AUditive Direct in Utero Observation (AUDIO): A Randomized Controlled Trial for a Prenatal Demonstration of Fetal Hearing
Abstract
:1. Introduction
1.1. Background
1.2. Aims and Objectives
2. Methods
2.1. Study Design
2.2. Patient Involvement
- Italian language comprehension;
- Age between 18 and 48 years old;
- Gestational age between 37 and 41 weeks;
- Single fetus in cephalic position.
- BMI superior to 30 kg/m2 before pregnancy and superior to 35 kg/m2 at the end of pregnancy;
- Uterine fibromatosis;
- Premature rupture of membranes or oligohydramnios;
- Fetal anomalies or genetic syndromes;
- Maternal infections in pregnancy (CMV, herpes virus, rubella, syphilis, toxoplasmosis);
- Pathologic CTG or uterine contractions;
- Gestational diabetes with insulin therapy;
- Cholestasis of pregnancy;
- Use of corticosteroids within the last hours;
- Use of prostaglandins for cervical ripening, within the last hours.
2.3. Intervention
2.4. Sample Size
2.5. Statistical Methods
2.6. Ethical Approval
3. Results
4. Discussion
4.1. Principal Findings
4.2. Clinical Implication
4.3. Research Implications
4.4. Strengths and Limitations
5. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Conflicts of Interest
References
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Variable | Group B (n = 105) | Group A (n = 105) | p-Value |
---|---|---|---|
Maternal age | 33.5 (5.55) | 33.6 (5.89) | 0.942 |
Gestational age at enrollment | 39 (1.15) | 39 (1.35) | 0.411 |
% Nulliparae | 62.86 | 64.76 | 1.00 |
BMI pre | 21.83 (3.39) | 21.79 (3.09) | 0.810 |
BMI post | 21.83 (3.39) | 26.09 (4.05) | 0.725 |
Neonatal weight (grs.) | 3321 (461) | 3408 (447) | 0.167 |
% of male fetuses | 51.43 | 46.67 | 0.484 |
pH | 7.29 (0.09) | 7.25 (0.10) | 0.238 |
Base excess (BE) | −5.10 (2.25) | −4.89 (3.48) | 0.792 |
% of vaginal delivery | 61.90 | 63.80 | 0.764 |
Variable | Group B (105) | Group A(105) | p-Value |
---|---|---|---|
Acceleration intervals (min.) | 21.9 (6.94) | 14.8 (5.01) | <0.001 |
Number of accelerations | 6.40 (3.57) | 7.42 (4.60) | 0.090 |
Intervals between fetal movements (min.) | 23.28 (7.61) | 17.77 (7.62) | <0.001 |
Number of movements | 4.17 (3.22) | 5.58 (6.22) | 0.082 |
Variable | Hazard Rate * | 95% CI | p-Value | p-Value ** | |
---|---|---|---|---|---|
Acceleration intervals (min) | 2.81 | 2.10 | 3.76 | <0.001 | 0.001 |
Numbers of accelerations | 1.75 | 1.33 | 2.30 | <0.001 | 0.001 |
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Larcher, L.; Farina, A.; Morano, D.; Rimondi, N.; Leccese, V.; Contro, E. AUditive Direct in Utero Observation (AUDIO): A Randomized Controlled Trial for a Prenatal Demonstration of Fetal Hearing. Diagnostics 2021, 11, 2026. https://doi.org/10.3390/diagnostics11112026
Larcher L, Farina A, Morano D, Rimondi N, Leccese V, Contro E. AUditive Direct in Utero Observation (AUDIO): A Randomized Controlled Trial for a Prenatal Demonstration of Fetal Hearing. Diagnostics. 2021; 11(11):2026. https://doi.org/10.3390/diagnostics11112026
Chicago/Turabian StyleLarcher, Laura, Antonio Farina, Danila Morano, Nadia Rimondi, Vincenza Leccese, and Elena Contro. 2021. "AUditive Direct in Utero Observation (AUDIO): A Randomized Controlled Trial for a Prenatal Demonstration of Fetal Hearing" Diagnostics 11, no. 11: 2026. https://doi.org/10.3390/diagnostics11112026
APA StyleLarcher, L., Farina, A., Morano, D., Rimondi, N., Leccese, V., & Contro, E. (2021). AUditive Direct in Utero Observation (AUDIO): A Randomized Controlled Trial for a Prenatal Demonstration of Fetal Hearing. Diagnostics, 11(11), 2026. https://doi.org/10.3390/diagnostics11112026