Ignite Creation Date:
2025-12-24 @ 2:52 PM
Ignite Modification Date:
2025-12-27 @ 7:40 AM
Study NCT ID:
NCT04622059
Status:
COMPLETED
Last Update Posted:
2021-03-18
First Post:
2020-04-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
AUditive Direct In-utero Observation (AUDIO): Prenatal Testing of Congenital Hypoacusis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D034381', 'term': 'Hearing Loss'}], 'ancestors': [{'id': 'D006311', 'term': 'Hearing Disorders'}, {'id': 'D004427', 'term': 'Ear Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D012678', 'term': 'Sensation Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000161', 'term': 'Acoustic Stimulation'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026421', 'term': 'Sensory Art Therapies'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D010812', 'term': 'Physical Stimulation'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 210}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2017-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-17', 'studyFirstSubmitDate': '2020-04-08', 'studyFirstSubmitQcDate': '2020-11-03', 'lastUpdatePostDateStruct': {'date': '2021-03-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "First alteration of the CTG's reactivity", 'timeFrame': '40 minutes', 'description': "lapse of time between the acoustic stimulation and the alteration of the CTG's reactivity , the units of measure is minutes"}, {'measure': 'First perception of fetal movements by the mother', 'timeFrame': '40 minutes', 'description': 'lapse of time between the acoustic stimulation and the perception of fetal movements by the mother, the units of measure is minutes'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['RCT', 'prenatal testing of hypoacusis'], 'conditions': ['Hearing Loss']}, 'descriptionModule': {'briefSummary': 'The objective of this randomized controlled study was to demonstrate whether fetal hearing can be assessed in utero.', 'detailedDescription': "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.\n\nThe 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.\n\nIf the CTG was non-reactive for 10 minutes women who were eligible for the study were randomized into two groups.\n\nAn 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.\n\nThe 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.\n\nNo 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.\n\nAll 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.\n\nA complete postnatal follow-up was obtained through the examination of medical records and parental interview.\n\nA 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%."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '48 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Understand the Italian language;\n2. Informative consensus;\n3. To be between 18 and 48 years old;\n4. To be sure of their gestational age, included between 37 0/0 and 41 5/7 weeks;\n5. Single fetus pregnancy in cephalic position;\n6. CTG with normal frequency and variability, without cardiac acceleration for 10 minutes, and with no uterine contractions.\n\nExcluding criteria:\n\n1. BMI before pregnancy more than 30 kg/m2, and at the end of pregnancy more than 35 kg/m2;\n2. Uterine fibromatosis;\n3. Premature rupture of membranes or oligohydramnios;\n4. Fetal pathology (malformation or genetic syndromes);\n5. Infective illness contract in pregnancy (CMV, herpes virus, rubella, syphilis, toxoplasmosis);\n6. Anomalous CTG, or with contractions\n7. Gestational diabet with insulin therapy;\n\n7\\) Cholestasis of pregnancy; 8) Use of corticosteroids within the last hours; 9) Use of prostaglandins for cervical ripening, within the last hours.'}, 'identificationModule': {'nctId': 'NCT04622059', 'acronym': 'AUDIO', 'briefTitle': 'AUditive Direct In-utero Observation (AUDIO): Prenatal Testing of Congenital Hypoacusis', 'organization': {'class': 'OTHER', 'fullName': 'IRCCS Azienda Ospedaliero-Universitaria di Bologna'}, 'officialTitle': 'AUditive Direct In-utero Observation (AUDIO): Prenatal Testing of Congenital Hypoacusis', 'orgStudyIdInfo': {'id': '104/2016/U/Sper'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'acoustic stimulation', 'description': 'Fetuses in the group A (n=105) received an acoustic stimulation', 'interventionNames': ['Behavioral: acoustic stimulation']}, {'type': 'NO_INTERVENTION', 'label': 'no acoustic stimulation', 'description': 'Fetuses in the group B (n=105) no intervention was performed'}], 'interventions': [{'name': 'acoustic stimulation', 'type': 'BEHAVIORAL', 'description': "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.\n\nThe 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.", 'armGroupLabels': ['acoustic stimulation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40138', 'city': 'Bologna', 'country': 'Italy', 'facility': 'IRCCS Azienda Ospedaliero-Universitaria di Bologna', 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Elena Contro', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'consultant in fetal medicine', 'investigatorFullName': 'Elena Contro', 'investigatorAffiliation': 'IRCCS Azienda Ospedaliero-Universitaria di Bologna'}}}}