks 0 days up to 36 weeks and 6 days
fetal growth restriction (FGR) measured by American College of Obstetricians and Gynecologists (ACOG): FGR: Fetus-estimated weight below 10th percentile. small for gestational age (SGA): Newborns-weight below the 10th percentile for gestational age.
will be monitored and recorded on all participants
Measured: 20 weeks 0 days up to 36 weeks and 6 days
spontaneous or indicated preterm delivery documented as occurring or necessary for related health issue
will be monitored and recorded on all participants
Measured: 20 weeks 0 days up to 36 weeks and 6 days
neonate apgar scores measured at birth: At 1 minute and 5 minutes (scoring 0, 1,or 2 in 5 physiological functions: Activity (muscle tone), Pulse (heart rate), Grimace (reflex response), Appearance (color), and Respiration (breathing)].
will be monitored and recorded on all participants
Measured: 20 weeks 0 days up to 36 weeks and 6 days
Number of neonates born with morbid conditions: respiratory, gastrointestinal, neurologic, metabolic; documented as present.
will be monitored and recorded on all participants
Measured: 20 weeks 0 days up to 36 weeks and 6 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2015 (estimated)
- Study startOct 2015
- Primary completionDec 2016
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Fetal DevelopmentStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
- Target duration
- 4 Weeks
Sponsor and investigators
- Lead sponsor
- University of Tennessee
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Luis M. Gomez, M.D., Principal investigator, Assistant Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02561364
- Sponsor's protocol ID
- 15-03853-XP
- Acronym
- BPP
- Status last verified
- Oct 2016
- First submitted
- 24 Sep 2015
- Last updated
- 12 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Harman, CR. Assessment of Fetal Health. In: Creasy RK, Resnik R, Iams JD, Lockwood CJ, Moor TM, editors. Maternal-fetal medicine: principle and practice. 6th ed. Philadelphia (PA):Saunders 2009. p. 361-95.
American College of Obstetricians and Gynecologists. Practice bulletin no. 116: Management of intrapartum fetal heart rate tracings. Obstet Gynecol. 2010 Nov;116(5):1232-40. doi: 10.1097/AOG.0b013e3182004fa9.
PubMed 20966730Macones GA, Hankins GD, Spong CY, Hauth J, Moore T. The 2008 National Institute of Child Health and Human Development workshop report on electronic fetal monitoring: update on definitions, interpretation, and research guidelines. Obstet Gynecol. 2008 Sep;112(3):661-6. doi: 10.1097/AOG.0b013e3181841395.
PubMed 18757666Druzin ML, Smith JF, Gabbe SG, Reed KL, Antepartum Fetal Evaluation. In: Gabbe SG, Niebyl JR Simpson JL, editors. Obstetrics: normal and problem pregnancies. 5th ed. Philadelphia (PA): Churchill Livingstone; 2007. p. 267-300.
Druzin ML, Fox A, Kogut E, Carlson C. The relationship of the nonstress test to gestational age. Am J Obstet Gynecol. 1985 Oct 15;153(4):386-9. doi: 10.1016/0002-9378(85)90075-4.
PubMed 3901768Gagnon R, Campbell K, Hunse C, Patrick J. Patterns of human fetal heart rate accelerations from 26 weeks to term. Am J Obstet Gynecol. 1987 Sep;157(3):743-8. doi: 10.1016/s0002-9378(87)80042-x.
PubMed 3631176Natale R, Nasello C, Turliuk R. The relationship between movements and accelerations in fetal heart rate at twenty-four to thirty-two weeks' gestation. Am J Obstet Gynecol. 1984 Mar 1;148(5):591-5. doi: 10.1016/0002-9378(84)90754-3.
PubMed 6702921Sorokin Y, Dierker LJ, Pillay SK, Zador IE, Schreiner ML, Rosen MG. The association between fetal heart rate patterns and fetal movements in pregnancies between 20 and 30 weeks' gestation. Am J Obstet Gynecol. 1982 Jun 1;143(3):243-9. doi: 10.1016/0002-9378(82)90812-2.
PubMed 7081342Baskett TF. Gestational age and fetal biophysical assessment. Am J Obstet Gynecol. 1988 Feb;158(2):332-4. doi: 10.1016/0002-9378(88)90149-4.
PubMed 3341411
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pattern of Human Fetal Biophysical Profile Scoring in Relationship to Gestational Age.
