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

NCT04622059 | Completed DMC

• 1 other identifier: 104/2016/U/Sper
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hearing Loss

Keywords

RCT; prenatal testing of hypoacusis

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

acoustic stimulation

EXPERIMENTAL

Fetuses in the group A (n=105) received an acoustic stimulation

Behavioral: acoustic stimulation

no acoustic stimulation

NO INTERVENTION

Fetuses in the group B (n=105) no intervention was performed

Interventions

acoustic stimulation BEHAVIORAL

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.

acoustic stimulation

Eligibility Criteria

• Age: 18 Years - 48 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Understand the Italian language;
• Informative consensus;
• To be between 18 and 48 years old;
• To be sure of their gestational age, included between 37 0/0 and 41 5/7 weeks;
• Single fetus pregnancy in cephalic position;
• CTG with normal frequency and variability, without cardiac acceleration for 10 minutes, and with no uterine contractions.
• Excluding criteria:
• BMI before pregnancy more than 30 kg/m2, and at the end of pregnancy more than 35 kg/m2;
• Uterine fibromatosis;
• Premature rupture of membranes or oligohydramnios;
• Fetal pathology (malformation or genetic syndromes);
• Infective illness contract in pregnancy (CMV, herpes virus, rubella, syphilis, toxoplasmosis);
• Anomalous CTG, or with contractions
• Gestational diabet with insulin therapy;
• \) Cholestasis of pregnancy; 8) Use of corticosteroids within the last hours; 9) Use of prostaglandins for cervical ripening, within the last hours.

Sponsors & Collaborators

• Elena Contro: lead

Study Sites (1)

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, 40138, Italy

Location

MeSH Terms

Conditions

Hearing Loss

Interventions

Acoustic Stimulation

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics; Sensory Art Therapies; Complementary Therapies; Physical Stimulation; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: consultant in fetal medicine

Study Record Dates

• First Submitted: April 8, 2020
• First Posted: November 9, 2020
• Study Start: September 1, 2016
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: March 18, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)