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Investigation of Foetal Auditory Abilities - Effects on Foetal Heart Rate

Not Applicable
Recruiting
Conditions
auditory perception
pregnancy
Reproductive Health and Childbirth - Normal pregnancy
Registration Number
ACTRN12624000442505
Lead Sponsor
niversity of Waikato
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
Female
Target Recruitment
101
Inclusion Criteria

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)

References
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

Exclusion Criteria

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.,
2013)

References
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

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
foetal heart rate[cardiotocography Foetal heart rate will be continuously measured during the 47-59 min long experimental session. This includes 9 min during the timbre and 6 min during the chord experiment as well as 2 min each for the two baseline periods and a 5 min break in between the experiments.]
Secondary Outcome Measures
NameTimeMethod
foetal movement[2D-ultrasound The 2D-ultrasound will be continuously used from the routine foetal check-ups at the beginning (approx. 5-10 min), during the baseline periods of both experiments (2 min each), the experiments themselves (15 min), and the break in between them (5 min). In sum, the 2D-ultrasound will be used for approximately 29-34 min in the heart rate studies.];maternal heart rate[cardiotocography Maternal heart rate will be continuously measured during the baseline periods of both heart rate experiments (2 min each), the experiments themselves (timbres: 9 min, chords: 6 min), and the break in between them (5 min). In sum, maternal heart rate will be measured for approximately 24 min.]
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