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Trial record 1 of 4 for:    18757666 [PUBMED-IDS]
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Biophysical Profile in Preterm Pregnancies (BPP)

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ClinicalTrials.gov Identifier: NCT02561364
Recruitment Status : Unknown
Verified September 2015 by University of Tennessee.
Recruitment status was:  Not yet recruiting
First Posted : September 28, 2015
Last Update Posted : September 29, 2015
Sponsor:
Information provided by (Responsible Party):
University of Tennessee

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.

Condition or disease
Fetal Development

  Show Detailed Description

Study Type : Observational [Patient Registry]
Estimated Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 4 Weeks
Official Title: Pattern of Human Fetal Biophysical Profile Scoring in Relationship to Gestational Age.
Study Start Date : October 2015
Estimated Primary Completion Date : October 2016
Estimated Study Completion Date : December 2016



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. gestational age at delivery as measured by ultrasound calculations [ Time Frame: 20 weeks 0 days up to 36 weeks and 6 days ]
    will be monitored and recorded on all participants

  2. 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 ]
    will be monitored and recorded on all participants

  3. 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 ]
    will be monitored and recorded on all participants

  4. 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 ]
    will be monitored and recorded on all participants

  5. 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 ]
    will be monitored and recorded on all participants

  6. 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 ]
    will be monitored and recorded on all participants

  7. 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 ]
    will be monitored and recorded on all participants

  8. 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 ]
    will be monitored and recorded on all participants



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
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.
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • lethal fatal anomalies
  • those not providing informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02561364


Contacts
Contact: Luis M. Gomez, M.D. (901) 448-2626 lgomez2@uthsc.edu
Contact: Catherine Watson, M.D. (901) 448 4795 chaar@uthsc.edu

Locations
United States, Tennessee
Regional One Health Ob-Gyn Clinic Not yet recruiting
Memphis, Tennessee, United States, 38103
Contact: Annette B. Hickerson, R.N.    901-448-4784    abpayne@uthsc.edu   
Regional One Health Center for High Risk Pregnancies
Memphis, Tennessee, United States, 38120
Sponsors and Collaborators
University of Tennessee
Investigators
Principal Investigator: Luis M. Gomez, M.D. Assistant Professor

Publications of Results:
Other 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.
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.

Responsible Party: University of Tennessee
ClinicalTrials.gov Identifier: NCT02561364     History of Changes
Other Study ID Numbers: 15-03853-XP
First Posted: September 28, 2015    Key Record Dates
Last Update Posted: September 29, 2015
Last Verified: September 2015

Keywords provided by University of Tennessee:
Fetal Biophysical Profile