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临床试验/ACTRN12624000442505
ACTRN12624000442505招募中Unknown

Investigation of Foetal Auditory Abilities to Perceive music - Effects on Foetal Heart Rate

niversity of Waikato0 个研究点目标入组 101 人开始时间: 2024年4月10日最近更新:
适应症

试验速览

阶段
Unknown
状态
招募中
发起方
入组人数
101

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
Randomised controlled trial
主要目的
Diagnosis
盲法
Blinded (masking used)

入排标准

年龄范围
18 Years 至 42 Years(—)
性别
Female

入选标准

  • All participants will be volunteers which will be selected based on the following inclusion criteria:
  • maternal age: 18-42 years old
  • singleton pregnancy
  • gestational age is between 35 weeks + 0 days – 36 weeks +6 days
  • no pregnancy complications
  • healthy mother and healthy foetus
  • age-appropriate foetal development: abdominal circumference above the 5th
  • percentile, estimated foetal weight greater than or equal to 10th percentile, and single
  • deepest pocket greater than or equal to 2 cm (Ministry of
  • Health, 2019)
  • foetal HR is within the normal range: 120-160 bpm (Von Steinburg et al., 2013)
  • Ministry of Health. (2019, December 13). New Zealand Obstetric Ultrasound Guidelines. https://www.health.govt.nz/system/files/documents/publications/new-zealand-obstetric-ultrasound-guidelines-2019-dec19.pdf)
  • Von Steinburg, S. P., Boulesteix, A. L., Lederer, C., Grunow, S., Schiermeier, S., Hatzmann, W., Schneider, K. T., & Daumer, M. (2013). What is the normal” fetal heart rate? PeerJ, 1:e82. https://doi.org/10.7717/peerj.82

排除标准

  • Women will be excluded if they meet one or more of the following exclusion criteria:
  • multifetal pregnancy
  • gestational age is < 35 weeks or >37 weeks
  • pregnancy complications which affect foetal HR, auditory, neuronal, or general foetal
  • development
  • maternal health issues which put either the mother-to-be or the foetus at risk or which
  • affect foetal cardiac, auditory, neuronal, or its general development
  • foetal abnormalities or health issues which affect foetal HR, auditory, neuronal, or its
  • general development (e. g. Down syndrome)
  • the foetus is small for gestational age: abdominal circumference < 5th percentile,
  • estimated foetal weight < 10th percentile, and single deepest pocket < 2 cm (Ministry
  • of Health, 2019)
  • the foetal HR is not within the normal range: <120/ >160 bpm (Von Steinburg et al.,
  • Ministry of Health. (2019, December 13). New Zealand Obstetric Ultrasound Guidelines. https://www.health.govt.nz/system/files/documents/publications/new-zealand-obstetric-ultrasound-guidelines-2019-dec19.pdf)
  • Von Steinburg, S. P., Boulesteix, A. L., Lederer, C., Grunow, S., Schiermeier, S., Hatzmann, W., Schneider, K. T., & Daumer, M. (2013). What is the normal” fetal heart rate? PeerJ, 1:e82. https://doi.org/10.7717/peerj.82

研究者

发起方
niversity of Waikato

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