Pattern of Human Fetal Biophysical Profile Scoring in Relationship to Gestational Age.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Fetal or neonatal survival measured as live birth or fetal demise
研究概览
简要总结
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.
详细描述
- PURPOSE: To determine whether human fetal biophysical profile (BPP) scoring varies according to gestational age in preterm pregnancies.
- 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.
- 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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •lethal fatal anomalies
- •those not providing informed consent
结局指标
主要结局
Fetal or neonatal survival measured as live birth or fetal demise
时间窗: 20 weeks 0 days up to 36 weeks and 6 days
will be monitored and recorded on all participants
次要结局
- gestational age at delivery as measured by ultrasound calculations(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 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)
- 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)
- spontaneous or indicated preterm delivery documented as occurring or necessary for related health issue(20 weeks 0 days up to 36 weeks and 6 days)
- 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)].(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)
- Number of neonates born with morbid conditions: respiratory, gastrointestinal, neurologic, metabolic; documented as present.(20 weeks 0 days up to 36 weeks and 6 days)