- ClinicalTrials.gov ID
- NCT02561364
- Acronym / sponsor ID
- BPP / 15-03853-XP
- Conditions
- Fetal Development
- Keywords
- Fetal Biophysical Profile
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of TennesseeUniversity, hospital or other
- Study start
- Oct 2015 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 28 Sep 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.
The purpose of this study is to evaluate the fetal biophysical profile (BPP) scoring in pregnant women from 20 weeks-0 days' to 36 weeks-6 days' gestation. A biophysical profile (BPP) is a score that is intended to assess fetal well-being. This test will be performed within the expected time of the routine ultrasound exam.
Detailed description
- PURPOSE: To determine whether human fetal biophysical profile (BPP) scoring varies according to gestational age in preterm pregnancies.
- RATIONALE: Fetal BPP and non-stress tests (NST) are useful tools in the assessment of fetal well-being in term fetuses. While for NST it has been established that the criteria for reassuring well-being are less strict in premature fetuses below 32 weeks' gestation, the pattern of BPP scoring according to preterm gestational age has not been fully investigated. The investigators consider that in premature fetuses, a reassuring BPP scoring does not need to be as strict as that used in term fetuses.
- STUDY/PROJECT POPULATION: The Investigators' aim to use BPP scoring during routine ultrasound visits that pregnant patients undergo as part of their prenatal care. A routine ultrasound visit is performed during 30 to 60 minutes. The use of BPP will not add additional time to that taken by the routine ultrasound visit. The investigators will use BPP scoring in women from 20 to 36 weeks' gestation who attend routine ultrasound visits at the MedPlex Outpatient Clinic - Regional One Health. The sonographers are trained in the performance of BPP. The investigators will include women with singleton and multiple pregnancies who are able to provide informed consent. The investigators will exclude women who do not consent for the study, those unable to provide informed consent, and those with lethal fetal anomalies.
- RESEARCH DESIGN Descriptive study with prospective collection of data.
- STUDY/PROJECT PROCEDURES: The study will involve the performance of a biophysical profile (BPP) scoring during routine ultrasound exams. The BPP is not intended to last more than 30 minutes. A BPP score is composed by ultrasound assessment of:
- amniotic fluid volume (normal = 2 points, low = 0 points)
- fetal movements (3 or more movements = 2 points, less movements = 0 points); we will record the total number of movements during the testing period
- fetal breathing (sustained 30 second breathing = 2 points, <30 seconds = 0 points); we will record time of sustained breathing during the testing period
- fetal tone (extension and flexion = 2 points, lack of extension/flexion = 0 points) For those patients undergoing standard of care scheduled BPP, information will be abstracted from the scheduled test. For those patients undergoing standard of care ultrasound but are not scheduled for BPP, additional BPP will be obtained within the time allotted for the already scheduled ultrasound. The investigators will correlate the BPP scoring with the non-stress test (NST) or Doppler flow reports in those fetuses already undergoing NST or Doppler studies for other obstetric indications not related to the purpose of this study.
- OUTCOME MEASURES:
Primary outcome: fetal or neonatal survival
Secondary outcomes:
- gestational age at delivery
- need for NST
- hospitalization
- need for antenatal steroids use
- fetal growth restriction
- spontaneous or indicated preterm delivery
- neonate apgars
- neonatal morbidity: respiratory, gastrointestinal, neurologic, metabolic
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 4 Weeks
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Pregnant patients that meet the all of the inclusion criteria and do not meet the exclusion criteria, will be approached during their routine prenatal care regarding their interest in participation. Women must be between 20 weeks to 36 weeks of their pregnancy.
Key inclusion criteria (4 listed)
- pregnant women between 20 wks 0 days and 36 wks and 6 days
- singleton or multiple pregnancies
- able to provide informed consent
- age 18 to 45 years old
Key exclusion criteria (2 listed)
- lethal fatal anomalies
- those not providing informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Fetal or neonatal survival measured as live birth or fetal demise
Time frame: 20 weeks 0 days up to 36 weeks and 6 days
will be monitored and recorded on all participants
8 secondary outcomes
gestational age at delivery as measured by ultrasound calculations
Time frame: 20 weeks 0 days up to 36 weeks and 6 days
need for non-stress test as necessary for related health issue, determined by the health history and measured by occurrence with supporting health documentation
Time frame: 20 weeks 0 days up to 36 weeks and 6 days
hospitalization measured as necessary for related health issue with documentation of procedures and length of stay
Time frame: 20 weeks 0 days up to 36 weeks and 6 days
need for antenatal steroids use as indicated for high risk of preterm delivery measured as necessary for related health issue, and utilized.
