Study Results
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Basic Information
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COMPLETED
100 participants
OBSERVATIONAL
2015-10-31
2017-03-31
Brief Summary
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Detailed Description
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2. 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.
3. 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.
4. RESEARCH DESIGN Descriptive study with prospective collection of data.
5. 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.
6. 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
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Study Design
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CASE_ONLY
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* singleton or multiple pregnancies
* able to provide informed consent
* age 18 to 45 years old
Exclusion Criteria
* those not providing informed consent
18 Years
45 Years
FEMALE
Yes
Sponsors
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University of Tennessee
OTHER
Responsible Party
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Principal Investigators
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Luis M. Gomez, M.D.
Role: PRINCIPAL_INVESTIGATOR
Assistant Professor
Locations
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Regional One Health Ob-Gyn Clinic
Memphis, Tennessee, United States
Regional One Health Center for High Risk Pregnancies
Memphis, Tennessee, United States
Countries
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References
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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.
Macones 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.
Druzin 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.
Gagnon 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.
Natale 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.
Sorokin 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.
Baskett 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.
Other Identifiers
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15-03853-XP
Identifier Type: -
Identifier Source: org_study_id
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