AUditive Direct In-utero Observation (AUDIO): Prenatal Testing of Congenital Hypoacusis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 210
- Locations
- 1
- Primary Endpoint
- First perception of fetal movements by the mother
Study Overview
Brief Summary
The objective of this randomized controlled study was to demonstrate whether fetal hearing can be assessed in utero.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 48 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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.
Exclusion Criteria
- Not provided
Arms & Interventions
acoustic stimulation
Fetuses in the group A (n=105) received an acoustic stimulation
Intervention: acoustic stimulation (Behavioral)
no acoustic stimulation
Fetuses in the group B (n=105) no intervention was performed
Outcomes
Primary Outcomes
First perception of fetal movements by the mother
Time Frame: 40 minutes
lapse of time between the acoustic stimulation and the perception of fetal movements by the mother, the units of measure is minutes
First alteration of the CTG's reactivity
Time Frame: 40 minutes
lapse of time between the acoustic stimulation and the alteration of the CTG's reactivity , the units of measure is minutes
Secondary Outcomes
No secondary outcomes reported
Investigators
Elena Contro
consultant in fetal medicine
IRCCS Azienda Ospedaliero-Universitaria di Bologna