Investigation of Foetal Auditory Abilities - Effects on Brain Activity

Recruitment & Eligibility

Status: ot yet recruiting

Sex: Female

Target Recruitment: 131

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

Name	Time	Method
foetal brain activity[functional near-infrared spectroscopy Foetal brain activity will be continuously measured for the 67 minute experimental session, with activity measured for 13.5 min during the timbre experiment, 12 min during the chord experiment, during the baseline periods of both experiments (2 min each) and the break in between them (5 min).]

Secondary Outcome Measures

Name	Time	Method
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 (25.5 min), and the break in between them (5 min). In sum, the 2D-ultrasound will be used for approximately 39.5-44.5 min in the brain activity studies.]