Biophysical Profile in Preterm Pregnancies — BPP  

Fetal Development Clinical Trial

Official title: Pattern of Human Fetal Biophysical Profile Scoring in Relationship to Gestational Age.

Status Completed

Clinical 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. This test will be performed within the expected time of the routine ultrasound exam.

Clinical Trial Description

1. PURPOSE: To determine whether human fetal biophysical profile (BPP) scoring varies according to gestational age in preterm pregnancies.

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 ;

Related Conditions & MeSH terms

• Fetal Development

• NCT number: NCT02561364
• Study type: Observational [Patient Registry]
• Source: University of Tennessee
• Status: Completed
• Start date: October 2015
• Completion date: March 2017