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

Status Completed

Clinical Trial Summary

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

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04622059
Study type	Interventional
Source	IRCCS Azienda Ospedaliero-Universitaria di Bologna
Contact
Status	Completed
Phase	N/A
Start date	September 2016
Completion date	July 2017

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms