New Ultrasound Parameters for Predicting Birthweight
NCT02196363
Fetal Development
Manchester, United Kingdom
View Trial DetailsNCT Number: NCT02561364
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.
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Notify Me18 year–45 year
Female
Observational
Regional One Health Center for High Risk Pregnancies, Memphis, Tennessee, United States
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.
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:
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.
Primary outcome: fetal or neonatal survival
Secondary outcomes:
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 20 weeks 0 days up to 36 weeks and 6 days
will be monitored and recorded on all participants
Time frame: 20 weeks 0 days up to 36 weeks and 6 days
will be monitored and recorded on all participants
Time frame: 20 weeks 0 days up to 36 weeks and 6 days
will be monitored and recorded on all participants
Time frame: 20 weeks 0 days up to 36 weeks and 6 days
will be monitored and recorded on all participants
Time frame: 20 weeks 0 days up to 36 weeks and 6 days
will be monitored and recorded on all participants
Time frame: 20 weeks 0 days up to 36 weeks and 6 days
will be monitored and recorded on all participants
Time frame: 20 weeks 0 days up to 36 weeks and 6 days
will be monitored and recorded on all participants
Time frame: 20 weeks 0 days up to 36 weeks and 6 days
will be monitored and recorded on all participants
Time frame: 20 weeks 0 days up to 36 weeks and 6 days
will be monitored and recorded on all participants
University of Tennessee
Other
Pattern of Human Fetal Biophysical Profile Scoring in Relationship to Gestational Age.
Acronym: BPP
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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