Biophysical Profile in Preterm Pregnancies
BPP
Pattern of Human Fetal Biophysical Profile Scoring in Relationship to Gestational Age.
1 other identifier
observational
100
1 country
2
Brief 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. This test will be performed within the expected time of the routine ultrasound exam.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Oct 2015
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 24, 2015
CompletedFirst Posted
Study publicly available on registry
September 28, 2015
CompletedStudy Start
First participant enrolled
October 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2017
CompletedMay 12, 2021
October 1, 2016
1.2 years
September 24, 2015
May 8, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Fetal or neonatal survival measured as live birth or fetal demise
will be monitored and recorded on all participants
20 weeks 0 days up to 36 weeks and 6 days
Secondary Outcomes (8)
gestational age at delivery as measured by ultrasound calculations
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
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
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.
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.
20 weeks 0 days up to 36 weeks and 6 days
- +3 more secondary outcomes
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- lethal fatal anomalies
- those not providing informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Regional One Health Ob-Gyn Clinic
Memphis, Tennessee, 38103, United States
Regional One Health Center for High Risk Pregnancies
Memphis, Tennessee, 38120, United States
Related Publications (9)
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.
BACKGROUNDAmerican 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.
PMID: 20966730BACKGROUNDMacones 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.
PMID: 18757666BACKGROUNDDruzin 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.
BACKGROUNDDruzin 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.
PMID: 3901768RESULTGagnon 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.
PMID: 3631176RESULTNatale 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.
PMID: 6702921RESULTSorokin 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.
PMID: 7081342RESULTBaskett 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.
PMID: 3341411RESULT
Study Officials
- PRINCIPAL INVESTIGATOR
Luis M. Gomez, M.D.
Assistant Professor
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Target Duration
- 4 Weeks
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 24, 2015
First Posted
September 28, 2015
Study Start
October 1, 2015
Primary Completion
December 1, 2016
Study Completion
March 1, 2017
Last Updated
May 12, 2021
Record last verified: 2016-10