AUditive Direct In-utero Observation (AUDIO): Prenatal Testing of Congenital Hypoacusis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 210
- 试验地点
- 2
- 主要终点
- First alteration of the CTG's reactivity
研究概览
简要总结
The objective of this randomized controlled study was to demonstrate whether fetal hearing can be assessed in utero.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 48 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- 未提供
结局指标
主要结局
First alteration of the CTG's reactivity
时间窗: 40 minutes
lapse of time between the acoustic stimulation and the alteration of the CTG's reactivity , the units of measure is minutes
First perception of fetal movements by the mother
时间窗: 40 minutes
lapse of time between the acoustic stimulation and the perception of fetal movements by the mother, the units of measure is minutes
次要结局
未报告次要终点
研究者
Elena Contro
consultant in fetal medicine
IRCCS Azienda Ospedaliero-Universitaria di Bologna