Comparison of a new novel fetal heart rate monitoring device to standard cardiotocography in detecting fetal heart rate during intrapartum period.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 260
- 试验地点
- 1
- 主要终点
- 1. Agreement between the two devices in detecting Fetal heart rate.
研究概览
简要总结
Fetal heart rate ( FHR ) monitoring is the key parameter of intrapartum fetal monitoring and indicator of fetal hypoxia. Current non invasive FHR device technologies have challenges like - high cost of machines, requirement of dedicated space and well trained person to interpret resultant waveform and readings.
This novel FHR monitoring device designed by Indian Institute of Technology Madras, extracts FHR from mother’s abdomen using photoplethysmography (PPG) method. It uses infrared technology to detect FHR, has simple robust design, is completely non invasive, safe for both mother and fetus and suitable for long term monitoring. It is easily portable, low cost, consumes less power, easy to use, requires less training or skill to operate and generates alarm if any abnormality in FHR.
The availability of such novel FHR monitoring devices at peripheral facilities would help in identifying at risk fetuses for timely referral and action and also to reduce stillbirths and birth asphyxia.
To compare FHR detection by novel FHR monitoring device with FHR information obtained from conventional cardiotocography.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Female
入选标准
- •Women with singleton pregnancy.
- •Gestation more than or equal to 32 weeks.
- •Admission in labour ward with labour pains.
排除标准
- •Presence of antenatally detected major fetal anomaly.
- •Intrauterine death.
结局指标
主要结局
1. Agreement between the two devices in detecting Fetal heart rate.
时间窗: Measurement of fetal heart rate for continuous 6 minutes during first and / or second stage of labour only once at enrollment.
2. Correlation coefficient between the two devices in detecting Fetal heart rate.
时间窗: Measurement of fetal heart rate for continuous 6 minutes during first and / or second stage of labour only once at enrollment.
次要结局
- Decision taken regarding delivery of fetus(Measurement of fetal heart rate continuously for 6 minutes during first/ second stage of labour during delivery once at the time of enrollment.)
- Detection of abnormal fetal heart rate/ Fetal distress(Fetal heart rate will be continuously measured for 6 minutes during first/ second stage of labour during delivery once.)
- Number of device adjustments required(During continuos measurement of fetal heart rate for 6 minutes during first/ second stage of labour.)
- Patient/ provider device satisfaction(During continuous measurement of fetal heart rate for 6 minutes during first/ second stage of labour once.)
- 5. APGAR at 1 and 5 minutes(6. Degree of resuscitation required)
研究者
Rahul Bhakat
Madras Medical College