AUditive Direct In-utero Observation (AUDIO): Prenatal Testing of Congenital Hypoacusis (AUDIO)

The objective of this randomized controlled study was to demonstrate whether fetal hearing can be assessed in utero.

Study Overview

• Status: Completed
• Conditions: Hearing Loss
• Intervention / Treatment: Behavioral: acoustic stimulation

Detailed Description

Unselected women at term of pregnancy (37-41 weeks of gestation) undergoing cardiotocography (CTG) according to routine clinical care and with a complete postnatal follow-up were consecutively recruited.

The two groups of women were selected in a random way, and it was an unblended randomization controlled trial (RCT), according to a list created by the website ww.randomization.com.

If the CTG was non-reactive for 10 minutes women who were eligible for the study were randomized into two groups.

An auditive stimulus was generated in group A. This stimulus was produced by hitting a diapason on an acoustic surface, at a distance of 2-3 cm from the mother's skin (in order to avoid mechanical vibration to reach the fetus) in the area near the fetus' head.

The same procedure was repeated three times, waiting 30 seconds between one stimulus and the following one. The total duration of stimulation was about 2 minutes. Cardiac accelerations on the CTG and fetal movements perceived by the mother were recorded in the ten minutes after the stimulus was produced.

No stimulation was produced in group B, but the CTG was prosecuted until the clinical criteria were satisfied. The total length of the CTG was variable from a minimum of 20 minutes to a maximum of one hour.

All the clinical variables were recorded in the Case Report Form (CRF) in particular the lapse of time needed for the first fetal cardiac acceleration and for the first fetal movement to occur.

A complete postnatal follow-up was obtained through the examination of medical records and parental interview.

A power analysis was carried out using Power Analysis Sample Size (PASS) software (Kaysville,UT,USA) and was conducted before the enrollment started. It was estimated that, for a survival comparison test (Log Rank), given the sample allocation ratio=1:1, 100 cases per group would be needed to validate a hazard ratio between group A and group B of 1.5 with a power of 80% and a Type I error of 5%.

• Study Type: Interventional
• Enrollment (Actual): 210
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Bologna, Italy, 40138
    • IRCCS Azienda Ospedaliero-Universitaria di Bologna

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 48 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

1. Understand the Italian language;
2. Informative consensus;
3. To be between 18 and 48 years old;
4. To be sure of their gestational age, included between 37 0/0 and 41 5/7 weeks;
5. Single fetus pregnancy in cephalic position;
6. CTG with normal frequency and variability, without cardiac acceleration for 10 minutes, and with no uterine contractions.

Excluding criteria:

1. BMI before pregnancy more than 30 kg/m2, and at the end of pregnancy more than 35 kg/m2;
2. Uterine fibromatosis;
3. Premature rupture of membranes or oligohydramnios;
4. Fetal pathology (malformation or genetic syndromes);
5. Infective illness contract in pregnancy (CMV, herpes virus, rubella, syphilis, toxoplasmosis);
6. Anomalous CTG, or with contractions
7. Gestational diabet with insulin therapy;

7) Cholestasis of pregnancy; 8) Use of corticosteroids within the last hours; 9) Use of prostaglandins for cervical ripening, within the last hours.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: acoustic stimulation; Fetuses in the group A (n=105) received an acoustic stimulation	Behavioral: acoustic stimulation; An auditive stimulus was produced by hitting a diapason on an acoustic surface, at a distance of 2-3 cm from the mother's skin (in order to avoid mechanical vibration to reach the fetus) in the area near the fetus' head. The same procedure was repeated three times, waiting 30 seconds between one stimulus and the following one. The total duration of stimulation was about 2 minutes.
NO_INTERVENTION: no acoustic stimulation; Fetuses in the group B (n=105) no intervention was performed

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
First alteration of the CTG's reactivity	lapse of time between the acoustic stimulation and the alteration of the CTG's reactivity , the units of measure is minutes	40 minutes
First perception of fetal movements by the mother	lapse of time between the acoustic stimulation and the perception of fetal movements by the mother, the units of measure is minutes	40 minutes

Collaborators and Investigators

• Sponsor: Elena Contro

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 1, 2016
• Primary Completion (ACTUAL): July 1, 2017
• Study Completion (ACTUAL): July 1, 2017

Study Registration Dates

• First Submitted: April 8, 2020
• First Submitted That Met QC Criteria: November 3, 2020
• First Posted (ACTUAL): November 9, 2020

Study Record Updates

• Last Update Posted (ACTUAL): March 18, 2021
• Last Update Submitted That Met QC Criteria: March 17, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: RCT; prenatal testing of hypoacusis
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Hearing Loss; Deafness
• Other Study ID Numbers: 104/2016/U/Sper

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No