A device to monitor the babys heart rate and contractions of the uterus during labour
- Conditions
- Health Condition 1: O76- Abnormality in fetal heart rate and rhythm complicating labor and deliveryHealth Condition 2: O998- Other specified diseases and conditions complicating pregnancy, childbirth and the puerperium
- Registration Number
- CTRI/2019/10/021622
- Lead Sponsor
- Janitri Innovations Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
1. Pregnant woman > 18 years of age
2. Gestational age between 37+0Â to 40+6 weeks
3. Cephalic presentation in labour
4. Both low and high risk pregnancies
5. Ability to understand study information and willing to provide written informed consent
1. Multiple pregnancy
2. Congenital anomalies of the foetus
3. Patient admitted with false labour pain
4. Patient undergoing elective caesarean sections
5. Any other condition of the mother or foetus where in, the investigator feels the participant is not eligible for the study.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method sensitivity and specificity of Keyar device with standard cardiotocogram to detect foetal distress during active labourTimepoint: 6 months
- Secondary Outcome Measures
Name Time Method To compare FHR, beat to beat variability measured using Keyar device with standard cardiotocogramTimepoint: 6 months