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临床试验/NCT02453230
NCT02453230已完成不适用

The Effect of Light on the Fetal Biophysical Profile

University of Nebraska2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2015年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
200
试验地点
2
主要终点
Amount of time needed to complete the biophysical profile

研究概览

简要总结

Since the 1960's, perinatal mortality in the United States has been declining at a steady rate. This decline has thought to be the result of improved surveillance of normal and abnormal fetal behavior and using that information to determine those babies at risk for stillbirth.

There are many tools available for surveillance. One of these tools, the bio-physical profile (BPP), incorporates a non-stress test (NST) with ultrasound assessment of fetal behavior . This test has been used for about the last 30 years with good safety and efficacy. The ultrasound evaluation includes monitoring fetal breathing, fetal gross and fine movement and amniotic fluid evaluation. NST and BPP have been found to have similar ability to predict fetal well-being, with similar safety and ease of performance. Several studies have observed the effect of sound as well as light on the NST and have found that it can shorten testing time without altering its ability to be interpreted properly or affecting fetal safety. However, similar studies have not been done with the BPP. Light stimulation has been proven to be safe for both the mother and the fetus with no harm having been demonstrated when used with NST.

详细描述

Since the 1960's, perinatal mortality in the United States has been declining at a steady rate. This decline has thought to be the result of improved surveillance of normal and abnormal fetal behavior and using that information to determine those babies at risk for stillbirth.

There are many tools available for surveillance. One of these tools, the bio-physical profile (BPP), incorporates a non-stress test (NST) with ultrasound assessment of fetal behavior . This test has been used for about the last 30 years with good safety and efficacy. The ultrasound evaluation includes monitoring fetal breathing, fetal gross and fine movement and amniotic fluid evaluation. NST and BPP have been found to have similar ability to predict fetal well-being, with similar safety and ease of performance. Several studies have observed the effect of sound as well as light on the NST and have found that it can shorten testing time without altering its ability to be interpreted properly or affecting fetal safety. However, similar studies have not been done with the BPP. Light stimulation has been proven to be safe for both the mother and the fetus with no harm having been demonstrated when used with NST.

Since the 1960's, perinatal mortality in the United States has been declining at a steady rate. This decline has thought to be the result of improved surveillance as well as neonatal and infant care. However, there is still a large percentage of mortality that is related to antenatal fetal and maternal complications. There has been much research in this area, to help predict which fetuses are more likely to have a poor outcome, and may benefit from intervention, such as early delivery. Several tests have been developed to help monitor fetal behavior and differentiate between fetal well-being and identify those at risk for adverse outcomes. Some of these tests include the contraction-stress test (CST) and the bio-physical profile (BPP), which incorporates the NST with ultrasound assessment of fetal behavior. These tests accurately reflect the acid-base status of the fetus as well as the level of fetal oxygenation.

The biophysical profile was originally developed as a method of assessing fetal health and help determine whether or not a complication of pregnancy was severe enough to warrant delivery. The time length needed to complete a biophysical profile is variable. The test is considered completed if the fetus meets all criteria. The test consists of four ultrasound components, and electronic fetal monitoring component: fetal heart rate reactivity by non-stress test, fetal breathing movements, fetal gross body movements, fetal tone/posture and amniotic fluid evaluation.

These components are scored as a "2" for present and "0" if not present. This makes for a maximum score of 10. Scores of 8 or greater are generally considered reassuring. A score of 6 is considered equivocal and requires further evaluation and follow-up. A score of 4 is concerning and delivery plan should be initiated soon. A score of 2 or 0 should means the fetus should be delivered immediately.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
14 Years 至 60 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • Mothers age 14-60 years old with singleton pregnancies at 20 0/7th weeks to 42 6/7th weeks gestational age
  • Biophysical testing has been ordered for any indication other than higher order multiple gestations.

排除标准

  • Patient declines to participate.
  • Multiple gestations (twins or more)

结局指标

主要结局

Amount of time needed to complete the biophysical profile

时间窗: Patients to be followed from initiation of biophysical profiles until delivery an expected average of 8 weeks)

Measure if ambient room light stimulation changes the amount of time required to perform the fetal biophysical profile

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Heather Said

D.O.

University of Nebraska

研究点 (2)

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