Time frame: 20 weeks 0 days up to 36 weeks and 6 days
fetal growth restriction (FGR) measured by American College of Obstetricians and Gynecologists (ACOG): FGR: Fetus-estimated weight below 10th percentile. small for gestational age (SGA): Newborns-weight below the 10th percentile for gestational age.
Time frame: 20 weeks 0 days up to 36 weeks and 6 days
spontaneous or indicated preterm delivery documented as occurring or necessary for related health issue
Time frame: 20 weeks 0 days up to 36 weeks and 6 days
neonate apgar scores measured at birth: At 1 minute and 5 minutes (scoring 0, 1,or 2 in 5 physiological functions: Activity (muscle tone), Pulse (heart rate), Grimace (reflex response), Appearance (color), and Respiration (breathing)].
Time frame: 20 weeks 0 days up to 36 weeks and 6 days
Number of neonates born with morbid conditions: respiratory, gastrointestinal, neurologic, metabolic; documented as present.
Time frame: 20 weeks 0 days up to 36 weeks and 6 days
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 12 May 2021.
- BackgroundHarman, CR. Assessment of Fetal Health. In: Creasy RK, Resnik R, Iams JD, Lockwood CJ, Moor TM, editors. Maternal-fetal medicine: principle and practice. 6th ed. Philadelphia (PA):Saunders 2009. p. 361-95.
- Background: PubMed 20966730American College of Obstetricians and Gynecologists. Practice bulletin no. 116: Management of intrapartum fetal heart rate tracings. Obstet Gynecol. 2010 Nov;116(5):1232-40. doi: 10.1097/AOG.0b013e3182004fa9.
- Background: PubMed 18757666Macones GA, Hankins GD, Spong CY, Hauth J, Moore T. The 2008 National Institute of Child Health and Human Development workshop report on electronic fetal monitoring: update on definitions, interpretation, and research guidelines. Obstet Gynecol. 2008 Sep;112(3):661-6. doi: 10.1097/AOG.0b013e3181841395.
- BackgroundDruzin ML, Smith JF, Gabbe SG, Reed KL, Antepartum Fetal Evaluation. In: Gabbe SG, Niebyl JR Simpson JL, editors. Obstetrics: normal and problem pregnancies. 5th ed. Philadelphia (PA): Churchill Livingstone; 2007. p. 267-300.
- Results publication: PubMed 3901768Druzin ML, Fox A, Kogut E, Carlson C. The relationship of the nonstress test to gestational age. Am J Obstet Gynecol. 1985 Oct 15;153(4):386-9. doi: 10.1016/0002-9378(85)90075-4.
- Results publication: PubMed 3631176Gagnon R, Campbell K, Hunse C, Patrick J. Patterns of human fetal heart rate accelerations from 26 weeks to term. Am J Obstet Gynecol. 1987 Sep;157(3):743-8. doi: 10.1016/s0002-9378(87)80042-x.
- Results publication: PubMed 6702921Natale R, Nasello C, Turliuk R. The relationship between movements and accelerations in fetal heart rate at twenty-four to thirty-two weeks' gestation. Am J Obstet Gynecol. 1984 Mar 1;148(5):591-5. doi: 10.1016/0002-9378(84)90754-3.
- Results publication: PubMed 7081342Sorokin Y, Dierker LJ, Pillay SK, Zador IE, Schreiner ML, Rosen MG. The association between fetal heart rate patterns and fetal movements in pregnancies between 20 and 30 weeks' gestation. Am J Obstet Gynecol. 1982 Jun 1;143(3):243-9. doi: 10.1016/0002-9378(82)90812-2.
- Results publication: PubMed 3341411Baskett TF. Gestational age and fetal biophysical assessment. Am J Obstet Gynecol. 1988 Feb;158(2):332-4. doi: 10.1016/0002-9378(88)90149-4.
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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.
Luis M. Gomez, M.D. principal investigator
Assistant Professor
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fetal Development, run by University of Tennessee at 2 sites 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 4 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 12 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Fetal or neonatal survival measured as live birth or fetal demise (time frame: 20 weeks 0 days up to 36 weeks and 6 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02561364, which also lists 9 linked publications.
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 12 May 2021.